Novartis' bid to fend off early Gilenya generics has failed in court. The Swiss drugmaker, attempting to salvage a 2026 patent, lost that fight at the U.S. Federal Circuit, leaving the multiple sclerosis blockbuster shielded from generics only through 2019.
The decision (PDF) sets up an impending generic rush that stands to not only erode Gilenya's sales but upturn the market for MS pills in general. Other brands, including Biogen's Tecfidera, will be forced to compete with cheaper Gilenya knockoffs years before they expected that fight, analysts said.
The U.S. Court of Appeals for the Federal Circuit on Wednesday agreed with the U.S. Patent Trial and Appeals Board’s 2015 finding that Gilenya's 2026 formulation patent is invalid. In affirming the PTAB’s decision, the appeals court wrote that it “considered all of Novartis’ remaining arguments,” but concluded “that they are without merit.”
Now, Novartis has a patent term extension expiring in 2019 and a dose patent expiring in 2027, according to its recent 20-F filing with the Securities & Exchange Commission.
It’s a blow to Novartis, knocking several years of branded pricing power from a drug that brought in $3.1 billion last year. FDA-approved in 2010 as the first oral MS therapy, Gilenya remains a growth driver at the pharma giant; last year, it posted sales growth of 14%.
India’s Torrent Pharma brought the PTAB challenge to Gilenya’s intellectual property, while Mylan and Apotex filed a separate challenge. The mandatory Hatch-Waxman Act stay on generic approvals expires in March 2018, Novartis said in its filing.
In late 2015—when the PTAB invalidated the 2026 Novartis patent on grounds that it was “obvious"—Bernstein analyst Ronny Gal said the decision could reverberate through the entire MS market. Gal expected generic Gilenya and knockoffs of Teva’s big-selling injectable, Copaxone, to deliver dual blows to rival therapies.
Gal argued that with those two brands lacking patent protection, other brands would take a back seat to cheaper generics.
Teva's original Copaxone formula already faces knockoff competition, but its longer-acting version recently caught a break: Sandoz and Momenta's would-be generic rival was turned back by the FDA in February, delaying its potential launch. Still, Copaxone generics aren’t far off as Teva has suffered a series of stinging courtroom defeats.
Also set to make a sizable impact on the MS field is Roche’s new entrant Ocrevus. Roche last month placed a $65,000 list price on its infusion drug, saying the cost would undercut the sticker on Merck KGaA's standard therapy Rebif. The “industry needs to start to reverse this trend” of skyrocketing MS medicine costs, a spokesperson told FiercePharma at the time.
Novartis’ IP setback with Gilenya comes shortly after Acorda felt similar pain with MS med Ampyra; a U.S. District Court invalidated four of its patent claims on grounds of obviousness.