- A U.S. appeals court has rejected Novartis’s bid to protect a key patent for its multiple sclerosis drug Gilenya, opening a path for generic competition.
- The U.S. Court of Appeals for the Federal Circuit declined to give Novartis a new hearing after a panel of judges in June declared the company’s patent invalid. That decision reversed a previous appeals court ruling in January that was favorable to Novartis and followed a lower court ruling in August 2020 that would have kept generic maker HEC Pharma out of the market until December 2027.
- Novartis said Wednesday it plans to appeal the latest decision to the Supreme Court and is evaluating “all available options” to fight for continued exclusivity. The Swiss drugmaker expects to lose $300 million in sales this year if generic drugmakers are allowed to launch copycat versions of Gilenya in the U.S.
Novartis’s loss in the appeals court affects more than its fight with HEC Pharma. The company had previously entered settlements with other drugmakers that delayed launches of their generic versions of Gilenya for various periods of time. Now, absent further court action, any company with Food and Drug Administration approval could launch their products “imminently,” Novartis said.
Gilenya has been a top seller for years, leading the company’s portfolio of neuroscience drugs with revenue of $2.8 billion in 2021. Still, the company has already started to see the effects of competition in other countries. Generic forms of the pill are available in some parts of Europe, even though Novartis is also engaged in litigation there. Sales of Gilenya dropped 23% to $555 million in the second quarter.
Novartis CEO Vas Narasimhan told investors in July that the patent fight wouldn’t have a “significant bearing” on mid-term growth for the drugmaker. Company officials had previously guided analysts to expect generic competition in 2024 after entering legal settlements with other rivals.
Meanwhile, the company is trying to focus on new drugs that can spur growth to make up for fading brands such as Gilenya, Gleevec and Afinitor. Inflammatory disease drug Cosentyx and heart failure treatment Entresto have already become big sellers. And, in the past few years, Novartis has won FDA approval for an MS drug called Mayzent, the cholesterol treatment Leqvio and a precision cancer therapy sold as Pluvicto.
The company has also made a series of restructuring moves this year aimed at cutting costs and boosting its profit margins.