Appeals Board Rules in Favor of Novartis and its Multiple Sclerosis Drug Gilenya

Novartis has extended its exclusivity on Gilenya from 2019 to 2027.

Gilenya (fingolimod) from Novartis was the first drug approved to treat multiple sclerosis (MS) that slows the progression of the disease and is a $3.2 billion-a-year blockbuster. The company has faced a challenge to its 2026 patent on Gilenya. In 2015, the U.S. Patent Trial and Appeals Board ruled that Gilenya's 2026 formulation patent was invalid. In April 2017, the U.S. Court of Appeals for the Federal Circuit agreed with the initial decision.

Recently, however, the appeals board of the U.S. Patent and Trademark Office disagreed with the earlier decisions and upheld Novartis’ 2026 patent. With this decision, Novartis now has extended its exclusivity on Gilenya from 2019 to 2027.

While the ruling is good news for Novartis, it also may benefit other companies as well. Celgene, in particular, will now have more time to develop its generic MS candidate ozanimod, for which the US Food and Drug Administration refused to accept an approval application due to incomplete pharmacology information. As a result, the earliest Celgene could hope to introduce ozanimod was 2019, by which time several other generic products would likely be on the market.

With all generic introduction delayed to 2027, Celgene has more time to revise its application and convince physicians that its generic version is safer than Gilenya, which carries warnings of side effects ranging from skin cancer and macular edema to progressive multifocal leukoencephalopathy (PML), a potentially fatal brain infection.

Analysts believe that Biogen will benefit from the Gilenya patent extension as well. Biogen has several branded MS drugs on the market, sales of which could have been negatively impacted by the entry of generic forms of Gilenya.

 

Emilie Branch

Emilie is responsible for strategic content development based on scientific areas of specialty for Nice Insight research articles and for assisting client content development across a range of industry channels. Prior to joining Nice Insight, Emilie worked at a strategy-based consulting firm focused on consumer ethnographic research. She also has experience as a contributing editor, and has worked as a freelance writer for a host of news and trends-related publications

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