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.