In a recent Law360 article, Thompson Coburn partner Olga Berson discussed how the settlement of patent litigation involving Moderna’s COVID‑19 vaccine and patents owned by Arbutus Biopharma and Genevant Sciences GmbH highlights a recurring and often overlooked freedom‑to‑operate risk in biopharmaceutical innovation. As she explained, the dispute underscores the challenges that arise when “patent portfolios covering enabling platform technologies” are held by companies that do not develop the therapeutic product itself. These portfolios, she noted, can have significant implications for biopharmaceutical IP due diligence.
Olga wrote that “beyond the size of the settlement, the dispute highlights a recurring challenge in biopharmaceutical intellectual property diligence.” She said that even when patent owners are not direct competitors, their rights over foundational technologies can still create major freedom‑to‑operate concerns.
She also addressed a key legal question that emerged during the litigation: whether government contractor immunity under 28 U.S.C. § 1498 applied. As she noted, “Section 1498 provides that when a patented invention ‘is used or manufactured by or for the United States,’ the patent owner’s remedy lies against the U.S. in the U.S. Court of Federal Claims rather than against the contractor in federal district court.”
Olga explained that the Moderna‑Arbutus/Genevant dispute demonstrates the type of intellectual property exposure that can arise from platform technologies held by companies outside the downstream therapeutic market. She wrote, “It may seem logical to focus freedom-to-operate analysis primarily on patents held by direct product competitors. Competitors developing similar therapeutic products may have strong incentives to assert overlapping patent rights.”
Read the full article here.
