With biosimilar challengers champing at the bit to snag a piece of AbbVie’s world-leading Humira sales, much is riding on the company’s IP protection. And Monday, that protection held up, notching a win in the latest battle between AbbVie and Coherus.
The U.S. Patent and Trademark Office’s Patent Trial and Appeal Board has announced that it won’t embark on the inter partes review of AbbVie’s ‘166 patent--a key formulation patent--that Coherus requested. It’s a decision that “was somewhat surprising” given the IP shield’s “broad claims” and Coherus’ “compelling argument,” Leerink Partners analyst Geoffrey Porges wrote in a note to clients.
But it’s a surprise the Illinois pharma giant will gladly take. While biosims don’t need to have the same formulation as reference products--meaning the decision won’t necessarily impact all potential Humira filers--the verdict “does signify to us that Coherus’ position may be weaker than first anticipated,” Porges wrote. Evercore ISI analyst John Scotti added in his own research note that the IPR shut-down “incrementally increases confidence” among investors in AbbVie’s IP position, too.
That confidence is something AbbVie has been working hard to secure. The company has repeatedly touted its “robust” Humira defense plans, but in May, Coherus won a spar when the PTAB announced it would embark on a review of Coherus challenge to Humira’s ‘135 methods patent.
Of course, other Humira IPR petitions have been shut down, too--highlighting the “risks all biosimilar developers will face if they produce business plans based on binary outcomes from PTAB decisions,” Porges wrote. In January, the body declined to review a pair of formulation patents on the arthritis blockbuster, determining that "based on the petition and the accompanying evidence … Amgen has not shown a reasonable likelihood of prevailing on any of its challenges.”
Amgen, which recently won FDA approval for Humira biosim Amjevita, is also battling AbbVie in court, though, and if it wants to keep copycats at bay until 2022--the year it’s guided to for knockoff entry--it’ll have to hope its methods patents can hold up there, Scotti noted.
Meanwhile, Humira isn't exactly living up to analysts' forecasts. They dubbed the med's Q3 performance "poor" after U.S. sales underperformed expectations by $107 million.