Six months after surviving a patent challenge involving its $3.2 million gene therapy, Sarepta faces a new lawsuit from another gene therapy developer claiming the approved treatment infringes its active patents.
Sanofi subsidiary Genzyme has filed a complaint in U.S. District Court in Delaware claiming that in producing groundbreaking Duchenne muscular dystrophy (DMD) treatment Elevidys, Sarepta encroaches on two of its patents involving the manufacture of viral vectors. Reuters published the lawsuit (PDF) on Tuesday.
Genzyme claims that its two patents protect “formulations and related methods” which allow viral vector particles to remain soluble and prevent their clumping during manufacture. Both patents are set to expire on June 1 of 2025.
Genzyme named Sarepta’s contract manufacturer Catalent in the complaint, but not as a defendant. The company is seeking a jury trial and damages.
In January in Delaware, U.S. District Judge Richard Andrews tossed out the claims of Regenxbio and the University of Pennsylvania against Sarepta, ruling that the patent they claimed was infringed was invalid. Regenxbio and Penn have another lawsuit ongoing against both Sarepta and Catalent.
Since it was approved in June of last year, Elevidys has had a highly successful launch, generating sales of $334 million through the first quarter of this year. Last month, the FDA broadened the population eligible to receive Elevidys to all DMD patients—ambulatory and non-ambulatory—age 4 and older. Previously, it was limited to ambulatory boys ages 4 to 5.
William Blair analyst Tim Lugo has pegged Elevidys’ sales to peak at $5 billion in 2027 before declining as the eligible population is expected to be reduced.
Roche handles regulatory efforts and commercialization of Elevidys outside of the U.S., per a $1 billion partnership between the companies.