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It will come as no surprise to patent practitioners that they must disclose to the U.S. Patent and Trademark Office (PTO) all relevant references, e.g., published articles, that are known to them. As the U.S. Court of Appeals for the Federal Circuit recently ruled in Bristol Myers Squibb Co. v. Rhone-Poulenc Rorer Inc., 2003 U.S. App. Lexis 7103 (Fed. Cir. April 15, 2003), a reference may be relevant to the examination of a patent application even if it is published after the patent application’s filing date. Failure to disclose such a reference cost French pharmaceutical maker Rhone-Poulenc Rorer Inc. a patent on a method for making Taxol, an important cancer-fighting agent. Inventors employed by Rhone-Poulenc Rorer in France developed a method of making Taxol. The inventors prepared a draft article describing their invention and submitted it to a patent agent. The article explained not only the methods used by the inventors, but also certain limitations on the effectiveness of these methods and problems encountered in practicing them. The French patent agent prepared and filed a French patent application, after which the article was published. The patent application specifically claimed the methods whose limitations were discussed in the published article. A corresponding patent application was later filed with the PTO. The patent attorney never provided to the examiner the article on which the French patent application was based. The examiner did, however, perform a computer search of chemical abstracts and located the article. He did not initial the article on the search report, which would have indicated that he had reviewed and considered the article. He examined the patent application and issued a U.S. patent without having considered the article. Rhone-Poulenc Rorer later filed a reissue patent application with additional claims through a different law firm. During prosecution of the reissue application before the same examiner, Rhone-Poulenc Rorer’s new attorney also failed to submit the article to the PTO. The examiner again performed a search and again located, but failed to consider, the article. The attorney finally submitted the article, and the examiner reviewed it, but after he had already allowed the application. He did not change his determination because of the article. Bristol-Myers Squibb Co. filed suit against Rhone-Poulenc Rorer, seeking a declaratory judgment that it did not infringe the reissue patent and that the patent was invalid and unenforceable. The trial court found that Rhone-Poulenc Rorer had procured both its original and reissue patents by inequitable conduct because it had intentionally withheld material information from the PTO. In upholding the trial court, the Federal Circuit explained that a verdict of inequitable conduct requires clear and convincing evidence that the patent holder failed to disclose material information with intent to mislead the PTO. Furthermore, it held that the more material the information, the lower the burden of proof of intent to mislead that is necessary to establish inequitable conduct. WHAT IS MATERIAL DATA? The court explained that materiality is not limited to prior art, but embraces any information that a reasonable examiner would be substantially likely to consider important in examining a patent application. In this case, the court found that the published article was material to the prosecution of the original patent based on the examiner’s obligation to review the application for enablement under 35 U.S.C. 112. A patent meets the standard of enablement if the disclosure would have enabled one of ordinary skill in the art to which the invention pertains at the time the application was filed to make and use the claimed invention without undue experimentation. In this case, the patent specifically recommended using procedures that had problems pointed out in the published article. The court noted that this article would therefore clearly call into question whether the patent application met the enablement standard. The Federal Circuit affirmed the finding that the article was material, after considering several arguments put forth by Rhone-Poulenc Rorer to show either lack of materiality or lack of deceptive intent. Initially, Rhone-Poulenc Rorer pointed out that the examiner twice discovered the article while searching the prior art and argued that the presumption of validity to which the patent is entitled includes a presumption that the examiner reviewed all articles found during the search. The court, however, explained that this presumption was rebutted by the examiner’s failure to place his initials next to the article’s listing on the computer search report, as specified by the Manual of Patent Examining Procedure, to indicate that a reference was reviewed. The fact that there was no copy of the article in the PTO file supported a finding that the examiner did not review the article and that the article was therefore not before the PTO. Rhone-Poulenc Rorer next argued that the article was not material because the examiner maintained his decision to grant the reissue application after reviewing the article. The court, however, explained that materiality is not determined by whether a particular examiner considered the reference to be important, but instead whether a reasonable examiner would consider the reference to be material. Furthermore, even if the standard of enablement under 35 U.S.C. 112 is met, making the patent valid, the patent can still become unenforceable if an applicant failed to disclose a reference that would be considered important by a reasonable examiner determining whether the patent application meets the enablement requirement. The court also found that disclosing the reference during examination of the reissue application did not cure the failure to disclose the reference during examination of the original application. Rhone-Poulenc Rorer further argued that neither the inventors nor their French patent agent believed the article to be material, claiming that one of the inventors had successfully utilized the procedures described in the patent application. The court, however, placed little weight on this argument, noting that the article would have caused one skilled in the art to question whether the procedures described in it would work, regardless of any additional information the inventors may have had. The court again emphasized that the issue is whether a reasonable examiner would find the article to be relevant, not whether the inventors believed the article to be relevant. Last, Rhone-Poulenc Rorer pointed out that, when deciding a motion for summary judgment on the issue of enablement, the trial court found that there was not clear and convincing evidence that the patent did not meet the enablement requirement, arguing that this finding was inconsistent with the trial court’s later finding that the article was material because it would cause one skilled in the art to question whether the patent application met the enablement requirement. The court explained that the issue was not whether the patent met the enablement requirement, but whether the article would be considered relevant by a reasonable examiner in determining whether the application met the enablement requirement. The common thread to the court’s responses to Rhone-Poulenc Rorer’s arguments on the issue of materiality is that materiality hinges on whether a reasonable examiner would want to consider the reference in determining if the application met the enablement requirement, and not whether the application was actually enabled or whether an examiner would allow the application after reviewing the article. If a reasonable examiner would consider the article to be relevant, then it must be disclosed, regardless of the conclusion that an examiner would reach on whether to allow claims after reviewing the reference. DECEPTIVE INTENT Turning to the issue of deceptive intent, the court first pointed out that deceptive intent must ordinarily be inferred from the facts and does not require direct evidence. Intent to mislead is inferred when the applicant knew, or should have known, that a reference the applicant failed to disclose was material. Rhone-Poulenc Rorer first argued that deceptive intent had not been shown because actions taken at the same time as the failure to disclose the article show good faith. For example, its French patent agent approved publication of the article in a widely circulated journal without requesting removal of the information that would cause the methods taught by the patent application to be questioned. The court pointed out that Rhone-Poulenc Rorer’s duty of disclosure was to the PTO, which was not satisfied by publication of the article. Rhone-Poulenc Rorer further argued that disclosure of the article during prosecution of the reissue application shows good faith. The court, however, explained that this disclosure did not show that the same good faith existed during prosecution of the original patent application, at which time the article was not disclosed. Therefore, Rhone-Poulenc Rorer would be unable to cure a failure to disclose the article during prosecution of the original application by disclosing the article during a subsequent prosecution of a reissue application. Rhone-Poulenc Rorer next argued that both the inventors and the French patent agent believed that the article was irrelevant, citing statements he made to his U.S. patent attorney during prosecution of the reissue application. However, the court found that these statements do not establish whether he believed the reference to be irrelevant during prosecution of the original patent application. Third, Rhone-Poulenc Rorer argued that the inventors had reason to believe that the invention as described and claimed in the patent application could work without undue experimentation at the time the original application was filed. The court first pointed out that the article did not assert such a belief, nor did it explain the foundation of such a belief. The court then said that the inventor’s beliefs regarding enablement were a separate issue from its intent in failing to disclose the article to the PTO. Last, the court found that a letter from Rhone-Poulenc Rorer’s French patent agent to the U.S. patent attorney instructing the latter to seek broad patent rights provided motive for withholding the article from the PTO, despite Rhone-Poulenc Rorer’s arguments that seeking broad patent protection is not an improper motive. In summary, the court explained that a patent may be unenforceable on the basis of the applicant’s failure to disclose a reference to the PTO even if the applicant believes that the reference is not relevant, the publication date of the reference is after the filing date of the application, the examiner discovers the reference and decides not to consider it or the examiner considers the reference during prosecution of a reissue application and then allows the application. Despite all these circumstances, a court may still find that a reasonable examiner would consider the reference to be important to the examination of the application. A FEW GUIDELINES In deciding which references must be disclosed to the PTO, applicants should observe the following guidelines:

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