NOVARTIS PHARMACEUTICALS CORP. V. BRECKENRIDGE PHARMACEUTICAL
Summary: A post-URAA patent that issues after but expires before a related pre-URAA patent is not a double-patenting reference against the pre-URAA patent.
A patent filed before the June 8, 1995 effective date of the Uruguay Round Agreements Act (URAA) has a 17 year term that begins on its issuance date. A patent filed after the effective date of the URAA has a 20 year term that begins on its earliest effective filing date. Here, Novartis owned a later-filed post-URAA patent (“Patent B”) and an earlier-filed pre-URAA patent (“Patent A”). However, Patent B, the later-filed post-URAA patent, expired before Patent A. The district court held that Patent B was a double-patenting reference against Patent A.
The Federal Circuit disagreed. The Federal Circuit held that where one patent was filed pre-URAA and the other patent was filed post-URAA, the issuance dates of the patents control whether one patent is a double-patenting reference of the other. In a prior decision in the Gilead Sciences, Inc. v. Natco Pharma Ltd. case, the Federal Circuit held that a later filed but earlier-expiring post-URAA patent was a double-patenting reference against an earlier-filed and later-expiring post-URAA patent, and that the expiration date was the benchmark of obviousness-type double-patenting. 753 F.3d 1208, 1212 (Fed. Cir. 2014). The Federal Circuit stated that because Gilead dealt with two post-URAA patents it did not control the present situation. The Federal Circuit reasoned that its holding in this case was consistent with the URAA transition statute, which gives pre-URAA patents the longest term possible under either the pre or post-URAA rules. It also reasoned that its holding was consistent with the purposes of the double-patenting doctrine, which is to limit a patent owner to one full term of patent rights. As a result of the Federal Circuit’s ruling, Novartis will enjoy one 17-year term of exclusive rights arising from Patent A.