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

• Decision Date: 29 July 2014
• Docket Number: No. 2013–1418.,2013–1418.
• Citation: 753 F.3d 1208
• Parties: 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.
• Court: U.S. Court of Appeals — Federal Circuit

753 F.3d 1208

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.

No. 2013–1418.

United States Court of Appeals,Federal Circuit.

April 22, 2014.

Rehearing En Banc Denied July 29, 2014.

Leora Ben–Ami, Kirkland & Ellis LLP, of New York, NY, argued for plaintiffs-appellees. With her on the brief were Patricia A. Carson and Benjamin A. Lasky.

Jeremy C. Lowe, Axinn, Veltrop & Harkrider LLP, of Hartford, Connecticut, argued for defendants-appellants. With him on the brief was Thomas K. Hedemann.

Before RADER, Chief Judge, PROST and CHEN, Circuit Judges.

Opinion for the court filed by Circuit Judge CHEN. Dissenting opinion filed by Chief Judge RADER.

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 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.

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 court's decision and remand.

I

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. The written descriptions of the patents are very similar and, in substantial parts, identical.

Despite their similarities in content, however, the '375 and '483 patents are not part of the same family of patents and were not before the same patent examiner. Instead, Gilead crafted a separate “chain” of applications, having a later priority date than the '375 patent family. That separate chain resulted in the issuance of the '483 patent. Because the patents do not claim priority to any common application, they will expire at different times as governed by the provisions of the Uruguay Rounds Agreement Act. The '375 patent was filed on February 26, 1996, and claims priority to a regular utility patent application filed on February 27, 1995. It expires twenty years later on February 27, 2015, and issued on September 14, 1999. The '483 patent was filed on December 27, 1996, and claims priority to a provisional utility patent application filed on December 29, 1995. Though filed after the application for the '375 patent, it issued first, on June 9, 1998, and expires last, on December 27, 2016.¹

After the '483 patent issued, Gilead filed a terminal disclaimer in the application that led to the '375 patent. Through it, Gilead disclaimed any portion of the '375 patent term that extended beyond the expiration date of the '483 patent—which, absent abandonment, would not occur since, as explained above, the '375 patent's expiration date is before the '483 patent's expiration date. From the prosecution history records, that appears to be the first time Gilead informed either the examiner of the '375 patent or of the '483 patent about the existence of the other patent application. No terminal disclaimer was filed for the '483 patent.

The following diagram illustrates the relevant dates for each patent, and how, because of different priority dates, the two patents have different expiration dates.

IMAGE

II

In March 2011, Gilead filed the current suit against Natco, alleging that Natco's Abbreviated New Drug Application No. 202–595 infringed the '483 patent. Among other defenses, Natco asserted that the '483 patent was invalid for obviousness-type double patenting in light of claim 8 of the ' 375 patent. In December 2012, the district court granted summary judgment in favor of Gilead on Natco's double patenting defense.

Relying on two district court cases, the court concluded that “a later-issued but earlier-expiring patent” cannot “serve as a double-patenting reference against an earlier-issued but later-expiring patent.” J.A. 7 (citing Abbott Labs. v. Lupin Ltd., 2011 WL 1897322 (D.Del. May 19, 2011) and Brigham & Women's Hosp. Inc. v. Teva Pharm. USA, Inc., 761 F.Supp.2d 210 (D.Del.2011)). ² It explained that “[t]he Uruguay Round Agreements Act of 1994, which became effective on June 8, 1995, changed the term for a U.S. patent from seventeen years from the patent issue date to twenty years from the earliest effective filing date.” J.A. 6 (citing Uruguay Round Agreements Act (“URAA”), Pub.L. No. 103–465, § 532(a), 108 Stat. 4809, 4983–85 (1994)). In the district court's view, any “extensions of the patent terms at issue were not unlawful because the extensions were not a result of gamesmanship, but instead were a result of changes to patent laws.” J.A. 7.

In May 2013, after Natco conditionally stipulated to infringement of two claims of the '483 patent, the district court certified its summary judgment ruling for appeal under Rule 54(b) because Natco's “only invalidity defense on the '483 patent” was obviousness-type double patenting. J.A. 10.

Natco filed a timely appeal. We have jurisdiction under 28 U.S.C. § 1295(a). For purposes of this appeal, we assume that the '483 patent claims a mere obvious variant of the invention claimed in the '375 patent.

III

This appeal presents a narrow question: Can a patent that issues after but expires before another patent qualify as a double patenting reference for that other patent? We conclude under the circumstances of this case that it can and, therefore, that the district court erred in excluding the '375 patent as a potential double patenting reference for the '483 patent.

A

The prohibition against double patenting is a longstanding doctrine of patent law. It is based on the core principle that, in exchange for a patent, an inventor must fully disclose his invention and promise to permit free use of it at the end of his patent term. As the Supreme Court has explained, “[i]t is self-evident that on the expiration of a patent the monopoly created by it ceases to exist, and the right to make the thing formerly covered by the patent becomes public property. It is upon this condition that the patent is granted.” Singer Mfg. Co. v. June Mfg. Co., 163 U.S. 169, 185, 16 S.Ct. 1002, 41 L.Ed. 118 (1896).³ The bar against double patenting was created to preserve that bargained-for right held by the public. See, e.g., Miller v. Eagle Mfg. Co., 151 U.S. 186, 197–98, 202, 14 S.Ct. 310, 38 L.Ed. 121 (1894); Suffolk Co. v. Hayden, 70 U.S. 315, 317, 3 Wall. 315, 18 L.Ed. 76 (1865); Boehringer Ingelheim Int'l GmbH v. Barr Labs., Inc., 592 F.3d 1340, 1346 (Fed.Cir.2010); In re Longi, 759 F.2d 887, 892 (Fed.Cir.1985); Application of Robeson, 51 C.C.P.A. 1271, 331 F.2d 610, 614 (1964); Odiorne v. Amesbury Nail Factory, 18 F.Cas. 578, 579 (C.C.D.Mass.1819). If an inventor could obtain several sequential patents on the same invention, he could retain for himself the exclusive right to exclude or control the public's right to use the patented invention far beyond the term awarded to him under the patent laws. As Justice Story explained in 1819, “[i]t cannot be” that a patentee can obtain two patents in sequence “substantially for the same invention[ ] and improvements”; “it would completely destroy the whole consideration derived by the public for the grant of the patent, viz. the right to use the invention at the expiration of the term.” Odiorne, 18 F.Cas. at 579. Thus, the doctrine of double patenting was primarily designed to prevent such harm by limiting a patentee to one patent term per invention or improvement.

The scope of the bar against double patenting has also been well-established in patent law jurisprudence. Federal courts for over a century have applied the principles of the doctrine as a means to preserve the public's right to use not only the exact invention claimed by an inventor when his patent expires, but also obvious modifications of that invention that are not patentably distinct improvements. See Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 967 (Fed.Cir.2001) (“The judicially-created doctrine of obviousness-type double patenting ... prohibit[s] a party from obtaining an extension of the right to exclude through claims in a later patent that are not patentably distinct from claims in a commonly owned earlier patent.”).⁴ With the addition of § 253 in 1952, however, Congress slightly altered the effect of the bar on double patenting.

In Application of Robeson, our predecessor court first addressed the impact of that statutory provision, which in part permits a patentee to disclaim any terminal...