Sanofi and generic drugmakers have been battling back and forth over patents protecting the company’s top oncology product, Jevtana. In the latest round, Sanofi proved victorious.
The company convinced an appeals court to overturn a prior loss it suffered on a patent that expires in 2031 and to affirm a victory on a patent that expires a decade earlier. Generic drugmakers had applied to the FDA to market Jevtana copycats ahead of the drug’s patent expirations, and Sanofi sued in response.
Following a bench trial, the U.S. District Court for the District of New Jersey invalidated several claims of Sanofi’s 592 patent on Jevtana, which expires in 2031, according to the FDA’s Orange Book. Sanofi appealed and the U.S. Court of Appeals for the Federal Circuit overturned that decision as there “was no case or controversy” over the claims, Circuit Judge Alan Lourie wrote in a Wednesday opinion.
In the same earlier judgment, the New Jersey court upheld two Sanofi claims on its 170 patent that expires in 2021. Fresenius Kabi, Accord Healthcare, Apotex and other generics companies challenged that decision, but the appeals court upheld the ruling.
The argument by generics companies that Sanofi’s 2021 patent was invalid for obviousness was “convoluted,” Judge Lourie wrote, adding that it lacks merit. The court weighed several arguments by generics makers and found them “unpersuasive,” the opinion says.
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The decision marks a win for Sanofi as it seeks to get the most out of Jevtana, which was the company’s top oncology product by sales last year and pulled in €422 million. In the first half of 2019, the drug generated €237 million. It’s approved to treat certain prostate cancer patients and won its initial FDA approval in 2010.
Oncology has been a growth engine for Sanofi as the drugmaker works to reshape itself and bolster its presence in rare diseases. For years, the company has faced pricing pressure in areas such as diabetes, leading to prior-year sales declines that the company has worked to turn around. During the second quarter, the company posted a 4% revenue increase at constant exchange rates.
