Indian court rejects AstraZeneca’s injunction request
The Delhi High Court has refused to grant AstraZeneca an injunction against the manufacture and sale of dapagliflozin by a group of India-based pharmaceutical companies.
AstraZeneca uses dapagliflozin in oral diabetes medicines, and its Indian distributors, Sun Pharma Laboratories and Abbott Healthcare, manufacture drugs consisting of dapagliflozin.
Torrent Pharmaceuticals, Micro Labs, Zydus Healthcare, Eris Lifesciences, USV and MSN Laboratories had all been named as defendants in the patent infringement suit brought by AstraZeneca.
However, the defendants challenged the suit, arguing that AstraZeneca had failed to disclose its patent applications in other countries.
AstraZeneca holds two patents for dapagliflozin in India. The first, IN 205147, expired in October this year. The second patent, IN 235625, will expire in May 2023.
In a hearing on Wednesday, November 18, the court refused to grant an injunction against the defendants.
“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,” said Justice Mukta Gupta.
The court found that, under section 8(2) of the Patent Act of 1970, the applicant must submit details relating to the processing of the patent application outside India.
In this case, AstraZeneca only submitted the documents in relation to the European Patent Office and not the US Patent and Trademark Office, where objections had been raised.
The High Court concluded that the validity of the patent was vulnerable for non-compliance with section 8(2), but refused to look further into the issue of invalidity.
According to the court, the vulnerability of the patent outweighs the balance of convenience and an irreparable loss caused to AstraZeneca.
The judge added that observations made in the hearing will have no bearing on the final decision, which will be decided after a full trial.
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