Novartis Pharmaceuticals Corp v. Breckenridge Pharmaceutical, 909 F.3d 1355

Novartis owned two related patents on everolimus: U.S. Patent No. 5,665,772 (’772, pre-URAA, filed Apr 7, 1995, issued Sept 9, 1997) and U.S. Patent No. 6,440,990 (’990, post-URAA, filed May 23, 1997, issued Aug 27, 2002). Both claim the same earliest effective filing date (Sept 24, 1993) and share inventors/ownership.
The Uruguay Round Agreements Act (URAA) changed U.S. patent terms from 17 years from grant to 20 years from earliest effective filing date as of June 8, 1995; a transition rule gives pre-URAA applications the greater of the two terms. As a result, the post-URAA ’990 expired Sept 24, 2013, while the pre-URAA ’772 expired Sept 9, 2014 (later extended by §156 PTE to 2019).
The parties stipulated that the asserted claims of the ’772 are obvious variants of the ’990 claims and that, if the ’990 is a proper obviousness-type double patenting reference, the ’772 claims are invalid.
The district court, relying on this court’s post-URAA decision in Gilead, held the later-issued but earlier-expiring post-URAA ’990 could serve as a double patenting reference and invalidated the ’772 claims.
On appeal, the Federal Circuit considered whether Gilead’s expiration-date-centered analysis controls when one patent is pre-URAA and the other post-URAA, and whether applying double patenting in that situation would require truncating the statutorily granted pre-URAA term.

Issue	Novartis (Plaintiff) Argument	Defendants (Appellees) Argument	Held
Can a post‑URAA patent that issues after but expires before a pre‑URAA patent serve as an obviousness‑type double patenting reference against the pre‑URAA patent?	No — for a pre‑URAA patent use the issuance date as the benchmark; the URAA transition §154(c)(1) protects the greater statutorily granted pre‑URAA term and Congress intended pre‑URAA filers to receive the greater term.	Yes — Gilead says expiration date is the proper benchmark; allowing a post‑URAA patent to be a reference prevents unjustified extension of public exclusion rights and protects the public’s right to practice the expired patent.	The court reversed: a post‑URAA patent that expires earlier than a pre‑URAA patent due solely to the change in law is not a proper obviousness‑type double patenting reference; apply pre‑URAA issuance‑date analysis to the pre‑URAA patent.

Gilead Sciences, Inc. v. Natco Pharma Ltd., 753 F.3d 1208 (Fed. Cir. 2014) (post‑URAA double patenting: expiration date is the relevant benchmark)
AbbVie, Inc. v. Mathilda & Terence Kennedy Inst. of Rheumatology Trust, 764 F.3d 1366 (Fed. Cir. 2014) (obviousness‑type double patenting applies post‑URAA where later priority date was used to extend exclusivity)
Takeda Pharm. Co. v. Doll, 561 F.3d 1372 (Fed. Cir. 2009) (definition and purpose of obviousness‑type double patenting)
Perricone v. Medicis Pharm. Corp., 432 F.3d 1368 (Fed. Cir. 2005) (double patenting doctrine overview)
Miller v. Eagle Mfg. Co., 151 U.S. 186 (U.S. 1894) (historical rule: issuance date governs double patenting in the pre‑URAA era)