Drug Regulation Patent

SpicyIP Tidbit: Astrazeneca sues Glenmark for infringement of anti-diabetes drug Saxagliptin


UK based Astrazeneca has sued Indian drugmaker Glenmark for patent infringement of its drug Saxagliptin, an anti-diabetes drug. The dispute arose due to Glenmark’s production and export of the drug Saxagliptin Monohydrate (API) in India, based on the Controller’s permission allowing Glenmark to manufacture the drug. Astrazeneca holds a patent in India until 2025 for the same drug.

The Delhi High Court has granted a  status quo order on the matter, allowing Glenmark to continue manufacturing the drug. Glenmark has categorically stated that it does not intend to launch the drug in India till Astrazeneca’s patent is valid. It has claimed that the drug is being manufactured for overseas regulatory submissions specifically. It may be noted that section 107(A) of the Indian Patents Act permits manufacture and export of patented drugs API for the purpose of overseas regulatory submissions.

In another matter involving an anti-diabetes drug, the Delhi high Court last month reportedly was assured by the Indian drug manufacturer Biocon that it would not commercialise the drug, keeping the window open for R&D purposes. The patent infringement suit has been filed by Novartis.

We are yet to get our hands on these orders. We shall keep our readers posted with the developments.

Anubha Sinha

Anubha Sinha

Anubha is a final year student at RML National Law University, Lucknow. Participating in a national IP moot kindled her interest in Intellectual Property where she had her first brush with software patenting. Her interest in the field also emerges from the exciting interface between IP and technology.

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