Does PTAB's Ex Parte Cellect Decision Endanger Biopharmaceutical Patent Terms?

• Published date: 22 April 2022
• Subject Matter: Intellectual Property, Patent
• Law Firm: Mayer Brown
• Author: Mr Scott A. McMurry and Ryan Babcock

In a warning to patent owners, a patent whose term had been extended through Patent Term Adjustment ('PTA') was recently found invalid for obviousness-type double patenting ('ODP') by the US Patent Trial and Appeal Board ('PTAB'). Ex Parte Cellect Patent Owner and Appellant, Appeal No. 2021-00503, 2021 WL 5755329 (PTAB, Dec. 1, 2021). This is particularly concerning for makers of biopharmaceuticals, especially immunotherapeutic proteins and other biologic drugs. The duration of the patents protecting these drugs is critical to their value, and the terms of these patents are often extended by PTA. Moreover, effective lifecycle management strategies for immunotherapeutics typically involve developing broad, independent patent portfolios (often covering new or extended medical indications), increasing the risk of generating potentially invalidating ODP art.

Backdrop: District Courts Split

Previously, several district courts have split on whether a PTA-based extension of patent term is vulnerable to ODP. In 2021, two New Jersey district court decisions found that ODP did not apply when the expiration dates of two patents differed solely due to PTA. Amgen, Inc. v. Sandoz Inc., No. 18-11026, 2021 WL 5366800, slip. op. at *26 (D.N.J. Sept. 20, 2021) (currently on appeal); Mitsubishi Tanabe Pharm. Co., et al. v. Sandoz, Inc. et al., 533 F. Supp. 3d 170, 213-215 (D.N.J. Apr. 7, 2021) (settled prior to appellate decision). The New Jersey district court decisions denied ODP challenges to PTA by relying on the Federal Circuit's holding in Novartis AG, et al., v. Ezra Ventures LLC, 909 F.3d 1367 (Fed. Cir. 2018) that the statutorily guaranteed right of a patent term extension ('PTE') should not be nullified by a judge-made doctrine such as ODP or by the lack of gamesmanship by the patentees in extending patent protection. In contrast to these New Jersey decisions, an earlier decision from a district court in Michigan held the opposite. Magna Electron. Inc. v. TRW Auto. Hold. Corp., et al., 2015 WL 11430786 (W.D. Mich. 2015). With this competing backdrop, the PTAB undertook its own analysis of PTA and ODP in Ex Parte Cellect and, in reaching its conclusion, rejected the rationales of the two New Jersey cases.

Interplay Between ODP and PTE

In Ex Parte Cellect, the PTAB considered the appropriateness of an ODP rejection of two related patents that had different expiration dates solely due to PTA. The PTAB framed the question as 'how a PTA under ' 154 should factor into a...