Supreme Court Declines to Revive Invalidated Hetlioz Patents for Vanda
The U.S. Supreme Court has declined to review Vanda Pharmaceuticals Inc’s attempt to revive patents for its sleep-disorder medication Hetlioz, which had previously been invalidated in a legal battle with generic drugmakers Teva Pharmaceutical Industries Limited and Apotex.
Vanda had filed a lawsuit in 2018 against Teva and Apotex in Delaware, alleging patent infringement after they sought approval to manufacture generic versions of Hetlioz. The Federal Circuit, a patent-focused court, ruled against Vanda, leading to the company’s appeal to the Supreme Court, which was declined.
This decision marks the Supreme Court’s avoidance of addressing when a patent can be invalidated as “obvious,” a matter not revisited since 2007, as per the report. Last year, a federal court granted final judgment in favor of Vanda Pharmaceuticals’ Freedom of Information Act (FOIA) case requesting records created by the FDA while reviewing Vanda’s application seeking approval of Hetlioz (tasimelteon).
Vanda’s annual revenue from Hetlioz sales surpassed $100 million in 2023. However, the company faced setbacks in its legal battle, with U.S. District Judge Colm Connolly ruling against Vanda in 2022, declaring its patents invalid based on various factors including clinical trial results and FDA guidance. The Federal Circuit upheld this decision in 2023, prompting Vanda’s appeal to the Supreme Court earlier this year.
Vanda argued that the Federal Circuit’s standard for obviousness deviates from Supreme Court precedents, potentially rendering many drug development advancements unpatentable, particularly impacting treatments for rare diseases. In response, Teva and Apotex contended that Vanda’s appeal was an attempt to extend its patent monopoly on Hetlioz, asserting that the case merely involved the application of settled obviousness law.
