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CAFC Rejects Lilly’s Bid to Clarify Law of Double Patenting En Banc in Case That Found Its Gemcitabine Cancer Treatment Invalid

November 1, 2010

The U.S. Court of Appeals for the Federal Circuit on Nov. 1 refused to address the law of double patenting en banc in a case which found Eli Lilly’s patent claiming gemcitabine as a cancer treatment invalid based on an earlier patent that the company was issued for using gemcitabine to treat viral infections (Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., Fed. Cir., No. 2010-1105, 11/1/10).

However, Judge Pauline Newman, joined by Chief Judge Randall R. Rader and Judges Alan D. Lourie and Richard Linn, dissented from the review denial, saying that “inconsistent precedent warrants clarification” en banc. “Until recently the law of double patenting was clear, but it has become distorted by divergent statements, leading to this flawed ruling,” Newman wrote.

District Court Finds ‘826 Patent Invalid Based on ‘614 Patent.

Eli Lilly and Co. markets the drug Gemzar® for the treatment of various forms of cancer. The active ingredient in Gemzar® is gemcitabine. Lilly’s patent (5,464,826) issued on Nov. 7, 1995 claims a method of using gemcitabine for treating cancer, while its earlier patent (4,808,614) claims a method of using gemcitabine for treating viral infections.

Sun Pharmaceutical Industries Ltd. filed an Abbreviated New Drug Application with the Food and Drug Administration for marketing approval on a generic version of  Gemzar® and certified that the ’614 and ’826 patents were invalid or not infringed.

Sun filed this declaratory action against Lilly, seeking a judgment that the ’826 patent is invalid and not infringed.

The district court concluded that, given that Claim 12 of the ’614 patent discloses gemcitabine’s anticancer use, Claims 2, 6, and 7 of the later ’826 patent, which claim a method of using gemcitabine for cancer treatment, are not patentably distinct as a matter of law.

Double Patenting Decision Upheld.

As reported in a July Intellirights story, the Federal Circuit affirmed that ruling. Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 611 F.3d 1381 (Fed. Cir. 2010).

In that decision, the panel relied on the decisions in Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 (Fed. Cir. 2003), and Pfizer Inc. v. Teva Pharmaceuticals USA Inc., 518 F.3d 1353 (Fed. Cir. 2008). Finding that precedent controlling, Judge Sharon Prost said that Geneva and Pfizer both found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent. Quoting language from both cases, she observed 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.”

The panel decision rejected Lilly’s argument that, in Geneva and Pfizer, the specification of the earlier patent disclosed a single use for the claimed compound, which was an essential part of the patented invention and thus necessary to patentability. To Lilly, the double patenting analysis of those cases does not apply to the later ’826 patent claims reciting a method of using gemcitabine for cancer treatment because, though the specification of the earlier ’614 patent disclosed gemcitabine’s use in treating both viral infections and cancer, the antiviral use provided the essential utility necessary to the patentability of the ’614 patent.

Prost disputed the suggestion that Pfizer involved a single disclosed utility that was alone essential to the patentability of the claimed compound. Further, she stressed that “the analysis in the Pfizer decision shows that obviousness-type double patenting encompasses any use for a compound that is disclosed in the specification of an earlier patent claiming the compound and is later claimed as a method of using that compound.”

Prost explained:

Pfizer never implies that its reasoning depends in any way on the number of uses disclosed in the specification of the earlier patent. … Instead, its broad analysis reflects that the court considered the multiple uses for the compound that were discussed in the specification of the earlier patent. Indeed, the Pfizer decision ultimately invalidated claims in the later patent that were separately directed to these multiple uses, including inflammation, inflammation-associated disorders, and the specific inflammation-associated disorders of arthritis, pain, and fever.…

Thus, the holding of Geneva and Pfizer, 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,” extends to any and all such uses disclosed in the specification of the earlier patent.

Further, Prost rebuffed Lilly’s argument that the district court erred in relying on the specification of the issued ’614 patent, rather than the specification of an earlier application, to determine the relevant disclosed uses of the compound gemcitabine for its obviousness-type double patenting analysis. “Both Geneva and Pfizer make clear that, where a patent features a claim directed to a compound, a court must consider the specification because the disclosed uses of the compound affect the scope of the claim for obviousness-type double patenting purposes,” she said. “In other words, the double patenting doctrine is concerned with the issued patent and the invention disclosed in that issued patent, not earlier drafts of the patent disclosure and claims.”

Dissenting Judges: Clarity on Double-Patenting Is Needed.

“The law of double patenting is contrary to the panel’s holding,” Newman argued in her dissenting opinion. Here, she quoted earlier circuit authority stating that the rule that “[d]ouble-patenting is altogether a matter of what is claimed.” General Foods Corp. v. Studiengesellschaft Kohle mbH, 972 F.2d 1272 (Fed. Cir. 1992). “This law was also fully established in our predecessor court,” Newman added, citing In re Vogel, 422 F.2d 438 (CCPA 1970).

Newman continued:

Uniformly, unlike 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. The panel opinion violates a vast body of precedent.

The panel apparently was misdirected by an overly-broad statement in Geneva Pharmaceuticals, Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 (Fed. Cir. 2003). Genevastated 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.” …

Extending Genevato cover the facts of this case does not further the policy of obviousness-type double patenting. “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.” … 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.…

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. Id.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.

Sun Pharmaceutical was represented by James F. Hurst of Winston & Strawn, Chicago. Lilly was represented by Charles E. Lipsey of  Finnegan, Henderson, Farabow, Garrett & Dunner, Reston, Va.

Matthew D. McGill of Gibson, Dunn & Crutcher, Washington, D.C., represented amicus curiae Washington Legal Foundation. Leslie Morioka of White & Case, New York, represented amicus curiae Biotechnology Industry Organization. David W. Ogden of Wilmer Cutler Pickering Hale and Dorr, Washington, D.C., represented amicus curiae Pharmaceutical Research and Manufacturers of America. Elizabeth J. Holland of Kenyon & Kenyon, New York, represented amici curiae Teva Parenteral Medicines Inc. and Teva Pharmaceuticals USA Inc.

Read the Nov. 1 order denying en banc review in Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co.
 


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