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Sanofi sues Lilly over insulin patents

Challenges development of Lantus biosimilar
Sanofi reception

Sanofi has launched a US lawsuit against rival pharma company Lilly claiming it has infringed patents related to its insulin glargine Lantus.

The suit, which was filed in the US District Court for the District of Delaware, is based on Lilly's filing of a new drug application for its own biosimilar version of Lantus, which is the world's leading insulin treatment for people with diabetes, with annual ales of about $7bn.

However, the drug is due to lose patent protection in the US in 2015, and Lilly is one of several companies, including Mylan, which is planning to launch a copycat version of the biologic, known as a biosimilar.

Lilly has already announced it has filed a biosimilar version of Lantus for approval in the EU, looking to take advantage of a global market for biosimilars that is expected to grow to $23bn by 2019 and is becoming an increasing concern for pharma companies.

It is Lilly's US filing that France-based Sanofi has taken issue with, however, claiming that Lilly has infringe four patents to do with Lantus and its SoloSTAR insulin pen.

According to Sanofi, Lilly has stated it does not intend to launch its product until the Lantus patent expires in February 2015.

However, Reuters reports that the lawsuit triggers an automatic 30-month stay of approval by the US Food and Drug Administration (FDA), which would delay entry onto the market for Lilly's product until the middle of 2016.

Sanofi has previously made comments that the company was prepared to deal with the Lantus biosimilar threat.

Speaking to PMLiVE in September last year, Sanofi's senior VP, global diabetes, Pierre Chancel, said that the company expects a combination of the strength of its existing presence in the diabetes market as well as the planned launch of its next-generation insulin U300 will keep Sanofi on top.

Article by
Thomas Meek

31st January 2014

From: Sales, Regulatory

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