Navigating the Implications of In re Cellect: What You Need to Know About Patent Term Adjustment & Obviousness-Type Double Patenting

On January 19, 2024, the Court of Appeals for the Federal Circuit issued an order denying the Petition for Rehearing En Banc in the much awaited In re Cellect matter. The mandate of the court issued today. 

It has been about five months since the panel of Circuit Judges Lourie, Dyk, and Reyna issued their landmark decision on the intersection of patent term adjustment (PTA) and obviousness-type double patenting (“ODP”). The decision is a bold statement of the Federal Circuit’s stance against multi-patent families based upon the same original filing, with its rationale deviating from the policies behind the ODP doctrine to prevent infringement claims by multiple parties. Cellect, LLC (“Cellect”) subsequently petitioned for rehearing en banc, to which USPTO Director Katherine Vidal was invited to file a response, and ultimately did so, supporting the Federal Circuit’s decision. Many amici filed briefs advocating for a rehearing, including pharmaceutical giants Abbvie, AstraZeneca, Johnson & Johnson, and Merck, to name a few. One late-filed amicus brief from Inari Agriculture, Inc. sided with the Director’s opposition. Despite the clear interest from the public in having the entire Federal Circuit revisit this issue, the petition was denied. See Industry Reactions to In re Cellect Decision.

En banc consideration is rarely granted. Federal Circuit Internal Operating Procedure #13 lists four reasons in which en banc rehearing could be granted: (1) necessity of securing or maintaining uniformity of decisions; (2) involvement of a question of exceptional importance; (3) necessity of overruling a prior holding of this or a predecessor court expressed in an opinion having precedential status; and (4) the initiation, continuation, or resolution of a conflict with another circuit. However, despite Cellect’s and amici’s reiterated importance of the matter and alleged conflict with Federal Circuit precedent, the Federal Circuit denied both rehearing and rehearing en banc. There has yet to be any indication whether this decision will be appealed further. Weighing heavily on this decision will certainly be the U.S. Supreme Court’s implicit deference to the Federal Circuit, having denied certiorari on three patent cases on appeal from the Federal Circuit already this year.¹

Implications

Following this denial, the Federal Circuit’s decision therefore stands: PTA must be applied before determination of patent term expiration and consideration of ODP. This differs from how patent term extension (PTE) resulting from FDA regulatory review delay is handled, with PTE being applied only after ODP analysis.² For those developing and managing patent portfolios, applicants/practitioners should consider pursuing more claims in a single application, intentionally using restriction/election practice to benefit from the safe harbor provisions of 35 U.S.C. §271(e)(1), weighing the benefit of PTE versus PTA for valuable assets, and prioritizing review of soon-to-expire patents to assess whether proactive filing of terminal disclaimers is advantageous. For those in court or post-grant proceedings, ODP as a tool for invalidating patents remains strengthened by the Federal Circuit’s August 2023 decision.

¹ Intel Corp. v. Vidal, Realtime Data v. Fortinet, and Fraxcell Techs v. AT&T all had cert denied on January 8, 2024.
² Novartis AG v. Ezra Ventures LLC, 909 F.3d 1367 (Fed. Cir. 2018).