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United States Court of Appeals for the Federal Circuit
December 7, 2018, Decided
2017-2173, 2017-2175, 2017-2176, 2017-2178, 2017-2179, 2017-2180, 2017-2182, 2017-2183, 2017-2184
[***1745] [*1357] Chen, Circuit Judge.
This case involves the complicated, potential double-patenting situation in which the [***1746] later-filed of two related patents, which share a common specification and effective filing date, expires before the term of the earlier-filed patent due to an intervening change in law by Congress defining a patent's term. When the patent owner filed for the first patent, the governing law defined the patent term as 17 years from the date the patent issued. When the patent owner filed for its second, related patent, the governing law was amended to define the patent term as expiring 20 years from the patent's earliest effective filing date. Because of the two patents' relatively early effective filing date, the change in patent term law caused the second patent to expire earlier than the first patent. The patent owner here concedes that the claimed inventions in the two related patents are obvious variants of each other. The legal question we confront in this appeal is whether the law of obviousness-type double patenting requires a patent owner to cut down the earlier-filed, but later expiring, patent's statutorily-granted 17-year [**3] term so that it expires at the same time as the later-filed, but earlier-expiring patent, whose patent term is governed under an intervening statutory scheme of 20 years from that patent's earliest effective filing date. See 35 U.S.C. § 154(a)(2) (2012).
Novartis Pharmaceuticals Corporation and Novartis AG (collectively, Novartis) appeal the district court's decision to invalidate U.S. Patent No. 5,665,772 based on obviousness-type double patenting. The invalidating reference, Novartis's U.S. Patent No. 6,440,990, [*1358] was filed after, and issued after, but expired before the '772 patent. Both patents claimed the same priority date. The '990 patent expired before the '772 patent because the '990 patent was filed after the June 8, 1995 effective date of the Uruguay Round Agreements Act of 1994 (URAA), § 532, Pub. L. No. 103-465, 108 Stat. 4809, 4983, and thus expired on September 23, 2013, 20 years from its earliest effective filing date. The '772 patent, on the other hand, was filed before the effective date of the URAA and—pursuant to the URAA transition statute 35 U.S.C. § 154(c)(1)—expired 17 years from its issuance, on September 9, 2014. Due to a five-year patent term extension (PTE) Novartis was subsequently granted under 35 U.S.C. § 156, the '772 patent's term expires on September 9, 2019. And due to the intervening change in law through the implementation of the URAA, the lifespan of the '772 patent encompasses [**4] that of the '990 patent (even without considering the § 156 five-year term extension).
Applying our decision in Gilead Sciences, Inc. v. Natco Pharma Ltd., 753 F.3d 1208, 1212 (Fed. Cir. 2014), which held that a later-filed but earlier-expiring patent can serve as a double patenting reference for an earlier-filed but later-expiring patent, the district court found the '990 patent to be a proper double patenting reference for the '772 patent. Because the parties stipulated to invalidity if the court concluded that the '990 patent is a double patenting reference to the '772 patent, the district court found claims 1-3, 7, and 10 of the '772 patent invalid. We disagree that the '990 patent is an invalidating reference.
Full case includes Shepard's, Headnotes, Legal Analytics from Lex Machina, and more.
909 F.3d 1355 *; 2018 U.S. App. LEXIS 34462 **; 128 U.S.P.Q.2D (BNA) 1745 ***
NOVARTIS PHARMACEUTICALS CORPORATION, NOVARTIS AG, Plaintiffs-Appellants v. BRECKENRIDGE PHARMACEUTICAL INC., PAR PHARMACEUTICAL, INC., WEST-WARD PHARMACEUTICALS INTERNATIONAL LIMITED, Defendants-Appellees
Prior History: [**1] Appeals from the United States District Court for the District of Delaware in Nos. 1:14-cv-01043-RGA, 1:14-cv-01196-RGA, 1:14-cv-01289-RGA, 1:14-cv-01494-RGA, 1:14-cv-01508-RGA, 1:15-cv-00078-RGA, 1:15-cv-00128-RGA, 1:16-cv-00431-RGA, 1:17-cv-00389-RGA, 1:17-cv-00420-RGA, Judge Richard G. Andrews.
Novartis Pharms. Corp. v. Breckenridge Pharm., Inc., 248 F. Supp. 3d 578, 2017 U.S. Dist. LEXIS 46595 (D. Del., Mar. 28, 2017)
patent, double patenting, expired, obviousness-type, pre-URAA, post-URAA, invention, district court, issuance, invalid, filing date, expiration date, effective, earlier-filed, later-filed, transition, later-expiring, earliest, inventor, variants, rights, earlier-expiring, Pharmaceutical, gamesmanship, intervening, unjustified, disclaimer, everolimus, terminal
Patent Law, Jurisdiction & Review, Standards of Review, Clearly Erroneous Review, Double Patenting, De Novo Review, Defenses, Patent Invalidity, Grounds