A US court has sided with Sanofi in a patent dispute with a clutch of companies that want to produce generic copies of cancer drug Jevtana (cabazitaxel).
The ruling vacates a previous legal decision deeming one of the patents to be invalid and affirms the validity of a second piece of intellectual property, boosting Sanofi’s attempts to protect Jevtana from generic competition.
Companies including Actavis and Mylan have received tentative US Food and Drug Administration (FDA) approvals for copies of Jevtana in recent years. In replying to the companies’ filings, the FDA pointed to the presence of patents that protect Jevtana through to 2031.
Sanofi responded to the generic drug filings by taking the companies to court. However, a New Jersey court ruled the ‘592 patent, which expires in 2031, was invalid as it was obvious. After Sanofi appealed the decision, the merit of that ruling became a key part of the court case that finished this week, with the court siding with Sanofi.
The case also featured a cross-appeal against the original ruling regarding another patent. Led by Fresenius Kabi, the cross-appeal sought to render another patent invalid on the grounds that the advance it covers is obvious. However, Fresenius’ legal team and the experts it presented failed to persuade the judges.
“The district court found the defendants’ experts cherry-picked data in the references to reach cabazitaxel and were not credible. Despite attempts by research groups around the world to develop effective taxane cancer treatments, the court recognised that cabazitaxel was only the third taxane to obtain FDA approval. The court thus determined that ‘[Sanofi’s] success, where others had failed’ supported non-obviousness”, wrote Judge Lourie in the ruling.
Lourie’s conclusion boosts Sanofi’s hopes of eking more money out of Jevtana, which came to market in 2010 as a treatment for prostate cancer patients.
Sales of Jevtana totalled €422m ($468m) last year, an increase of almost 10% over 2017. The performance made Jevtana Sanofi’s top selling cancer drug, accounting for almost 30% of all oncology sales.
At the halfway point of 2019, Jevtana had generated revenues of €237m ($263m), putting it on track for another year of growth.