As Novartis awaits the U.S. Supreme Court’s decision on whether to take up its Gilenya patent dispute, the high court has cleared the way for copies of the nearly $3 billion multiple sclerosis blockbuster to hit the market in the short term.
The Supreme Court on Thursday lifted a stay blocking Gilenya generics from launching in the U.S.
In response, Novartis said it will “continue to vigorously defend the validity of the Gilenya patent." The company maintains plans to petition the Supreme Court to review the Federal Circuit’s decision, a company spokesperson told Fierce Pharma over email.
The latest Supreme Court move follows a brief victory for Novartis in late September after prior setbacks in the high-stakes case. Late last month, U.S. Chief Justice John Roberts signed off on the Swiss drugmaker's petition to temporarily block (PDF) the Federal Circuit’s mandate to lift an injunction waylaying Gilenya copycats.
Novartis has sued numerous generic manufacturers, such as China’s HEC Pharm, over their FDA applications to crank out fingolimod—Gilenya’s generic moniker. Novartis has settled with many of the companies, including India’s Aurobindo Pharma, Dr. Reddy’s Laboratories and Sun Pharmaceuticals, as well as North American generic players like Viatris and Canada-based Apotex, Reuters notes.
Those decisions pave the way for certain Gilenya generics to launch before a pivotal patent expiration in 2027.
But HEC Pharm wasn't content to settle and challenged Novartis' intellectual property in court. In doing so, the company secured several wins, which forced Novartis to take its case all the way to the Supreme Court.
As Novartis’ third biggest drug by revenue, Gilenya’s exposure to copycat competition could take a serious bite out of the company’s overall sales, Novartis warned in early fall. Should Gilenya generics launch this year, the company expects lower-cost rivals to siphon some $300 million from Novartis’ 2022 total revenue. For all of 2021, Gilenya brought home (PDF)Csales of about $2.8 billion for Novartis.
Back in June, the appeals court scrapped a prior verdict in Novartis’ favor, siding with HEC and finding a Gilenya patent invalid. The decision centered on Gilenya’s so-called '405 patent, which covers methods for treating relapsing multiple sclerosis with a specific dose of the drug. Problem is, the patent fails to account for loading doses, which are higher or more frequent doses at the start of treatment, the court said at the time.
In response to Novartis’ application for a stay on Gilenya generics, HEC Pharm earlier this month argued that “Novartis makes $3.8 million per day on Gilenya in the United States alone, charging at least 10 to 20 times what its generic competitors would,” according to court documents filed in October.
If Novartis were allowed to “continue to restrain generic competition even for the months it will take until its petition is denied, it will have squeezed virtually every last dollar from its monopoly pricing of Gilenya,” HEC continued in its response to Novartis’ application.
Gilenya doesn’t come cheap. According to Drugs.com, a 0.5-mg capsule of the med costs $302 before discounts, which means a month’s supply of the immunosuppressant would run for a whopping $9,053 out-of-pocket.