Federal Circuit Declines to Rehear Double Patenting Case in a Split Decision
November 01, 2010
Last Month at the Federal Circuit - December 2010
Judges: Rader, Newman, Lourie, Bryson, Gajarsa, Linn, Dyk, Prost, and Moore
[Appealed from: E.D. Mich., Judge Steech]
In Sun Pharmaceutical Industries, Ltd. v. Eli Lilly & Co., No. 10-1105, (Fed. Cir. Nov. 1, 2010), the Federal Circuit denied Eli Lilly and Company’s (“Lilly”) petition for a rehearing en banc, in a 5-4 vote of a panel decision (Sun Pharmaceutical Industries, Ltd. v. Eli Lilly & Co., No. 10-1105 (Fed. Cir. July 28, 2010)) holding claims defining a method of treating cancer with the compound gemcitabine invalid for obviousness-type double patenting.
The patent forming the basis for the double patenting ruling claimed gemcitabine and its antiviral use. It also disclosed, but did not claim, the use of gemcitabine to treat cancer. That disclosure was added in a continuation-in-part application filed on the same day that Lilly filed the application leading to the patent held invalid in the panel decision. The original application leading to the earlier patent was prior art under § 102(e) to the later patent.
Judges Newman, Linn, and Lourie, and Chief Judge Rader, dissented from the denial to review the panel decision en banc. The minority questioned the panel’s ruling because it relied on what the earlier patent disclosed, rather than what it claimed. The dissenting judges noted that until recently, the law of double patenting was clear but had become distorted by divergent statements leading to the panel’s flawed ruling. In the minority’s opinion, the law of double patenting was previously concerned only with what is claimed. The specifications are irrelevant to this analysis, other than to guide in construing the claims, because obviousness-type double patenting occurs when the claims of a later patent are an obvious variant of the claims of an earlier patent. The minority further cautioned that the double patenting analysis occurs only when the earlier patent is not prior art against the later patent.
In this case, the minority believed that the law of double patenting was contrary to the panel’s holding. The dissenting judges pointed to the Court’s holding General Foods Corp. v. Studiengesellschaft Kohle mbH, 972 F.2d 1272, 1277 (Fed. Cir. 1992), as establishing the rule that double-patenting is altogether a matter of what is claimed. The minority noted that this holding has been followed many times by the Court, as well as being fully established by the Court’s predecessor court. In the minority’s view, “[u]niformly, unlike the examination for obviousness based on prior art, the issue of obviousness-type double patenting is directed to whether the invention claimed in a later patent is an obvious variant of the invention claimed in an earlier patent.” Slip op. at 4. In sum, the dissenting judges characterized the panel opinion as violating “a vast body of precedent.” Id.
Further, the minority suggested that the panel’s decision was misdirected by an overly broad statement in Geneva Pharmaceuticals, Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 (Fed. Cir. 2003). In Geneva, the Court stated that “[o]ur predecessor court recognized that a claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use.” Slip op. at 4 (citing Geneva, 349 F.3d at 1385-86 (citing In re Byck, 48 F.2d 665, 666 (CCPA 1931) (“[i]t would shock one’s sense of justice if an inventor could receive a patent upon a composition matter, setting out at length in the specification the useful purposes of such composition, manufacture and sell it to the public, and then prevent the public from making any beneficial use of such product by securing patents upon each of the users to which it may be adapted.”). The minority emphasized that the Geneva decision failed to mention the further statement in Byck that the case did not involve a situation where the patentee might have disclosed a use of the invention which, together with other elements, might have constituted a separate invention for which he would be entitled to a patent, in view of a prior art reference. Further, according to the minority, this statement from Geneva “took on a life of its own” as in Pfizer, Inc. v. Teva Pharmaceuticals, USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008), “where the court declined to apply section 121 (negating double patenting among divisional) and found double patenting despite a restriction requirement, citing Geneva for authority.” Slip op. at 5.
Thus, the minority does not believe that Geneva should be extended to Lilly’s situation, because Geneva “does not further the policy of obviousness-type double patenting.” Id. In the dissenting judges’ view,
“[o]bviousness-type double patenting is a judicially created doctrine intended to prevent improper timewise extension of the patent right by prohibiting the issuance of claims in a second patent which are not patentably distinct from the claims of a first patent.” Id. Here, the minority believes that the panel failed to explain how Lilly’s claims to a new use for a compound, discovered after a first use was disclosed in the original application, improperly extends the patent right to the compound overall. Further, the minority noted that there was no dispute that Lilly would be entitled to a separate patent on the new use of the compound if Lilly had not included the disclosure of the new use in the specification of the continuation-in-part filed the same day. The dissenting judges challenged that such a disclosure would “improperly extend” any patent.
According to the minority, if the majority of the court now believes that the law should be changed in accordance with the panel’s ruling, en banc treatment would be particularly appropriate. In the dissenting judges’ opinion, “[t]he denial of Lilly’s petition for rehearing en banc leaves the innovation community without guidance on which the trial courts, and the uses of the patent system, can rely.” Id. at 7.
Summary authored by Jessica L.A. Marks, Esq.