United States Patent Law and Practice with Special
Reference to the Pharmaceutical and Biotechnology Industries
John Richards
Ladas & Parry
26 West 61 Street
New York NY 10024
Fax + 01 212 246 8959
e-mail: nymail@ladasparry.com
1. Introduction
Attitudes to patents vary over time and with changing economic circumstances. When the Court of Appeals for the Federal Circuit was created in 1982 to have appellate jurisdiction throughout the United States over all patent matters irrespective of whether the lower decision was in respect of an ex parte matter starting in the Patent and Trademark Office, an interference proceeding being appealed from the Patent and Trademark Office, a district court decision relating to a dispute involving patent law or a decision of the International Trade Commission relating to the possible exclusion of goods produced abroad on the ground that they infringed a U.S. patent, a major change in the environment occurred. Since then, the Court of Appeals for the Federal Circuit has, with some intervention from the United States Supreme Court and Congress, rewritten large swathes of patent law and much of this rewriting has been in the field of biotechnology and pharmaceutical inventions. Nevertheless, there have been several different phases in the development of the law even since 1982. In its early years, the new court seemed to have seen one of its primary roles as reestablishing the credibility of the patent system by reversing a trend in which large numbers of the patents brought before the courts were being held to be invalid. It did this by reasserting the requirement of the patent statute that patents carry with them a presumption of validity. Since then, however, the court has taken care to ensure that the protection afforded to patentees is confined to what it believes they have really invented by focusing on the problems that arise when claims are construed too broadly or when the claims as written are broader than the invention actually made and described.
Legislative changes have also occurred over this period. The most significant affecting the biotechnology and pharmaceutical industries include:
1) providing for extension of the patent term to compensate for delays in securing marketing authority from FDA to sell new drugs for humans and to make it an act of infringement to apply to the FDA for marketing approval of a patented drug to be effective before the expiration of the patent and to remove from the definition of patent infringement acts relating to the collection of data for use in submissions to the FDA for marketing approval of a drug etc.
Paralleling these changes in the attitude of the courts and Congress there have also been changes in approach within the United States Patent and Trademark Office (U.S.P.T.O.) over the past decade, particularly in the field of inventions relating to biotechnology. In the early 1990's the U.S.P.T.O. was reluctant to accept that there was utility in almost any biotechnology application and frequently demanded clinical data to show that an invention worked. This presented enormous problems for what were then still relatively small start-up companies pursuing research in this area. They were confronted with what was effectively a Catch 22 situation. In order to obtain a patent they were required to show clinical data. Obtaining clinical data was very expensive. Investors would only provide money for generation of such data if they were sure that a patent would be granted. However the U.S.P.T.O. would not grant the patent without the data. A series of public hearings in 1994 severely criticized the U.S.P.T.O. position on this issue. This resulted in a policy change so that in assessing the utility of inventions in this field, the U.S.P.T.O. focused on whether there was a specific and credible utility disclosed in the application and the burden was placed on the examiner to provide reasons for doubting the credibility of what was asserted. The result of this change was a perception that the U.S.P.T.O was now making it too easy for applicants to secure protection, particularly for short chains of DNA or for proteins having no known physiological role since a utility for the former could be asserted as a probe and the latter for, for example as dog food. In 1999 interim rules were adopted which became final in 2001 adding a requirement that an asserted utility must not only be specific and credible but also substantial. The objective was to avoid granting patents for new pieces of DNA or protein when no significant use for them was disclosed.
We will see a number of examples of these trends in reviewing recent developments in the biotechnology and pharmaceutical areas.
The United States Patent statute provides that utility patents may be granted for the invention of "any new and useful process, machine, manufacture or composition of matter or any new useful improvement thereof". It is specifically provided that the term "invention" includes a discovery and that the term "process" means "process, art or method and includes a new use of a known process, machine, manufacture, composition of matter or material."
This broad statutory definition of subject matter has enabled the United States to take a lead in widening the scope of subject matter for which patent protection may be obtained. The Supreme Court has noted the breadth of this language in Diamond v. Chakrabarty, a case relating to bacteria that had been genetically modified to enable them to digest oil and so be of use in environmental protection against oil spills, in the following words:
In choosing such expansive terms as "manufacture" and "composition of matter" modified by the comprehensive "any", Congress plainly contemplated that the patent laws would be given wide scope.
The relevant legislative history also supports a broad construction. ... The Committee Reports accompanying the 1952 Act inform us that Congress intended statutory subject matter to "include anything under the sun that is made by man" ... This is not to suggest that Section 101 has no limits or that it embraces every discovery. The laws of nature, physical phenomena, and abstract ideas have been held not patentable. Thus a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter. Likewise, Einstein could not patent his celebrated law E = mc2; nor could Newton have patented the law of gravity. Such discoveries are `manifestations of ... nature, free to all men and reserved exclusively to none'.
Today the breadth of these words has been taken to heart by the Court of Appeals for the Federal Circuit so that the restrictions on patentability are effectively limited to abstract ideas, physical phenomena and laws of nature.
Although some nineteenth century cases confined the scope of composition of matter patents claiming new chemical compounds to such compounds when produced by a defined process, since at least 1902 it has been clear that such a claim covers the compound irrespective of its means of production. Purified natural products have been held to be patentable in cases where it was not obvious that one would have wished to purify the naturally occurring material. In recent years the focus in such cases has been much more on whether what is claimed is new (i.e. different from what existed in nature) than on whether it constituted a "composition of matter".
Unlike many other countries, therapeutic methods of treating humans are patentable in the United States, although there are now restrictions on obtaining remedies in respect of inventions that are surgical techniques. In 1996 Congress took steps to limit the rights of owners of certain types of patents relating to surgical uses of unpatented instruments. This change is discussed in Section 8.4.2 of this paper
The rationale of the Chakrabarty case that anything under the sun that is new and man made may be patentable has been extended to plant seeds and plant cell culture lines notwithstanding the fact that special protection for plants is possible by means of plant patents or under the Plant Varieties Protection Act.
In line with this rationale, the Patent Office has announced that in principle genetically modified non-human animals are patentable and has issued a patent on the so-called Harvard mouse (a mouse genetically modified so as to be susceptible to cancer and, thus, facilitate medical research in this field). The Patent Office announcement in this matter was challenged in the case of Animal Legal Defense Fund v. Quigg on the ground that the Patent Office had not complied with the necessary formal procedures for a rule making. The challenge was rejected by the Court on the ground that no new rule had been made and the announcement was merely an "interpretation" of prior court decisions.
The effect of this broad definition of patentable subject matter is that in the pharmaceutical and biotechnology fields, as long as the claimed invention is new, useful and not obvious and that the specification contains a proper written description which describes the best mode for putting the invention into practice that is known to the applicant and provides proper enablement to put the invention into practice, one can claim the following.
1) New chemical entities, including new intermediates and in appropriate cases new salts, enantiomers and polymorphs.
2) Methods of making new compounds.
3) Methods of treatment, diagnosis etc using new compounds.
4) New methods of making both old and new compounds.
5) New compositions, possibly containing known compounds but in different dosage amounts or forms.
5) New methods of treatment, diagnosis etc. using old or new compounds.
6) New methods of modulating biochemical processes which are carried out in a human, animal or plant.
7) New kits for example containing a new combination of materials or of materials and equipment used for diagnosis or treatment.
8) Newly identified DNA as long as it is claimed in a form which differs from that in which it occurs naturally (that is to say it is claimed in purified or isolated form). Newly created DNA is treated as a new chemical compound.
9) New organisms and parts of organisms such as seeds, for example those containing modified DNA.
10) New vaccines.
11) New vectors, such as plasmids, new hybridomas and new antibodies.
12) New research techniques and in some cases at least the products obtained from using these techniques.
Additionally recent case law has much expanded the types of computer related invention that can be patented. This has some significance in the biotechnology and pharmaceutical areas since it means that one can patent for example software for modeling molecular shapes such as the shape of receptor sites and predicting the type of molecule that lay bind to such receptors. It may also be possible to patent novel compounds discovered by use of such models. The Patent Office now even accepts as a potentially patentable "manufacture" a signal on a carrier wave carrying such a computer program and possibly even data carried on such a signal meets the utility requirements set out below.
It is worth noting that the Court of Appeals for the Federal Circuit, although it has been subject to criticism for doing so, applied the case law developed in dealing with chemical inventions to the new realm of biotechnology.
The utility requirement is becoming the most significant hurdle to overcome in seeking patent protection for pharmaceutical and biotechnology inventions.
35 USC 101 requires that in order to be patentable, an invention must be useful. As noted in connection with the discussion of patentable subject matter, unlike many countries, the United States has always had a broad view of what is useful and the courts have never, for example required that an invention show an advantage over the prior art or be capable of commercialization in order to be patentable.
The leading case is Brenner v Manson. which had a somewhat unusual fact pattern in that the question before the court was whether an affidavit submitted in support of an application showed that the party who filed it had in fact established a utility for the invention in question. The issue before the court related to the production of a compound that had no known utility, although utilities were known for related compounds (the compound in question was a steroid). The majority of the Supreme Court concluded that it did not matter whether an invention was for a product or a process and that in the chemical field unless a claim was for something that was shown to have a specific and substantial utility the
metes and bounds of that monopoly are not capable of precise delineation. It may engross a vast, unknown, and perhaps unknowable area. Such a patent may confer power to block off whole areas of scientific development without compensating benefit to the public. The basic quid pro quo contemplated by the Constitution and the Congress for granting a patent monopoly is the benefit derived by the public from an invention with substantial utility. Unless and until a process is refined and developed to this point- where specific benefit exists in currently available form- there is insufficient justification for permitting an applicant to engross what may prove to be a broad field.
The majority of the court concluded with the observation that
a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.
In this decision the court used two words on which little emphasis was placed for the next thirty years but as noted below have become important in the PTO's approach to biotechnology inventions namely that the utility is both substantial and specific. The next question is how specific must this utility be and what needs to be demonstrated to affirm such utility. The most common situation in which this question arises is in connection with pharmaceuticals, for example in the content of whether demonstration that a compound has an effect in a laboratory animal is sufficient to justify the patentability of that compound. Case law holds that it does at least where the animal tests show some real world utility.specific therapeutic use". In fact case law holds that for any invention a statement of utility in the specification that corresponds to the claims should be taken by the PTO as meeting the requirement of 35 USC 101 unless there is a reason for one skilled in the art to question the objective truth of the statement of utility or its scope
The position is, however, different where the claim is to a method of treating a disease. In such cases clinical data may in some cases be called for. If the examiner doubts the utility of the invention, as is commonly the situation in cases relating to treatment of difficult-to-cure conditions, one can file an affidavit or declaration proving that the invention does in fact produce the results claimed. . Patent Office standards in this area remain strict and claims for treatment of human diseases for which there is no good animal model may require the submission of clinical data. Until recently clinical data was required for almost all claims for treatment of cancer. This standard has now been lowered for some types of cancer where good animal models exist. However, as more knowledge about cancer becomes available and it becomes clear that different types of cancer respond to different treatments, the PTO has become increasingly reluctant to accept claims directed to cancer as such but has required limitation to particular types of cancer. As late as 1995, the PTO still maintained in In re Brana that a showing of efficacy against a cell line used by the National Cancer Institute was insufficient to show utility of chemicals that were stated to be useful "as antitumor substances" and that in vivo data would be needed to make this showing. The Federal Circuit disagreed stating:
The Commissioner ... confuses the requirements under the law for obtaining a patent with the requirements for obtaining government approval to market a particular drug ...
and
FDA approval ... is not a prerequisite for finding a compound useful within the meaning of the patent laws. ... Usefulness in patent law, and in particular in the context of pharmaceutical inventions, necessarily includes the expectation of further research and development. The stage at which an invention in this field becomes useful is well before it is ready to be administered to humans. Were we to require Phase II testing in order to prove utility, the associated costs would prevent many companies from obtaining patent protection on many promising new inventions ...
For other types of disease, such a treatment of Alzheimer's disease or AIDS, however, clinical data may still be called for, placing a very severe burden on the applicant.
Criticism of the PTO on the ground that the tests that it was employing for determination of utility were too tough, especially in the field of biotechnology led to a number of public hearings in 1994 following which new utility examination guidelines and accompanying legal analysis were finalized on July 14, 1995 and are applicable to all inventions. These guidelines were then criticized as being too liberal in their approach and as having swung too far in the opposite direction. They have been replaced by new guidelines that were issued in January 2001. The guidelines include specific provisions concerning inventions for biotechnology and human therapy but are stated to be of general application.
The guidelines provide that the Examiner is to review the application to determine if the applicant has asserted any specific, substantial and credible utility for the claimed invention. For example claiming a new protein as an animal food supplement or a shampoo ingredient would, according to the PTO materials meet neither the requirement of being substantial nor specific since the only properties claimed are properties common to all proteins. The requirement that the utility disclosed is "specific and substantial" is new and aimed mainly at problems that have arisen in the biotechnology industry where, for example an invention may involve a new protein whose function has not yet been determined. The PTO is trying to discourage claims that such an invention meets the utility requirements simply because it could be used, for example as land fill.
The development of the biotechnology industry has presented new problems in defining utility, especially when what is claimed is a piece of DNA. Under the guidelines, the current test being applied by the PTO is to enquire whether or not what is claimed has a specific, substantial and credible utility. This test adds the requirement of substantiality to the guidelines used previously. The reason for the change was to avoid the claims, for example to a new protein which claimed its utility as an animal feed because, although the protein had been isolated from a cell, no-one yet knew what it function was. Similar problems arise with pieces of DNA which are stated to be probes but no information is given as to what they are probes for. Products that require further research to find out what their "real world" function is will be regarded as lacking utility, an approach that seems fully consistent with Brenner v. Mason. Such an analysis is now used by the PTO not only to reject applications in which no specific, substantial and credible utility is disclosed but also to narrow claims in applications where such utility has been shown, but only for specific materials so that the claims are commensurate in scope with the utility shown. Such an approach may be used, for example, to force the applicant to replace the word "comprising" when referring to a piece of DNA by the words "consisting of".
The utility guidelines should be read in conjunction with the PTO's training materials. The Examiners are advised that if the applicant has asserted that the claimed invention is useful for any particular purpose and this assertion would be considered credible by a person of ordinary skill in the art, in view of all the evidence of record, or if the invention has a well established utility wherein a person of ordinary skill in the art would immediately appreciate why the invention is useful then a rejection based on lack of utility is not to be made. If the applicant asserts that the claimed process is useful for treating a human or animal and this utility is credible, the Examiner should not require that the applicant demonstrate that the therapeutic agent is safe or fully effective. The applicant has to provide a "reasonable correlation between the activity and the asserted use." Data from in vitro or animal testing even if not in an art recognized model is generally sufficient to support the asserted utility and the Examiner should not require the submission of clinical data.
If the applicant, however, has not asserted any specific utility for the claimed invention and the invention does not have a well-established utility, a lack of utility rejection under 35 USC 101 is to be made. A separate rejection under 35 USC 112, first paragraph, is also to be made, "on the basis that the applicant has not shown how to use the invention due to lack of disclosure of a specific utility."
In order to support the utility rejection, the Examiner must establish a prima facie showing that it is more likely than not that a person skilled in the art would not consider credible any specific utility asserted by the applicant for the claimed invention. A prima facie showing
must contain:
(i) a well reasoned statement that clearly sets forth the reasoning used in concluding that the asserted utility is not credible; (ii) support for the factual findings relied upon by the Examiner in reaching this conclusion; and (iii) support for any conclusions of the Examiner that evidence provided by the applicant to support an asserted utility would not be considered persuasive to a person of ordinary skill in the art.
The guidelines provide that the Examiner whenever possible must provide documentary evidence to support the factual basis needed to establish a prima facie showing of no utility.
Once the Examiner has made a prima facie showing, the burden shifts to the applicant to rebut the prima facie showing. This can be done, inter alia, by amending the claims, providing reasoning or arguments, or by providing evidence in the form of a declaration under 37 CFR 1.132 or printed publications.
The Examiner is then to review the original disclosure, the evidence of record and the applicant's submission and "only where the totality of the record continues to show that the asserted utility is not credible, should a rejection based on lack of utility be maintained."
The most recent problem that has arisen is in respect of research tools. As noted above, Brenner v Manson emphasized that for protection an invention had to be more than experimental. This has raised questions as to whether, for example probes consisting of short sequences of DNA, for example expression sequence tags used for identifying longer pieces of DNA such as genes are patentable. Although this issue has attracted most attention in the field of expression sequence tags (EST's - pieces of DNA that can be used to try to find new genes by hybridizing to them), it is in fact part of a broader issue as to the proper scope of research tool patents in general and whether they should be permitted to cover products obtained by their use or just the use of the research tool itself. The PTO's current approach to EST's is set out in the current training materials. Essentially these indicate that an examiner should ask the following questions when assessing issues of utility: 1) Does the claimed invention have a well established utility that is specific, substantial and credible?2) If not, has the applicant made any assertion of utility? 3) If yes, is that assertion specific? 4) If yes, does that assertion identify a substantial utility? 5) If yes, is the assertion of specific and substantial utility credible?Applying these tests to the issue of a claim for DNA fragments the training materials indicate that if the specification lacks evidence of an activity for the DNA or proteins coded therefrom and simply asserts utility as a probe to obtain a gene, the proper approach to take is to reject the claim on the ground that there is no specific or substantial utility asserted. The training materials indicate that in such a case, the use of the DNA fragment is not particular to the sequence being claimed (almost any DNA fragment can be used as a probe) and so is not specific and that in the absence of knowledge as to whether the protein that would be coded by any gene found by the probe has any substantial utility, the probe lacks substantial utility. Brenner v Manson
Other specific situations addressed in the training materials include:
4. The Description Requirements
The second major hurdle encountered in patenting many pharmaceutical and biotechnology inventions is the need to comply with the requirements of the first and second paragraphs of 35 USC 112.
The first paragraph addresses the requirements of the specification. The second that of the claims.
The requirement set out in the first paragraph of 35 USC 112 is that a patent specification contains a written description of
1) the invention;
2) the manner and process of making and using the invention "in such full, clear, concise and exact terms as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and use" the invention, and that the specification; and
3) describes the best mode "contemplated" by the inventor for carrying out the invention.
In cases where priority is claimed under 35 USC 119 from an application filed abroad, that foreign application must comply with the requirements of the first paragraph of 35 USC 112 for the priority claim to be effective.
The PTO Rules require that
(a) The specification must include a written description of the invention or discovery and of the manner and process of making and using the same, and is required to be in such full, clear, concise and exact terms as to enable any person skilled in the art or science to which the invention or discovery to which it pertains or with which it is most nearly connected, to make and use the same.
(b) The specification must set forth the precise invention for which a patent is solicited, in such manner as to distinguish it from other inventions and from what is old. It must describe completely a specific embodiment of the process, machine, manufacture, composition of matter or improvement invented and must explain the mode of operation or principle whenever applicable. The best mode contemplated by the inventor of carrying out his invention must be set forth.
The rules go on to require that where the invention relates to an improvement, the specification must "particularly point out "the parts of the invention to which the improvement relates".
4.1 Written description and enabling disclosure are separate requirements.
Case law has made it clear that the requirement for a "written description" of the invention and an "enabling disclosure" are separate requirements. For example a specification may contain sufficient information to enable a skilled chemist how to produce a particular compound because it gives detailed information as to how to produce analogous compounds but if it makes no reference to the compound in question, the "written description" requirement has not been met since there is no way of knowing whether the inventor in fact regarded the compound in question as part of his invention.
4.2 The Written Description Requirement
Claims that are broader than the supporting disclosure may be held to be invalid. Thus if the claim excludes a feature that the description indicates is essential such a claim may be invalid, particularly if the inventor admits that he only thought of omitting the feature from the claim after seeing the products of competitors.
In general problems can arise as to whether this requirement was met when the applicant amends the claims during prosecution of the application. In view of the Federal Circuit's view that the purpose of this requirement is to determine whether or not the inventor had possession of the invention at the time of filing the application, issues can arise, especially in the area of biotechnology or other areas of technology where there is a low degree of predictability, even with the original claims, notwithstanding the fact that the original claims themselves are deemed to be part of the original disclosure. In such a case, in order to comply with this requirement, it is necessary that "the disclosure of the application relied upon reasonably conveys to the artisan that the inventor had possession at [the time of filing] of the later claimed subject matter". In 1997, in University of California v. Eli Lilly and Co. the Court of Appeals for the Federal Circuit affirmed a lower court decision that a patent which included claims directed to mammalian, vertebrate and human cDNA was invalid because there was no written description of the cDNA. The Federal Circuit noted that a written description of DNA "requires a precise definition, such as by structure, formula, chemical name or physical properties". The Court stated that describing a method for preparing cDNA or describing the protein coded for by the cDNA while describing how to make and use the cDNA did not meet the written description requirement. A prior decision in Fiers v. Sugamo held that
"An adequate description of DNA requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it; what is required is a description of the DNA itself".
The moral to be drawn from these cases is that when drafting one's application one should try to ensure that basis has been provided for as many different ways of claiming the invention as possible, for example by providing bases for claiming subgeneric groupings and sub combinations of integers so that if one ever needs to fall back to claims for such limited views of the invention one can point to a specific written description of them in the original text.
4.3 PTO Guidelines and Training Materials on Written Description Requirements
Coincident with the publication of new Utility Guidelines as discussed above, the U.S. PTO also issued new Written Description Guidelines early in 2001. According to these guidelines, examiners should carry out the following steps to determine whether the written description requirement is met:
The Guidelines note that the question of adequacy of a written description most often arises where claims are amended or added during prosecution. They do, however, note that such issues may also arise in connection with claims as originally filed in certain circumstances, even though such claims in themselves should be taken as part of the description for purposes of determining whether the written description requirement has been complied with. Thus the Guidelines state
The claimed invention as a whole may not be adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional in the art or known to one of ordinary skill in the art. This problem may arise where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art-recognized correlation or relationship between the structure of the invention and its function. A lack of adequate written description also arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process.
The training materials issued by the U.S. PTO additionally point out that a claim should be rejected as lacking adequate written description if the specification makes it clear that a particular feature is essential to the invention but this is lacking from the claim. They also contain some specific examples of relevance to the biotechnology and pharmaceutical industries.
They include the following:
Objections possible under 35 USC 112 occur more commonly in the Patent Office during prosecution than in litigation relating to granted patents. The standard of disclosure required for U.S. patents is still high as compared to that in many other countries and one must always be careful to ensure that a full description of the invention is filed so that the disclosure enables one skilled in the art to put the invention into practice without undue experimentation. The fact that some experimentation is required does not condemn the specification nor does the fact that the skilled worker may have need to consult outside references to produce an operable result. The specification must be enabling as of the date of filing the application. In particular it should be noted that the description must contain sufficient information to make and use the invention, the "use" requirement being one that has in recent years caused problems in inventions relating to pharmaceuticals where one may not know, perhaps, the required dosages to be used for a drug until clinical testing has been carried out. In this context it should be noted that references to "the invention" in 35 USC 112 refer to the invention as it is claimed in each of the claims so that the specification may be enabling for some of the claims but not for others.
When considering the enablement test, the person who must be able to utilize the specification to make or use the invention is one "skilled in the art to which the invention pertains or with which it is most nearly connected" and so a reasonable degree of expertise can be assumed.. In In re Howarth the Court of Customs and Patent Appeals noted that the relevant art which it could be assumed that one skilled in the art had available in seeking to implement the teaching of the patent was not only the actual knowledge that the worker had but also what he or she would know to search out. However, unlike the position when considering the prior art that was relevant to questions of novelty and obviousness, it did not include everything that had ever been published. The court pointed out
Well known text books in English are obvious research materials. Similarly, public records concerning U. S. patents are likely to be checked and information in them is reasonably accessible in view of published abstracts and our classification system. ... We do not exclude the possibility that foreign patents and foreign language printed publications may also be relevant...
On the other hand, when no guide at all has been given, as here, an applicant must show that anyone skilled in the art would actually have possessed the requisite knowledge or would reasonably be expected to check the source which the applicant relies upon to complete his disclosure and would be able to locate the information with no more than reasonable diligence.
The applicant had omitted to describe how to produce a starting material needed to carry out the claimed invention and wished to rely on disclosures in Rhodesian, Panamanian and Luxembourg patents to show that the information on how to produce the starting material was known. The court held that these references were too obscure to be used for this purpose.
The question of what constitutes undue experimentation was considered by the Federal Circuit in In re Wands where the Court noted a prior decision of the PTO Board of Appeals which had listed factors to be considered and then applied them to the case before it. The factors to be considered were:
(1) the quantity of experimentation necessary;
(2) the amount of direction or guidance provided;
(3) the presence or absence of working examples;
(4) the nature of the invention;
(5) the state of the prior art;
(6) the relative skill of those in the art;
(7) the predictability or unpredictability of the art; and
(8) the breadth of the claims.
An example of the combination of the last two factors leading to a conclusion of non-enablement is In re Vaeck where it was held that the lack of knowledge about cyanobacteria ("a diverse and relatively poorly studied group of organisms") and claims to a chimeric gene and cyanobacteria containing it resulted in the disclosure failing to provide enablement for such claims. The disclosure did provide enablement for claims to certain specific plasmids that had been constructed containing the gene. The Court opined that
There is no reasonable correlation between the narrow disclosure in appellants' specification [of only one species of cyanobacteria in the examples and nine genera - out of 150 known genera- mentioned in the specification] and the broad scope of protection sought in the claims encompassing gene expression in any and all cyanobacteria.
A similar theme was stated in Genentech Inc v. NovoNordisk A/S:
To be enabling, the specification of the patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation.
In the chemical field, there have been cases that have held that as long as the means for carrying out the invention is fully disclosed, there is no absolute requirement to include working examples in the specification and that the absence of such examples does not ipso facto mean that the patent is invalid for failure to provide enabling disclosure or describe the best mode. It would, however, be foolhardy to make a practice of omitting examples from chemical patent specifications. In the area of genetic engineering the PTO is still reluctant to accept that anything that is not exemplified could in fact be produced without undue experimentation. Prophetic or paper examples are often included in United States patent applications to provide appropriate disclosure. This practice has been sanctioned by the courts. It should, however, be noted that if this is done the examples should not be written in the past tense so as to give the false impression that they have been carried out.
The corollary of the strict enablement requirement is that the claims of the patent may be drafted broadly to cover the invention described irrespective of whether all possible embodiments have been reduced to practice.
Exactly how much disclosure is needed to support a broad claim is a matter of fact in each case. As was noted in In re Fisher.
the scope of the claims must bear a reasonable correlation with the scope of enablement provided by the specification to persons of ordinary skill in the art. In cases involving predictable factors such as mechanical or electrical elements a single embodiment provides broad enablement in the sense that, once imagined, other embodiments may be made without difficulty and their performance characteristics predicted by resort to known scientific laws. In cases involving unpredictable factors such as most chemical reactions and physiological activity, the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved.
Subsequent cases have down-played a distinction between chemical and non-chemical inventions and emphasized that the key question is the predictability of the art in question.The fact that there was an error in one of the examples was excused in this case on the ground that the error would not have required one skilled in the art to carry out undue experimentation to realize what was wrong and put it right. However, in Genentech v. Novo Nordisk A/S the Federal Circuit held a chemical patent invalid for lack of enabling disclosure when the specification disclosed no specific starting materials or conditions to be used. The court stated
(such) failure to meet the enablement requirement... cannot be rectified by asserting that all the disclosure related to the process is within the skill of the art. It is the specification not the knowledge of one skilled in the art, that must supply the novel aspect of the invention in order to constitute adequate enablement.
National Recovery Technologies v. Magnetic Separation Systems was according to the Federal Circuit
a classic example of a claim that is broader than the enablement taught in the specification. The ideal solution to [the] problem is clear ... Claim 1 claims this ideal solution in the step of "selecting for processing those of said process signals as pass through irregularities in the bodies of said material items." However, the specification does not describe how to perform this ideal selection step.
In effect the claim defined the problem to be solved but there was no description as to how to solve it.
Similar problems may arise in cases where the invention claimed relates to a single element defined only by function.
In any case care must be taken to avoid drafting a claim that is so broad as to cover a significant number of inoperative embodiments (i.e. those lacking any utility) but it is not necessary that all of the embodiments claimed have a high degree of utility. On the other hand skillful drafting so as to confine the claims only to those embodiment that fulfil the promise of the specification may, as long as those skilled in the art can determine which is which without undue experimentation, serve to avoid some of the potential problems in this area.
It should particularly be noted that 35 USC 112 in paragraph 6 specifically provides that in claims for a combination of integers, each of the integers may be recited in the claim in "means for" or "step for" form and that use of this form is to be construed to cover not only the means described in the specification, but equivalents thereto. Where one wishes to rely on such functional language in the claims therefore it is important to describe, at least in outline as many alternatives as possible.
The requirement to describe the best mode is a separate and in addition to providing a written description and an enabling disclosure. The purpose of the provision is to prevent inventors from obtaining patents while at the same time concealing preferred embodiments of the inventions they have conceived.
If at the time of filing a patent application in the United States, or in a foreign country from which priority is claimed, the inventor knew of an embodiment for carrying out the invention that forms the subject of the claims of his patent as granted that is better than any of the embodiments described in the application the patent or at least the claims covering the embodiment in question will be invalid for failure to comply with the best mode requirement. Unlike most of patent law, however, the test here includes a subjective element. The requirement to disclose the best mode is not absolute. It is to disclose what the inventor contemplated as the best mode. Thus to succeed in challenging a patent on this ground it is necessary to show that the inventor did know of the mode in question at the time of filing the application. However, it is irrelevant whether the patent applicant was in fact the inventor of that best mode if he in fact knew of it. In Chemcast Corp. v. Arco Industries the court applied a two part test for determining whether the best mode requirement was met
The first is whether, at the time the inventor filed his patent application, he knew of a mode of practicing his claimed invention that he considered to be better than any other. This part is wholly subjective and resolves whether the inventor must disclose any facts in addition to those sufficient for enablement. If the inventor in fact contemplated such a preferred embodiment, the second part of the analysis compares what he knew with what he disclosed - is the disclosure adequate to enable one skilled in the art to practice the best mode or, in other words, has the inventor "concealed" his best mode from the "public." Adequacy of disclosure, as opposed to its necessity, is largely an objective enquiry that depends upon the scope of the claimed invention and the level of skill in the art.
Thus the first step involves a subjective test and the second step an objective one.
One potentially problematical area relating to sufficiency has been in relation to inventions relating to microorganisms in cases where the microbe being claimed or that is required to be used is not generally available to the public. Provision in the specification of full details as to how to obtain the organism in question from natural sources may suffice to meet the requirements of 35 USC 112 even without a deposit. In re Argoudelis it was held that a microorganism needed for the performance of a patented invention must be permanently available to the public once the patent had issued and that the microorganism must have been deposited in a culture collection before filing the patent application. It has, however, been held that in cases where deposit of a microorganism is necessary in order to meet the sufficiency requirement, the depository in which the deposit is made need not be independent. The court further held that in this case one could add to the specification information relating to the details of a deposit with an independent depository after filing the application. For foreign applicants, it is common to rely on the provisions of the Budapest Treaty to meet the deposit requirements. However, care should be taken in doing this.
In Ex parte Hildebrand, the Appeal Board was confronted with the question of whether a "simple" Budapest deposit complied with the requirement that in cases where an invention involves the use of a microorganism which is not generally available or which cannot be adequately described in an application, the applicant must provide an assurance that upon grant of any patent samples of a culture of that microorganism shall be freely available. The Board concluded that it did not. It reached this conclusion notwithstanding the provision in the rules attached to the Budapest Treaty that in respect of patents granted and published by any industrial property office, that office may from time to time communicate to the international depositary where the microorganism is on deposit a list of accession numbers given by that authority to deposits referred to in granted patents. The Treaty itself requires that once such notification has been given, the depositary has to release the organism to anyone who requests it. The majority of the Board concluded that this rule did not impose a positive obligation relating to granted patents on international depositaries and, thus, there was no assurance that microorganisms would be released once the U.S. patent was granted.
It, therefore, seems that it would behoove applicants who are relying on deposits of microorganisms under the Budapest Treaty to comply with U.S. enablement requirements to take some positive steps to ensure that microorganisms will be released to the general public once a patent has been issued. One way to do this might be to insert into the declaration at the time of the original deposit a statement that samples should be released to anyone who can show that the deposit number was referred to in a granted United States patent.
4.7 Sequence Listings in Biotechnology Cases
In recent years problems in identifying new materials in the field of biotechnology so compared to the prior art (particularly when the materials contain long sequences of amino acids or nucleotides) have led to additional requirements for the specification. In 1990 the Patent Office issued rules requiring that for applications filed after October 1, 1990, relating to the requirements to be applied to applications referring to amino acid or nucleotide sequences. The rules now apply to any application which contains disclosure of an unbranched sequence of four or more L-amino acids commonly found in naturally-occurring proteins and listed in WIPO Standard ST (1998), Appendix 2, Table 3 or of an unbranched sequence of ten or more nucleotides as set out in Table 1 of the same WIPO standard.:
(1) Specified symbols and format must be used in which each sequence mentioned in the description and claims is listed using symbols and format as specified in the rules, with each sequence to be given an identification number. Each time a sequence appears or is discussed in the description and claims, its identification number must be given.
(2) The sequence listings must be included in the application in a separate section starting on a new page. Such pages should contain no more than 66 lines and have no more than 72 characters per line. Additionally they should contain specified information not only about the patent application with which they are filed but also information about the organism from which the sequence comes and in some cases information about features of the sequence also.
(3) A copy of the Sequence listing section must also be submitted in computer readable form (diskette or magnetic tape), which must be readable by one of a number of computer/operating systems specified in the rules. This must be accompanied by a statement that the paper and computer copies of the sequence are the same for example "the information recorded in computer-readable form is identical to the written sequence listing".
(4) If the computer readable listing is identical with a computer readable copy submitted by the applicant in another application on file in the U.S. P.T.O., reference may be made to the other application in lieu of filing a duplicate computer readable copy in the application.
4.8 The Effect of Early Publication on Drafting U.S. Patent Applications
35 USC 154(d) provides that for a patent application which is subject to early publication, the applicant has provisional rights to obtain a reasonable royalty from any one who uses the invention as long as the invention as claimed in the early publication is "substantially identical to the invention as claimed in the published application." At least until case law clarifies what this means, in order to take advantage of this provision one should try to ensure that one has present in the application at least by the time it is published claims that have a good chance of proceeding to grant without the need for amendment. Additionally, if one is forced to amend and wishes to be able to take advantage of the reasonable royalty provision, one can republish the application after each amendment is filed so as to establish the earliest possible publication date for the revised claims and so maximize the period for which a reasonable royalty will be payable.
Whether one needs to change one's practice in the light of these changes in the law, however, probably depends upon whether there is any real risk that a potential infringer will wish to use the invention in the period between publication and grant of the patent. In most cases this is likely to depend on the capital investment and lead time required to carry out an infringement. A wise businessperson is unlikely to invest heavily in a development which he or she knows is likely to be patented within a year or two so that the investment cannot be productive after patenting has occurred. For inventions whose production or use requires little capital investment or lead time, there will be a large temptation for third parties to try to make some money between publication of the application and grant of the patent and the patent applicant should draft claims with these provisions in mind and consider republication after amendment.
The United States Constitution provides for the grant of patents to "inventors" and, unlike most countries in the world, patent applications must be filed in the name of the actual inventors of the subject matter to be protected and not in the name of their employer or other assignees. The requirement of United States law that patents are granted not to the first person to file a patent application, but (subject to certain provisos) to the first person to invent the subject matter makes the question of determining actual inventorship more important in United States patent practice than elsewhere.
The issue of inventorship is always a difficult one. However, it seems clear that merely suggesting an idea or desideratum without suggesting means to implement the idea or to achieve the desideratum is not itself an act of inventorship, at least in cases where the recipient of the idea or suggestion had to carry out substantial experimentation to achieve a practical result. Indeed, in Huck v. Textron the court stated:
The suggestion or conception of an idea or appreciation of a result to be accomplished, rather than the means of accomplishing it, particularly when the means constitute an essential part of the invention, does not constitute joint or sole inventorship. The mere fact that others made suggestions and possibly gave assistance does not necessarily make them inventors.
On the other hand, the courts have held that once conception has occurred, the inventor may make use of the services of others in perfecting his invention without losing his right to a patent and that merely taking the idea of another and devising alternative means of implementation does not rise to the level of "inventorship". A person who merely suggests something to aim at without contributing to the means needed to reach that objective will not normally be an inventor, unless perhaps the definition of the aim was in itself inventive. In the case of new chemical compounds, an idea as to the use of the compound is necessary for conception to be complete.
A useful example of how to determine inventorship is found in the AZT case, Burroughs Wellcome Co. v. Barr Laboratories Inc. In this case the facts were as follows:
1) the NIH had devised a test to test the efficacy of candidates for inhibition of HIV using live HIV and a unique line of T-cell clones.
2) Burroughs Wellcome had tested AZT in laboratory mouse screens and had found it to have an effect on retroviruses (HIV is a retrovirus) and based on this proceeded to prepare a patent application for filing in the UK covering treatment of persons infected with HIV by use of AZT.
3) Two days prior to the finalization of the draft patent application Burroughs sent a sample of AZT under a code number to the United States National Institute of Health (NIH) for testing in its more powerful test, noting the results that it had achieved itself in its mouse screens.
4) The NIH found the sample sent to be tested by Burroughs effective against HIV in its test and advised Burroughs who then filed the patent application.
In an infringement action, the defendant argued that the invention had not been made until the NIH testing was done and that the persons at the NIH who had carried out the tests were co-inventors. In their view up to that point conception of the invention was not complete. As noted by the court,
They argue that [reasonable] expectation [of success] is of paramount importance when the invention deals with uncertain or experimental disciplines, where the inventor cannot reasonably believe an idea will be operable until some result supports that conclusion. Without some experimental confirmation, they suggest, the inventor has only a hope or an expectation and has not yet conceived the invention in sufficiently definite and permanent form. But this is not the law. An inventor's belief that his invention will work or his reasons for choosing a particular approach are irrelevant to conception.
The draft patent application was found to be ample evidence that the invention had been made without the contribution of the NIH. The Court noted that conception is the touchstone of inventorship and so each inventor had to contribute to the conception of the invention and this was complete when only ordinary skill would be necessary to reduce the invention to practice without extensive research or experimentation.
Although it is not necessary for inventors physically to work together for them to be joint inventors, some form of collaboration between them is necessary. 35 USC 116 sets out certain rules on the question of joint inventorship pointing out that to be a joint inventor, each inventor may make a different type or amount of contribution, and that it is no longer necessary that each inventor made a contribution to every claim. It is, however, necessary that each inventor made a contribution to at least one claim.
The relevant provisions on both novelty and statutory bars are set out in 35 USC 102. They are more complicated than in many other countries but may be summarized in the following table:
Section What done By whom Where When
102(a) Known or used Others In U.S Before invention
Patented or published " anywhere "
102(b) Patented or published Anyone anywhere more than 1 year Public use or sale " in U.S before U.S filing
102(d) Foreign patent appl. filed+ Inventor etc outside U.S. more than 1 year before U.S filing#
102(e) U.S. patent appl. filed Others in U.S. Before invention
on which patent granted*
102(g)(1) Prior invention Others who in WTO Before invention
file in US
102(g)(2) Prior invention Others in U.S. Before invention
+Case law holds that it is not necessary for the same invention to be claimed in the foreign application in the same terms as in the United States simply that they should both be generally directed at the same invention.
# additionally the foreign patent must actually have been granted before the U.S. application is filed. Convention priority does not help in this case.
*under the 1999 amendments, U.S publications of pending applications and PCT publications of pending applications designating the United States which are published in English will also be relevant prior art under this provision.
We will not dwell in detail on these issues but a few comments may be useful on novelty issues that are unique to the United States.
Prior use of an invention is only a bar to a patent if it occurs inside the United States and this occurred either before the applicant's invention or more than one year before the applicant's date of filing its United States patent application.
There is no anticipation if a prior product merely could have been used for the claimed process or only a minor modification would be needed to bring it within the scope of the claims. On the other hand, merely discovering new properties of something that was used before or failing to appreciate the results of what one was doing does not avoid anticipation.
A difficulty arises in cases where it transpires that someone had previously done what was claimed, but had done so by accident. An example of this would be a process carried out in a particular way so that a small amount of a particular product is produced by chance rather than by design. In this situation, the case law holds that there is in general no anticipation. The doctrine is, however, strictly applied to situations where the prior use was truly fortuitous and it is always difficult to predict whether a particular situation will be regarded as accidental or whether the courts will take the view that what one now seeks to claim was inherent in the prior use.
The simple issue of secret prior use or experimental use by another rarely comes before the courts, since a situation in which these issues arise will almost always also raise the question of who first invented the subject matter in question and a decision on this point normally disposes of the case.
There is one situation in which the question of prior use is of importance in its own right. This is when the prior inventor in fact did not develop his invention. As will be discussed later, under the "prior invention" provisions of the statute the earlier inventor will prevail only if he has not abandoned his invention. No such limitation exists in respect of making a finding of anticipation based on prior use. The law is still not fully developed, but it appears that even though a "mere abandoned experiment" does not constitute anticipatory prior use, prior use can be anticipatory if it is fully developed in the United States. This is so even if no steps are taken actively to bring it to the notice of the public and even though the device is soon superseded by an improvement.
In order to be anticipatory under 35 USC 102(b), a prior use must be "public". As under 35 USC 102(a), it must also have been a use of the complete invention. It has been held that the public use requirement of 35 USC 102(b) is met if the invention is open to the public so that any member of the public can see it if he so desires. However, "the party asserting patent invalidity on the basis of [prior] public use ... must show such use by evidence that is clear and convincing." Use by one member of the public without that use informing other members of the public of the true nature of the invention has been held to be sufficient to constitute a bar under this section. In The National Research and Development Corp v. Varian Associates 30 USPQ2d 1537, the case was one where an inventor's supervisor had disclosed the invention to another in a private conversation without making it clear that the disclosure was confidential and the recipient of this information had then gone ahead to make his own equipment in accordance with the disclosure, this equipment having been made more than one year before the actual filing date of the U.S. patent application in question. This was held to be prior use. The court did, however, expressly state that this case can not be cited as a precedent. The Federal Circuit has held that "any use of [the] invention by a person other than the inventor who is under no limitation, restriction or obligation of secrecy to the inventor" is a public use. However, case law on what is meant by "public" is sometimes difficult to follow. For example permitting use by co-workers of a toy unrelated to the employer's business has been held by the Federal Circuit not to be a public use, whereas disclosure to a party of one's friends was held by the same court to be a public use. The court based its differing conclusions on the different degrees of "control" that the inventor exercised over the use by others in the two cases.
Furthermore, any commercial use of a process by the patentee or patent applicant within the United States more than one year prior to the date of filing a patent application is deemed to be a public use. However, secret commercial use by a third party who developed the invention independently may not act as a bar to the grant of a patent.Colgate-Palmolive-Peet 77 USPQ 138 (3d Cir 1948). It may, however, be difficult to persuade a court that a commercial use was not public unless positive steps to maintain secrecy were adopted even if the process in question is carried out entirely within a third party's plant. There is a policy reason why the courts have come to different conclusions as to why commercial secret use (for example where the invention relates to the process for manufacture of a product and the nature of the invention cannot be determined from the product as sold) is a bar if done by the inventor but not if done by a third party. The policy view taken by the courts has been that the purpose of the patent system is to encourage early filing of patent applications. To allow an inventor to use his or her invention commercially and only file a patent application when a competitor comes on to the market would have the effect of extending the effective term of the patent since in addition to the statutory term, the patentee would also benefit form his or her pre-patent filing commercialization. No such factors arise in respect of commercial use by a third party. Of course, if the products of the commercialization reveal the nature of the invention other grounds for denying patentability come into play.
In cases where the prior use was of an essentially experimental nature it has been held that experimental use does not fall within the definition of public use. The fact that a use was experimental may excuse an act that would otherwise constitute a prior use, for example giving a sample to a member of the public without any express imposition of confidence, at least in cases where it was necessary to carry out experimentation in a way that involved members of the public. Similarly, there was no bar when a patented outdoor lighting system had been used in a public rest area on a highway in a case where public testing was needed to determine the durability of the system in real life conditions and the patentee had done nothing to lead the public to believe the invention was being put into the public domain. On the other hand, to succeed with a claim that a use was experimental probably requires that he who claims to be the experimenter retains some degree of control over the "experimentation" and keeps some records as to what develops.
The purpose of the "experimental use exception" is to give the inventor the opportunity to reduce the invention to practice so that once this has occurred, subsequent uses no longer qualify for the exception. This fact severely limits the possibility of claiming that a prior use was experimental in connection with design patents since a design is reduced to practice as soon as an embodiment is constructed. However, if the experimentation was confined to functional aspects of the device then an exception may still exist.
Since public prior use may be difficult to prove, the courts have held that "corroboration is required of any witness whose testimony alone is asserted to invalidate a patent regardless of his or her level of interest."
This is a bar only under 102(b) and so applies only if the product to which the invention relates was on sale in the United States more than one year before the United states filing date.
It is important to note that for this bar to come into play, it is not necessary that there has been an actual sale of something falling within the claims, merely that something of this type was "on sale", that is to say offered for sale. Two key elements must be considered when analyzing any situation as to the applicability of this provision. Firstly one must consider the nature of the transaction which occurred before the relevant date and secondly one must consider what it was that constituted the subject matter of the transaction.
In applying this ground of invalidity, the courts for many years tended to look to the totality of the circumstances, which led to some inconsistencies, for example when sales discussions took place about articles whose development was not yet complete when the "sales" transaction took place. Following a 1998 decision of the Supreme Court in Pfaff v. Wells Electronics which rejected the totality of the circumstances approach the law is now considerably clearer. The Supreme Court held that for the on-sale bar to apply two conditions had to be satisfied at least one year before the filing date of the patent application.
First the product must be the subject of a commercial offer for sale. ...
Second the invention must be ready for patenting. That condition may be satisfied in at least two ways: by proof of reduction to practice before the critical date; or by proof that prior to the critical date the inventor had prepared drawings or other descriptions of the invention that were sufficiently specific to enable a person skilled in the art to practice the invention.
The purposes of the "on sale" bar to patentability were reviewed in the Court of Appeals for the Federal Circuit in 1985. The court noted four policies that had to be considered:
(1) discouraging the removal of inventions from the public domain by granting a patent to the inventor after the public had come to believe the invention was freely available as a result of the sale of products embodying it,
(2) favoring wide spread disclosure of inventions,
(3) giving the inventor a reasonable amount of time after sales started to decide whether the invention was worth patenting, and
(4) preventing the inventor from unduly extending the period of his monopoly by delaying the filing of a patent application until he feared that he might start to experience competition.
The Federal Circuit has held that in order to succeed with a challenge to the validity of a claim under the on sale bar, the challenger must
demonstrate by clear and convincing evidence that there was a definite sale or offer to sell more that one year before the application for the subject patent, and that the subject matter of the sale or offer to sell fully anticipated the claimed invention ...
The mere fact that an agreement was to supply experimental systems on a "cost plus" basis may not suffice to avoid the on-sale bar, if the invention was ready for patenting at the time of the transaction.
For a sale to act as a bar to a subsequent patent, it is not necessary that the sale disclosed the nature of the invention to the purchaser. It is sufficient that it has been developed to the point where a patent application could be filed and was in fact marketed. However, in the case where there is no actual sale prior to the start of the grace period, but only an offer for sale, it seems that perhaps the offer must be accompanied by some information as to the nature of the invention in order to create the bar.
The question of what constitutes an offer for sale for the purposes of the on sale bar was considered by Federal Circuit in Group One Limited v. Hallmark Cards Inc. The court held that since a national standard was necessary for determining whether or not a product was "on sale", it was not appropriate to look to state law for an answer to what constituted a commercial offer for sale as referred to by the Supreme Court in Pfaff. One should instead " as a general proposition" look to the Uniform Commercial Code to define whether a communication or series of communications rises to the level of a commercial offer for sale. Article 2 is currently in the process of being revised, mainly so as to take account of the development of e-commerce and the adoption of the federal Electronic Signatures in Global and National Commerce Act ("E-sign) and the Commissioners own model state law, the Uniform Electronic Transactions Act (UETA). However, other changes are likely to be made including a provision that it is possible to form a contract even though the acceptance may include terms different from or additional to those of the offer. (Proposed new Article 2-206(3)). It is not clear what effect, if any this may have on the question of what constitutes an offer for sale so as to trigger the on-sale bar.
A sale that is made solely for experimental purposes is not a bar as long as the purchaser lacked authority to use the invention or to exploit its commercial value. An intraorganization sale from a British company to its American affiliate has been held to trigger the on sale bar even though both companies were wholly owned subsidiaries of the same parent. The court laid some emphasis in this case that control of the two companies was in fact different even though they both answered to the same shareholders. It has, however, been held that it is unlikely that there could be an experimental use exception to the on sale bar in the case of design patents.
In Continental Plastic Containers v. Owens Brockway Plastic Products, the Federal Circuit pointed out the different policies behind the prior use bar and the on-sale bar in the following terms
The primary policy underlying the "public use" case is that of detrimental public reliance, whereas the primary policy underlying an "on sale" case is that of prohibiting the commercial exploitation of the design beyond the statutorily prescribed time period.
It therefore did not apply the holding in Tone Bros to an on-sale bar case.
In Brassler U. S. A. LLP v. Stryker Sales Corp the issue before the court was whether the on sale bar applies in the case of a joint invention where the sale in question was from the employers of one group of joint inventors to the employers of a second group of joint inventors. The court held that since the sale in question was of a substantial number of products falling within the claims and that the parties had clearly treated it as commercial, the relationship between the parties with regard to inventorship was irrelevant to the question of whether an on-sale bar came into effect.
In order for the bar to come into effect, it is not necessary that the seller knew exactly what it was that was being sold. Thus in Abbott Laboratories v. Geneva Pharmaceuticals it was held that the commercial sale of a particular anhydrous form of a compound and triggered the on-sale bar even though it had not been appreciated that the material being sold contained that anhydrous form, that fact being discovered only later when samples of the material that had been sold were analyzed. The Court distinguished earlier cases which had held that there was no anticipation where a reaction may have been carried out inadvertently while carrying out some other process on the ground that in such cases the earlier work had produced no useful or appreciated result. This was not the case here where the prior sales had been of useful product that had been appreciated.
6.3 The Effect of a Prior U.S. Application or PCT Application designating the United States
As amended by the 1999 law changes which became effective on November 29, 2000, 35 USC 102(e)bars the grant of a patent if:
the invention was described in
(1) an application for patent published under [the new "18 month publication" provision] by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the [PCT] shall have the effect under this subsection of a [published] national application ... only if the international application designating the United States was published ... in the English language; or
a patent granted on an application for a patent by another filed in the United States before the invention thereof by the applicant for patent, except that a patent shall
not be deemed filed in the United States for the purposes of this subsection based on the filing of an international application filed under the [PCT].
The new text apparently applies only to patents issued on applications filed on or after November 29, 2000 or earlier filed applications which were published voluntarily. For older patents and applications, the old law continues to apply. This reads as follows:
the invention was described in a patent granted on an application for a patent by another filed in the United States before the invention thereof by the applicant for patent, or on an international application by another who has fulfilled the requirements [for entry into the United States under the PCT] before the invention thereof by the applicant for patent.
It should be noted that despite the general rule that an international application filed under the PCT has effect as a national application as of its international filing date, this does not apply to this section. Under the pre-November 2000 law a PCT application that gave rise to a U.S. Patent was effective as of the date on which national phase entry was completed. Under the new law, a PCT application published in English and designating the United States is effective in the same way as a published U.S. application. However, a U.S. Patent issued directly from a PCT application will no longer be effective as prior art against a later filed application of another unless the PCT publication of the application was in English.
6.4 Prior Invention by another who
had not Abandoned, Suppressed or Concealed it.
This section is the most important practical aspect of the United States view that a patent should be granted to the first person to make an invention rather than the first person to file a patent application. Although consideration of this provision occurs most commonly in the context of interference proceedings as discussed below, it should be noted that it is also relevant as a defense in an infringement action.
35 USC 102(g)(2) bars the grant of a patent if
Before the applicant's invention thereof the invention was made in this country by another who has not abandoned, suppressed or concealed it.
35 USC 102(g)(1), which was added to the law by the 1999 reforms, provides that during an interference proceeding or a priority contest between granted patents, the grant of a patent may be barred or if already granted a patent may be held invalid if
another inventor involved therein establishes, to the extent permitted in section 104, that before such person's invention thereof the invention was made by such other inventor and not abandoned, suppressed or concealed.
The section goes on to state
In determining priority of invention there shall be considered not only the respective dates of conception and reduction to practice of the invention but also the reasonable diligence of one who was first to conceive and last to reduce to practice from the time prior to conception by the other.
It should be noted that under this provision "offensive" use of prior invention made abroad so as to attack the validity of someone else's patent or application was not possible until the change made by the 1999 reforms. Prior to these reforms, one could only rely on an invention made in the United States to challenge another's right to a patent on the ground of prior invention, although one could, since changes earlier in the 90's rely on evidence of one's own invention in many countries abroad to establish a date of invention earlier than the date relied upon bu one's challenger. The effect of the 1999 reforms was to enable inventors in other WTO-member countries to take full advantage of the first to invent provisions of U.S. law during interference proceedings or in court proceedings between interfering patents. . Prior to this change some concern has been expressed as to whether the prior amendments made to comply with the GATT-TRIPS Agreement should have amended this provision also. This has now been done.
Although issues of first invention normally come up in the context of interferences or priority contests between granted patents, 35 USC 102(g)(2) makes it clear that in an appropriate case, prior invention by another can be a ground of invalidity of a patent or refusal of an application. However, in the absence of a U.S. patent or patent application, it is still not possible to rely on evidence of an earlier invention as a defense to an infringement action if that evidence is outside the United States.
The practical effect of this provision is that normally the first person to reduce the invention to practice gets the patent unless either he or she abandoned, suppressed or concealed the invention or someone else who was first to conceive of the invention but was second to reduce it to practice was diligent in seeking to reduce the invention to practice from a date that is earlier than the conception date of the second to conceive. This leads to the famous paradox that could occur in a three-way contest as to who had the right to a patent whereby no one is apparently entitled to a patent. An example of the paradox arises in the following situation: the invention was conceived by A, B and C in that order and reduced to practice in the order C, A, B: B and C were both diligent in reducing the invention to practice but A was not. As between A and B, A has priority as being the first to conceive and reduce to practice. As between A and C, C prevails since he was the first to reduce to practice and A's earlier date of conception does not help because he was not diligent in reducing the invention to practice. As between B and C, however, B prevails because although he was the later to reduce to practice he was the first to conceive and worked diligently from before C's date of conception to reduce the invention to practice.
Until the 1990's, 35 USC 104 limited the rights of those who make inventions outside the United States to take advantage of this provision, at least until knowledge of the invention reaches the United States. However, for "defensive" purposes at least for U. S. Patent applications filed since December 8, 1993 it has been possible to establish dates of invention a reference in Canada and Mexico that are on or after that date and since January 1, 1996, it has been possible to take advantage of inventive activity in World Trade Organization-member countries in order to establish a date of invention (although the earliest date that will be recognized is January 1, 1996). The party seeking to assert such a date of invention outside the United States must be willing to adhere to United States rules on discovery during any proceedings that are instituted to determine the veracity of the claim that has been made.became effective on December 8, 1993. Up to now therefore, in most cases still, the earliest date that a foreigner can assert in such a conflict is the date of a foreign patent application from which his United States application claims priority under the Paris Convention or a reciprocal arrangement between the United States and the country of the original filing.
It should, however, be noted that even under the previous law, the mere fact that an invention is made outside the United States is not the determining factor in determining whether one can take advantage of 35 USC 102(g) to establish a date earlier than the claimed priority date; the determining factor is the location of the evidence. It was therefore not uncommon for inventors outside the United States to send disclosures of their inventions to their United States patent attorneys and have them sign a statement that they have read and understood the disclosure so as to establish a date on which the invention was known in the United States. This date will suffice for establishing a date of conception of the invention in the United States.
In explaining what is required in order to establish a date of conception, the CCPA stated in Townsend v. Smith
The conception of the invention consists in the complete performance of the mental part of the inventive art. All that remains to be accomplished in order to perfect the act or instrument belongs to the department of construction not invention. It is therefore the formation in the mind of the inventor of a definite and permanent idea of the complete and operative invention as it is thereafter to be applied in practice that constitutes an available conception within the meaning of the patent law. A priority of conception is established when the invention is made sufficiently plain to enable those skilled in the art to understand it.
It is not, however, necessary that the inventor knows that the invention will work for conception to be complete. However, recent case law in the particular in the field of biotechnology has pointed out situations where conception was not complete until there was actual reduction to practice, for example where the invention lies in a piece of DNA which cannot be conceived until its sequence is known.
In order to establish a date of conception there must be a disclosure or manifestation of the invention of sufficient detail that one skilled in the art could construct the invention without undue experimentation or research. A mere idea without the means to apply it is not conception. In chemical cases an idea of the utility of a compound as well as its structure and a means for its production may be required. Case law makes it clear that because conception is a mental act, "the inventor must prove his conception by corroborating evidence, preferably by showing a contemporaneous disclosure." While such corroboration typically comprises disclosure to someone other than the inventor, since Peters v. Hopkins it has been possible that
conception can be established by means other than ... disclosure ... For example; An inventor might write a complete description of his invention and deposit the same in a sealed packet with another person for safe keeping, without disclosure of the contents. The production of the packet with proof of the date of receipt would be sufficient evidence of the existence of the conception on that date.
Reduction to practice involves actual physical production of an embodiment of the invention and a successful test thereof by or on behalf of the inventor. The inventor must, however, consider the test to have been successful. Furthermore " in order to establish reduction to practice, an inventor must prove that he contemporaneously appreciated that the embodiment met all of the limitations of the interference count. Failure to be able to reproduce satisfactory results may evidence a failure to have reduced the invention to practice successfully. On the other hand, there is no need for the reduction to practice to have developed an invention to the point at which it is commercially viable. The reduction to practice requirement is, however, deemed to be fulfilled by the filing of a patent application in the United States (and possibly now in another WTO country as long as it was filed after the relevant date, although there is as yet no case law on this point) as long as that application meets all of the disclosure requirements for patent protection. Filing of such an application is said to be a constructive reduction to practice. In cases of chemical compounds, reduction to practice includes establishing a utility for the compound.
The importance of the degree of diligence between the dates of conception and reduction to practice is as noted above set out in the statute itself. It should, however, be noted that diligence throughout the entire period from conception to reduction to practice may not be required. What is necessary is to show diligence from a date prior to the date of conception by the other party. The question of what is reasonable diligence is a factual one and may depend upon the inventor's resources. However, unexplained periods of inactivity towards reducing the invention to practice will weigh heavily against a finding of diligence. Periods of inactivity by an attorney who has been asked to draft a patent application are imputed to the inventor.
The question of whether an inventor has abandoned, suppressed or concealed an invention arises after the invention has been made (i.e. reduced to practice) but before a patent application has been filed. The question of abandonment is similar to that which arises under Section 102(f). As pointed out by Judge Rich in Paulik v. Rizkalla, the wording was included in the statute as a codification of prior case law which have applied equitable principles on a case-by-case basis. One thing seems clear, however, it is not necessary to show any intent to suppress or conceal an invention for a court to find that it was in fact concealed or suppressed. For example the courts have deemed an invention to be suppressed, concealed or abandoned if the invention was not made public or a patent application filed within a reasonable period after the invention was completed. In one case where the first to invent was only spurred into filing a patent application after doing nothing for many years when someone else filed an application on the same invention, he was found to have concealed and so forfeited the right to a patent. Similarly, scantily explained delay in the assignor's patent department of four years between the date on which an invention disclosure was apparently complete and the filing of a patent application was held to be suppression.
6.5 Novelty of Product by Process Claims
In recent years the Patent Office has reversed its previous view that product by process claims are permissible only if the product in question cannot be defined in any other way. The exact scope of such claims is a matter of controversy. Patent Office practice, however, is to permit such claims only if the product itself rather than its method of production is novel and the applicants bear the burden of proof to show such novelty.
In 1991 a substantial controversy arose over a Federal Circuit Court of Appeals decision which held that a product by process claim (that is to say a claim along the lines "product X whenever obtained by carrying out process Y") could be infringed by sale or use of product X even though this had been produced by a totally different process. The court reasoned that since in determining questions of patentability in order to secure grant of a product by process claim one had to show that the product itself was novel, there was no reason why a similar standard should not apply to questions of infringement.
The issue came before a different panel of the Federal Circuit a year later in the case Atlantic Thermoplastic Company Inc. v. the Faytex Corp. This time the court undertook a detailed analysis of the history of product by process claims going back to an 1877 Supreme Court decision. By tracing the history of Supreme Court and Court of Appeals decisions throughout the United States the court this time came to the conclusion that in order to infringe a product by process claim it was necessary that the process used for production of the product was that specified in the claim. In a footnote the court noted that its previous decision had been based on a "undeveloped record" and had not considered the prior case law on the subject.
In the later decision the court recognized that in determination of patentability it was appropriate to construe product by process claims broadly and to ignore the process limitation. This was justified because permitting inventions to be defined in product by process form was an exception from the general principle laid down in many cases that an article should be defined by its structure rather than its manner of manufacture and, therefore, the only reason why product by process claims were permitted at all was to reduce the burden on the applicant in defining his invention. Providing this facility, however, did not water down the basic requirement that the product itself must be novel in order to establish patentability. In assessing infringement on the other hand case law had traditionally held that the scope of a product by process claim was limited by the process stated and referred to a Supreme Court decision of 1884 (Cochrane v Badische Anilin & Soda Fabrik as precedent for this conclusion. The Federal Circuit panel hearing the Atlantic Thermoplastic case believed that this was still good law today.
The issue has not yet been reconsidered at the Federal Circuit level. However, some district courts have felt that since Scripps was the first of the two panel decisions by the Federal Circuit and there has been no en banc decision by the circuit court overruling it, Scripps is the decision to be followed.
Again we will confine our discussion to points that may be specific to United States patent law and gloss over points that are common to all patent systems.
The leading decision on the question of obviousness is that of the Supreme Court in Graham v. John Deere. The case related to a modification of the mounting of the shank of a plow which was intended to absorb the shock that occurs when the blade of the plow hits rocks in the ground. The modification involved locating the shank below rather than above the plate on which it was mounted. At trial the patentees argued that this arrangement allowed the shank to flex along its entire length whereas the prior arrangement permitted only a short portion of the shank to flex and that this change reduced the wear on the shank. The Supreme Court noted that no such argument had been used before the Patent Office when the application was examined and concluded that such arguments were an afterthought and held the claimed invention to be obvious. In doing so, the Court set out a tripartite test for obviousness. The court stated:
While the ultimate question of patent validity is one of law, the section 103 condition,...lends itself to several basic factual inquiries. Under section 103, the scope and content of the prior art are to be determined; differences between the prior art and the claims at issue are to be ascertained; and the level of ordinary skill in the pertinent art resolved. Against this background, the obviousness or nonobviousness of the subject matter is determined.
The court then went on to consider what it called "secondary considerations" in the following terms:
Such secondary considerations as commercial success, long felt but unsolved needs, failure of others, etc., might be utilized to give light to the circumstances surrounding the origin of the subject mater sought to be patented. As indicia of obviousness or nonobviousness, these inquiries may have relevancy.
More recent case law has elevated these "secondary factors" to "objective factors" and regards them as being of equal importance to the other three factors set out by the Supreme Court in the Graham case. However, if application of the first three factors points to a conclusion of obviousness, the invention will be said to be prima facie obvious and the burden will shift to the applicant to show that by application of the objective factors, the prima facie case has been overcome. As discussed below, this is a matter of particular importance in dealing with questions of structural obviousness in chemical inventions.
One of the key questions in applying these factors is, of course, the extent to which it is proper to combine the teachings of different pieces of prior art. The Federal Circuit summarized its prior case law on this question to reach a conclusion of obviousness in Ruiz v. A. B. Chance Co.
The reason, suggestion, or motivation to combine may be found explicitly or implicitly: 1) in the prior art references themselves; 2) in the knowledge of those of ordinary skill in the art that certain references, or disclosures in those references, are of special interest or importance in the field; or 3) from the nature of the problem to be solved leading inventors to look to references relating to possible solutions to that problem. While the references need not expressly teach that the disclosure contained therein should be combined with another, the showing of combinability must be clear and particular. (Internal citations omitted.)
However, as was noted in In re Beattie
As long as some motivation or suggestion to combine the references is provided by the prior art taken as a whole, the law does not require that the references must be combined for the reasons contemplated by the inventor.
Mere optimization of a prior invention by routine experimentation has been held to be prima facie obvious, as has simply changing the order in which a process has been carried out or splitting a single step of the prior art into two. Such prima facie holdings may, however, be overcome in suitable cases, for example by showing non-obvious results.
7.1 Special Problems in Chemical Cases
Special problems can arise in chemical cases where a question often arises as to whether a compound having a minor difference in structure to a prior compound is obvious. The leading case (In re Papesch) held that in such cases, if the new compound possesses properties that are surprising and unexpected then the mere fact that the change in structure is a minor one does not render the new compound obvious. In determining questions of obviousness, one must consider the compound as a whole, and that includes both its structure and its properties.
In the case of In re Dillon, the Court of Appeals of the Federal Circuit with 12 judges sitting en banc reversed a previous decision of a panel of three of its members to effect what may be a significant change in the tests of obviousness applied to patent claims directed to novel chemical compounds and compositions.
In its en banc decision, the Federal Circuit decided that structural similarity was sufficient for finding of prima facie obviousness in respect of a claim for a new compound or composition if there is something in the prior art that gives reasons or motivation to make that new compound or composition, even if these are totally unrelated to its newly discovered surprising properties. The Court indicated that the evidence of surprising properties could still be used to rebut the presumption of obviousness rising from the structural similarity commenting
Such rebuttal or argument can consist of a comparison of test data showing that the claimed compositions possess unexpectedly improved properties that the prior art does not have ..... that the prior art is so deficient that there is no motivation to make what might otherwise appear to be obvious changes .... or any other argument or presentation of evidence that is pertinent.
The Court was, however, emphatic that in order to establish prima facie obviousness it was not necessary that there should be a suggestion in the prior art "[t]hat the claimed compound or composition will have the same utility as one newly discovered by the applicant." Additionally it is important to note that when referring to unexpected improved properties the court required that these were "properties that the prior art does not have" not simply properties that the prior art was not known to have. That is where the structural similarity is close and one wishes to rely on the properties of a new compound to overcome an obviousness argument, there must be some actual difference in the properties of the new compound from the prior art and not merely some newly discovered property that is common to both of them before one can obtain compound per se protection for the new compound.
In the area of biotechnology the degree of unpredictability resulting from the degeneracy of the genetic code has led to decisions holding that knowing "the amino acid sequence of a protein does not necessarily render particular DNA molecules encoding the protein obvious."
An issue which frequently arises in the pharmaceutical field is what test to apply when there may be some general teaching in the prior art pointing vaguely in the direction of the invention but nothing too specific. Today the test can be summarized as being that the Federal Circuit will find a claim obvious if the prior art points in the general direction of the invention (thereby arguably making it obvious to try) and those skilled in the art would believe that what was pointed to by the prior art would have a reasonable expectation of success. The issue was well considered in In re O'Farrell
The question is: when is an invention that is obvious to try nevertheless nonobvious?
The admonition that "obvious to try" is not the standard has been directed mainly at two kinds of error. In some cases, what would have been "obvious to try" would have been to vary all parameters or to try each of numerous possible choices until one possibly arrived at a successful result, where the prior art gave either no indication of which parameters were critical or no direction as to which of many choices were likely to be successful. ... In others what was "obvious to try' was to explore a new technology or general approach that seemed to be a promising field of experimentation, where the prior art gave only general guidance as to the particular form of the claimed invention or how to achieve it. ... Neither of these situations applies here.
Obviousness does not require absolute predictability of success. ... For obviousness under S. 103, all that is required is a reasonable expectation of success.
In making the assessment of the significance of the prior art, the Court should in an appropriate case take into account the degree to which reliable prediction can be made in the field.
However, optimization of what has been done before by routine experimentation does not give rise to a patentable invention. Nor do unexpected results necessarily evidence patentability if there was a strong motivation in the art to carry out what was claimed at the time the alleged invention was made.
7.3 Does disclosure of a genus make all species within it obvious?
The term "selection" patent which is widely used outside the United States, is one that was until recently unknown to most United States patent practitioners, and although some court decisions have hinted that the selection patent concept may be useful. Before reviewing the cases, however, it is worth reminding ourselves that an enquiry into the obviousness of a claimed invention is a two step process first to consider whether what is claimed is prima facie obvious and second, if it is whether the applicant or patentee can rebut that initial finding by showing something surprising or superior about what is claimed. In the case of In re Jones the Federal Circuit Court of Appeals held that a novel ammonium salt of a known herbicidal compound was patentable despite the prior publication of the genus of ammonia salts of the compound and specific discussion of certain of them. The court took the view that the prior publication was of a "potentially infinite genus" of such ammonia salts and held that the compound claimed was not "sufficiently similar in structure to (the compounds of the prior art) as to render it prima facie obvious". Thus the fact that the evidence submitted by the applicant to try to show advantageous properties for his salt was not particularly convincing did not preclude the patentability of the compound claimed.
In In re Baird the Federal Circuit built on the Jones decision citing this as precedent for the proposition that "The fact that a claimed compound may be encompassed by (prior) disclosed generic formula does not by itself render that compound obvious". The court went on to find that the prior generic disclosure did not "teach or fairly suggest selection" of the compound now claimed, pointing out that the specific teaching of the prior art had been of complicated analogs of the compound now claimed and that " A disclosure of millions of compounds does not render obvious a claim to three compounds, particularly when that disclosure indicates a preference leading away from the claimed compounds". Following the Baird decision the Patent Office issued guidelines according to which the question to be decided in species-genus situations was the same as considering all other cases of obviousness namely whether the prior teaching provided any motivation to produce what was now being claimed. Such consideration requires looking at predictability in the particular art, the properties of the species as compared to those taught for the prior genus and the closeness in structure of the claimed species to typical or preferred species taught in the prior generic disclosure.
As with our consideration if novelty and obviousness, we will confine our discussion to aspects of U.S. law that may differ from what is common in other parts of the world.
35 USC 271 gives a patentee the right to bring an action both for direct infringement against anyone who within the United States makes, uses, offers to sell or sells any patented invention within the United States or who imports a patented invention into the United States or who carries out certain other acts discussed below and for indirect infringement against anyone who actively induces an act of infringement of such an invention or who contributes to infringement by selling a component of a patented machine, manufacture, combination or composition or a material for use in practicing a patented process. The statute specifically states that offers for sale are infringements only if the sale that is offered will occur before the expiration of the patent. Certain specific provisions also apply for infringement of patents relating 1) to the export from the United States of "all or a substantial portion" of the components of a patented invention in "such manner as to actively induce" their combination outside the United States; 2) to import of products into the United States of products made abroad which had they been made in the United States would have been an infringement of a United States patent; 3) to drugs so that testing required to enable filing of an application for marketing approval with the FDA is not itself an infringement, although the filing of application for marketing approval itself is an act of infringement if the purpose of the filing is to engage in commercial exploitation of the invention before the expiration of the patent and 4) to patents relating to medical processes.
In order to be held as a direct infringer of a United States patent under 35 USC 271(a), it is necessary during the life of the patent to have made, used, offered to sell or sold what is claimed in the patent within the United States or to have imported the patented invention into the United States. Under this test one can be liable for patent infringement even though one was unaware of the patent or that the acts one is carrying out are tortious. Furthermore it has long been the law that one does not have to sell the product one produces to be an infringer of a patent, mere manufacture, at least if for a commercial purpose will suffice. The possibility of suit against someone offering a product for sale was added to the statute as part of the Uruguay Round Amendments Act, taking effect on January 1, 1996. If the offer for sale originates from the United States there may be an infringement even if the physical embodiment never enters the United Sates as was the case in Halmar Robicon Group v. Texas Instruments where a letter making an offer for sale originated in Texas but the goods in question were made in Japan and shipped direct to a customer in Canada. It appears that the term "offer for sale" in this context may have a broader meaning than is normal in contract law and may include acts that a contract lawyer would find to be merely an invitation to make an offer. It seems clear, however, that an uncompleted offer to donate an alleged infringing article is not an infringement.
Limited use of an invention for non-commercial experimental purposes may, however, be permissible without being an infringement. To succeed with such a defense, it is however, necessary that the use be of an entirely non-commercial nature.
8.2 Process Patent Amendment Act
The Process Patent Amendment Act (PPPA - Title 9 of the Omnibus Trade and Competitiveness Act 1988 codified at 35 USC 271 (g)) provides for process patent protection by amending the U.S. Patent law to provide that the owner of a U.S. patent relating to a process of production of goods can exclude others from using, selling offering for sale or importing products made by that process into the United States. Protection does not, however, exist if the product in question is one that is being materially changed by a subsequent process or if the product becomes a trivial and non-essential component of another product. The exact meaning of this provision is not entirely clear and the legislative history of the statute seems to imply that Congress intended the provision to apply to processes claiming intermediates in a multi stage process for preparing a final product even though only the final product was imported into the United States, but only if production of that intermediate was an effective bottleneck controlling the whole process.
A product will only be caught by the act if the process by which it was made was carried out after the patent issued so that importation of a product into the United States will not be an infringement under this provision even if it occurs after the grant of the patent in question if the actual manufacture abroad took place before the grant of the U.S. patent. Furthermore, no remedy shall be granted for infringement on account of a non-commercial use or retail sale of an imported product that is the result of a patented process unless there is no other adequate remedy for infringement on account of the importation or other use or sale of the product.
Remedies available under the provisions are further limited in respect of those who were merely using an infringing product without knowledge that it was the product of a patented process. Certain tests are set out for determining whether one was "innocent" so as to result in a possible limitation on the remedies given to the patentee for such use or sale. The most significant feature of these is a presumption of good faith on the part of the alleged infringer if he has inquired of one engaged in the manufacture of the product whether there are any patents that person "reasonably believes could be asserted to be infringed" if the product was imported, sold or used in the United States. In making such a request, the requester must agree to draw his supplier's attention to any patents that are listed by the manufacturer to whom the request was made and request an assurance that no process covered by a listed patent is used in the production of the product in question. Unless there are mitigating circumstances, failure to make such a request will be regarded as showing a lack of good faith. Any patent owner who has marked all of his goods sold in the United States with the number of a process patent that will be infringed by their production is, however, relieved from the obligation of replying to any such inquiry.
The Process Patent Amendment Act also provides that the burden of proof of asserting infringement of a process patent may be reversed in cases where the action is based on the importation, sale, offer for sale or use of the product of a process patented in the United States, if the court finds that "a substantial likelihood exists that the product was made by the patented process and the plaintiff has made a reasonable effort to determine the process actually used in production of the product by the defendant and was unable to so to determine."
An attempt to broaden the interpretation of the legislation to include not only process claims, but also claims to materials used in a process carried out abroad failed in the case of Amgen Inc. v U.S. International Trade Commission.
In determining whether an infringement of a patent has occurred, it is not necessary that the infringement absolutely falls within the literal wording of the claim if the doctrine of equivalents applies. The doctrine can be traced back to the 1853 Supreme Court case of Winans v. Denmead. The objective is to prevent "fraud on the patent". This doctrine was ratified in the 1950 Supreme Court decision of Graver Tank Mfg. Co. v. Linde Air Products Co. Typically pioneer patents will be given a broader range of protection than an improvement patent. Under Graver Tank the main formulation of the doctrine is that it is an infringement of a patent claim even if it is not literally infringed if the allegedly infringing device or process "performs substantially the same function in substantially the same way to achieve the same result" as the patented invention.
The issue came before the Supreme Court again in 1997 in Warner-Jenkinson v. Hilton Davis. This case followed a period in which many people felt that the doctrine of equivalents was being over used and that fear that something might be held to be an equivalent to what was claimed was having a chilling effect on investment and innovation. The Supreme Court upheld the viability of the doctrine but imposed two important limitations on its application. The first of these was that the doctrine is to be applied by determining whether the accused product or process contains elements identical or equivalent to each claimed element of the invention rather than viewing the accused product or process as a whole. The second was to enhance the role of prosecution history in limiting the scope of protection to be given under the doctrine. The Supreme Court stated that the burden is to be placed on the patentee to establish the reason for an amendment required during patent prosecution as not being required to establish the patentability of the claim. The court then would decide whether that reason is sufficient to overcome prosecution history estoppel as a bar to application of the doctrine of equivalents to the element added by amendment.
The second of these requirements has been applied vigorously by the Court of Appeal for the Federal Circuit. In the case of Festo v. Shoketsu Kinzoku KK,. the Federal Circuit Court, when considering whether an amendment to a claim during prosecution would create an estoppel against a broad interpretation of that claim for purposes of determining infringement under the doctrine of equivalents, held that
(1) an amendment that narrows the scope of a claim for any reason related to the statutory requirements for a patent will give rise to prosecution history estoppel with respect to the amended claim element;
(2) a "voluntary" claim amendment that narrows the scope of the claim for a reason related to the statutory requirements for a patent will give rise to prosecution history estoppel as to the amended claim element;
(3) when a claim amendment creates prosecution history estoppel with respect to a claim element, there is no range of equivalents available for the amended claim element, thereby completely barring application of the doctrine of equivalents as to the amended element ("complete bar"); and
(4) failure to explain a claim amendment invokes a presumption of prosecution history estoppel, thereby providing no range of equivalents under the doctrine of equivalents as to a claim element that was affected by such an amendment.
It was also held that these criteria apply irrespective of whether the amendment was made by restricting a particular claim during prosecution or by replacing a broad claim with a narrower one if the purpose of the replacement was to present a claim that lacked the problems which resulted in the claim that was being replaced being unpatentable.
The Supreme Court has agreed to review the Federal Circuit's decision in Festo on certiorari and oral argument is due to take place on January 8, 2002.
Unless and until it is overruled on appeal, the Festo decision creates some practical problems in drafting patent applications for use in the United States. The simple answer to how to avoid limitation on the application of the doctrine of equivalents after Festo is to avoid limiting claims during prosecution for reasons relating to patentability. How is this to be accomplished? One way would be by filing multiple applications. However, this may be impracticable in many circumstances. A number of other possibilities come to mind:
8.4 Special Provisions Relating to Drug Patents and Patents for Medical Uses
8.4.1 Effect of ANDA Filing by Generic Drug Manufacturers
The Drug Price Competition and Patent Term Restoration Act of 1984, amended the law relating to patent infringement to overrule the decision of the Court of Appeals for the Federal Circuit in Roche Products, Inc. v. Bolar Pharmaceutical Co., Inc. In that case, the court had held that clinical testing of a copy drug prior to the expiration of the patent on the active ingredient so as to expedite FDA approval of the copy drug after the patent expired was an infringement of the patent. The Act represented a compromise between the ethical and generic drug manufacturers. In return for permitting generic drug manufacturers a simplified procedure for securing FDA approval for generic drugs by filing an Abbreviated New Drug Application which did not require repetition of all of the testing carried out by the original introducer of the drug, certain amendments were made to the Patent Act.
35 USC 271(e) now excludes from patent infringement any activity in relation to a product (other than a new animal drug or a veterinary biological product) which is solely or reasonably related to the development and submission of information required for federal approval of the manufacture, use or sale of a drug. It is, however, made a patent infringement to submit an IND or an application for marketing approval in respect of a drug which is subject to patent protection if the purpose of the submission is to obtain approval under the Food, Drug and Cosmetic Act to engage in the commercial manufacture, use or sale of a patented drug (or certain other biotechnology products) before the patent on it expires.
The Food Drug and Cosmetic Act requires that applicants for New Drug Applications for pioneer drugs must file information about patents for their drugs with the FDA (these are collected in Approved Drug Products with Therapeutic Equivalence Evaluations, the so-called "Orange Book" and make any appropriate amendments when the drug is approved for sale). Third parties have no rights to challenge the propriety of an Orange Book listing. As a result of the Hatch-Waxman Act , applications for permission to market generic versions of drugs, filed as Abbreviated New Drug Applications, must include a certification as to one of the following: (I) that no patent information was filed by the original innovator of the drug; (II) that the patent has expired; (III) the date on which the patent expires; or (IV) that the patent is invalid or will not be infringed. Applicants for an ANDA must up-date their certifications if additional relevant patents are added to the Orange Book, unless the patentee delays more than thirty days after the issue of the patent to enter it in the Orange Book. If the certification is of type (IV), the ANDA applicant must give the patentee notice and advise the patentee why it believes the patent is invalid, unenforceable or not infringed. If within 45 days of giving this notice, the patentee institutes a suit for patent infringement, the FDA must delay grant of marketing approval until a court holds that there is no infringement or 30 months have elapsed, whichever is the sooner. (The thirty month term may be subject to extension, for example if the defendant failed to cooperate in expediting trial of the action.)
The ability of the ANDA applicant to challenge the validity of pioneer pharmaceutical patents has led to significant litigation in which the ANDA applicant is effectively protected from serious damage since the statute provides that damages can be awarded against such an applicant at this stage only if it has actually undertaken commercial manufacture, which is unlikely. A further bonus for the ANDA applicant is that if its challenge to the validity of the pioneer patent is successful or if it is held that the product in question is not an infringement, the challenger will be guaranteed a lead time of at least 180 days over any other ANDA applicant for the same drug. A first instance decision of invalidity or non-infringement suffices to start the 180 day period, even if the decision in question is appealed. Various ploys by the pioneer drug producers and the generic manufacturers to use the 180 day lead time in interesting ways have come under scrutiny from the FTC as being possible violations of the antitrust laws.
The courts have extended the exception to cover testing of new medical devices.
8.4.2 Limitation of Remedies for Surgical Method Patents
Most recent changes in patent law have favored the patentee. In 1996, however, Congress took steps to limit the rights of owners of certain types of patents relating to medical uses. This was done by an amendment that deprived a patentee of its infringement remedies (to civil trial, injunction, damages and attorney's fees) where a medical practitioner or a related healthcare entity performs a patented medical activity. The statute defines medical activity as:
the performance of a medical or surgical procedure on a body, but shall not include (i) the use of a patented machine, manufacture or composition of matter in violation of such patent, (ii) the practice of a patented use of a composition of matter in violation of such patent, or (iii) the practice of a process in violation of a biotechnology patent.
In essence therefore the limitation is confined to surgical techniques relating to humans using instruments that are not themselves patented.
A related healthcare entity is an entity such as a hospital, health maintenance organization or nursing home with which the medical practitioner has a professional affiliation. The term "body" has been defined as a human body, organ, or cadaver or a non-human animal used in medical research or instruction directly relating to the treatment of humans. The term "patented use of a composition of matter" does not include a claim for a method of performing a medical or surgical procedure on a body that recites the use of a composition of matter where the use of that composition of matter does not directly contribute to achievement of the objective of the claimed method.
Two possible types of indirect infringement are known in the United states: induced infringement and contributory infringement.
35 USC 271(b) provides that an act of actively inducing another to infringe a patent shall itself be treated as an act of infringement.
Induced infringement can only be alleged where there is some positive act of inducement by the person being sued to another to carry out a direct infringement of that which is claimed. Such a positive act may be in instructing, directing or advising the third party as to how to carry out a direct infringement. Since an amendment to the law in 1984 it has been an act of infringement to supply in or from the United States all or a substantial portion of the components of a patented invention in such manner as to actively induce the combination of such components outside the United States in a manner that would constitute infringement if carried out inside the United States. That is to say one can not supply from the United States a kit of parts with instructions to assemble them to produce something which if produced in the United States would be a patent infringement.
8.5.2 Contributory Infringement
The doctrine of contributory infringement, like the doctrine of equivalents, grew up to provide patentees with some additional protection against those who unfairly took advantage of their inventions. In this case the problem to be solved was that which arises where the actual infringer is someone who it may be difficult to sue, for example an individual end user who actually infringes, for example a patent for a do-it-yourself decorating technique but where it is not possible to obtain a patent for the actual article that is sold commercially. However, the application of the doctrine is not confined to method claims. It dates back to at least the 1871 case of Wallace v. Holmes where the court upheld a claim for patent infringement of a claim to an oil lamp where the real invention was the burner but the claims also recited other common features of such lamps where the infringement was by sale of the burner alone. The court concluded that purchasers of the burner would complete the rest of the lamp with conventional parts themselves. Suit against the producer of the burners was preferable to a multitude of innocent purchasers of the burner who were technically responsible for completing the infringement. Again, like the doctrine of equivalents, the doctrine of contributory infringement is open to abuse. In this case the risk is that it will facilitate the ability of patentees to monopolize unpatented materials. In the hey-days of antitrust enforcement, this was a real concern and in the 1940's. The Supreme Court in the Mercoid cases it was held that any attempt to control the market for unpatented goods was a patent misuse.
The 1952 Act adopted a compromise position. Under 35 USC 271(c), contributory infringement arises when there is a sale, offer for sale or importation into the United States of a component of a patented article or a material or apparatus for use in a patented process if the component material or apparatus constitutes a material part of the invention and the person supplying it knows that it is especially made for or especially adapted for use in an infringement of a patent. The latter provision is, however, subject to a proviso that it does not apply if the article sold is a staple article or commodity of commerce which is suitable for a substantial noninfringing use. In order for there to be contributory infringement, there must be a sale of a material component of the patented invention which is not itself a staple article of commerce with knowledge that the component is especially made for use in an infringement of a patented invention. There is no contributory infringement if the article sold is not especially adapted for infringement nor if the seller had no knowledge that it was so adapted. It is, however, not necessary to sue a direct infringer as well as a contributory infringer in order to succeed. As noted by the Supreme Court in Dawson Chemical Co. v. Rohm & Haas Cothe section provides the patentee with a "lawful adjunct of his patent rights, a limited power to exclude others from competition in nonstaple goods."
The law was changed in 1984 so as to reverse a previous decision relating to infringements by sales of kits of parts for assembly abroad. The law now provides that supply in or from the United States of a component of a patented invention that is especially made for or adapted for use in an invention and is not a staple article of commerce suitable for a substantial non-infringing use knowing that the component is so adapted or made is an infringement of a patent covering the assembled product containing the component in question even if the assembly is carried out abroad if the combination of such components within the United States would constitute a patent infringement.
As part of the 1984 legislative package making it easier for manufacturers of generic drugs to obtain FDA approval to market these drugs, Congress provided for extensions of the terms of patents in some cases to enable the pharmaceutical industry to obtain an extension of the term of patents for new drugs to compensate for the time taken to obtain FDA approval before they could be marketed.
A single extension of the term of a patent may be obtained if the patent relates to the active ingredient of a human or animal drug product or a combination of such active ingredients, a medical device, a food additive or a color additive or to methods of manufacturing or using such products and the product is subject to regulation under the Food, Drug and Cosmetic Act.
A patent relating to one of these regulated products is a candidate for an extension if the date of first marketing the product, or in the case of a process using recombinant DNA technology the first use of the process, was delayed as a result of regulatory review. Subject to a statutory maximum discussed below and subject to the applicant having been diligent in seeking regulatory approval, the extension shall be for the same period as marketing was delayed as a result of the regulatory review.
The regulatory period is defined in different ways for the five different categories of product covered by this provision: (1) new drugs for human use, (2) new food or color additives, (3) new medical devices, (4) new animal drugs and (5) new veterinary biological products. The basis for the differences is that the approval procedures differ between these classes of products. By way of example it may be noted that for new drugs for human use, the regulatory period is one half of the term starting on the date on which an investigational new drug exemption is granted, thereby permitting clinical testing in the United States and ending on the date on which a request for marketing approval is filed plus the entire period during which the request for marketing approval is pending. It may therefore be useful for those resident outside the United States to file an IND for a new drug earlier than might otherwise have been the case in order to maximize the benefits they may obtain from the law.
A petition for extension of the term of a patent must be filed within 60 days of the marketing approval being given and must be filed before the patent expires.
Extensions of patents under the act are, however, subject to two types of limitation: a maximum duration of extension and a limitation on the scope of the patent during the extended period.
The limitations on the duration of the extension are twofold. First, the extension shall not result in the final expiration of the patent occurring more than 14 years after sale of the product is approved. Second, the actual duration of the extension shall not exceed 5 years if the patent issued after the new law came into effect or no permitted clinical investigation prior to filing a formal request for approval of the new product was carried out before the new law came into effect. However, if the patent had issued before the new law came into effect and such preliminary testing had been carried out, but no approval for commercial marketing had been issued by that date, the maximum period of extension is two years.
The scope of protection during the extension is limited to the product which has been approved following the regulatory review, an approved use thereof or a method of manufacturing the approved product depending on the claims of the patent. Thus, if one has three patents relating to drug X, one for the product per se and describing its use in the treatment of disease Y, a second for an improved means of producing drug X and a third for use of drug X in the treatment of disease Z, and one submits two applications to the FDA for approval of drug X, one for its treatment of disease Y and the other for its treatment of disease Z only two of the three patents may be extended, one for each of the two review periods.
Failure to disclose all relevant facts in a petition for an extension is a ground for invalidating the extension.
A subsequent law relating to an extension of terms relating to animal drugs is modeled on the provisions that already exist for human drugs. As with human drugs provision is made for the filing of an Abbreviated New Drug Application with the Federal Food and Drug Administration to expedite the marketing of generic animals drugs once patent protection for them has expired. It is, however, expressly provided that the new provisions do not apply to any new animal drug "which is primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology or other processes involving site specific genetic manipulation techniques".
The abbreviated procedure will not apply for a period of five years after first approval under "normal" FDA procedures for any active ingredient unless the application for the ANDA contains a certificate showing that no valid patent will be infringed in which case a four year delay period before the abbreviated procedure can be used shall apply. In cases where a second application for a particular compound has already been approved (for example, as a result of its being approved for a different use) a period of three years from the original approval of the new use will apply before an abbreviated new drug application will be approved.
The law also provides for release of certain safety and effectiveness data in connection with new animal drug applications to be made available to members of the public for certain limited purposes and also introduces limitations on the distribution of animal drugs by requiring that certain of them can be supplied only "upon the lawful or written or oral order of a licensed veterinarian in the course of veterinarian's professional practice."
Finally, the law provides for extension of the patent term in respect of patents relating to new animal drugs to compensate for the time taking in obtaining regulatory review and approval. These terms are calculated in essentially the same way as for human drugs and are subject to the same overall limitation that the maximum term of extension is five years.
The question of how to determine whether a patent was capable of extension came up in Hoechst-Roussel Pharmaceuticals v. Lehman. Warner-Lambert had received FDA approval to market a drug for treatment of Alzheimer's disease whose active ingredient is tacrine hydrochloride. Hoechst-Roussel sued Warner-Lambert for infringement of its patent claiming 1-hydroxytacrine and a method of treating a patient in need of memory enhancement by administering an effective amount of 1-hydroxytacrine. Tacrine hydrochloride, after ingestion, metabolizes into, inter alia, 1-hydroxytacrine. Warner-Lambert entered into a consent judgment in which it admitted that tacrine hydrochloride infringes certain claims of Hoechst-Roussel's patent.
Hoechst-Roussel applied for an extension of the term of its patent under the provisions of the Patent Term Extension Act which provides for the availability of an extension of the term of a patent if the claimed product must undergo regulatory review before it can be marketed. The Commissioner of Patents and Trademarks denied the application on the basis that Hoechst-Roussel's patent did not claim tacrine hydrochloride or the method of using tacrine hydrochloride.
Hoechst-Roussel appealed the decision to the Court of Appeals of the Federal Circuit and the decision of the lower court was affirmed. The Federal Circuit stated that the issue was whether the patent claimed the product that was subject to regulatory review, not whether the marketing of the product would infringe the claims of the patent.
CLAIMS DIRECTED TO COMPUTER MODELING OF CHEMICAL COMPOUNDS
Patent 6,178,384
Patent No 5,699,268
1. A computer-based method of designing chemical
structures having a preselected functional characteristic, comprising
the steps of:
(a) producing a physical model of a simulated receptor
phenotype encoded in a linear character sequence, and providing
a set of target molecules sharing at least one quantifiable functional
characteristic;
(b) for each target molecule;
(i) calculating an affinity between the receptor
and the target molecule in each of a plurality of orientations
using an effective affinity calculation;
(ii) calculating a sum affinity by summing the calculated affinities;
(iii) identifying a maximal affinity;
(c) using the calculated sum and maximal affinities to:
(i) calculate a maximal affinity correlation coefficient between
the maximal affinities and the quantifiable functional characteristic;
(ii) calculate a sum affinity correlation coefficient between
the sum affinities and the quantifiable functional characteristic;
(d) using the maximal correlation coefficient and sum correlation
coefficient to calculate a fitness coefficient;
(e) altering the structure of the receptor and repeating
steps (b) through (d) until a population of receptors having a
preselected fitness coefficient are obtained;
(f) providing a physical model of a chemical structure encoded
in a molecular linear character sequence, calculating an affinity
between the chemical structure and each receptor
in a plurality of orientations using said effective affinity calculation,
using the calculated affinities to calculate an affinity fitness
score;
(g) altering the chemical structure to produce a variant of the
chemical structure and repeating step (f); and
(h) retaining and further altering those variants of the chemical
structure whose affinity score approaches a preselected affinity
score.
Patent No 5,684,711
1. A system for generating compounds having a prescribed set of
activity/properties, comprising:
chemical synthesis means for synthesizing, in accordance with
synthesis instructions, a directed diversity chemical library
comprising a plurality of chemical compounds;
analysis means for analyzing said chemical compounds to obtain
structure-activity data pertaining thereto;
comparing means for comparing said structure-activity data of
said chemical compounds against said prescribed set of activity/properties
to identify any of said chemical compounds substantially conforming
to said prescribed set of activity/properties;
classifying means for classifying said identified chemical compounds
as lead compounds;
structure-activity model derivation means for analyzing said structure-activity
data of said compounds and historical structure-activity data
pertaining to compounds synthesized and analyzed in the past to
derive structure-activity models having enhanced predictive and
discriminating capabilities;
reagent identifying means for identifying, in accordance with
said structure-activity models, reagents from a reagent database
that, when combined, will produce a set of compounds predicted
to exhibit activity/properties more closely matching said prescribed
set of activity/properties; and
synthesis instruction generating means for generating synthesis
instructions that, when executed, enable said chemical synthesis
means to synthesize said set of compounds.