The prospects for Vanda Pharmaceuticals’ 10-year-old circadian rhythm drug Hetlioz have grown that much dimmer after the U.S. Supreme Court shot down the company’s attempt to challenge an appeals court decision invalidating several of the drug’s patents in 2023.
The High Court has rebuffed (PDF) Vanda’s bid to contest the May 2023 ruling from the U.S. Court of Appeals for the Federal Circuit roughly four months after the company appealed to the Supreme Court to review the decision, according to a SCOTUS order list published Monday.
Vanda first sued Israeli-American pharma Teva and Canada-based Apotex in Delaware back in 2018, alleging the generic drug makers had tread on certain Hetlioz patents after applying to make copycats of the med, which was first approved by the FDA in 2014 to treat non-24-hour sleep-wake disorder.
In December 2022, the Delaware federal court both rejected Vanda’s infringement claims and took things a step further by ruling that four of Vanda’s patents were invalid. An appeals court upheld the decision in 2023, prompting Vanda to seek the Supreme Court’s aid in January, Reuters reports.
"We are disappointed that the Supreme Court has decided not to hear our case and clarify the lower court standard for obviousness in patent law," Mihael H. Polymeropoulos, president, CEO and chairman of Vanda's board said in a statement. "However, we are pleased that our case has drawn attention to an area of law that has broad and significant implications in life sciences innovation."
The failure of Vanda’s legal Hail Mary will likely take a heavy toll on the company and the future success of its decade-old drug.
For all of 2023, Hetlioz generated slightly more than $100 million in sales, representing a steep 37% decline from the $159.7 million it brought home in 2022. In its most recent earnings report, Vanda blamed (PDF) the sales falloff on the Hetlioz generic launches in the U.S.
Aside from Hetlioz, Vanda also markets the schizophrenia and bipolar disorder drug Fanapt as well as the multiple sclerosis drug Ponvory. Vanda shelled out $100 million in December to pick up U.S. and Canadian rights to Ponvory from Johnson & Johnson’s Actelion subsidiary.
Vanda’s total 2023 revenues clocked in at $192.6 million, of which Hetlioz sales accounted for slightly more than 50%.
Vanda’s Monday share price was down about 4.3% on news of the Supreme Court rejection.
Meanwhile, this marks the second major setback for Hetlioz this year.
In early March, the FDA denied Vanda’s request for a hearing over the regulator’s 2019 rejection of Hetlioz in jet lag disorder. Separately, Vanda revealed around the same time that the FDA had also swatted down its expansion bid for Hetlioz in insomnia. That second rejection came after the FDA in February alerted Vanda it had identified shortcomings in the drug’s insomnia application that “precluded discussion of labeling and postmarketing requirements/commitments,” Vanda said in a release at the time.
Still, it hasn’t all been bad for Vanda this year. Earlier this month, the FDA signed off on the company’s Fanapt tablets to treat adults with manic or mixed episodes associated with bipolar I disorder.
Fanapt, also known as iloperidone, started its development journey in the mid-1990s, ping-ponging between Novartis and Titan Pharmaceuticals before Vanda acquired the drug in 2004. The FDA rejected the drug in 2008 but ultimately approved iloperidone in schizophrenia in 2009 under the Fanapt moniker.
Elsewhere, Vanda last week parried a hostile takeover bid by Future Pak to acquire the Washington, D.C.-based company at what Vanda claimed was a discount to its “intrinsic value.” Vanda managed to ward off the takeover attempt through what’s known as a “poison pill”—an approach that works by imposing a significant penalty on any person or group that acquires ownership of 10% or more of its shares of common stock without prior approval of the company’s board.
Editor's note: This story has been updated with comments from Vanda.