Sanofi files Lilly lawsuit
pharmafile | February 3, 2014 | News story | Sales and Marketing | FDA, Lantus, Sanofi, lilly
A row which has been brewing between Sanofi and Eli Lilly & Company has now erupted with the French manufacturer accusing Lilly of riding roughshod over its rights to Lantus.
Sanofi’s multi-billion dollar seller Lantus (insulin glargine injection) is used to help patients with diabetes control their blood sugar – and Lilly wants to produce its own version.
Sanofi has filed a lawsuit with the US States District Court for the District of Delaware, alleging that Lilly has infringed four patents on Lantus and follow-on product Lantus SoloStar.
The move stems from Lilly and partner Boehringer Ingelheim’s announcement in December that the US Food and Drug Administration (FDA) had accepted for filing LY2963016, which uses the same active ingredient as Lantus.
LY2963016 was accepted for review by the European Medicines Agency in July.
The US manufacturer insists it is doing nothing wrong. “Lilly respects the intellectual property of others and does not believe the application for approval of its new insulin glargine product infringes any valid claim of the asserted patents,” said Doug Norman, Lilly’s vice president and general patent counsel.
Lilly added that its new drug application included a paragraph IV certification challenging six of the seven Sanofi patents listed in the FDA Orange Book for Lantus and SoloStar – and said it would not launch its product before Sanofi’s patent expires on 12 February, 2015.
However, the legal action automatically means the FDA will not approve the product anyway for 30 months – taking it until the middle of 2016 – although the court could find in favour of Lilly before then, in which case the FDA would follow suit.
More than 24 million people in the US – and 380 million people worldwide – are estimated to have type 1 or type 2 diabetes, with the latter type accounting for up to 95% of cases.
The insulin market has become increasingly competitive with newer products reaching the market and downward pressure on pricing – particularly in the US where some managed-care organisations and pharmacy benefit managers are starting to shift towards single-source formularies.
Sanofi knows that it needs a replacement for its veteran diabetes treatment and competition already exists, with Mylan having rights to develop and market Biocon’s biosimilar version of the drug, called Glargine, for example.
Sanofi was cheered in December by the news that its investigational insulin U300 may have advantages over Lantus.
In the EDITION II trial it demonstrated similar blood sugar control, with 23% fewer patients experiencing night-time low blood sugar compared with Lantus, and Sanofi says it offers the benefit of a smaller subcutaneous injection compared with Lantus too.
Adam Hill
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