In an effort to maintain stability in the pharmaceutical industry, plant gene editing company Inari Agriculture has filed an amicus brief with the U.S. Supreme Court urging the denial of the U.S. Court of Appeals for the Federal Circuit’s decision in In re: Cellect. This decision relates to the application of the obviousness-type double patenting (OTDP) doctrine in the context of patent term adjustments (PTA).
The U.S. Patent and Trademark Office (USPTO) also filed a brief in opposition to Cellect’s petition for writ of certiorari, supporting the Federal Circuit’s conclusion that provisions governing PTA contemplate the application of OTDP to patents receiving PTA that are not terminally disclaimed to earlier-expiring patents claiming indistinct subject matter.
Last August, the Federal Circuit issued its Cellect ruling, applying the OTDP doctrine to Cellect’s patent claims from their expiration date after any PTA added under Section 154 for agency delay. The ruling 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. In January, the Federal Circuit denied Cellect’s petition for rehearing, with Inari filing an amicus brief in the rehearing arguing that the decision addresses open gamesmanship of PTA by patent applicants.
Inari 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 due to oligopolistic market conditions in the industry. Inari notes actions taken by the Federal Trade Commission (FTC), the Executive Branch, and 12 state governments against market-dominant firms like Corteva and Syngenta.
To practice its own seed engineering technology, Inari has been forced to file requests for ex parte reexamination at the USPTO, including requests for Corteva patents that allegedly seek to extend patent rights by more than 20 years. Despite concerns from pharmaceutical industry groups that the Federal Circuit’s Cellect decision could destabilize incentives to invest in innovation, Inari argues that research and development investments have increased significantly following the Federal Circuit’s 2014 decision in Gilead v. Natco.
Inari also highlights the differences between PTA and PTE that invite abuse from patent applicants. While patent applicants are not likely to manipulate regulatory processes to delay drug approval, Inari cites strategies for maximizing PTA using USPTO procedural rules for patent prosecution available online. In a footnote, Inari points out that several Corteva patents 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.
According to Inari, the Federal Circuit’s Cellect ruling has improved behaviors among patent applicants. While continuation patents can still be pursued without patentably distinct claims under Section 120, terminal disclaimers allow parties to avoid issues that invalidate patent claims. Inari argues that the Federal Circuit’s ruling allows Section 120 to work within the context of Section 101’s mandate that an invention shall be entitled to “a patent,” not multiple patents.
The USPTO’s brief in opposition agrees 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 indicate that OTDP analysis should be applied as ordinary when a terminal disclaimer is not filed. The USPTO notes that 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 argues that the Federal Circuit erred in expanding OTDP beyond its equitable roots, the USPTO’s brief notes that Cellect did not identify any authority requiring such a finding. The USPTO contends that Cellect’s question presented was not sufficiently important to grant cert due to the unanimous nature of the decision below, impacting only a small subset of U.S. patents that receive PTA.
