Amgen secures five-year ban on psoriasis drug copycat
Court affirms decision that two Otezla patents are not invalid | Apremilast generics set for 2028 release.
The US Court of Appeals for the Federal Circuit upheld a judgment in a patent infringement lawsuit in Amgen’s favour, banning rivals Sandoz and Zydus from making generic versions of psoriasis medication Otezla for the next five years.
The Federal Circuit delivered its judgment yesterday, April 19.
Swiss generics manufacturer Sandoz appealed a decision from the US District Court for the District of New Jersey that held that two of Amgen’s patents covering Otezla, US patent numbers 7,427,638 and 7,893,101, were not invalid as obvious.
Amgen cross-appealed a decision from the same court that claims in another Otezla patent, US number 10,092,541, were invalid.
The Federal Circuit affirmed both decisions. With the ‘638 and ‘101 patents enforced, Sandoz and Zydus will not be able to make generic versions of Otezla until their expiration in February 2028—a date that could have been extended to 2034 had the ‘541 patent been upheld.
Otezla (apremilast) is a phosphodiesterase-4 (PDE4) inhibitor used to treat psoriasis and related conditions, and has US Food and Drug Administration (FDA) approval. The district court noted the commercial success of the drug in its judgment, with approximately 1.7 million prescriptions for Otezla between its launch in 2014 and April 2020.
Sandoz and Zydus submitted Abbreviated New Drug Applications (ANDAs) for FDA approval to market generic versions of apremilast. Celgene, the original owner of the patents, said the generics would infringe the ‘638 and ‘101 patents, and the ‘541 after that was issued. Amgen bought Otezla from Celgene in 2019 and was substituted as plaintiff in the case the following year.
The ‘638 patent includes claims to pharmaceutical compositions comprising apremilast, including oral formulations, as well as dosing forms, and the ‘101 patent is directed to solid forms (eg, crystalline polymorphic forms) of apremilast. The ‘541 patent claims methods of treating psoriasis with apremilast according to a specific dosing schedule.
Five-year ban rather than a decade
In its assessment of Sandoz’s claim that the patents were invalid, the district court looked to objective indicia of non-obviousness, noting that apremilast “unexpectedly
provided substantial improvement over previously known phosphodiesterase inhibitors in terms of both efficacy and tolerability” and addressed a “long-felt, unmet need” in providing an oral treatment for psoriasis without the risks and barriers of other medicines.
The appeals court affirmed these findings, as well as the determination that claims in the ‘541 patent were invalid as the methods for treatment would have been “within the ability of a skilled artisan” to know. Sandoz said this patent would have kept its generic off the market until 2034.
“Today’s decision affirms the permanent injunction entered by the district court prohibiting Sandoz and Zydus from making, using, selling, offering to sell, or importing each of their generic versions of Otezla until February 2028,” Amgen said in a statement on Wednesday.
A spokesperson for Sandoz said the firm was pleased that the decision enables it to market generic Otezla in 2028 instead of 2034, Reuters reported.
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