Decide on AstraZeneca’s diabetes drug pleas within 15 days, apex court tells Delhi HC

The HC had last week rejected the global pharma major’s application to restrain marketing of the blockbuster anti-diabetes drug by domestic companies.

The Supreme Court on Monday asked the Delhi High Court to decide expeditiously on petitions filed by British pharmaceutical multinational AstraZeneca seeking to prevent Indian generic drug makers, including Intas Pharma, from manufacturing and selling low-cost versions of its diabetic medicine Dapagliflozin.

The HC had last week rejected the global pharma major’s application to restrain marketing of the blockbuster anti-diabetes drug by domestic companies like Torrent, USV, Micro Labs, Eris LifeSciences and Zydus, thus paving the way for sale of diabetes drugs at competitive prices in the Indian market.

AstraZeneca has filed 12 petitions against several generic companies for infringement of patents covering Dapagliflozin, which is marketed in India by Sun Pharma and Abbott Healthcare through licensing agreements with AstraZeneca.

A Bench led by Justice LN Rao, while rejecting AstraZeneca’s senior counsel Mukul Rohtagi’s request to direct Intas to maintain accounts of the newly launched drug, asked the HC to decide the matter either on November 27, the next date of hearing, or within 15 days.

Though Rohtagi didn’t press for interim orders, he requested that the case be decided in 10 days.

AstraZeneca in its appeal stated that Dapagliflozin was “purely manmade and not found in nature”. The drug meant for Type-2 diabetes is protected by two patents — one for the skeletal structure, granted in 50 countries and the other covering Dapagliflozin alone, granted in over 70 countries — it said.

AstraZeneca holds two patents for Dapagliflozin in India. The first expired on October 2 and the other one is due to expire on May 15, 2023.

Challenging the HC order, the British pharma giant said the high court should have directed Intas to maintain status quo at least till the disposal of the case. It alleged that Intas did not challenge the validity of either of its patents for 15 years and never cleared the way in any one of the six ways under the patents law, i.e. no pre-grant or post-grant oppositions, revocations or voluntary or compulsory licence or suit.

According to the appeal, if Intas wasn’t restrained from launching its infringing drugs in the commercial market, the global firm will face damage as it is the sole supplier of the product. The lifestyle disorder requires the highest quality of medication, especially in India, which has a very high prevalence of patients with this disease, it said.

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