The US Patent Office's Patent Trial and Appeal Board (PTAB) on Thursday rebuffed Alvogen's filing requesting an inter partes review of a patent covering Celgene's Revlimid (lenalidomide). In its decision, PTAB stated that it found no "reasonable likelihood that [Alvogen] would prevail with respect to at least one of the claims challenged in the petition."
The patent, number 7,968,569, describes a combination cancer therapy that "encompasses administering an immunomodulatory compound with one or more other therapeutically active agents" to a patient with relapsed multiple myeloma. The patent specifically covers a dosing regimen schedule for Revlimid administered in combination with dexamethasone in which the former drug is administered for 21 consecutive days followed by a seven-day rest period. Alvogen sought to challenge claims one to 15 of the patent on the grounds that the regimen was obvious at the time of invention.
PTAB concluded that Alvogen failed to provide evidence that the dosing schedule would have been recognised as "particularly common" or "routine" by an ordinarily skilled person. Additionally, the patent office said that Alvogen also failed to prove that the regimen would have been discovered through routine optimisation.
RBC Capital Markets analyst Brian Abrahams noted that the decision protects Revlimid against generic competition in the US until 2023, adding that the ruling alleviated "a potential issue that could unnerve investors" ahead of votes on Bristol-Myers Squibb's deal to purchase Celgene. Last month, PTAB also declined to hear Dr. Reddy's Laboratories' patent challenge against Revlimid (for additional analysis, read ViewPoints: Bristol-Myers Squibb, Celgene deal passes first big hurdle).
Alvogen announced in 2017 that it had requested FDA approval to launch a generic version of Revlimid and initiated a patent challenge. Meanwhile, earlier this year, the drugmaker launched the first generic version of the therapy in certain European countries after gaining regulatory approval last April.
Sales of Revlimid reached $9.7 billion in 2018.
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