- Biogen Inc. watched the last line of defense for its Avonex franchise fall on Friday, as a jury invalidated a key patent covering the multiple sclerosis drug.
- Patent '755 concerns certain methods for making proteins that function similarly to human fibroblast interferons, such as those used to create Avonex. Since 2010, Biogen has been in legal battles with Bayer AG, EMD Serono Inc., Pfizer Inc. and Novartis AG, claiming products from those rival companies infringe on its patent.
- Yet in the U.S. District Court for the District of New Jersey, a jury determined "the prior art regarding the use of interferons for many different medical conditions," was enough to invalidate '755, according to Leerink analyst Geoffrey Porges. In other words, the ideas laid out in '755 weren't new at the time of its issuance.
Avonex (interferon beta-1a) first gained Food and Drug Administration approval in 1996. More than two decades later, Biogen continues to squeeze out an incredible amount of money from the drug — a cool $2.15 billion last year, for instance.
But such solid returns won't last forever. Already, Avonex is on the decline due to market competition from newer multiple sclerosis treatments and biosimilars. Revenues from the drug fell 12% from 2015 to 2016 and another 7% 2016 to 2017. What's more, Biogen has turned much of its attention to Tecfidera (dimethyl fumarate), which had one of the best drug launches in recent memory and currently sits as the big biotech's number one cash driver.
Though it deals Avonex another blow, the jury's decision to invalidate '755 doesn't really change the drug's downward trajectory, according to Porges.
"This patent is effectively Biogen’s only remaining patent protection for Avonex, since its true composition of matter patent expired in 2013; while Biogen has made much of this patent and actively asserted it against branded infringers marketing different versions of beta interferon, we don’t believe investors were convinced of its utility," he wrote in a Feb. 26 note.
"We certainly regarded this patent as of limited utility to keep competitors of any kind off the market, given the obvious continuing sale of Rebif, Betaseron and Extavia, despite the patent’s issuance."
To that point, Biogen's stock began trading at $294 apiece on Monday, up less than 1% from Friday's market close.
Less clear is whether Biogen will appeal the jury's decision. The company declined a BioPharma Dive request for comment.
In the meantime, the threats to Avonex will likely come from branded competition rather than generics. In the first nine months of 2017, for example, sales of Bayer's Betaferon/Betaseron (interferon beta-1b) reached €499 million (about $554 million).
"The challenges of manufacturing, developing, and commercializing a biosimilar version of an interferon are very significant, and the difficulties of showing true 'biosimilarity' have deterred most or all of the most obvious generic manufacturers," Porges wrote.