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The Supreme Court has rejected D.C. drugmaker Vanda Pharmaceuticals Inc.’s request to review its patent infringement lawsuit against a pair of pharma competitors — a result that will likely ding future sales of one of its drugs.
Vanda owns patents covering the use of tasimelteon — sold under the brand name Hetlioz — to treat non-24-hour sleep-wake disorder, a condition where there’s little synchronization between a person’s circadian rhythm and the length of a day. It is Vanda’s biggest seller and one of three drugs it has on the market.
The U.S. and Israel-based Teva Pharmaceuticals Inc. and Toronto’s Apotex Inc. both filed with the Food and Drug Administration to market generic versions in 2018. Vanda initially sued alleging infringement on four patents.
In December 2022, the U.S. District Court for Delaware found the claims asserted by Vanda to be obvious. To be eligible for a patent, an invention must be considered novel, useful and “not obvious” to a person of “ordinary skill” in a particular field, according to patent law guidelines. In this case, the court ruled that Vanda’s patent claims are obvious based on “prior art teachings” about Hetlioz and related drugs. “Prior art” is generally considered anything that is made available, or disclosed, to the public that might be relevant to a patent's claim before the filing date of a patent application.
In October, Vanda said it intended to go to the Supreme Court to contest a May 2023 ruling from the U.S. Court of Appeals for the Federal Circuit that upheld a lower-court ruling that Vanda’s patents were invalid.
"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 Polymeropoulos, president, CEO and chairman of Vanda, 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. We look forward to future cases that may resolve these issues for the benefit of innovators, patients and public health."
Vanda did not respond to a request for further comment.
The company reported $192.64 million in total revenue across 2023, with $100.17 million from the sale of Hetlioz. That was down from $254.38 million in revenue in 2023 with $159.66 million attributed to Hetlioz. Vanda said the 37% decrease in Hetlioz sales was the result of “the at-risk launch of generic versions” in the U.S.
Vanda also markets the schizophrenia and bipolar disorder drug Fanapt, as well as the multiple sclerosis drug Ponvory. It paid $100 million in December to pick up the rights to Ponvory from a Johnson & Johnson subsidiary.
The Supreme Court’s rejection follows news last week that Vanda rejected acquisition overtures from private contract-manufacturer Future Pak LLC and that it has adopted a shareholder rights plan — better known as a poison pill — to reduce the likelihood of its suitor taking an offer directly to shareholders.
