As you’ve no doubt learned by now, a patent grants its holder potentially very valuable patent rights. The holder of a patent can bring enforceable actions in the federal court system and seek both monetary as well as injunctive relief. It seems that practically every other day you can read in the newspaper about some ongoing,high-stakes patent litigation. Businesses can rise or fall on the validity of a single patent claim. For these reasons alone, the importance of the USPTO’s ability to issue meaningful, valid patents cannot be understated. Against this backdrop, however, is the inconsolable fact that the patent office must process hundreds of thousands of patent applications every year (Figure above) and examine millions of claims. In the active give and take between the patent applicants and the USPTO, a very significant amount of correspondence will be generated. In most instances, the examiner will need to rely on the veracity of the statements of the applicants because the patent office does not have the means or the mandate to carry out independent tests to verify the applicant’s characterization of the prior art and/or their invention. Very often the decision of whether a patent is granted distills down to the statements that applicants make in their patent application and/or their communications with the office during the prosecution of the application. The very credibility of the U.S. patent system depends on the credibility of those persons involved in trying to get U.S. patents issued. For these reasons, the patent laws impose a duty of candor and good faith on those individuals associated with the filing or prosecution of patent applications.
Beyond the honesty in communication (candor) required by the U.S. patent system to issue strong patents, there is an affirmative duty on applicants for patents in the United States to disclose any material information that they are aware of that might affect the patent ability of their invention. Although we have already learned that examiners at the USPTO will independently search the prior art during patent examination, they often do not have the familiarity with the subject matter that the patent applicants and their representatives do. This collective duty of disclosure,candor, and good faith are critical to the mission of not only the USPTO but to the applicant as well, for at least three reasons.
The first reason is that patentees should want the strongest possible system of patent procurement and enforcement possible. To have such a system, all parties involved in the patent process need to work collectively to uphold the integrity of the system. No jury or judge will view your patent favorably if the entire system itself is a sham.
Second, the holder of the patent wants the strongest patent possible. If a patent is to have value, it must survive the rigors of litigation, and patents that have been procured through less than fully honest means are going to work against the patentees should they try to enforce the patent in federal court.
If the first two reasons were too tangential to convince you then may be the third will:
Apatent that is obtained through inequitable conduct can be found non enforceable, and therefore essentially useless, even if the inequitable conduct applies only to a single claim of that patent. This means the entire patent is contaminated despite the possibility that the inequitable conduct was more limited in nature. This sanction has teeth and is enforced vigorously in federal court where patent infringement actions are heard.
You may wonder, How does the issue of inequitable conduct typically arise since the USPTO is not likely to raise the matter? The answer is as follows. Somebody is infringing your patent and you don’t like him doing that, at least without his paying you royalties for all of your hard work, expenses, and sheer inventive genius. You write him a letter explaining that you believe your patent covers what he is doing and either he needs to quit doing what he is doing or negotiate a license with you.
He responds: “Patent, you call that a patent? Sue me!” So you take him up on his challenge and hire a lawyer (more like a team of lawyers) to bring a cause of action against the infringe. The accused in fringer then hires a team of lawyers, and you take your case to the federal district court having the appropriate jurisdiction. You sue him for infringement and allege incredible damages, he counterclaims, first arguing that he never infringed your patented claims to begin with. Second, even if he did infringe your claims, those claims are not valid because the subject matter is not novel. Next, he’ll say even if he does infringe your claims and even if they are novel, they are obvious and therefore invalid. Fourth, he’ll say even if he did infringe your aims and even if they are novel and non obvious, that they are invalid because you failed to properly enable the invention. Finally (and he has probably been saying this all along), he will say even if he did infringe your patent and even if it was nov eland non obvious, and even if the patent was fully enabled, that you used inequitable conduct to obtain at least one of the claims in that patent and thus the entire patent is invalid.
Sound far-fetched? It might seem hard to believe that very many patent practitioners or inventors would be guilty of such ignoble conduct, after all we are mostly honest and hardworking people, right? Well, somewhat surprisingly, you might find that the inequitable conduct defense results in quite a few invalid patents, including some pretty important and high-profile cases. “Why is this?” you might ask, and the answer will to a large part depend on who you ask. If you ask the defendants(e.g., generic drug companies seeking to invalidate innovator patents), they will say because the greedy individuals and companies overstepped their bounds and were so hell-bent on monopolizing the market that they would say anything or do anything to get their patent issued and then, on top of all that, have the sheer audacity to try to enforce it. On the other side of the line, you will have the patent practitioner sand inventors who will point to the incredibly complex nature of patent prosecution,the heavy burden on the applicant to decide what references might be material to patent ability, an ever-changing and ever-growing list of sins that amount to inequitable conduct resulting in a way-too-low bar being used to invalidate patents, the sometimes preternatural dislike for companies trying to enforce their patents when the industries represented by those companies are not in high favor, and, finally, the occasional possession and use of amazingly powerful retro spectroscopes” by the federal courts.For at least some of these latter reasons, the federal courts have at least espouse da reluctance for too easily finding inequitable conduct, but a quick glance at some of the recent case law may give one pause. In any event, whatever reason you choose for your motivation to act equitably in patent procurement, it is important that at a minimum you come to understand exactly what that burden is, as an inventor (or patent practitioner) in the patent procurement process.
Because it is such an important topic and because the inventor is a party whose actions and statements can directly affect the outcome of the patent prosecution, the entire substance of the duty of disclosure, candor and good faith is produced here for you to read in its entirety before further explanation and some real examples from actual court cases.
37 CFR 1.56 Duty to disclose information material to patent ability
A patent by its very nature is affected with a public interest. The public interest is best served, and the most effective patent examination occurs when, at the time an application is being examined, the Office is aware of and evaluates the teachings of all information material to patent ability. Each individual associated with the filing and prosecution of a patent73 has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to the patentability as defined in this section. The duty to disclose information exists with respect to each pending claim until the claim is canceled or withdrawn from consideration, or the application becomes abandoned. Information material to the patent ability of a claim that is canceled or withdrawn from consideration need not be submitted if the information is not material to the patent ability of any claim remaining under consideration in the application. There is no duty to submit information which is not material to the patent ability of any existing claim. The duty to disclose all information known to be material to patent ability is deemed to be satisfied if all information known to be material to patent ability was cited by the Office or submitted to the office in the manner prescribed by §§ 1.97(b)–(d) and 1.98.74 However, no patent will be granted Conan application in connection with which fraud on the office was practiced or attempted or the duty of disclosure was violated through bad faith or intentional misconduct. The Office encourages applicants to carefully examine:
Prior art cited in search reports of a foreign patent office in a counterpart application, and
The closest information over which individuals associated with the filing or prosecution of a patent application believe any pending claim patentable defines, to make sure that any material contained therein is disclosed to the Office.
Under this section, information is material to patent ability when it is not cumulative to information already of record or being made of record in the application, and
It establishes by itself or in combination with other information, a prima facie case of non-patentability of a claim; or
It refutes, or is inconsistent with, a position the applicant takes in:
Opposing an argument of non-patentability relied on by the Office, or
Asserting an argument of patentability.A prima facie case of non-patentability is established when the information compels a conclusion that a claim is non-patentable under the preponderance of evidence, burden of proof standard, giving each term in a claimits broadest reasonable construction consistent with the specification, and before any consideration is given to evidence which may be submitted in an attempt to establish a contrary conclusion of patentability.
Each inventor named in the application;
Each attorney or agent who prepares or prosecutes the application; and
Every other person who is sub stantively involved in the preparation or prosecution of the application and who is associated with the inventor, with the assignee or with any one to whom there is an obligation to assign the application.
Individuals other than the attorney, agent or inventor may comply with this section by disclosing information to the attorney, agent, or inventor.
In any continuation-in-part application, the duty under this section includes the duty to disclose to the Office all information known to the person to be material to the patent ability, as defined in paragraph (b) of this section, which became available between the filing date of the prior application and the national or PCT international filing date of the continuation-in-part application.
Okay, you got all that? If not everything, we hope you at least gathered up a few pertinent items. The first being that the applicant for patent as well as other parties involved with the application process (including you, the inventor) have an affirmative duty to submit information that is material to patent ability. You might reasonably ask,“But how do I know what is material to patent ability and even if I did, who would I report it to?” Let’s take the second part first because that one is easier. If you are an inventor or are otherwise substantively involved with the case, perhaps you are the assignee with knowledge and interest in the case and you have a patent agent or attorney of record who is handling the case, then you need to give the information to your representative so he can submit it to the patent office. However, this does not by itself alleviate you of your duty as an inventor because as you might glean from section (d) of 37 CFR 1.56, the duty on the inventor cannot end on reporting the information to the attorney or agent.
If you are the inventor and are representing yourself (pro se), then you will need to supply the information yourself to the USPTO. The information submitted must be listed on an information disclosure statement, and the forms can be found on the USPTO web site. Briefly, there is a section for U.S. patent and published patent applications, foreign patent applications, and patents as well as non-patent references.For U.S. patents and patent publications, only a citation is necessary. For non–U.S.patent references or any other reference, the citation must be indicated on the form and a hardcopy of the reference must be provided. If the reference is written in a language other than English, a summary of the relevancy of the document in English or an English translation must be provided.
Having settled the how to file the information let’s turn our attention to the sometimes thornier problem of deciding what references need to be cited and/or sent to the USPTO. First the good news: There is no affirmative duty on the applicant,inventors, or any other individuals associated with the relevant parties and the filing of the patent application to search for information that might be material to patent ability.
Of course, a thorough knowledge of the prior art is often critical to getting and staying competitive in your field. Furthermore, understanding how the claims in your patent application relate to (and are different from) the prior art is good to know before you go through all the trouble and expense of developing your invention and filing the patent application. A lone inventor working in his basement, entirely cut off from the outside world since birth might write a patent application for his mousetrap invention and submit the application with no information disclosure sheet, despite the fact that numerous embodiments of his claimed invention have been known in the art for quite some time. He may not be guilty of inequitable conduct, though he may not get a patent on his mousetrap either (unless, perhaps, it truly is a better mousetrap).
If you fail to submit a reference that you are aware of that is deemed to be material to patent ability in patent litigation, then you risk losing the entire patent to inequitable conduct. However, many technical areas are so broad that an attempt to include all potentially relevant reference would require renting a truck for the weekend to haul all of the references to the USPTO for delivery. If you are an inventor or somebody most involved in the patent process from the technical side of things, it is best to provide your agent or attorney with any and all references (or citations) that you think could be relevant so that they can make the ultimate determination. You can assist in the process by highlighting to your representative any references you feel are especially relevant. In that manner, if there are a large number of references, the agent or attorney will be less likely to miss those that are most crucial. As a practical matter,you should be particularly alert to anything you or your colleagues have published on any subject matter related to what it is you now intend on patenting and also any priorart that you have taken into account when conceptualizing and/or reducing to practice your own invention. In this regard, you may have to fight any instinctual tendencies toward mitigating the contribution of others in your field toward the genesis of your own ideas—invention often does not involve, nor does it require, a spontaneous flash of genius. Most ideas are somehow related to or are in some way derived from other ideas, and it is important that you also consider any of your source materials when making disclosures to the patent office. Conversely, it is common to err in the opposite manner as well. Just because you did not use a particular piece of prior art in the development of your invention does not mean it is not material to patent ability. For example, you might have independently conceived of a compound and then later discovered that somebody else published very similar compounds. The mere fact that you did not know about his work or did not take his work into account when you made your discovery does not alleviate you from your duty of making that citation or reference available to the USPTO—it may not have been material to your invention but could still be material to the patent ability of your invention.
Beyond submitting any known prior art, parties of interest must confirm that the patent application is an accurate reflection of their invention. If statements or data characterizing the invention in the specification are relied on to support the patent ability of one or more of the claims in the patent application then those statements or that data need to be accurate and also should be representative of the claimed invention.This also applies to data and statements in declarations and related documents submitted to the patent office to support the patent ability of the claimed invention; selective disclosure of only favorable data while omitting contradicting data is frequently not a good idea (“when in doubt, send it out”).
To better appreciate the standard by which inequitable conduct is measured, let’sreview an actual recent court opinion, Bristol-Myers Squibb Company v. Rhone-Poulenc Rorer, Inc., where this issue was heard. This case serves to explain how materiality and intent are inextricably related. Perhaps less abstractly, it will also show why it is important for the scientists to pay close attention to what they publish as well as to documents that they are asked to review. This decision arose from an appeal from the U.S. District Court for the Southern District of New York (D-SDNY),which held the Rhone-Poulenc Rorer (RPR) patent relating to methods of preparingTaxol_R (hereinafter referred to by its generic name paclitaxel) as well as claiming key intermediates in the paclitaxel synthesis to be unenforceable due to inequitable conduct. A brief review of the facts of the case is presented next.
The patent at issue claimed a semi synthesis of paclitaxel as well as certain intermediates useful in that synthesis. Paclitaxel is a very popular drug for use in the treatment of certain cancers, including lung, ovarian, and breast cancers. The drug was originally discovered by the National Cancer Institute through screening samples from natural sources for cytotoxicity. It is interesting that paclitaxel was initially isolated from the bark of the Pacific yew tree in very low yields. For example, in one of the original isolations, 1200 kg Pacific yew bark had to be harvested to isolate just 10 g of paclitaxel. The naturally isolated material was tested and showed very promising activity in early clinical studies, but due to logistical and environmental concerns, it quickly became evident that an alternative method to produce the compound would be needed. The government looked to the pharmaceutical industry to form a partnership to provide the material and run the clinical trials necessary for FDA approval. In 1989, Bristol-Myer Squibb (BMS) was awarded the contract, and they were able to get the drug approved by the end of 1992. Although the drug is currently produced directly by a fermentation process and then isolated, there was an intermediate period where the drug was efficiently produced by semisyn the sis from a metabolic precursor, 10-deacetylbaccatin (10-DAB), a compound that could be isolated from a renewable source, the needles of the European yew.
Process claims for taxolsemisynthesis.).
When organic chemists use the term protecting groups, they are referring to groups of atoms that can be used to mask reactive functionalities when reactions at those functionalities are not desired. Once the desired reactive transformations are completed elsewhere on the molecule, the protecting groups can then be removed.The keys to successful protecting group strategy are that the groups must be able to be placed selectively onto the desired functionalities, that they remain where they need to be for the period when they need to be present, and they can be removed selectively at the end without causing unwanted changes elsewhere on the molecule. The more different types of functionalities a molecule has, the more complex the protecting group scheme can become. It is seldom easy to predict ahead of time with great certainty what combination of protecting groups will result in a successful synthesis.This is part of the art and challenge of organic synthesis. In this vein, it is important to appreciate the contextual nexus between the complexity of the taxol molecule with its densely functionalized skeleton and the very huge demand for the chemical semisynthes is of the molecule. For some time, this was a very hot area of research in both industrial and academic labs. The work described in the patent application summarized the culmination of some very successful chemistry of potentially high commercial and public health significance.
Figure : Process claims for taxolsemisynthesis.
The decision by RPR to patent the method came about when one of the discoverer’s of the method sent RPR’s patent counsel a draft publication that described the synthesis of paclitaxel from 10-DAB that they intended to submit for publication to the Journal of the American Chemical Society (JACS). Of particular note,the draft publication explained that the conversion of 10-DAB to taxol “could be successfully achieved only with specific protecting groups and under unique reaction conditions.” It also discussed some of the limitations of certain protecting groups as follows:
_ “A methoxymethyl [MOM] protecting group at C-2 could not be removed following esterification”
_ “The trimethylsilyl [TMS] group could also be selectively introduced at C-7,but it proved unstable to the subsequent esterification conditions”
_ “The tert-butyldimethylsilyl [TBDMS] group could not be cleanly introduced”at C-7.
The RPR patent agent working in France recommended that a patent application be filed before submission of the manuscript. The French patent agent drafted a patent application covering the subject matter and claim 1, which refers to a protecting group at R2, and R3 contained no limitation as to what type of protecting groups might be used. In claim 2, which depends from claim 1, the description is given that R2 is chosen from groups including the MOM-group, and R3 is chosen from groups including trimethylsilyl (this occurs where the alkyls are all C-1 (see the bolded portion of claim 2). This means that claim 2 explicitly included some of the protecting groups that the inventors stated in their JACS publication would not work.
Well, this oversight should have been no problem because the patent agent then sent a draft copy of the application to two of the inventors, asking them to carefully read it over and make any comments or changes as necessary. Of course one should probably only assume that they read the document over very carefully (everybody loves to read patent applications, right?) but it appears they still included more than they should have in their claims because the claimed protecting groups appeared to contradict the statements in their own JACS publication. Further compounding the error, the French patent agent sent the patent application for filing in the United States but did not send the then-published JACS paper to the U.S. attorney for submission or consideration as a possibly material reference. The patent attorney in the United States prosecuted the patent application without sending the reference, not least because the reference had never been brought directly to his attention. The patent eventually issued as 4,924,011.
In a subsequent action, RPR instructed a U.S. attorney to file a reissue application on their behalf. The reissue application included the original claims plus three additional claims to actual intermediates useful in the synthesis; the reissue application issued in 1993 and was assigned the number RE 34,277. It is interesting(but ultimately not dispositive to the CAFC’s decision) that the JACS reference was submitted during the reissue application proceeding, and the examiner signed off that he had seen the reference.
In 1995, BMS filed suit in the D-SDNY seeking a declaratory judgment that they did not infringe the RE 34,277 reissue patent and that in any event the patent was invalid and unenforceable.83 RPR then filed suit against BMS asserting in fringement in a different court, and the case was transferred for consolidation in the D-SDNY.During the initial court proceedings, the D-SDNY issued an opinion that by clearand convincing evidence, RPR had attained the RE 34,277 patent through inequitable conduct; therefore, the patent was unenforceable.84 RPR appealed the D-SDNY’sopinion to the CAFC, which upheld the D-SDNY’s opinion.
Before getting into the CAFC’s reasoning, let’s briefly recapture what the DSDNY found that RPR did wrong. Their primary sin, it seems, is that they did notsubmit the JACS reference to the examiner during the prosecution of the application that resulted in the issuance of 4,924,011—there is no doubt from the facts given that the French agent knew about the publication, but from these same facts, it does not appear that the U.S. attorney knew about it. Notice that RPR did submit the reference during the prosecution of the reissue application which was examined by the same examiner and is the actual patent that RPR is trying to enforce.
Here are some additional facts we should keep in mind as we review the basis for the D-SDNY’s decision as well as the CAFC’s upholding of that decision:
The primary mistake for RPR was that the French patent agent did not send the U.S. attorney prosecuting the case the JACS reference. Since intent to deceive is a basic requirement of a finding of inequitable conduct, then we need to take into account the entire context of the French agent’s actions to help glean that intent. In this regard it is helpful to understand that European patent law doe snot place an affirmative burden on the applicant to submit references to the
European patent office, either now or at the time this case took place. It would be hard to expect a French agent to have the same sensitivity and appreciation of this requirement as the U.S. practitioner.While this does not relieve the Frenchagent of his responsibility to comply with U.S. patent law, we still have to ask whether the failure to give the reference to the U.S. attorney was done with the specific intent of deceiving the USPTO or could have been an oversight.
The reference was not a typical prior art reference in that its disclosure did not affect the novelty of the invention. Patent attorneys and agents are naturally more attuned to looking and thinking about references in terms of how they affect the novelty and non obviousness of an invention, and this requires that the references be prior art. The JACS paper was not only not prior art (the paper was submitted after the patent application) but it disclosed information about how the inventors performed the synthesis, not whether the synthesis was noveland non obviousness in view of a prior art reference. Was the failure to think about the reference as a “material reference” despite it not being prior art and not relating to the novelty or non obviousness of the invention an intentional deception by the French agent or was it an oversight?
The USPTO examiner conducted an independent search of the subject matter,and in the search report, the JACS paper turned up—in other words, the examiner’s search identified the paper even though it was not submitted. Nevertheless,there was no evidence that he actually reviewed the reference but the search report was entered into the file. Remember that the U.S. attorney who understood the U.S. law and the affirmative burden it places on applicants did not know about the reference, the French agent did. The French agent would have seen the search report in the file and would have known that the U.S. examiner saw at least the abstract to the reference. If you were the French agent after having seen the JACS reference turn up in the examiner’s search report,might you have assumed the examiner looked at his own search report and if he had a question about any reference, asked the applicants?
In the reissue application, the U.S. attorney (this time a different attorney) prosecuting the case was informed by the French agent about the JACS reference,but even the U.S. attorney did not submit it initially. In fact, he informed the French agent by letter that the JACS reference would not affect the previously issued patent (4,924,011) because in his view it was not prior art (which is actual evidence of what was argued in point 2 above). In any event, he later submitted the reference, and the exact same examiner from the original patent who was now examining the reissue application, signed off on the reference and issued the reissue application with the same claims (plus three new ones).So in fact, how material did the reference turn out to be?
In its decision upholding the D-SDNY, the CAFC panel noted that its own precedent required both materiality and intent, and that if there was more evidence of one,there could be less evidence of another. In particular, the federal courts will more easily find intent where there is a high degree of materiality. In regard to whether the failure to submit the JACS reference was material, the CAFC noted that the reference was material because it called into question whether the applicants had provided adequate written description to get the first claim issued. In particular, they found the reference contradicted the scope of what they were claiming in the patent. Since it was a publication by some of the inventors themselves, one would expect the reference would be given extra weight in terms of the credibility of the assertions in the publication. In order for a patent to be granted, it must satisfy the written description requirement: The patent application must describe the claimed subject matter in such a way that one of ordinary skill in the art can make and use the claimed invention with out requiring undue experimentation. In this case, the JACS publication calls in to question at least some of the claimed scope of the invention. Clearly, the in vention was n’t completely inoperable but some non performing embodiments had been included in the claims; there were specifically claimed protecting groups that probably would not work for their intended purpose. Is this material to patent ability and if so,how material? The answer from the D-SDNY and the CAFC was yes and very much.But why did the failure to cite the reference in the first patent application count against the reissue application where the reference was submitted and the reissue patent still issued in view of the JACS reference? This is a good question that implicitly contains two separate questions. The first of the two questions might be,
Isn’t the reissue application a fresh start? The quick answer is no, once a patent issues and is contaminated by inequitable conduct, the damage cannot be undone through a reissue application. The second question, which requires more analysis, goes to the fact that the reference was reviewed under an actual examination, with the same examiner against the exact same claims, and the claims were found to be patentablein view of that reference. Does it matter that in the real-world examination that took place in the reissue application, the reference did not change the outcome of the patent ability of the claims? In addition, in the real-world litigation, the D-SDNY judge (the same judge who found inequitable conduct) refused to grant BMS’s request for summary judgment of invalidity of the patent for nonenablement. This means that the District Court did not believe that the sum of the evidence justified a conclusion,as a matter of law, that the claims were not enabled. Together, these facts might seem to be strong evidence of an actual low level of materiality for the failure to cite the JACS reference. However, in regard to materiality, there is a catch: The materiality of the reference must be judged in a perceived sense from the vantage point of a hypothetical examiner—not the particular examiner who actually examined the patent in question—as the panel in this opinion quoted from a previous decision from a similar case:
The standard to be applied in determining whether a reference is “material” is not whether the particular examiner of the application at issue considered the reference to be important; rather, it is that of a “reasonable examiner.” Nor is a reference immaterial simply because the claims are eventually deemed by an examiner to be patentable there over. (Molins PLC v. Textron, Inc., 48 F.3d 1172, 1179 (CAFC 1995)).
The CAFC further explained that their earlier decision in Molins also pertained to an affirmation of inequitable conduct, “notwithstanding that the withheld reference wa slater cited in a reexamination and the claims were allowed to issue.”
We recognize that [the withheld references] were cited eventually to the PTO and that the examiner initialed them and passed the reexamination application to issue there after.However, the references were not cited when they should have been. (Molins, Id at1182).
The CAFC dealt with the second argument regarding the District Court’s rejecting the defendant’s summary judgment motion for invalidity for noninvolvement by stating:
The issue of whether a reference would be considered important by a reasonable examiner in determining whether a patent application is allowable, including whether the invention is enabled, is a separate issue from whether the invention is actually enabled.In other words, considering whether a reference is material to enablement is not the same as the final determination of whether the invention is actually enabled. The legal determination of enablement versus nonenablement takes into account much more than any single reference but that does not mean that any single reference is not material.
The conclusion of inequitable conduct requires a finding of intent and materiality such that the overall formula might be represented by materiality × intent =inequitable conduct so that a higher value for materiality means a lower required intent. In effect, a higher level of materiality allows one to more easily conclude that the requisite intent was present. The putative reason for this is because intent can seldom be proven directly (absent a confession), but rather intent is inferred from the surrounding circumstances. As a practical matter, in terms of how the federal courts appear to apply the finding of intent, one of those surrounding circumstances is the materiality of the omission or commission in question.90 If a highly material item is omitted, one is more likely to assume that the omission was intentional because people are presumably less likely to unintentionally leave out important references and more over, the motivation for making a material omission or commission is present because there is a reason to do it; the person is trying to get a patent, and the act in question is deemed significant enough to affect that process. In contrast, if the omission or commission is of something inconsequential, then one is less likely to in ferintent because it is natural to pay less attention to insignificant details and the requisite motivation is less apparent. So from that sense, one can appreciate the CAFC’s logic by which they are reading materiality not so much from the standpoint of whether the omission of the reference was actually material but rather if it would have been judged material from the standpoint of the applicants at the time of their omission–it is their intent we are concerned with. Where the apparent materiality is high (even though the real materiality was not so high), then the Court is willing to infer the requisite intent to deceive; in this decision, the CAFC emphasized the hypothetical materiality as it should have been perceived by the applicants. The CAFC, in effect,appeared to attempt to place themselves into the applicant’s representative’s shoes and tried to approximate what the applicant’s representatives should or would have thought to do under those circumstances.
Until now, we have primarily focused on the omission by the French agent to submit the JACS reference but we also need to consider the role of the inventors as well, since we have already discussed that the affirmative duty to submit material information extends to them as well. We do know that the French agent was already aware of the JACS reference, but it probably would be too much to expect that inventors check to make sure their agent or attorney actually submitted the references to the USPTO. However one should expect that the inventors will review the draft of the patent application before it is submitted, to make sure that what is placed in the patent application is an honest appraisal of what the invention actually is and does. So this brings us to the view from the inventor’s perch. The inventors were the ones most familiar with the technology that was being patented. They knew, better than anybody,whether the patent application was an accurate description of the method that they intended to patent. So why didn’t they correct the patent application? If the patent application had been corrected, the likelihood of the reference being material would have decreased because they would not have been attempting to claim embodiments that their own reference specifically taught against trying.
This begs many questions regarding the context of the inventors, but that notwithstanding,you can now better appreciate that inequitable conduct is a real concern for inventors, agents, and attorneys. We cannot control the federal court jurisprudence,but we can try to make sure the inequitable conduct vulture never nests in any of our patents. As inventors or people involved in that end of the process, it is important that all references we have that might be relevant in any way to our invention are submitted to our attorney or agent. If we know that some of these references are particularly relevant, we need to explain very carefully how they are relevant. From the case we just discussed, we learned that relevant documents goes beyond prior art documents; any reference relating to the potential patent ability of our invention needs to be handed over to our agent and explained. We also learned that as inventors we have a duty to carefully read over everything our representative passes on to us related to the patent application. For example, patent application drafts are not something to simply be glanced at and then filed away. We inventors know the technical material in those patent applications much better than our patent representative, the draft in our hand is often just his best guess at what our invention is; we need to make sure that it is right. If we’re not sure about something, then we need to ask and not assume that something has been written a certain way for a special legal reason (please don’tgive your attorney too much credit!).
If you think you have the idea of inequitable conduct by now and prefer to move onto the next chapter then please feel free to do so. If however, you enjoy reading about the misfortunes of others who have seen their hard-won patents evaporate during litigation due to a finding of inequitable conduct then by all means, please read on. Our next case, Aventis Pharma S.A. et al. V. Amphastar et al., relates to recent generic drug litigation that did not go well for the company that discovered and built the market for their blood-thinning product. This opinion from the CAFC resulted from an appeal of a District Court’s finding of inequitable conduct against Aventis Pharmaceuticals for their prosecution of the patent covering their product marketed as Lovenox_R in the United States. Lovenox_R is a mixture of low molecular weight heparins that has been a highly successful antithrombotic agent. The defendant in this case, AmphastarPharmaceuticals, is a generic drug manufacturer that wished to market a generic version of Lovenox_R .Amphastar filed a paragraph IV certification (under Hatch-Waxman rules) alleging (among other things) that Aventis US reissue patent RE38,743 was obtained through inequitable conduct and was thus unenforceable (sound familiar?). During the prosecution of the RE 38,743 reissue, the patent examiner cited a prior art reference that he alleged disclosed the same composition that Aventis was trying to claim (thus alleging that it was not novel and thus not paten table),and even if it were not the same composition as what was in the prior art, it was close enough to be considered obvious (and thus not paten table). To try to overcome the examiner’s rejection, Aventis relied on declarations from one of its research
directors (who incidentally was not one of the listed inventors). To establish that their claimed material defined a different product, the research director explained that their composition had a longer half-life, but apparently what he did not say was that the half-life comparison was done at a different dose. The Aventis mixture used for the comparison submitted to the USPTO was tested at a dose of 40 mg,and the product prepared by the prior art process was tested at 60 mg. The examiner still rejected the application asserting, in part, that the differences in half-life were not statistically significant. In response, a second declaration was submitted by the same Aventis research director. In this second declaration, the researcher submitted a the past tense indicate that the experiments were actually carried out. It’s a thin but deep line. Clearly separating what actually has been done from what could be done or what has sort of been done is a good start. The biggest challenge might be in describing experimental procedures in which most of it has occurred as written, but perhaps different experiments have been combined since multi step procedures are often not done in a linear fashion. There is no one size fits all way to address this situation other than to clearly delineate the preparation and testing of examples and to not imply something has been done that has not.
Number of tables containing the raw data of the mean half-life comparisons together with statistics showing that they were statistically significant. The dose of the A vent is compound could be found in the table, but the dose of the prior art mixture was not given. The District Court found inequitable conduct because the half-life was material to patent ability, that there was a strong inference of intent to deceive the USPTO because it found no credible reason for comparing the two materials at different doses and because comparisons at the same dose actually showed very little difference (and the applicants knew this). On appeal to the CAFC, Aventis argued(among some other things) that the District Court erred because:
If the dosing was material, the examiner would have asked what the dose of the prior art composition was.
Half-life comparisons are often done at different doses.
Half-life is typically independent of dose.
Aventis also argued that they had, in fact, informed the examiner that the halflives were determined at different doses because in the first declaration, the Aventis declarant stated: “this represents an increase of 250% in the half-life and is very significant because it enables the same effect to be achieved at a lower dose.
Un fortunately for Aventis, the CAFC upheld the District Court and also decided against Aventis; they simply were not convinced that leaving out the dosage of the composition they were testing against was in advertent. The problem for Aventis wasthat even if it were inadvertent, the whole thing looked suspicious because every other dose of their compound compared had the same half-life as the prior art compound.As the District Court had stated, “[the half-life justification] was incredible because:
there was no statistical difference in half-lives when the 60 mg dose of [the priorart composition] was compared to the patented composition at a 20 mg, 60 mg or80 mg dose, i.e., there was a statistical difference only when a 40 mg dose of the patented compound was compared” (emphasis added). If Aventis was trying to prove their claimed composition was different than the prior art composition, they needed to do so at the same dose. If the half-life was different between the two compositions at the same dose, then that would establish that they were different. Further, the CAFC pointed out that “Even if we acknowledge that half-life data at other doses for the patented compound were provided to the examiner, the date were provided in a very mis leading way.”
The CAFC decision was not unanimous. The dissenting judge opined that in equitable conduct should be reserved for only the “most extreme cases of fraud and deception” and that the threat of inequitable conduct was an “atom bomb” remedy,presumably more useful as a threat then actually used. The dissenting judge argued that inequitable conduct has taken on a “new life as a litigation tactic.” In supporting his policy views, the dissenting judge harkened back to a previous case in which the CAFC had referred to the use of the inequitable conduct as a “plague.”
The plague of inequitable conduct litigation, the dissenting judge highlighted the fact that the CAFC took the case Kings down Med. Consultants, Ltd. V. Hollister, Inc.96en banc, specifically to deal with that issue. In revisiting Kings down, the dissenting judge averred that “inequitable conduct was not a remedy for every mistake, blunder or fault” in patent prosecution. Particularizing his criticism, the dissenting judge pointed out that the CAFC (and presumably the district courts) were allowing the materiality of the offense to completely swallow the intent requirement. What might be simple mistakes in the patent prosecution process have resulted in findings of inequitable conduct because the mistake allegedly was material to the patent ability even when the mistake was clearly not intentional, and even if intentional, it wa shard to justify the “atom bomb” of inequitable conduct. Turning his attention to the facts of the instant case, the judge highlighted the fact that the data the declarant sub mitted were from a clinical study chart that the declarant did not prepare himself .Rather he explained the chart as it appeared to him; he did not intentionally conceal data that were already on the chart, the data were not there and he did not add to them. Acknowledging that such an omission might be negligent, the dissenting judge opined that it did not rise to the standard of intent.
Not mentioned by the dissenting judge but something worth highlighting given the gist of this text is that the declarant whose conduct resulted in the non enforceability of this very important patent was not a lawyer. He most likely was not aware of U.S. federal court law as it relates to inequitable conduct. We do not know if his agent or attorney explained to him his duty in light of the declaration he was signing.Perhaps if the attorney had gone carefully over the declaration, he might have caught the omission, but he did not. As scientists, we may not know the law of in equitable conduct (but we hope you know a little more now), but that does not alleviate us from the duty of candor and disclosure with the USPTO. Being clever in our day-to-day life is normally a good thing but is not always a good thing in the patent procurement process. Because of the ever-shifting quicksand nature of inequitable conduct, the only safe advice is to be completely open and forthcoming in your dealings with both your agent or attorney and the USPTO.
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