Biogen has sued Boston-based biotech Creative Biolabs for allegedly selling copycat versions of its unapproved Alzheimer’s disease (AD) hopeful aducanumab.
The drug, a monoclonal antibody, works to inhibit amyloid beta clumps in the brain, which researchers believe (but have so far failed miserably to prove) is a cause of AD.
Biogen was one of a host of biopharmas using this approach but saw poor results in later-stage trials. The Big Biotech, in fact, all but ditched the drug around a year ago before some data dredging saw it come back from the dead with a glimmer of hope it could help a subpopulation of patients.
Biogen is expected to file with the FDA soon on the back of these reworked phase 3 data (though with the spread of COVID-19, drug approval and review timelines are surely now up in the air), with some analysts giving it a shot of an actual nod despite the weak data.
If it did manage to be the first AD drug on the market for more than 15 years, it could theoretically make billions. But according to a filing with a Boston federal court this week, Creative Biolabs is selling illegal copycat versions of its experimental drug, earning Biogen’s ire.
Creative Biolabs describes itself as an antibody discovery company and as a biopharma services firm.
“Plaintiffs Biogen and UZH [University of Zurich: Biogen licenses a U.S. patent from UZH] bring this action under the federal patent and trademark laws as well as Massachusetts state law to stop Defendant [Creative BioLabs] from unlawfully selling purported copies of an innovative therapeutic antibody for treatment of Alzheimer’s disease developed by Biogen at a cost of hundreds of millions of dollars,” Biogen says in the complaint.
“Defendant’s willful infringement of Biogen and UZH’s intellectual property rights threatens to cause irreparable injury both to Biogen and to investigators who might mistakenly use Defendant’s unauthorized copycat products in their scientific and clinical research.”
Biogen says that while Creative “touts itself as a biotechnology” company developing novel antibodies, its website “confirms that it is brazenly copying patented commercial products and products in development to offer for sale on its websites.”
Here, the Big Biotech says it advertises and offers to sell aducanumab. “Defendant offers for sale at least numerous aducanumab products on its website, including two for which Defendant lists 'BIIB037' on its website as an alternate name for the product,” despite having no legal right to do so.
Biogen says there could also be a safety issue, as it’s unlikely Creative uses the “same rigorous manufacturing controls” Biogen does in making the drug and could “pose a likely public health hazard if it were confused with the aducanumab Biogen manufactures for its clinical trials.”
Biogen is seeking an injunction against the sale as well as an infringement of its patent.