MSD targets Mankind’s diabetes generic in patent suit
Merck Sharp & Dohme (known as MSD outside the US) has filed a complaint against New Dehli-based Mankind Pharma, looking to halt the approval of a generic version of the type two diabetes treatment, Januvia (Sitagliptin).
The US pharma giant filed the lawsuit at the US District Court for the District of Delaware yesterday, April 4, claiming that Mankind’s submission of an Abbreviated New Drug Application (ANDA) to make and market the generic infringed one of its patents.
The patent-in-suit, US patent number 7,326,708 covers “Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor” and is expected to expire in April 2026.
Mankind Pharma worked with US company Lifestar Pharma to prepare and submit the ANDA to the US Food and Drug Administration (FDA).
MSD claims that Mankind and Lifestar cooperated with the goal of selling the ANDA product before the expiration of the ‘708 patent and that the generic includes sitagliptin phosphate as an active ingredient, which is covered by the patent.
“Notwithstanding Mankind’s knowledge of the claims of the ’708 patent, Mankind has continued to assert its intent to manufacture, offer for sale, sell, distribute, and/or import Mankind’s ANDA Product with its product labelling following FDA approval of Mankind’s ANDA prior to the expiration of the ’708 patent,” the complaint said.
MSD seeks a declaratory judgment ruling that Mankind and Lifestar infringed the ‘708 patent and a preliminary or permanent injunction preventing Mankind and its partners from selling the generic before the expiration of the patent.
In February, MSD teamed up with AstraZeneca to file a pair of lawsuits against MSN and Sandoz, claiming that their planned generic versions of leukaemia treatment Calquence (acalabrutinib) infringe six patents.
MSN and Sandoz specified that they wanted to create an acalabrutinib oral capsule at a 100mg dosage, the same dosage as AstraZeneca’s variant.
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