US Supreme Court denies Vanda's bid to revive sleep drug patents
Vanda denied opportunity to revive patents for its sleep-disorder drug in dispute against Teva | Decision also rejects revisiting the 2007 case, KSR International v Teleflex, concerning the issue of obviousness in patent claims.
Vanda Pharmaceuticals' bid to resurrect patents for its sleep-disorder drug, which had been ruled invalid in its dispute with Teva Pharmaceuticals and Apotex, has been denied.
The US Supreme Court, on April 22, 2024, declined Vanda’s request to contest an appeals court decision that invalidated multiple patents of its drug, Hetlioz (tasimelteon), in May 2023.
The decision also rejects revisiting the precedential 2007 case, KSR International v Teleflex, which concerned the issue of obviousness as applied to patent claims.
In KSR, the Supreme Court expanded the test for finding patents invalid as obvious, calling for a broader and more flexible analysis.
Mihael Polymeropoulos, president, CEO and chairman of the board at Vanda, said: "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.
“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," he added.
The patents in question are US Patent numbers RE46,604; 9,730,910; 10,149,829; and 10,376,487 owned by Vanda.
Hetlioz, approved by the US Food and Drug Administration, is for the treatment of non-24-hour sleep–wake disorder—a circadian rhythm disorder that causes too little nighttime sleep and too much daytime sleep.
Approximately 55% to 70% of totally blind individuals suffer from Non-24, noted Vanda in its original complaint.
Generic versions of Hetlioz
Vanda initiated its suit against Teva and Apotex in 2018, accusing the pair of patent infringement of Vanda’s sleep drug through their proposed generic versions of Hetlioz.
Teva’s and Apotex’s abbreviated new drug applications (ANDA) both alleged that the asserted claims in the patents are invalid and that all or most of the claims will not be infringed by the ANDA products.
Vanda countered by contending that the ANDA submissions constituted infringement of claim 3 of the RE604 patent; claim 14 of the ’829 patent; claim 4 of the ’910 patent; and claim 5 of the ’487 patent.
However, US district judge Colm Connolly, in December 2022, ruled that all four claims were invalid for obviousness.
Vanda appealed the district court’s obviousness and infringement determinations.
In May 2023, the US Court of Appeals for the Federal Circuit upheld that patents owned by Vanda Pharmaceuticals were invalid.
The Federal Circuit supported Judge Connolly's ruling, allowing Teva and Apotex to use prior art from Vanda's clinical trial to strengthen their argument that Vanda's patents were obvious.
Vanda appeals to US Supreme Court
Vanda later filed a petition with the US Supreme Court, seeking a review of the earlier judgment by the Federal Circuit.
The petition, filed on January 12, argued that the Federal Circuit's deviation from established standards posed a threat to patent law, particularly in the pharmaceutical sector.
Vanda held that the Federal Circuit's standard for obviousness diverged from the principles articulated by the Supreme Court—stating that the Federal Circuit “has charted its own course”.
“Rather than pegging obviousness to ‘predictable results,’ that court instead holds that a combination of known elements is obvious when an ordinarily skilled artisan would have a ‘reasonable expectation of success’ in the results reached,” said Vanda.
Vanda is represented by Paul Hughes, Sarah Hogarth, Christopher Bruno, April Weisbruch and Grace Wallack from McDermott Will & Emery.
Apotex is represented by Aaron Lukas and Blake Coblentz from Cozen O'Connor.
Teva is represented by John Christopher Rozendaal, Deirdre Wells and William Milliken from Sterne Kessler Goldstein & Fox.
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