Indian high court allows sitagliptin generics

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Indian high court allows sitagliptin generics

Home/Policies & Legislation | Posted 19/04/2013 2 Post your comment

In the latest development in Merck Sharp and Dohme’s (MSD’s) court case over the patent infringement of its diabetes drugs, an Indian high court has refused to grant interim relief to MSD, thus allowing generics to remain on the Indian market.

On 5 April 2013, the Indian High Court of Delhi dismissed the application by MSD to prevent Indian firm Glenmark Pharmaceuticals (Glenmark) from manufacturing and marketing its anti-diabetes drugs Zita (sitagliptin) and Zita Met (metformin/sitagliptin). The court came to its decision based on the fact that ‘the salt used in the drugs was not of a generic nature’.

MSD is suing India’s Glenmark for infringing its patent on two diabetes drugs. MSD filed a lawsuit with the Delhi High Court on 2 April 2013 regarding its Indian patent on sitagliptin; a chemical compound sold under the Januvia (sitagliptin) and Janumet (metformin/sitagliptin) brand names. Glenmark started selling its generic versions, Zita (sitagliptin) and Zita Met (metformin/sitagliptin), a week ago at prices 20–30% below MSD’s.

MSD is not surprisingly disappointed with the decision and is reported to be ‘considering all options, including an appeal of the decision’.

The decision comes in the wake of the Indian Supreme Court decision not to grant a patent to Novartis for its cancer drug Glivec (imatinib mesylate), ruling that the drug was not a new invention [1].

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Reference

1. GaBI Online - Generics and Biosimilars Initiative. Indian Supreme Court rejects Glivec patent [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Apr 19]. Available from: www.gabionline.net/Policies-Legislation/Indian-Supreme-Court-rejects-Glivec-patent

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Source: The Economic Times India, The Hindu Business Line

Comments (2)

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Posted 03/10/2013 by Jodi H, GaBI Online Editorial Office

Response to ‘formulation of sitagliptin’

Dear Karunakar,
Thank you for your comment. The Indian High Court has said that generics are allowed, therefore, also students/research scholars will be allowed to make generic formulations for research purposes.
Best regards,
Jodi