Lead Opinion
Ferring B.V. (“Ferring”) and Aventis Pharmaceuticals, Inc. (“Aventis”) brought suit against Barr Laboratories, Inc. (“Barr”) for infringement of Ferring’s patent, U.S. Patent No. 5,407,398 (filed Dec. 17, 1985) (“ ’398 patent”). Barr moved for summary judgment, arguing that the ’398 patent was unenforceable due to inequitable conduct and, alternatively, that Barr did not infringe the’398 patent. The district court granted summary judgment on both grounds. We affirm the district court’s grant of summary judgment on the ground that the patent is unenforceable due to inequitable conduct, and we do not reach the issue of infringement.
BACKGROUND
Ferring patented a medicinal compound and a method of administering said compound. Specifically, claim one of Fer-ring’s ’398 patent (the independent composition claim) claimed an “antidiuretic composition for humans comprising a gas-trointestinally absorbable, antidiuretically effective, amount of [the peptide] 1-deam-ino-8-D-arginine vasopressin and a phar-maceutically acceptable carrier in solid oral dosage form for absorption in the gastrointestinal tract of said humans.” ’398 patent at col.4 1.23-29. 1-deamino-8-D-argiriine vasopressin and other compounds were known in the art to prevent the diuretic symptoms associated with diabetes when they were absorbed through the walls of the patient’s mouth via a dissolving tablet, or through the patient’s nasal passage via a liquid spray or plastic tube. However, such modes of administering the medicine proved cumbersome and time-consuming. Therefore; the claimed solid oral dosage form of the compound and method of administering it were thought to be an improvement over thé prior art, because the medicine was designed to be simply swallowed and absorbed through the gastrointestinal tract. As the inequitable conduct claim arises from the prosecution history of the ’398 patent, we will begin there.
I
On December 17, 1985, Hans Vilhardt and Helmer Hagstam filed an application for the ’398 patent.
In response, on June 12, 1986, Vilhardt, through his counsel, submitted four declarations including two from Vilhardt himself, one from a Dr. Myron Miller, and one from a Dr. Paul Czernichow. These declarations each relayed the writer’s scientific belief that the term “peroral” in the ’491 patent meant that the compound could be administered “through the mouth,” but only for absorption through the cheek of the mouth or under the tongue. However, the declarations failed to disclose that Czernichow had been receiving research funding from Ferring from 1985-86.
Despite the declarations, on November 13, 1986, the examiners rejected certain claims of the ’398 patent as anticipated or obvious over the ’491 patent: The rejection stated: “As Applicants are the exclusive licensee of the Zaoral [’491] patent, it is obviously expeditious for Applicants to argue that ‘peroral’ referred to in the [’491] patent referred only to sublingual or buccal routes, whereas the instant mode of administration excludes such routes as it involves absorption by the gastrointestinal tract.” J.A. at 4390.
The inventors requested reconsideration after which a new examiner, Examiner Siegel, reaffirmed the rejections. Examiner Siegel stated that the ’491 patent “clearly teaches orally administering said vaso-pressin,” and that “oral administering of a drug ... unambiguously means gastrointestinal absor[p]tion.” J.A. at 3067.
On November 13, 1987, the inventors appealed this rejection to the Board of Patent Appeals and Interferences (“Board”). On September 21, 1990, the Board accepted the declarants’ view that, as a general rule, the “peroral” administration of a peptide would not be read in the art as suggesting the administration for gastrointestinal absorption. This is because peptides are normally “hydrolyzed in the stomach and it would be expected that their biological activities would be lost” prior.to gastrointestinal absorption. J.A. at 3688. Thus, the ’491 reference standing alone would not anticipate the applicant’s claims regarding the peroral administration of the peptide. However, the Board determined that the applicants’ claims were obvious over the ’491 patent in light of an article written by Ivan Vavra in 1973. Vavra disclosed that l-deamino-8-D-argi-nine vasopressin is structurally unique among peptides in that it does not degrade quickly. The Board found that although the term “peroral” may not usually suggest the gastrointestinal absorption of a peptide, the ’491 patent’s disclosure of the “peroral” administration of l-deamino-8-D-arginine vasopressin, when combined with Vavra’s disclosure that this peptide is slow to degrade, would render the applicant’s claims obvious. The Board thus affirmed the examiners’ obviousness rejection. However, because the examiners had not relied on the Vavra reference, the Board designated its decision as “a new rejection under the provisions of 37 C.F.R. [§ ] 1.196(b),” and explained that the applicant could “elect to have further prosecution before the examiner in response to the new rejection ....” J.A. at 3690.
Vilhardt communicated with each of these declarants before their declarations were submitted to the PTO. Vilhardt also sent Barth a “draft declaration.” While it is unclear exactly what was contained in the draft declaration, Vilhardt admitted that he gave Barth “some lines,” telling him “what he should describe in the affidavit.” J.A. at 5544. Vilhardt also sent Robinson a “draft declaration.”
In sum, four of the five declarations submitted to the PTO in 1990 were written by scientists who had been employed or had received research funds from Ferring, and Vilhardt participated in the drafting of two of the four declarations submitted by non-inventors. The examiners were not otherwise made aware of the Ferring connections. After these declarations were submitted, the examiners allowed the previously rejected claims, and the ’398 patent issued on September 10, 1991. The PTO did not provide any explanation for its allowance.
II
Ferring exclusively licensed the right to market and sell its patented antidiuretic compound to Aventis.
The undisputed evidence in this case supports the finding of inequitable conduct by the patentee and its agents and the grant of summary judgment. The reluctance of the PTO to issue the ’398 patent was evident. Each affidavit submitted in support of its issuance was thus highly material to the prosecution history. That three of the challenged declarations were submitted after several iterations of rejected attempts to obtain the patent’s issuance speaks loudly as to motive and intent. While credibility determinations from a courtroom observation may at times be necessary on the issue of intent, here, the entire record presents clear and convincing evidence of an intent to mislead the examiners, even viewing the evidence, as it must be viewed, in the light most favorable to Plaintiff. The submission of the Czernichow and Robinson declarations, and to a lesser extent that of Barth, support a finding of intent to mislead the PTO.
J.A. at 18. The court specifically found that “it must have been clear to Dr. Vil-hardt at the preliminary meeting with the examiner that a non-inventor affidavit was sought for purposes of obtaining objective evidence that the invention was not anticipated by the prior art or obvious.” J.A. 16 (emphasis added). Ferring and Aventis timely appealed.
DISCUSSION
Appellants argue that the district court erred in granting summary -judgment to Barr on both the issues of inequitable conduct and infringement. Because we find that the district court properly granted summary judgment to Barr on the inequitable conduct ground, we do not reach the infringement issue.
“Inequitable conduct occurs when a patentee breaches his or her duty to the PTO of ‘candor, good faith, and honesty.’ ” Warner-Lambert Co. v. Teva Pharms. USA, Inc.,
I
We first consider the district court’s determination that there were no genuine issues of material fact with respect to materiality and intent. Our review.in this respect is without deference. Dayco Prods.,
A. Materiality
For patent applications that have been prosecuted prior to 1992, we have held that “[ijnformation is deemed material if there is a substantial likelihood that a reasonable examiner would have considered the information important in deciding whether to allow the application to issue as a patent.” Li Second Family L.P. v. Toshiba Corp.,
The general law of evidence has long recognized that the testimony of any witness may be rendered suspect by a past relationship with a party.
In Refac, the PTO examiner rejected an application because it did not sufficiently enable one skilled in the art to make the invention.
In Paragon, the examiner requested “disinterested third party” declarations and when the inventors submitted the declarations, they failed to disclose that one of the declarants owned stock in the assign-ee’s company at the time of his declaration and had previously been a consultant for the company.
Here, appellants argue that the Ferring affiliations of declarants Czernichow, Robinson, and Barth, were immaterial as a matter of law because (1) those affiliations supposedly did not bear directly on the critical assertion that each made in his declaration, meaning that the relationships were not the source of the information in the declarations, and (2) the declarants did not have a direct financial stake in the success of the patent.
Our jurisprudence does not suggest such a narrow view of materiality.
First, we agree with the district court that the declarations themselves were “highly material.”
Second, we think it is equally clear that the summary judgment record shows that the past relationships were significant. Most significantly, one of the declarants, Robinson, was the research director at Ferring at the same time that Vilhardt was serving as a consultant to Ferring and was conducting his research on the very peptide at issue. Robinson was also a paid consultant for Ferring in the year immediately prior to his declaration. Czernichow was receiving research funding from Fer-ring at various points throughout the prosecution of the' ’398 patent and directly received funding before and after his 1986 declaration and continuing at least to the period immediately before his 1990 declaration. Finally, while Ferring may not have made payments to Barth personally, Ferring did fund Barth’s research projects through Barth’s employer. The privilege logs submitted by Ferring refer to all three of the declarants as “Ferring Consultants.”
These relationships were not isolated, nor were they confined to the distant past. The declarants clearly had ongoing and mutually beneficial relationships with Fer-ring during the prosecution of the ’398 patent. In particular, Robinson’s prior position as Ferring’s research director and his subsequent' consultant work for Fer-ring were extremely significant affiliations. The declarants were not disinterested. See Refac,
Under such circumstances, the applicant is on notice as to the materiality of information regarding the declarants’ ties to Ferring. Of particular relevance here, we found in Refac that an examiner’s characterization of the inventor’s affidavit as “self-serving” put the inventors “on notice ... that affidavits from disinterested persons were needed in order to overcome the substantive ground of the rejection.” Id. at 1581-82 (emphasis added). Here, on summary judgment the district court was correct to conclude as a matter of law that the examiners’ request for non-inventor declarations was for declarations from individuals without intimate ties to the inventors or Ferring itself. The court could conclude from the record as a matter of law that this concern was pertinent to the further affidavits submitted following remand by the Board since the central concern was still the ’491 patent as prior art whether alone or in combination with the Vavra reference.
Finally, on the issue of materiality, appellants argue that they could have, at trial, presented evidence to raise a fact issue concerning either the significance of the experts’ views or the significance of the past relationships. But the appellants presented no such contrary evidence in response to the summary judgment motion. As we discuss below in connection with the issue of intent, the appellants cannot raise a genuine issue of material fact by speculating as to what evidence might have been introduced at trial.
Thus, the district court correctly determined that the undisputed facts established a threshold showing of materiality; indeed, the record established that the undisclosed information at least in the aggregate was highly material as a matter of law.
B. Intent
Even if an omission is found to be material, the omission must also be found to have been made with the intent to deceive. “Materiality does not presume intent, which is a separate ' and essential component of inequitable conduct.” GFI,
We need not in this case attempt to lay down a general rule as to when intent may be or must be inferred from the withholding of material information by an applicant. Suffice it to say that we have recognized, in cases such as Paragon, that summary judgment is appropriate on the issue of intent if there has been' a failure to supply highly material information and if the summary judgment record establishes that (1) the applicant knew of the information; (2) the applicant knew or should have known of the materiality of the information; and (3) the applicant has not provided a credible explanation for the withholding. See Bruno Indep. Living Aids,
First, Barr established that Vilhardt knew of significant past relationships of at least two of the declarants. Vilhardt was aware that Robinson was Ferring’s preclinical; research director while Vilhardt was serving as a consultant to Ferring researching the very peptide at issue. Robinson served as Vilhardt’s contact at Ferring during this time. Vilhardt was also aware of Bath’s affiliation with Fer-ring. Although he testified that he did not believe that Barth was a Ferring “consultant,” he indicated that he was aware of a working arrangement between Ferring and Barth’s employer under which Ferring had funded support for Barth’s research. Additionally, as Ferring notes in its brief, “[bjetween 1988 and 2000, [Barth] worked a month most years in Dr. Vilhardt’s laboratory for which he was paid a maintenance stipend.” Ferring’s Br. at 28.
As to the second question — Vilhardt’s knowledge of the materiality of the information — it is undisputed that the examin
Finally, the appellants urge that there is potentially a credible explanation here for the withholding. The crux of appellants’ argument is that there are possible benign explanations for the withholding and that evidence might have been developed at trial to support those theories. Thus, appellants assert that it was improper for the district court to grant summary judgment to Barr “without seeing or hearing from the accused Dr. Vilhardt,” Aventis’ Br. at 34, and complained that “Barr’s counsel did not ask Dr. Vilhardt or any other declarant a single question which would bear on the issue of intent.” Ferring’s Br. at 30. We find this argument to be quite remarkable. On summary judgment, in order to create a genuine issue, the appellants bore the burden of submitting an affidavit from Vilhardt to contradict the movant’s evidence of intent if they believed that testimony from Vilhardt would establish credible evidence for the withholding.
Appellants’ specific arguments fare no better. Appellants argue that Vilhardt, as a foreign scientist, was not familiar with patent prosecution, and therefore would not have known of “some obligation to disclose declarants’ associations with Fer-ring.” Aventis’ Br. at 28. There is no record evidence supporting Vilhardt’s lack of knowledge.
Appellants also argue that “there was no reason for Dr. Vilhardt, a foreigner and non-lawyer, to have understood the examiner to be requesting declarations from persons with no relationship to Ferring.” Aventis’ Br. at 25. Here again, appellants offered nothing to support such an inference. As we have already discussed in Refac, once the examiner discounts an affidavit for bias, the applicant is deemed to be on notice that a disinterested affidavit is required.
In short, appellants’ argument concerning credible explanations consists entirely of speculation. Conclusory allegations and attorney arguments are insufficient to overcome a motion for summary judgment. Biotec Biologische Naturverpackungen GmbH & Co. KG v. Biocorp, Inc.,
Far from there being a credible explanation for the withholding, there is evidence in the summary judgment record supporting a conclusion that the past relationships were deliberately concealed. Although Vilhardt (who was already known by the examiners to have an affiliation with Fer-ring) submitted a CV with his declaration which disclosed that he had previously been the Research Director at Ferring, Robinson’s declaration came with no CV and no indication that he was recently Ferring’s Research Director. Likewise, Barth’s declaration was submitted with no CV. Unlike the others, Czhernichow’s declaration was accompanied by an extensive CV. However, it failed to mention his research funding from Ferring. Under similar circumstances, we concluded that the omission of prior employment with the pat-entee supported a showing of intent. See Refac,
We conclude that the district court properly granted summary judgment on the issue of intent.
II
Having found that there were no genuine factual disputes with respect to the issues of materiality and intent, we turn to the question whether the court properly weighed materiality together with intent to determine that the conduct was “inequitable.” We review the district court’s ultimate finding of inequitable conduct for abuse of discretion. See Kingsdown Med. Consultants, Ltd. v. Hollister Inc.,
In evaluating the conduct here, we note again that the omitted affiliation with respect to Robinson in particular was highly material since Robinson had actually been employed by Ferring. So too there was not simply a single omission. Rather, there were multiple omissions over a long period of time — a fact that heightens the seriousness of the conduct. See Refac,
In coming to this conclusion, we fully recognize that inventors often consult their colleagues or other persons skilled in the art whom they have met during the course of their professional life. Accordingly, when an inventor is asked to provide sup
CONCLUSION
For the foregoing reasons, the decision below is affirmed.
AFFIRMED
COSTS
No costs.
Notes
. Inventors Vilhardt and Hagstam had been employed by Ferring and, in 1984, they assigned all of their prospective rights to the '398 patent to Ferring. Prior to the prosecution at issue, the inventors had twice filed applications for their invention, and both times their application was rejected as anticipated or obvious over U.S. Patent No. 3,497,-491.
. Czernichow testified that he was not receiving funding from Ferring in June 1986, when he submitted his first declaration.
. It is unclear from the record whether Czer-nichow was receiving research funding at the very time he drafted his second declaration.
. The salt form of l-deamino-8-D-arginine vasopressin, "DDAVP,” is the actual product at issue here. Ferring and Barr disagree as to whether DDAVP is covered by the ’398 patent. Because our opinion is confined to the inequitable conduct issue, we do not reach Barr's non-infringement claim, which would require us to resolve whether DDAVP is covered by the patent.
. See, e.g., GFI, Inc. v. Franklin Corp.,
. Although the PTO amended the language of 37 C.F.R. § 1.56 in 1992, we have continued to use the pre-1992 language regarding materiality for evaluating patents that were prosecuted before the amendment. See Dayco Prods.,
. See United States v. Robinson,
. Contrary to appellants' assertions, Juicy Whip v. Orange Bang, Inc.,
. "While it is not necessary to cite cumulative prior art because it adds nothing to what is already of record (although it may be prudent to do so), one cannot excuse the submission of a misleading affidavit on the ground that it
. Appellants argue that "Refac in fact held that, even after trial when credibility could be and was weighed, omitted disclosure of prior contacts that two PTO declarants [ (Bullen and Cikra) ] had had with the assignee of the patent in question did not suffice for materiality or intent, and did not constitute inequitable conduct.” Ferring’s Br. at 31. This is a misrepresentation of Refac 's holding. There was no issue on appeal in Refac as to whether the omitted disclosure of the prior contacts of these two declarants was inequitable conduct. Our opinion simply described the district ■court's opinion.
. See also Warner-Lambert Co.,
. The record is unclear as to whether Vil-hardt was aware of Czernichow’s longstanding relationship with Ferring.
. Appellants argue that the district court improperly made credibility findings concerning Vilhardt on summary judgment. TypeRight Keyboard Corp. v. Microsoft Corp.,
. The situation here is quite different from that in In re Harita,
. Anderson v. Liberty Lobby, Inc.,
. Barr’s evidence that Vilhardt was involved in the drafting of the declarations consists of Vilhardt’s own deposition testimony that he sent “draft declarations” to both Barth and Robinson, as well as statements by Czerni-chow and Barth indicating that they did not write all parts of their declarations.
. See, e.g., Scholle Corp. v. Blackhawk Molding Co., Inc.,
. For example, an inventor is required to provide the Patent Office with all prior art references known to the inventor that are "material to patentability”; if the inventor provided selected references, he was accused of inequitable conduct in the selection; and if he provided an entire search report, he was accused of burying the significant references. The inventor was also required to provide a one-sentence statement about each reference that he listed; much was made of whatever was and was not in that sentence.
Dissenting Opinion
dissenting.
“Inequitable conduct” in patent practice means misconduct by the patent applicant in dealings with the patent examiner, whereby the applicant or its attorney is found to have engaged in practices intended to deceive or mislead the examiner into granting the patent. It is a serious charge, and the effect is that an otherwise valid and invariably valuable patent is rendered unenforceable, for the charge arises only as a defense to patent infringement.
As this litigation-driven issue evolved, the law came to demand a perfection that few could attain in the complexities of patent practice. The result was not simply the elimination of fraudulently obtained patents, when such situations existed. The consequences were disproportionally pernicious, for they went far beyond punishing improper practice. The defense was grossly misused, and with inequitable conduct charged in almost every case in litigation, judges came to believe that every inventor and every patent attorney wallowed in sharp practice. This history was recently summarized as follows:
As is known, about 20 years ago inequitable conduct was frequently pleaded as a defense to patent infringement; a patent that is “unenforceable” due to a finding of inequitable conduct is dead. The defense was so misused by alleged infringers that the Federal Circuit once called this defense a “scourge” on U.S. patent litigation .... The famous Kings-down seemed to put a stop to the defense of inequitable conduct....
Michael D. Kaminski, Effective Management of U.S. Patent Litigation, 18 Intell. Prop. & Tech. L.J. 13, 24 (2006) (footnote omitted) (citing Kingsdown Med. Consultants, Ltd. v. Hollister, Inc.,
My colleagues on this panel have regressed to that benighted era, rejecting the efforts of Kingsdown to bring objectivity to charges of inequitable conduct, instead reviving the culture of attack on inventor rights and attorney reputations based on inference and innuendo. My colleagues, endorsing several novel and unsupportable presumptions of wrongdoing, do injury to the reasonable practice of patent solicitation, even as they defy the rules of summary judgment.
This is not hyperbole. Practitioners from an earlier era well recall the adverse impact on industrial innovation when patents were not a reliable support for commercial investment, based in part on the judicial belief that patents and their practice were seriously flawed. With invalidation of most of the patents that reached the courthouse, the contribution of a di
The Federal Circuit recognized that specious charges of inequitable conduct were a disincentive to technologic innovation, and in Burlington Indus. v. Dayco Corp.,
In Kingsdown, the Federal Circuit held that in order to invalidate a patent for inequitable conduct in obtaining the patent, there must be both a material misrepresentation and intent to deceive. The court established that it is necessary to consider all of the evidence including evidence of good faith, and that both materiality and deceptive intent must be proved by clear and convincing evidence. Kings-down established that no longer would negligence alone support a holding of inequitable conduct. The Federal Circuit did not believe that inventors and patent attorneys are more or less virtuous than anyone else; they simply held that charges of deceptive action must be proved on objective standards, as the law requires for property-forfeiting charges under the common law. Experience shows that Kings-down ’s simple changes in the law were an important contribution to restoration of the patent system as an incentive to industrial innovation, for this court has recognized that a “ ‘patentee’s oversights are easily magnified out of proportion by one accused of infringement.’ ” Northern Telecom, Inc. v. Datapoint Corp.,
Today my colleagues on this panel not only ignore Kingsdown and restore a casually subjective standard, they also impose a positive inference of wrongdoing, replacing the need for evidence with a “should have known” standard of materiality, from which deceptive intent is inferred, even in the total absence of evidence. Thus the panel majority infers material misrepresentation, infers malevolent intent, presumes inequitable conduct, and wipes out a valuable property right, all on summary judgment, on the theory that the inventor “should have known” that something might be deemed material. The panel majority,
The Accused Conduct
The examiner, at an interview at'which the inventor Dr. Vilhardt was present, asked for “non-inventor” affidavits on the meaning of “peroral” and its significance to the claimed invention, apparently in accordance with the PTO custom that an inventor’s statements are not adequate.
Dr. Paul Czernichow was a world renowned pediatric endocrinologist, Professor of Pediatrics at the Hospital des En-fants-Malades, Paris, and had published 106 papers. The record states that Fer-ring had provided equipment used in a clinical trial that Dr. Czernichow had previously conducted at the hospital. He received no remuneration from Ferring for this trial, and was not paid for his affidavit. Although the majority makes much of his “extensive CV” that fails to mention the funding for the clinical trial, the majority fails to point out that 25 of the 28 pages of his CV list his publications, and the first 3 pages — where his qualifications, work experience and honors are listed— are organized such that one would not expect partial funding for a research project to appear. The most reasonable inference, to which Ferring is entitled on summary judgment, is that Dr. Czemi-chow’s relationship with Ferring was so remote as to not be worthy of a listing in his CV. Further, as my colleagues acknowledge, the summary judgment record contains no evidence that Dr. Vilhardt was aware of this prior relationship. Indeed, the only evidence on this issue is his answer upon being asked whether he knew whether Dr. Czernichow had been a Fer-ring consultant: “Not to my knowledge, no, but whether he had some kind of grant from Ferring I wouldn’t know, but I never heard him described as a consultant.”
Dr. Tomislav Barth was a Professor at the Academy of Sciences of the Czech Republic in the Department of Organic Chemistry and Biochemistry, with twenty-five years of experience in the fields of peptide biochemistry, metabolism, pharmacology and pharmacokinetics. The record states that Ferring had made research grants to the Czech Academy of Sciences, and that Dr. Barth worked on such projects, although he was not compensated by Ferring. Dr. Barth later did some experimental work for Ferring for “allowances and accommodation and costs,” but he was not engaged in such work at the time of his declaration and was not paid for his affidavit. There is no evidence in the summary judgment record that Dr. Vilhardt was aware of this prior affiliation, apart from his speculation during questioning
Dr. Myron Miller was the Chief of Geriatric Medicine at the Veterans Administration Medical Center in Syracuse, New York, and had published 111 scientific papers. The record shows no research or employment relationship with the applicant, and none is asserted. Dr. Miller submitted two declarations, one to define “peroral” and one concerning gastrointestinal absorption. He was not paid for these statements.
Dr. I.C.A.F. Robinson, a neurophysiologist and an expert in neurophysin chemistry, was at the time of his declaration the head of the Division of Molecular Neuroen-docrinology at the National Institute for Medical Research in London; he held a doctorate in endocrinology from Oxford University and had published 161 scientific papers. Dr. Robinson worked for Ferring as director of pre-clinical research for one year from 1985-86, and as a paid occasional consultant until 1989. He too was not paid for his statements, and by the time of his 1990 declaration, his consulting relationship with Ferring had ended. His declaration was not submitted in response to the examiner’s request for “non-inventor” testimony in 1986; it was filed four years later, after the Board had affirmed the applicant’s interpretation of “peroral” and entered a new rejection based on obviousness.
In short, the summary judgment record consists of declarations by four respected non-inventor scientists, three of whom had a scientific relationship with Ferring, and Dr. Vilhardt knew of only one of these affiliations — Dr. Robinson’s affiliation that was omitted from a declaration submitted after the relationship ended and four years after the examiner’s request for “non-inventor” testimony. There is no evidence, or even an allegation, that any of these scientists had anything to gain or lose as a result of the issuance of the ’398 patent. The finding of the panel majority that all of the affiants had “intimate ties” with the patentee is a mischaracterization, and the inference that their scientific opinions may be biased and were submitted with deceptive intent is a travesty. Further, such a charge of malfeasance cannot be decided adversely on summary judgment. See generally IV Wigmore on Evidence § 1104 (3d ed.1957) (every witness is in law assumed to be of normal moral character for veracity). There is simply no evidence of any intention to withhold these relationships; in fact, there is no evidence that Dr. Vilhardt even thought about whether or not to disclose these affiliations, much less that he made the deliberate decision to withhold material information from the PTO. Indeed, the professors’ reputations are enough, on the face of their scholarship, to put into dispute the panel majority’s summary judgment that they deliberately concealed information that was important to the credibility of their affidavits.
Nonetheless, my colleagues, without inquiry or evidence, rule that deceptive intent must be inferred. The panel majority posits that the examiner was necessarily misled, and intentionally so, by the absence from their affidavits or curricula vitae of these relationships. The majority reaches this conclusion that clear and convincing evidence of materiality and intent are established, not upon considering and weighing the particular facts, but by adverse inference and presumption, on summary judgment. That is not the law of inequitable conduct, and it is not a reasonable application of any of the rules and protocols of evidence. See Baker Oil
Materiality
The issue here is not patent validity. The panel majority’s finding of “materiality” is not substantive scientific materiality, but materiality per se of the relationship of the affiant to the applicant. There is no evidence or assertion that any of the affi-ants mis-defined “peroral” or presented a false opinion, or that the examiner was deceived by the information provided or not provided, or that these scientists provided misinformation or deliberate omissions in order to deceive the examiner. There is no evidence that the examiner, in asking for the views of “a non-inventor,” was asking for or expecting the views of a stranger to the applicant.
The panel majority places great weight on the cases of Paragon Podiatry and Refac, where, on quite different facts, the court found deliberate misrepresentation of the relationship of an affiant for deceptive purposes. These cases do not support the sweeping inference now applied. In Paragon Podiatry Lab., Inc. v. KLM Labs., Inc.,
The panel majority misreads these cases as holding that prior employment history is always material if (1) the declarant’s testimony is material and (2) the prior affiliation is “significant.” Given the minimal affiliations found “significant” in this case, and the majority’s holding that affidavits are always material, under the majority’s rule the negligent omission of a past affiliation with an applicant will always be inequitable conduct. Neither Paragon nor Refac supports a broad rule that past affiliations are always material, whatever those affiliations and whatever their relation to the subject matter. To the contrary, these cases were analyzed and findings made in accordance with the Eingsdown criteria. Materiality requires evidence, as does deceptive intent. The panel majority’s new per se rule is contrary to precedent, contrary to the rules of
Paragon and Refac, like all precedent in this area, illustrate that questions of materiality and intent are factual in nature, and that per se inferences of bad faith and deception are improper. In Juicy Whip, Inc. v. Orange Bang, Inc.,
Whether a past relationship between a declarant and the patent applicant is material to patentability depends on the facts of the relationship and the nature of the declaration. It is not per se material; and failure to explain the relationship is not per se deception. Indeed, it is rare that any scientist working in a specialized field would not have interacted professionally with other scientists and with the industries in that field. Such relationships do not warrant an inference of bias and deception. There must be evidence and analysis, not innuendo. Scientific integrity should not be impeached by per se rules without foundation.
On the facts of this case, where the declarants provided a text-book definition of “peroral” and their scientific opinion of the gastrointestinal behavior of the product, the past connections of these declar-ants do not establish per se material misrepresentation. “Information is material if a reasonable examiner would have considered it important to the patentability of a claim.” Regents of Univ. of Cal. v. Eli Lilly & Co.,
Intent
In cases involving an omission of material information, “there must be clear and convincing evidence that the applicant made a deliberate decision to withhold a known material reference.” Baxter Int’l, Inc. v. McGaw, Inc.,
In its motion for summary judgment, Barr put forward no evidence of deceptive intent. Nonetheless, the majority holds that clear and convincing evidence of deceptive intent may be inferred on summary judgment where the record establishes that the applicant “knew or should have known” that omitted information was material. The majority’s ruling is directly contrary to Kingsdown, which held that even gross negligence may not establish deceptive intent, and that “the involved conduct, viewed in light of all the evidence, including evidence indicative of good faith, must indicate sufficient culpability to require a finding of intent to deceive.”
The majority cites Bruno Indep. Living Aids and Critikon, Inc. to supports its proposition that the court has recognized
in cases such as Paragon, that summary judgment is appropriate on the issue of intent if there has been a failure to supply highly material information if the summary judgment record establishes that (1) the applicant knew of the information; (2) the applicant knew or should have known of the materiality of the information, and (3) the applicant has not provided a credible explanation for the withholding. See Bruno Indep. Living Aids,394 F.3d at 1354 ; Critikon, Inc.,120 F.3d at 1257 .
Maj. op. at 1191. That is an inaccurate summary of precedent. Paragon involved an affirmative misrepresentation, not an omission, and that case contains no suggestion of a “should have known” standard of materiality. See Paragon,
Nor was there a mere failure to disclose a known material reference in Critikon, Inc. v. Becton Dickinson Vascular Access, Inc.,
Although some recent panel decisions appear to have relied on precedent overruled by Kingsdoum, such decisions cannot overrule an en banc decision of this court, or the numerous post-Kingsdoum cases that have held fast to the requirement of clear and convincing evidence of both materiality and intent. See, e.g., Hoffmamu-La Roche,
Numerous cases affirm the principle that inequitable conduct requires consideration of the record as a whole», including evidence of good faith. See, e.g., Warner-Lambert Co. v. Teva Pharms. USA, Inc.,
Heretofore, no case has found inequitable conduct based on omitted information when there was no evidence of intentional omission and not even circumstantial evidence of deceptive intent. The panel majority’s holding that deceptive intent is established as a matter of law if the applicant “should have known” that information might be material to patentability, further revives the “plague” of the past, with burdens that far outweigh any conceivable benefits.
Summary Judgment
The court not only creates a new rule of law, but faults the patentee for failing to provide, on the summary judgment record, evidence to respond to an unknown “should have known” per se rule that until now was absent from this law. It is improper, and unfair, to require nugatory evidence on a point that was not raised in the motion for summary judgment, and then to grant the motion because the balancing evidence was not there. The panel majority not only charges the inventor Dr. Vilhardt with at least negligence, but denies him the opportunity now to respond to the court’s creative new ruling. Although in Therma-Tru Corp.,
In Poller v. Columbia Broadcasting System, Inc.,
It is only when the witnesses are present and subject to cross-examination that their credibility and the weight to be given their testimony can be appraised. Trial by affidavit is no substitute for trial by jury which so long has been the hallmark of “even handed justice.”
For summary judgment of inequitable conduct there must be clear and convincing evidence of materiality and deceptive intent, even on the non-movant’s view of the facts. In this case, credibility has been placed at issue. The panel majority improperly draws adverse inferences against the party opposing summary judgment, inferring (1) that when the examiner requested “non-inventor” declarations, he expected experts who had no relationship with Ferring; (2) that Dr. Vilhardt understood that to be the examiner’s request; and (3) that when Dr. Vilhardt contacted these distinguished scientists and obtained their affidavits — an act my colleagues characterize as “completely natural” — he and Ferring deliberately concealed their past connections, with the intent to deceive the PTO. The Supreme Court has reiterated that “Summary judgment in favor of the party with the burden of persuasion, however, is inappropriate when the evidence is susceptible of different interpretations or inferences by the trier of fact.” Hunt v. Cromartie,
The panel majority holds that “to create a genuine issue, the appellants bore the burden of submitting an affidavit from Vil-hardt to contradict the movant’s evidence of intent.” Maj. op. at 1192. Setting aside the fact that the movant did not put forward any evidence of intent, there is no requirement in law that the non-movant submit an affidavit in opposing summary judgment. Ferring was free to rely on other more reliable forms of evidence, such as deposition testimony. See Fed.R.Civ.P. 56(c); 10A Charles A. Wright, Federal Practice and Procedure § 2722 p. 373 (3d ed. 1998) (“Because a deposition is taken under oath and the deponent’s responses are relatively spontaneous, it is one of the best forms of evidence for supporting or opposing a summary-judgment motion.”) In its response to the motion for summary judgment, «Ferring stated that Dr. Vilhardt had never considered one way or another whether to include the omitted information, and pointed to Dr. Vilhardt’s deposition testimony that he had “no idea” whether the patent office had asked for declarations from persons other than the inventors, and further that he had selected these scientists because they were “knowl
At a minimum, the issue should be remanded, on correct law. It is not the law that a declarant’s past affiliations are always material, and it surely is not the law that “should have known” establishes deceptive intent, which requires scienter and deliberateness. On its face, “the involved conduct, viewed in light of all the evidence,” does not “indicate sufficient culpability to require a finding of intent to deceive,” the standard of Kingsdoum,
. An examiner later dismissed the requested declarations defining "peroral,” stating that "such evidence is not necessary to construe the meaning of an ordinary term in the English language.”
. Indeed, the panel majority's citation to Digital Control Inc. v. Charles Mach. Works,
. My colleagues draw an adverse inference because Dr. Vilhardt initially did not recall the contacts, seventeen and thirteen years earlier, with the scientists concerning these affidavits. After being shown file correspondence indicating such contacts, Dr. Vilhardt explained that he had not recalled these contacts, had not understood what the questioner had meant by the term "affidavit” and that, while he didn't "remember distinctly what happened in those days,” he believed that most of the correspondence was handled by the attorneys.