Mumbai: The Delhi high court has rejected global pharma major AstraZeneca’s application seeking a restraining order against marketing of a blockbuster anti-diabetes drug Dapagliflozin by domestic companies, including Torrent, USV, Micro Labs, Eris LifeSciences and Zydus, thus paving the way for affordable diabetes drugs in the Indian market.
With nearly a dozen companies launching generic versions at competitive prices, the stage is set for a price war between the players to get a slice of the growing Rs 15,000-crore diabetes market. AstraZeneca had sued several generic companies for the infringement of patents covering Dapagliflozin.
In a keenly watched court battle, the high court in a hearing on Wednesday concluded that its patent is “prima facie invalid as it lacks inventive merit”, legal sources told TOI. AstraZeneca holds two patents for Dapagliflozin in India — the first expired in October, while the second will expire in May 2023. Simply put, the second patent was not found to have inventive merit over what was already existing in prior art (earlier patent).
The order by Justice Mukta Gupta, accessed by TOI, said “since the defendants have 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 interim injunction which is declined”.
AstraZeneca’s Dapagliflozin is sold under the brand Forxiga, and is part of a popular class of drugs called SGLT2 inhibitors, valued around Rs 4,500 crore (MAT October 2020), approved for use in type 2 diabetes. It is also distributed by Sun Pharma and Abbott Healthcare under the brands Oxra, Oxramet, Oxramet XR and Gledepa, Gledepa MET IR and Gledepa MET XR respectively. Recently, certain generic versions have entered the market, nearly halving the therapy cost for patients.
“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”, S Majumdar, counsel on behalf of Torrent, said. The company has faced patentability objections in the US, which it failed to disclose here.
When contacted, an AstraZeneca spokesperson said, “The 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, and are committed to taking all steps which are necessary in law in 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 revoked 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 invention under section 2(1)(j), the Act provides that invention means a new product or process involving an inventive step and capable of industrial application.”