Please login to the form below

Not currently logged in
Email:
Password:

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

Share

Tags

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Four Health Communications

Formerly known as Packer Forbes Communications, Four Health Communications is an award-winning, integrated healthcare communications agency for pharma, biotech, NGOs...

Latest intelligence

Marketing to healthcare professionals – what’s the key ingredient missing from most campaigns?
What do you think is the difference between a campaign developed to win a share-of-mind with consumers and a campaign designed to gain the attention of healthcare professionals?...
What everyone forgets about good organisational change in pharma
Natasha Cowan speaks to Daphne Chung, Head of Organisational Transformation, to learn how she ensures smooth organisational change that takes all stakeholders into account....
Live from Singapore: Oncology in APAC - Evaluating the opportunity for novel therapies
Live webinar: Tuesday 11th December 2018,16:00 SGT / 17:00 JST...

Infographics