Novartis takes Gilenya fight to Supreme Court as generic competition looms
Novartis stands to lose more than a quarter billion dollars in sales this year if Gilenya generics are allowed to market. So it’s taking the fight all the way to the Supreme Court.
The Swiss pharma giant announced on Wednesday that a US federal appeals court has refused to rehear its Gilenya patent case against private Chinese biotech HEC Pharm. Next up? Novartis plans on petitioning the Supreme Court to uphold the validity of its patent No. 9,187,405, referred to in court documents as the ‘405 patent, covering a 0.5 mg dosing regimen of the multiple sclerosis drug.
Gilenya was first approved back in 2010 as a first-line MS treatment, expanding to the pediatric setting eight years later. Sales topped out at nearly $2.8 billion last year, making Gilenya Novartis’ third-highest seller in its Innovative Medicines segment.
HEC filed for approval of a generic version back in 2016 and won approval in 2019. Novartis quickly slapped the company with a handful of lawsuits asserting various Gilenya patents, which expire in 2027. The Swiss pharma pulled an early win in the US District Court of Delaware in August 2020, when a permanent injunction was granted against HEC’s generic until the ‘405 patent expires in December 2027.
A three-judge appeals panel upheld the decision again this January — but a new panel reversed the decision at a rehearing in June, overturning the January judgment in a 2-1 vote and ruling the ‘405 patent invalid.
Lawyers for Novartis filed for another rehearing in July, calling the case “extraordinary.” After HEC requested a rehearing of the January decision, one member of the three-judge panel retired, and a new judge agreed to grant the rehearing and reverse the court’s previous ruling.
“Apparently for the first time in this Court, a precedential opinion has been abrogated — and the outcome flipped — on panel rehearing based merely on the replacement of one judge,” attorneys for Novartis said in court documents back in July.
HEC isn’t the only pharma company that has approached regulators with a Gilenya generic. A suite of other companies, including Zydus Pharmaceuticals, Apotex, Bionpharma, Emcure Pharmaceuticals and others, has filed ANDAs. Novartis said in a news release on Wednesday that it’s settled with a number of generic rivals, who have agreed to hold their launches until after the dosing regimen patent expires in 2027.
The company has also sought refuge in court, telling Endpoints News earlier this year, “We believe that generics are not permitted to launch while the petition for rehearing remains pending and the formal mandate closing the appeals process has not been issued … In the meantime, our Group guidance assumes no Gilenya Gx launches in the US in 2022.”
As a result of the court’s latest decision, though, competitors may hit the market “imminently,” Novartis noted on Wednesday. The arrival of generics could drive Gilenya sales down $0.3 billion this year, the company said.
In 2017, the late Rep. Elijah Cummings (D-MD) and current Rep. Peter Welch (D-VT) wrote in a letter to former Novartis chief Paul Hudson that the House Committee on Oversight and Government Reform was launching an investigation into the rising cost of MS treatments. They noted that Gilenya prices nearly doubled from $50,775 in 2010 to $91,836 in 2017. Hudson jumped over to Sanofi in 2019.
Just last week, a federal judge dismissed a whistleblower case alleging that Novartis bribed physicians to prescribe Gilenya through a series of “sham” speaker programs disguised as educational sessions. While that case was dismissed, Novartis did shell out $678 million to settle similar claims from the US Department of Justice back in 2020.