Back in January, the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board declined to review a patent on AbbVie’s Humira after wannabe biosimilar rival Amgen put forth an inter partes review challenge. But this time, the Illinois pharma wasn’t so lucky.
Tuesday, the PTAB announced it would embark on a review of Coherus’ challenge to Humira’s '135 methods patent, though that “does not definitively mean … the patent is no longer viable,” Barclays analysts wrote in a note to clients. It’ll now be about a year before the board makes a decision--and even if it the PTAB upturns Humira's IP shield, AbbVie could appeal, which could take another year or so.
Still, though, the '135 patent--which relates to Humira’s rheumatoid arthritis dosing regimen--“constitutes one of the cornerstones of the Humira IP estate,” the analysts wrote. So the PTAB’s decision “represents an important toehold for biosimilar developers to get around AbbVie’s patent defenses.”
AbbVie, for its part, has repeatedly assured investors that it has a “robust” defense system in place on the world’s best-selling med. That system includes methods patents covering Humira’s other indications, such as Crohn’s, Evercore ISI analyst Mark Schoenebaum wrote to investors.
“We are confident in the validity of our patents and will vigorously defend them. Humira is protected by many patents covering all aspects of its manufacture, formulation and indications and the patents are the result of AbbVie’s investment in biologic innovation and the unique attributes of Humira,” company spokesman Greg Miley told FiercePharma in a statement.
The PTAB is already fielding other IPRs, though--including one from Boehringer Ingelheim on the same '135 patent and a pair of new ones on other Humira patents, Schoenebaum noted. The board still needs to decide whether to institute those reviews, and Schoenebaum expects “additional IPRs/litigation to commence prior to potential biosimilar approvals,” he wrote.
An opening for Humira biosimilar competition in the U.S. isn’t exactly what AbbVie needs anytime soon. Its hep C combo, Viekira Pak--meant to take some of the load off the aging blockbuster--has struggled to get going against Gilead’s heavyweight meds, and third entrant Merck & Co. has only increased its difficulties. For Q1, Humira offset the hep C underperformance, recording a $151 million beat on U.S. sales to keep total revenues in line at $5.96 billion.
- see the IPR documents (PDF)
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