Don’t sleep on AbbVie’s recent federal court victory which upheld its patents on big-selling cancer drug Imbruvica, warns one influential biopharma analyst.
In the case, Delaware judge Colm Connolly ruled that Alvogen and India's Natco Pharma infringed four patents in creating their generic versions of the blockbuster cancer drug, sparking the infringement claim. After the win, AbbVie is in a strong position to grow after its massive Humira loss of exclusivity in 2023, Bernstein analyst Ronny Gal wrote to clients on Monday.
“This is probably the most underappreciated piece of company-specific news of the past two weeks,” Gal wrote. “This is subject to appeal, but to the extent that the verdict is upheld, AbbVie will not have a major [intellectual property] loss after Humira until 2030.”
In a recent SEC filing, AbbVie said that “no generic entry for any Imbruvica product is expected prior to March 30, 2032,” thanks to prior settlements with generic makers.
While analysts have long maintained that AbbVie will be in serious trouble when Humira loses its patent protection in 2023, Gal sees a brighter outlook, thanks in part to the recent ruling.
“AbbVie looks the best when compared to its peers on patent expires," Gal wrote.
Last year Imbruvica generated sales of $5.3 billion for AbbVie and $4.1 billion for development partner Johnson & Johnson. Launched in 2013, Imbruvica has received 11 approvals in six disease areas including lymphoma. It also is the lone drug to treat Waldenstrom macroglobulinemia and chronic graft-versus-host disease.
The win for AbbVie is also significant considering the heat the company has faced recently for the patent thickets it has built around its blockbuster drugs.
AbbVie has applied for 165 patents for Imbruvica, 88 of which the company has won. More than half of the applications were filed after the drug gained its initial FDA approval. The nine-plus years of protection will bring estimated spending on the drug at more than $41 billion, says I-MAK.
In February, during a Senate Finance Committee hearing, Sen. John Cornyn (R-Texas) blasted the company.
“I support drug companies recovering a profit based on their research and development of innovative drugs,” Cornyn said. “But at some point that patent has to end, that exclusivity has to end, to be able to get it at a much cheaper cost.”
As for Humira, which hit the market in 2002 and generated nearly $20 billion in sales last year, its exclusivity has been extended by 130 patents. The drug's forthcoming loss of exclusivity is a major reason AbbVie struck its $63 billion buyout of Botox maker Allergan.
While AbbVie's patent defense strategy has been a boon, Gal also believes that such successes will eventually lead to changes in legislation that will hinder future efforts for pharmaceutical giants.
Patent walls take advantage of “weakness in the procedures of the PTO and courts to extend exclusivity," Gal wrote last year, and such moves will “gradually lead to efforts to reform.” Gal believes the moves also undercut the pharma industry’s argument that it’s merely seeking a “fair return” on investments.