Amicus, USPTO Urge Denial of Cellect SCOTUS Petition

On August 21, plant gene editing company Inari Agriculture filed an amicus brief with the U.S. Supreme Court urging it to leave in place the U.S. Court of Appeals for the Federal Circuit’s precedential decision in In re: Cellect, which relates to the application of the obviousness-type double patenting (OTDP) doctrine in the context of patent term adjustments (PTA). Inari’s amicus brief was filed the same day that the U.S. Patent and Trademark Office (USPTO) filed its brief in opposition to Cellect’s petition for writ of certiorari, arguing that the Federal Circuit was right to conclude that provisions governing PTA codified at 35 U.S.C. § 154 contemplates the application of OTDP doctrine to patents receiving PTA that are not terminally disclaimed to earlier-expiring patents claiming indistinct subject matter.

The Federal Circuit issued its Cellect ruling last August, finding that OTDP doctrine applied to Cellect’s patent claims from their expiration date after any PTA added under Section 154 for agency delay. The opinion distinguished how OTDP is applied in circumstances where a patent term extension under 35 U.S.C. § 156 is added for delays in regulatory approval. This January, the Federal Circuit denied Cellect’s petition for 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. This right to practice expired claims is crucial in the agriculture context, Inari argues, due to the oligopolistic market conditions in that industry. The brief notes that the Federal Trade Commission (FTC), the Executive Branch and 12 state governments have taken legal action against market-dominant firms like Corteva and Syngenta.

In order to practice its own seed engineering technology, Inari contends that it has been forced to file a series of requests for ex parte reexamination at the USPTO, including reexamination requests for eight Corteva patents that allegedly seek to extend that company’s patent rights by more than 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. While patent applicants are not likely to manipulate regulatory processes to delay drug approval, Inari cited several articles available online recommending strategies for maximizing PTA using the USPTO’s procedural rules for patent prosecution. In a footnote, Inari points out that several Corteva patents it has targeted in reexamination proceedings received PTA after Corteva took an extension to respond to restriction requirements or submitted an issue fee payment as late as possible.

The Federal Circuit’s Cellect ruling has improved behaviors among patent applicants, according to Inari. While applicants can still pursue continuation patents without patentably distinct claims under 35 U.S.C. § 120, terminal disclaimers allow those parties to avoid the issues that arose to invalidate Cellect’s patent claims. Inari argues that the Federal Circuit’s ruling allows Section 120, which does not limit continuation patents to distinct inventions, to work within the context of 35 U.S.C. § 101’s mandate that an invention shall be entitled to “a patent,” not multiple patents. Inari further 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. Limitations on PTA when a terminal disclaimer has been filed, codified at Section 154(b)(2)(B), indicate that OTDP analysis should be applied as ordinary when a terminal disclaimer is not filed, according to the USPTO. 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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