United States: The US Supreme Court declared on Monday that it will not hear Vanda Pharmaceuticals’s appeal to reinstate its invalid patent for sleep-disorder drug Hetlioz, which has come amid a dispute with generics companies Teva and Apotex.

High Court Rejects Vanda’s Bid

The Supreme Court refused to hear Vanda’s appeal of a decision by the American patent-related US Court of Appeals for the Federal Circuit that, since 2018, had sanctioned Teva and Apotex in Delaware for patent infringement after they had requested to make generics of Vanda’s Hetlioz, a circadian rhythm drug used to treat rare sleep disorders, as reported by Reuters.

Marks Key Decision in Patent Dispute

For the first time since 2007, the Supreme Court refused to review the question of when the courts can rule that the patent testing of an older publication describing the same invention is “obvious.”

The Federal Circuit’s obviousness standard materially departs from the Supreme Court’s longstanding holdings,” Vanda attorney Paul Hughes said. “While we are disappointed that the Supreme Court declined review of this case, we remain hopeful that the court will ultimately correct the governing standard.”

“Doing so is imperative in the pharmaceutical context to ensure that life-changing therapeutics are timely developed and reach underserved patients,” Hughes added.

Teva and Apotex Respond to Supreme Court Decision

A company representative stressed that Teva was glad the matter had finally been solved by the Supreme Court’s decision. When the spokesman of Apotex was contacted regarding the matter, he did not come across immediately.

Thanks to Washington-based Vanda making more than $100 million in contributions to the sales of Hetlioz in 2023, the company made a record, according to its report for the year.

US District Judge Colm Connolly struck the lawsuit against Vanda down at that time and cleared the way for other drug companies to enter the market. Connolly set Vanda’s patents aside on the basis that designing and analyzing clinical trial data and FDA guidance, along with other documents, would have led the field of scientists to the conclusion that the invention was obvious.

The Federal Appellate Court also ruled in favor of the plaintiffs in 2023. Vanda filed a petition with the US Supreme Court in January and was consequently heard by the court.

Vanda explained to the judges that the Federal Circuit has carved its path and applied the hurdle for obviousness that the Supreme Court does not allow, as reported by Reuters.

“Most relevant here, it threatens to render many advancements in drug development unpatentable,” Vanda said. “That is an especially pernicious result for rare diseases, where patent-based incentives are crucial for innovators to invest the billions required to develop new, successful treatments.”

As part of their defense, Teva of Israel and Apotex of Canada stated that Vanda’s move was merely an attempt to prolong Hetlioz’s patent monopoly and that the case “involves nothing more than the ordinary application of the facts and the law, which are well known.”