- Novartis successfully faced down an inter partes review challenge to a key patent for its multiple sclerosis drug Gilenya that is valid until December 2027, helping to stave off generic competition to the blockbuster product — at least for the time being.
- The favorable patent decision has implications for both Novartis, as well as the overall MS market, including companies like Celgene and Biogen.
- Due to an IPR decision in 2017, investors initially expected generic versions of Gilenya to enter the market by August 2019, which would have posed a competitive challenge to branded MS drugs.
An IPR decision to uphold a December 2017 patent for the oral multiple sclerosis medication Gilenya (fingolimod) has implications for several major drugmakers.
First for Novartis, the distributor of Gilenya. The drug was approved in 2010 and was the first oral MS drug to enter the market. The drug brought in nearly $3.2 billion in 2017, making it the largest single contributor to the Swiss company's pharmaceutical unit last year.
While Novartis admits that sales have been weak in some quarters due to competition in the U.S., the drug is still a large revenue driver for the company.
Somewhat counterintuitively, the ruling could also help Novartis' MS rivals, which will benefit from not having to compete against a cheaper copy of a top drug.
Biogen, for example, has long been a leader in the MS space, with six currently marketed drugs competing for the neurodegenerative disease that make up about 90% of the company's revenues. Tecifidera, Biogen's oral MS entry and its best-selling product, brought in $4.2 billion in 2017. While a leader, Biogen's portfolio has been aging and investors have been worried about the exposure the company faces to competition.
For Celgene, this is a reprieve of sorts from a streak of bad news. The company has had a number of setbacks in recent years, but perhaps the most striking was the Refusal to File letter from the Food and Drug Administration for its MS drug ozanimod. The company is expected to resubmit in early 2019. Investor enthusiasm for the drug had been dampened since ozanimod was expected to enter a market already hit by generics.
"Ozanimod will no longer be launching [versus] a generic Gilenya in 2019. This gives ozanimod at least a 3 year window to launch in a branded market and establish presence in MS," wrote Evercore ISI analyst Umer Raffat.
The analyst points out that while the currently upheld patent extends out to 2027, there still could be generic entry in the 2022 to 2024 timeframe based on other litigation.
"Beyond 2022, ozanimod's GI indications may also likely be coming on label which will help growth even in a generic Gilenya environment (since Gilenya is only approved in MS)," he added.