Sanofi brings patent infringement case in New York against Merck Inc. in relation to insulin glargine biosimilar.
Sanofi announced have brought on 8 August 2017 an infringement action against Merck Sharp & Dohme Corp. ("Merck") in the district court of New Jersey (United States District Court for the District of New Jersey), in the United States. The Sanofi complaint about infringement of two patents.
The complaint was prompted by a notification, received from Merck late June, in which Merck is said to have applied to the FDA for approval new drug (New Drug Application - NDA (505 (b) (2)) for insulin glargine in a bottle. Merck also stated that its application for approval included a certification "paragraph IV", challenging all Sanofi patents listed in the Orange Book of the FDA for Lantus� and Lantus� SoloStar� from Sanofi products.
Comment: The FDA has issued a tentative approval for Lusduna (insulin glargine biosimilar) in July 2017 and the biosimilar was EU approved in January 2017.
Related news and insights
Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), announced that Health Canada has approved Ferriprox (deferiprone) for the treatment of iron overload in patients with sickle cell disease (SCD) or other anemias.
The Menarini Group and Radius Health announced positive topline results from the phase III EMERALD study evaluating RAD 1901 (elacestrant) as a monotherapy versus the standard of care (SoC) for the treatment of ER+/HER2- advanced or metastatic breast cancer (mBC).
Gilead Sciences, Inc. announced the FDA approved a new low-dose tablet dosage form of Biktarvy (bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg tablets) for pediatric patients weighing at least 14 kg to less than 25 kg who are virologically suppressed or new to antiretroviral therapy.