Novartis Pharms. Corp v. Breckenridge Pharm. Inc.

A post-URAA patent that issues after, and expires before, a pre-URAA patent does not qualify as a double-patenting reference against the pre-URAA patent.

December 07, 2018

GENERICally Speaking

Case Name: Novartis Pharms. Corp v. Breckenridge Pharm. Inc., No. 2017-2173, 2018 U.S. App. LEXIS 34462 (Fed. Cir. Dec. 7, 2018) (Circuit Judges Prost, Wallach, and Chen; Opinion by Chen, J.) (Appeal from D. Del., Andrews, J.) 

Drug Product and Patent(s)-in-Suit: Zortress® and Afinitor ® (everolimus); U.S. Patent No. 5,656,772 (“the ’722 patent”)

Nature of Case and Issue(s) Presented: Novartis owns the ’722 patent, which recites the compound everolimus, and U.S. Patent No. 6,440,990 (“the ’990 patent), which claims certain methods of treating cancer using everolimus. Both patents claim the same priority date, but the ’990 patent expired before the ’722 patent because the ’990 patent was filed after the June 8, 1995 effective date of the Uruguay Round Agreement Act of 1994 (“URAA”). The ’990 patent expired on September 23, 2013, twenty years from its effective filing date. Meanwhile, the ’722 patent expired on September 9, 2014, seventeen years from its issuance. Novartis was granted a five-year patent term extension for the ’722 patent, meaning its term expires on September 9, 2019.

Relying on Gilead Sciences, Inc. v. Natco Pharmaceutical Ltd., 753 F.3d 1208 (Fed. Cir. 2014), the district court found that the post-URAA ’990 patent was a proper double patenting reference against the pre-URAA ’722 patent. As a result, the district court found that the ’722 patent was invalid for obviousness-type double patenting because those claims, as stipulated by the parties, were not patentably distinct from the claims of the ’990 patent. On appeal, the Federal Circuit framed the relevant question as whether a post-URAA patent that issues after and expires before a pre-URAA patent qualifies as a double patenting reference against the pre-URAA patent. The Federal Circuit answered in the negative.

Why Novartis Prevailed: In Gilead, the Federal Circuit “recognized that the change in patent term law under the URAA altered the analytical inquiry for double patenting.” Pre-URAA courts used the issuance date of a patent for terms of assessing obviousness-type double patenting. Post-URAA, on the other hand, the proper inquiry for an obviousness-type double patenting is the expiration date of the patent in question.

The Federal Circuit went on to explain, however, that Gilead did not control, as its application is limited to situations where both patents-in-question are post-URAA patents. Here, the ’772 patent was a pre-URAA patent. As a result, the Federal Circuit applied the traditional pre-URAA obviousness-type double-patenting analysis, meaning the pertinent inquiry was the issuance date of the ’722 patent. Under that analysis, the ’990 patent was not a proper obviousness-type double-patenting reference for the ’772 patent. When the ’772 patent issued, the ’990 patent had not yet issued and thus did not exist as a double-patenting reference against the ’772 patent.

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