Sun Pharmaceutical Industries v. Eli Lilly – en banc denied

November 12, 2010 – Blog Post

In a 5-4 split, the Federal Circuit denied a petition for a panel rehearing and a rehearing en banc in Sun Pharm. v. Eli Lilly on November 1.

The original, unanimous panel decision of July 28 affirmed a district court decision holding invalid U.S. Patent No. 5,464,826 (“the ‘826 patent”), which claims a method of using the drug gemcitabine (marketed as “Gemzar®”) to treat cancer, due to obviousness-type double patenting over U.S. Patent No. 4,808,614, (“the ‘614 patent”), which claims gemcitabine itself plus a method of using it for treating viral infections. Both the district court and the Federal Circuit noted that the ‘614 patent disclosed, but did not claim, the use of gemcitabine to treat cancer. In support of their rulings that an earlier patent’s disclosure can render a later patent invalid via obviousness-type double patenting, the Federal Circuit panel and the district court relied on Geneva Pharm., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 (Fed. Cir. 2003) and Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353 (Fed. Cir. 2008).

In dissent of the denial for a rehearing, Judge Newman wrote that both Federal Circuit and Court of Customs and Patent Appeals precedents have established that “double patenting is concerned only with what is patented—that is, what is claimed,” and that “[t]he specifications of the patents are irrelevant to the double patenting analysis, other than to guide in construing the claims.” Thus, the dissent argued, the ‘826 patent should not be invalid over the ‘614 patent for obviousness-type double patenting.

The dissent noted that earlier precedent at the Federal Circuit trumps subsequent conflicting panel decisions. As the dissenting judges saw a conflict between the panel decision here and prior precedent, they opined that scenarios like this make Federal Circuit law seem less stable.

Thus, the Federal Circuit judges have a closely split difference of opinion on the role of patent references’ specifications in questions of obviousness-type double patenting. Judicial confirmations for the Federal Circuit’s three currently-vacant seats have the potential to shift this balance in one direction or another. Until then, patent applicants with multiple applications for related technologies may wish to make sure to write their specifications in ways that avoid disclosing unclaimed, novel uses. If the Federal Circuit continues in the direction of Sun Pharm. v. Eli Lilly, statements in specifications could be used against the validity of subsequent patents for related technologies for obviousness-type double patenting reasons, even if the specification is unavailable as prior art for an obviousness determination based on 35 U.S.C. § 103.