A Claimed Intermediate Used In The Synthesis Of A Compound Does Not Render A Later Claim Directed To The Compound Invalid For Obviousness-Type Double Patenting

In Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., Nos. 11-1561, -1562 (Fed. Cir. Aug. 24, 2012), and Eli Lilly & Co. v. APP Pharmaceuticals, LLC, No. 12-1307 (Fed. Cir. Aug. 24, 2012), the Federal Circuit affirmed the district court's finding that claims 1, 2, 3, and 7 of U.S. Patent No. 5,344,932 ("the '932 patent") are not invalid for obviousness-type double patenting.

The Trustees of Princeton University ("Princeton") own the '932 patent, which is exclusively licensed to Eli Lilly & Co. ("Lilly"). Claims 1, 2, 3, and 7 of the '932 patent are composition claims that specifically and generically cover pemetrexed, an anticancer drug marketed by Lilly under the brand name Alimta®.

Teva Parenteral Medicines, Inc., Barr Laboratories, Inc., and APP Pharmaceuticals, LLC (collectively "Teva") filed ANDAs seeking approval to market generic versions of Alimta®. Teva's ANDAs included Paragraph IV certifications that the '932 patent was invalid, unenforceable, or would not be infringed by the proposed generic formulations. In response, Lilly and Princeton sued Teva for patent infringement. Teva conceded infringement but argued that the asserted claims of the '932 patent were invalid for obviousness-type double patenting over two prior patent claims: (1) claim 3 of U.S. Patent No. 5,028,608 ("the '608 patent"); and (2) claim 7 of U.S. Patent No. 5,248,775 ("the '775 patent"). Following a bench trial, the district court concluded that claims 1, 2, 3, and 7 of the '932 patent were not invalid for obviousness-type double patenting, and enjoined approval of Teva's proposed generic products until after expiration of Lilly's exclusive rights. Teva appealed.

On appeal, the Federal Circuit affirmed the district court's decision, holding that the asserted claims of the '932 patent are not invalid for obviousness-type double patenting over claim 3 of the '608 patent or claim 7 of the '775 patent.

"Rather than a composition and a previously disclosed use, the claims at issue recite two separate and distinct chemical compounds . . . . That alone suffices to undermine Teva's argument regarding the '775 Intermediate, for the asserted claims of the '932 patent do not recite a use of the same compound, but a different compound altogether." Slip op. at 19.

Claim 3 of the '608 patent recites an antifolate compound that is structurally related to pemetrexed, but was never advanced to clinical testing. The only difference between the compound claimed in the '608...