Obvious-Type Double Patenting and PTEs: Defeating ODP Rejections and Avoiding Terminal Disclaimers

Obviousness-type double patenting (ODP) is not statutory and is intended to prevent an inventor from improperly extending a patent's life by having two patents on the same invention. ODP may arise between pending applications, between a patent and one or more pending applications, and between multiple patents, even if not owned by the same party.

In December 2018, the Federal Circuit brought some clarity to ODP in the context of pre-Uruguay Round Agreements Act (URAA) and URAA patents and applications. In Novartis AG v. Ezra Ventures LLC, the court held that (PTE) granted under 35 U.S.C. Section 156. Recently Judge Shipp cited Ezra in Amgen, Inc. v. Sandoz Inc., 2021 U.S. Dist. LEXIS 224304 (D. NJ Sept. 20, 2021), for the same principle: "these statutorily authorized time extensions do not cause a patent to be invalid for obviousness-type double patenting ('ODP'). ODP is a 'judicially created doctrine intended to prevent improper timewise extension of the patent right.' ... A difference in expiration dates between two patents that arises solely from a statutorily authorized time extension, such as a patent-term adjustment pursuant to 35 U.S.C. § 154(b) or a patent-term extension pursuant to 35 U.S.C. § 156, cannot be the basis for an application of ODP." Id. at *84-85.

In Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc., the court clarified that Gilead Sciences Inc. v. Natco Pharma Ltd. (Fed. Cir. 2014) (that a later-issued but earlier-expiring patent could invalidate an earlier-issuing but later-expiring patent for ODP) only applies to post-URAA patents.

In Breckenridge and Ezra, involving a pre-URAA patent and a post-URAA patent, the Federal Circuit cabined Gilead to circumstances where both the patent and the asserted reference patent are URAA. Importantly, the Federal Circuit definitively stated that ODP could not invalidate a validly obtained PTE.

Instead of a terminal disclaimer, arguments of separate patentability are an option. Arguments for separate patentability may arise in a genus-species context (such as in UCB, Inc. v. Accord Healthcare, Inc., 890 F.3d 1313 (Fed. Cir. 2018)) or may be supported by carefully presented real world objective evidence of patentability, such as commercial success, long-felt need, and failure of others.

Listen as our authoritative panel of patent attorneys examines ODP, including the impact of Breckenridge and Ezra and other recent decisions. The panel will offer best practices to defeat ODP rejections and avoid terminal disclaimers.