Delhi HC declines AstraZeneca’s request on diabetes drug patent

• Delhi High Court refused Astrazenca’s plea to restrain the marketing of a famous anti-diabetes drug Dapagliflozin by domestic companies.
• Domestic Companies are facilitating a way for affordable medicines in the Indian market.
• AstraZeneca holds two patents for Dapagliflozin in India.

Mumbai, THDNewsDesk: The Delhi High Court has refused global pharma Astrazenca’s application asking for a restraining order against the marketing of a famous anti-diabetes drug Dapagliflozin by domestic companies. It includes Torrent, USV, Micro Labs, Eris LifeSciences, and Zydus. They are facilitating a way for affordable medicines in the Indian market.

There is a tight competition between the companies to get a piece of the growing Rs 15,000 crore diabetes market. Numerous companies are launching generic versions at competitive prices. AstraZeneca had charged various companies for violation of patents covering Dapagliflozin.

On Wednesday, the court encountered a heated battle that concluded that its patent is “prima facie invalid as it lacks inventive merit.” AstraZeneca holds two patents for Dapagliflozin in India. The first expired in October, while the second will expire in May 2023.

The verdict by Justice Mukta Gupta stated, “since the defendants have a prima facie laid a credible challenge to the validity of suit patent on the ground of obviousness and for non-compliance of section 8(2) of the Act, this court finds that the plaintiffs have not made out a prima facie case for grant of the interim injunction which is declined.”

AstraZeneca’s Dapagliflozin is traded under the brand name Forxiga and is categorized under a popular class of SGLT2 inhibitors. The worth is approximate Rs 4500 crore (MAT October 2020), permitted for use in Type 2 diabetes. Sun Pharma also markets it, and Abbott Healthcare branded under Oxra, Oxramet, Oxramet XR and Gledepa, Gledepa MET IR, and Gledepa MET XR, respectively. Various universal versions have currently entered the market, nearly cutting down half of the therapy cost for the patients.

S. Majumdar counselled on behalf of Torrent stated, “The court also found that failure to share vital information under section 8(2), with the Indian Patent office was a breach enough to deny an interim order to the patent holder.”

AstraZeneca’s spokesperson stated, “Th order contains several positive findings in its favour, especially on those issues which formed the main thrust of the attack. AstraZeneca has been informed that findings mainly on two issues have been rendered against it. We are currently studying the order of the High Court. We are committed to taking all steps which are necessary in law and order to protect and enforce its patent for Dapagliflozin which it believes to be a world-class invention.”

Majumdar added, “For a suit patent to be received under section 64(1)(a) no prior publication is required. However, if there is a prior patent for the same invention, no second patent can be granted. Even the definition of the invention under section2(1)(j), the Act provides that invention means a new product or process involving an inventive step and capable of industrial application.”

Source-Times Of India