Disclosure of compounds without link to claimed method fails to meet written description requirementApril 14, 2009

In a recent decision, the Federal Circuit reversed a district court's denial of judgment as a matter of law after a jury determined the asserted claims of an invention were not invalid under the written description requirement. The court, however, affirmed the district court's determination of no inequitable conduct.The Federal Circuit held the jury lacked substantial evidence for its verdict. Specifically, the court noted that vague functional descriptions are essentially invitations for skilled artisans to conduct further research and therefore are not sufficient description to meet the written description requirement of § 112. The specification disclosed three classes of compounds that could be used in the claimed methods. However, it only disclosed specific examples of one of the classes of compounds, and did not disclose any examples of the described compounds actually linked to use in the claimed method. The patentee was further hampered in that the jury held the patent was entitled to a priority date of 1989, but most of the patentee's testimony and other evidence regarding the written description issue centered on the application's filing date in 1991. The court held none of this evidence could support the jury's verdict, as it was directed to the wrong timeframe. Therefore, the court held the written description requirement not met, and the asserted claims invalid.The court affirmed the district court's holding of no inequitable conduct. Neither party contested the relevant acts (failing to correct a figure and to disclose certain non-prior art references that were relevant to patentability) were properly held material. The Federal Circuit agreed with the district court that there was insufficient evidence of intent to deceive to support a finding of inequitable conduct. More on Ariad Pharms., Inc. v. Eli Lilly & Co. after the jump.Plaintiffs Ariad Pharmaceuticals and others ("Ariad") sued Eli Lilly for infringement of multiple claims of U.S. Patent No. 6,410,516 ("the '516 patent"). Specifically, Ariad asserted two of Eli Lilly's drugs, Evista® and Xigris®, infringed claims of the patent. The '516 patent relates to gene regulation, specifically transcription factors found in cells regulating gene expression. Specifically at issue is a transcription factor named NF-κB, which is an all-purpose cellular response for responding to foreign or harmful stimuli to produce responding proteins. The claims at issue involve the reduction of NF-κB activity. The jury returned a verdict of infringement, also finding the claims of the '516 patent were not invalid for anticipation, lack of enablement, or lack of written description. At a separate hearing, the district court rejected Eli Lilly's defense of inequitable conduct and held the claims were directed to patentable subject matter. Eli Lilly appealed the court's denial of its judgment as a matter of law (JMOL) on the § 112 issues and the finding of no inequitable conduct. On appeal, the Federal Circuit first addressed the written description issue. The key determination in such an analysis is to determine if the specification conveyed with clarity to those skilled in the art that, as of the application's priority date, the applicant was in possession of the invention. The court highlighted factors used to determine whether sufficient disclosure to support generic claims to biologic subject matter exists. The factors include "the existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology and the predictability of the aspect at issue." Eli Lilly argued Ariad failed to provide such support, alleging that it did not adequately disclose how the claimed reduction of NF-κB activity was achieved in order to allow support that the applicants had possession of the invention as of the priority date. Lilly specifically argued the disclosure of types of molecules potentially capable of reducing NF-κB activity amounted "to little more than a research plan."The court looked to the various claimed molecules necessary to perform the methods including reducing NF-κB activity. The specification disclosed three such molecules, (1) specific inhibitors, (2) dominantly interfering molecules, and (3)decoy molecules. With regard to specific inhibitors, the specification only referred to I-κB, which is a naturally occurring molecule that holds NF-κB in an inactive state. The sequence of I-κB was disclosed in a figure of the specification, but not until the patent's 1991 filing date; it was not present as of the patent's 1989 priority date. As such, it could not provide written description support for the claims. The other testimony relevant to the 1989 date was that one of ordinary skill in the art would be able to isolate I-κB. The Federal Circuit held such a vague functional description, which was essentially an invitation to conduct further research, was insufficient to meet the written description requirement of § 112. With respect to the second molecule, dominantly interfering molecules, the specification disclosed no examples of any molecules of this class. Therefore, the Federal Circuit again held the specification, at best, was simply an invitation for future research in the area of these molecules. Finally, with regard to decoy molecules, the Federal Circuit noted the specification disclosed hypothetical example structures of such molecules. Although the disclosure of structures is preferred and in some instances may result in the satisfaction of the written description requirement, there was no disclosure linking the disclosed decoy molecules with methods of reducing NF-κB activity. As a result, this disclosure also could not satisfy the written description requirement. Based on these conclusions, the Federal Circuit held the jury lacked substantial evidence for its verdict, and therefore the asserted claims were invalid as failing to meet the written description requirement. The court then turned to Eli Lilly's inequitable conduct claim. Lilly asserted inequitable conduct based on two facts. The first related to Figure 43 of the '516 patent, which improperly described the sequence of the I-κB-α gene. Also, from the context of the figure, one of ordinary skill in the art would infer the sequence was from a mouse or other mammal, but it was in fact from a chicken. The parties did not dispute this constituted a material error; the only issue was whether there was sufficient intent to deceive. Eli Lilly alleged Ariad and its prosecuting attorneys were aware of the errors in the figure and purposely concealed them from the Patent Office. The Federal Circuit reviewed evidence relating to the prosecution history of various related applications involving multiple attorneys and multiple law firms. While an Ariad employee disclosed the inaccuracy of the figure to its attorney, during the shuffle of the attorneys handling the prosecution of the '516 patent Figure 43 was deleted in only some of the various related applications. The Federal Circuit did not find this error to rose to the level of intent to deceive the Patent Office, observing it was more plausible the failure to correct the Figure in all related applications was "an honest but imperfect attempt to correct mistakes." The second error that Eli Lilly asserted involved the failure to submit four references to the USPTO during prosecution. These references were not prior art, because they were published after the priority date of the '516 patent, however they were published by a co-inventor of the patent and potentially provided evidence of inherent anticipation by certain prior art compounds. Again, the materiality of these references was undisputed. Here, the Federal Circuit did not find that one co-inventor's authorship and therefore clear knowledge relating to NF-κB activity was withheld with intent to deceive. The court noted it was improper to rely upon evidence of materiality of errors alone to infer intent; there must be deceptive intent by clear and convincing evidence. Here, the inventor testified he considered disclosing the references, but did not want to "inundate the patent office" with all reports of NF-κB. The court held these references "plausible, even if ultimately legally incorrect, and Lilly failed to show that deceptive intent was the better explanation for [the inventor's] behavior." As such, there was also inadequate evidence of intent to deceive here, and the court therefore affirmed the district court's rejection of the inequitable conduct defense.Judge Linn authored a concurring opinion, noting the court's result was required by its precedent, but reiterating his opposition to the existence of a separate written description requirement in § 112.To read the full decision in Ariad Pharms., Inc. v. Eli Lilly & Co., click ← Return to Filewrapper

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