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Gilead Scis., Inc. v. Natco Pharma Ltd.

Gilead Scis., Inc. v. Natco Pharma Ltd.

United States Court of Appeals for the Federal Circuit

April 22, 2014, Decided

2013-1418

Opinion

 [*1209]  [***1552]   Chen, Circuit Judge.

Gilead Sciences, Inc. ("Gilead") owns United States Patent Nos. 5,763,483 and 5,952,375, which are directed to antiviral compounds and methods for their use. While the patents list the same inventors and the written descriptions disclose similar content, they do not claim priority to a common patent application and have different expiration dates. Gilead sued Natco Pharma Limited ("Natco") for infringement of the '483 patent after Natco filed a request with the Food and Drug Administration seeking approval to market a generic version of one of  [**2] Gilead's drugs that is allegedly covered by the '483 patent. In response, Natco asserted that the '483 patent was invalid for obviousness-type double patenting over Gilead's '375 patent. In Gilead's view, the '375 patent cannot serve as a double patenting reference against the '483 patent because, even though the '483 patent's expiration date is twenty-two months after the '375 patent's expiration date, the '375 patent issued after the '483 patent.

 [*1210]  The United States District Court for the District of New Jersey agreed with Gilead and, pursuant to a stipulation, granted it final judgment on infringement. Natco appeals that judgment and argues that the '375 patent should qualify as an obviousness-type double patenting reference for the '483 patent because it expires before the '483 patent. Because the obviousness-type double patenting doctrine prohibits an inventor from extending his right to exclude through claims in a later-expiring patent that are not patentably distinct from the claims of the inventor's earlier-expiring patent, we agree with Natco that the '375 patent qualifies as an obviousness-type double patenting reference for the '483 patent. We therefore vacate the district  [**3] court's decision and remand.

The '375 and '483 patents were issued to the same inventors and are commonly owned by Gilead. The inventions disclosed in both patents are related to the inhibition of viruses through selective interference with certain enzymes.  [***1553]  The written descriptions of the patents are very similar and, in substantial parts, identical.

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753 F.3d 1208 *; 2014 U.S. App. LEXIS 7494 **; 110 U.S.P.Q.2D (BNA) 1551 ***; 2014 WL 1584450

GILEAD SCIENCES, INC., HOFFMANN-LA ROCHE, INC., F. HOFFMANN-LA ROCHE, LTD., AND GENENTECH, INC., Plaintiffs-Appellees, v. NATCO PHARMA LIMITED AND NATCO PHARMA, INC., Defendants-Appellants.

Subsequent History: US Supreme Court certiorari denied by Gilead Sciences, Inc. v. Natco Pharma Ltd., 2015 U.S. LEXIS 1787 (U.S., Mar. 9, 2015)

Prior History:  [**1] Appeal from the United States District Court for the District of New Jersey in Nos. 11-CV-1455 and 11-CV-4969, Judge Susan D. Wigenton.

Gilead Scis., Inc. v. Natco Pharma Ltd., 2012 U.S. Dist. LEXIS 180717 (D.N.J., Dec. 21, 2012)

Disposition: VACATED AND REMANDED.

CORE TERMS

patent, double patenting, invention, expires, expiration date, inventor, obviousness-type, disclaimer, terminal, variants, modifications, patentee, issuance, earliest, district court, subject matter, filing date, qualify, public right, earlier-expiring, later-expiring, invalid, cases, expiration of a patent, right to exclude, infringement, practicing, twenty-two

Patent Law, Double Patenting, General Overview, Terminal Disclaimers, Standards & Tests, International Trade Law, Trade Agreements, Intellectual Property Provisions, Infringement Actions, Exclusive Rights, Limitations