CAFC Denies En Banc Review of "Distorted" Law of Double-Patenting

Sun Pharma. Ind. Ltd. v. Eli Lilly and Co., No. 2010-1105, (Nov. 1, 2010, Order)

Eli Lilly filed a first application describing a new class of chemical compounds having antiviral utility, including the compound named gemcitabine. Thereafter, Lilly filed a continuation-in-part application disclosing but not claiming the anticancer utility of gemcitabine, and on the same day Lilly filed a separate application (ultimately issuing as the '826 patent) having a different inventive entity, describing and claiming the use of gemcitabine to treat cancer.

Nevertheless, the Federal Circuit struck down the ’826 patent this past July on double-patenting grounds, holding that a patent is invalid if it claims a method of using a chemical compound if that method was described (even if not claimed) in an earlier patent.

This decision was seen as a "dramatic expansion" of the double patenting doctrine. The judicially-created double patenting doctrine prevents a patentee from receiving two patents for one invention.  However, when a second patent covers matter described in a prior patent, the second patent is still valid so long as the invention is patentably distinct from the invention claimed in the first patent. By applying the doctrine in this case, it was argued that the CAFC limited Eli Lilly to one patent for two inventions.

Eli Lilly filed for en banc review, and the Federal Circuit denied the motion by a narrow 5-4 margin.  A dissenting opinion authored by Newman (and joined by Rader, Lourie and Linn) argued that the law of double patenting "has become distorted by divergent statements":

Until recently it was beyond dispute that the law of double patenting is concerned only with what is patented—that is, what is claimed. To determine whether there is double patenting it is the claims that are compared; thus, obviousness-type double patenting occurs when the claims of a later patent are an obvious variant of the claims of an earlier patent. The specifications of the patents are irrelevant to the double patenting analysis, other than to guide in construing the claims. A double patenting analysis occurs only when the earlier patent is not prior art against the later patent.

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“Obviousness-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.” Braat, 937 F.2d at 592. The panel failed to explain how Lilly’s claims to the use of gemcitabine to treat cancer, discovered after gemcitabine’s antiviral use was disclosed in the original application, improperly extend the patent right to gemcitabine as a compound, let alone how these claims would “shock one’s sense of justice.” For purposes of this case, there is no dispute that Lilly would be entitled to a separate patent on the anticancer use if Lilly had not included the disclosure of anticancer use in the specification of the continuation-in-part filed the same day. Such disclosure does not “improperly extend” any patent.

The amici curiae explained that particularly for biological/pharmaceutical products, new uses may be discovered as research continues after the initial filing. . . . A change of law “in ways that negatively impact the patentability of important later-discovered uses” serves no public purpose in areas in which commercial development requires patent protection. If the majority of the court now believes, as a matter of policy, that the law should be changed in this new direction, en banc treatment is particularly appropriate, for the court’s rule is that the earlier precedent prevails unless overruled en banc. A situation in which the court ignores this rule, and applies whatever law the panel prefers, is an indictment of the ability of this court to provide stable law in the areas entrusted to us.

The denial of Eli Lilly’s petition for rehearing en banc leaves the innovation community without guidance on which the trial courts, and the users of the patent system, can rely. I respectfully dissent.

Read the dissenting opinion here (link)