Sanofi wins Cancer patent dispute to hold off generic rivals

A US court has sided with Sanofi in a patent dispute with a multitude of companies that want to produce generic copies of cancer drug Jevtana.

The ruling went back on its previous decision of deeming the Sanofi patent invalid. Actavis and Mylan had received tentative approval for generics of Jevtana, but Sanofi quickly responded by taking these two companies to court and appealing the invalid patent ruling. Sanofi used the merit of the previous ruling as a key part of its current court case.

In the appeal Judge Lourie found that: ‘The defendants’ experts cherry-picked data in the references to reach Jevtana and were not credible.’ The court recognized that Jevtana was only the third taxane cancer treatment to reach FDA approval despite attempts from research groups from around the world attempting to replicate. Thus the court ‘determined that Sanofi’s success where others had fallen supported non-obviousness.’ In patent terms obviousness is when an ‘invention’ or ‘product’ is not patentable because it is already known. A useful example I found on the internet was:

·       You have invented A+B
·       A is known in the prior art
·       B is known in the prior art
·       Upon looking at A and B, would someone of skill/knowledge consider A+B to be already known
·       If the answer is yes, then A+B is obvious
·       If the answer is no, then A+B is non-obvious

So, in the previous patent ruling the Sanofi treatment was ruled as obvious, which they subsequently challenged and due to a lack of credible data from other research groups to reach/match Jevtana’s trial results  the court ruled the treatment as non-obviousness.

This is a success for Sanofi as it hopes to boost the money it is making out of Jevtana. Sales last year reached $468m an almost 10% increase from 2017. This made Jevtana Sanofi’s best-selling cancer drug, accounting for almost 30% of all oncology sales. As of 2019 currently, the sale of Jevtana has generated revenues of $263m, putting it on track for another year of growth.

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