Gilead Sciences, Inc. v. Natco Pharma Ltd.

Addressing invalidation of a patent for obviousness-type double patenting, the U.S. Court of Appeals for the Federal Circuit vacated and remanded a district court's decision, finding that a later-issued, but first-expiring patent could invalidate a first-issued, but later-expiring patent if both patents are commonly owned and do not have a common priority claim.  Gilead Sciences, Inc. v. Natco Pharma Ltd., Case No. 13-1418 (Fed. Cir., Apr. 22, 2014) (Chen, J.) (Rader, C.J., dissenting).

Gilead owns two patents directed to antiviral compounds and methods for their use.  Gilead sued Natco Pharma (Natco) for infringement of the first of the two patents after Natco filed an Abbreviated New Drug Application (ANDA).  Natco responded by arguing that this first patent was invalid for obviousness-type double patenting based on the second of the two patents (which was not even asserted by Gilead in the case).

In granting summary judgment against Natco, the district court relied on other district court cases finding that "a later-issued but earlier-expiring patent" cannot "serve as a double-patenting reference against an earlier-issued but later expiring patent."  Natco appealed.

On appeal, the Federal Circuit considered whether the non-asserted second patent–which issued after but expires before the first patent–can qualify as a double patenting reference against the first patent.

In its analysis, the Federal Circuit noted that  both patents were issued to the same inventors and were commonly owned by Gilead, the first patent had a later priority date than the second patent and the first patent did not have a terminal disclaimer.  However, the Federal Circuit also concluded that the second patent claimed an invention of which the first patent's claims were obvious variants and was only issued because–due to a double patenting rejection–a terminal disclaimer was filed by the patentee to disclaim any patent term of the second patent that would have extended beyond that of the first patent.

The Federal Circuit considered various public policy concerns, including the potential for patentee gamesmanship during prosecution to try to obtain additional patent term exclusivity for obvious variants of their inventions.  The Federal Circuit determined that the comparison of Gilead's patent expiration dates should control, not merely the issuance dates.  Accordingly, the Court moved away from traditional double patenting analysis that focuses on patent issuance because, as in this case, an earlier-issuing patent may not expire before a later-issued patent under the Uruguay Round Agreement Act.  The Federal Circuit found that the first patent, although issued first and without a double patenting rejection, could later be invalidated for obviousness-type double patenting based on the later-issuing, non-asserted second patent.

Chief Judge Rader dissented, arguing that an expansion of the judicially created doctrine of obviousness-type double patenting was not warranted in this case.  He argued that the majority overstated policy concerns to justify their decision and that, instead, the Federal Circuit should have exercised judicial restraint to avoid unforeseen consequences under the new first-inventor-to-file framework of the America Invents Act.

Gilead Warns: Examine Patent Portfolios for Double Patenting Pitfalls

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