Amicus, USPTO urge denial of Cellect SCOTUS petition
“While pharmaceutical industry groups have warned the Federal Circuit that the Cellect decision could destabilize the incentives to invest in innovations, Inari argues research and development investment has increased significantly despite claims similar to those following the Federal Circuit 2014 decision in Gilead v. Natco.”
On the 21st of August, plant gene editing company Inari Agriculture submitted an amicus brief to the U.S. Supreme Court urging the court to leave in place U.S. Court of Appeals Federal Circuit precedent Inari’s brief was filed on the same day as the USPTO’s brief in opposition to Cellect’s petition for writ. SS 154 contemplates that OTDP will be applied to patents that receive PTA but are not terminally disclaimed by earlier-expiring claims of indistinct matter. The opinion differentiated how OTDP applies in situations where a 35 U.S.C. SS 156 was added to account for delays in regulatory approval. In January, the Federal Circuit rejected Cellect’s request for a rehearing. Inari filed an amicus brief in the rehearing arguing that the appellate court’s decision addresses open gamesmanship of PTA by patent applicants.
Inari: Cellect Ruling Has Improved Filing Behaviors Around Continuation Patents
Inari’s Supreme Court brief now argues that applying OTDP to patents receiving PTA supports the U.S. patent system’s fundamental quid pro quo ensuring that the public benefits from its ability to practice technologies following the expiry of patent claims. Inari argues that this right to practice expired patent claims is vital in the agriculture industry due to oligopolistic conditions. Inari argues that in order to practice its seed engineering technology it has been forced by the USPTO to file a number of requests for ex parte review, including requests for reexaminations for eight Corteva Patents that allegedly attempt to extend the company’s rights by more 20 years. While pharmaceutical industry groups have warned that the Federal Circuit’s Cellect decision could destabilize incentives to invest in innovation, Inari argues that research and development investments have increased significantly despite similar claims following the Federal Circuit’s 2014 decision in Gilead v. Natco, which expanded the references that could be considered in OTDP analyses.
Inari’s brief also reiterates the company’s arguments that PTA is different from PTE in ways that invite abuse from patent applicants. Inari cited articles online that recommended strategies for maximizing PTA by using the USPTO’s procedural rules for Patent Prosecution. While patent applicants will not manipulate regulatory processes to delay drug approval, Inari cited a number of articles available on the internet recommending strategies to maximize PTA. In a footnote Inari notes that Corteva received PTA for several Corteva Patents targeted in reexamination procedures after Corteva requested an extension to respond or pay an issue fee as late as possible. Inari says that applicants can still pursue continuations patents under 35 U.S.C. SS 120 and terminal disclaimers enable those parties to avoid issues that arose in invalidating Cellect’s claims. Inari argues the Federal Circuit’s decision allows Section 120 to be used within the context 35 U.S.C. SS 101 mandates that an invention is entitled to “a single patent” and not multiple patents. Inari suggests that the Federal Circuit’s recent decision in Allergan USA V. MSN Laboratories Pte. Ltd. (2024), in which the court held that a parent patent receiving PTA causing it to expire after a child patent is not invalid under OTDP, confirms that the Federal Circuit is in the best position to continue refining the OTDP doctrine.
USPTO: Section 154’s Explicit Terminal Disclaimer Reference Implies OTDP Analysis
The USPTO’s brief in opposition agreed with Inari that the Federal Circuit properly applied OTDP analysis in the context of the PTA provisions of Section 154. According to the USPTO, Section 154(b), which limits PTA when a disclaimer of terminal effect has been filed, indicates that OTDP should be applied when a disclaimer of terminal effect is not filed. Because OTDP and terminal disclaimers are “two sides of the same coin,” Section 154’s explicit reference to terminal disclaimers differentiates PTA from PTE as Section 156 doesn’t include a similar carveout for terminal disclaimers.
While Cellect’s petition argues that the Federal Circuit erred in expanding OTDP beyond its equitable roots by applying it without finding laches or fraud, the USPTO’s brief notes that Cellect did not identify any authority requiring such a finding. Further, the USPTO contends that Cellect’s question presented was not sufficiently important to grant cert due to the unanimous nature of the decision below, and that the Supreme Court’s decision would only impact a small subset of U.S. patents that receive PTA.
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Steve Brachmann
Steve Brachmann graduated from the University at Buffalo School of Law in May 2022, earning his Juris Doctor. He served as the president of the Intellectual
