Teva and Apotex prevail in sleep drug dispute
The dispute centred on a treatment that helps people adjust their circadian rhythm | Path now clear for generic drug makers to unveil biosimilar versions of the drug.
Teva Pharmaceuticals and Apotex have retained their win in a dispute over a sleep disorder medicine after the US Court of Appeals for the Federal Circuit held that patents owned by Vanda Pharmaceuticals were invalid.
The case emerged when Vanda sued Apotex and Teva last year, alleging that their abbreviated new drug applications (ANDAs) infringed claims in a quartet of patents safeguarding its blockbuster treatment, Hetlioz (tasimelteon).
According to the lawsuit, the claims relate to a method of treating non-24-hour sleep-wake disorder ( Non-24), 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 complaint.
Teva’s and Apotex’s ANDAs 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 suing Teva and Apotex in the District of Delaware 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.
Blockbuster drug
It is unsurprising that Vanda is seeking a robust defence of its blockbuster drug. In 2021, Vanda recorded sales of $173.5 million, with Hetlioz accounting for 65% of the company’s revenue, according to a report by Fierce Pharma.
Teva and Apotex stipulated to infringement of claim 5 of the ’487 patent, denied infringement as to the other claims, and alleged that all asserted patent claims were invalid.
The patents-in-suit are patents, US numbers RE46,604, 10,149,829, 9,730,910, and 10,376,487 (the ’487 patent), all of which are listed in the FDA’s Orange Book for Hetlioz
In December 2022, the US District Court for the US District of Delaware ruled that all four claims were invalid for obviousness.
The court also held that Teva and Apotex did not infringe claim 3 of the RE604 patent, but did not make infringement findings for the asserted claims in the ’829 patent or ’910 patent.
Vanda appealed the district court’s obviousness and infringement determinations.
But the Federal Circuit this week affirmed the earlier ruling, finding that: “The district court did not err in finding all of the challenged claims obvious. In light of our invalidity conclusion, we do not reach the question of infringement.”
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