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Ariad’s Method Claims Held Invalid for Lack of Written Description, but Held Enforceable

April 03, 2009

Decision icon Decision

Last Month at the Federal Circuit - May 2009

Judges: Linn (concurring), Prost, Moore (author)

[Appealed from: D. Mass., Judge Zobel]

In Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., No. 08-1248 (Fed. Cir. Apr. 3, 2009), the Federal Circuit reversed the district court and granted Eli Lilly and Company’s (“Lilly”) motion for JMOL that Ariad Pharmaceuticals, Inc.’s (“Ariad”) U.S. Patent No. 6,410,516 (“the ’516 patent”) failed to meet the written description requirement of 35 U.S.C. § 112.

Ariad had sued Lilly, alleging that Lilly’s Evista and Xigris products infringed certain claims of the ’516 patent, and a jury found that the asserted claims were both valid and infringed. The district court also held a separate bench trial, after which it found no inequitable conduct and that the claims complied with 35 U.S.C. § 101. Lilly appealed these decisions on numerous grounds, including that the broad claims of the ’516 patent were not adequately supported by 35 U.S.C. § 112.

On appeal, Lilly argued that although the inventors of the ’516 patent broadly sought to cover all methods for inhibiting NF-κB (a naturally occurring transcription factor) in a cell, the inventors did not provide a single
example where they actually inhibited NF-κB or describe any actual molecules capable of doing so. In response, Ariad argued that it did not need to describe any actual molecules because they were not specifically recited in the claims and that it was entitled to broadly claim methods of reducing NF-κB activity without describing the necessary molecules. The Federal Circuit rejected Ariad’s argument, holding that whether or not the claims recite a compound, the patentee must still describe some way of performing the claimed methods by sufficiently disclosing and describing the molecules capable of reducing NF-κB activity.

The Court specifically analyzed the ’516 patent’s disclosure and found that its functional descriptions of unknown molecules thought to inhibit NF-κB were insufficient. First, its description of a specific inhibitor molecule of NF-κB amounted to no more than a “vague functional description and an invitation for further research [that] does not constitute written disclosure of a specific inhibitor.” Slip op. at 12. Second, as to dominantly interfering molecules, the Court held that the specification contained no example of such a molecule and failed to adequately describe properties essential for these molecules to function. Third, the Court held that although the specification disclosed specific exemplary sequences for the decoy molecules, the ’516 patent did not describe how the decoy molecules would actually reduce NF-κB activity. Accordingly, the Court held that the specification of the ’516 patent did not provide adequate written description support for the “vast scope” of the broad claims asserted against Lilly:

Ariad sought and obtained the
broad claims we now hold to be
invalid. For its own reasons, Ariad
maintained the breadth of these
claims through claim construction
and into trial. . . . [A]s it stands,
Ariad chose to assert claims
that are broad far beyond the
scope of the disclosure provided
in the specification of the ’516
patent. Cf. Liebel-Flarsheim Co.
v. Medrad, Inc
., 481 F.3d 1371,
1380 (Fed. Cir. 2007) (“The motto,
‘beware of what one asks for,’
might be applicable here.”).

Slip op. at 16.

Finally, the Federal Circuit upheld the district court’s finding of no inequitable conduct based on a lack of clear and convincing evidence of intent to deceive. First, the Court considered whether an intent to deceive could be inferred where an undisputedly inaccurate yet material figure in the specification was never corrected, even when the in-house attorney and one prosecuting attorney had knowledge of the error. The Court held that without “more evidence of deliberate concealment,” the circumstances did not support an inference of intent to deceive. Id. at 20. Second, the Court found that a named inventor’s failure to submit four material references to the PTO did not amount to inequitable conduct when the inventor had “plausible, even if ultimately legally incorrect” reasons for withholding the references. Id. at 22.

In a concurring opinion, Judge Linn agreed with the invalidity result, finding it consistent with Court precedent. He expressed dissatisfaction, however, with the written description requirement generally, suggesting that the Court should have instead decided the case based on “the important enablement issue raised by Lilly,” i.e., whether claims written broadly enough to cover all methods for achieving a particular result could be enabled under § 112. Linn Concurrence at 2-3. According to Judge Linn, this alternate invalidity argument was left unresolved in the present case, and it has never been specifically addressed by the Court.