DELHI HIGH COURT REFUSES TO GRANT INJUNCTION TO A GLOBAL PHARMA COMPANY FOR NON-COMPLIANCE OF INDIAN PATENT LAW

The #DelhiHighCourt has in a matter of Astrazeneca AB and Anr vs Torrent Pharmaceuticals Ltd and other tagged matters passed a Judgment dated 18-11-2020 and refused to grant interim #injunction in favor of the Plaintiff, a global #pharma Company, on the ground that it failed to disclose information to the Indian #Patent Office about its patent applications for same or similar inventions in other countries.

In this case, the Plaintiff claimed to be the owner of a pharmaceutical composition namely ‘Dapagliflozin’ (Product), which helps in controlling diabetes and diabetes complications.  The Plaintiff’s authorised distributors in India include Sun Pharma Laboratories Limited and Abbott Healthcare Private Limited, who make drugs comprising of Dapagliflozin. The Plaintiff has applied for patent of the said Product in a Patent Suit in India and other countries such as the United States of America (USA), etc.

But the Defendants had challenged the Patent Suit on the ground that the Plaintiff has failed to disclose about its patent applications in other countries. Thus, they challenged the validity of the Patent Suit.

However, the Plaintiff filed a suit before the Delhi High Court and sought for permanent injunction restraining the Defendants from manufacturing and selling products that comprised of ‘Dapagliflozin’.

The Delhi High Court made the following observations in this case:

1- That as per Section 8 (2) of the Patent Act 1970 (the Act), the applicant must submit the particulars of all the applications for patent of same or substantially the same invention filed in other countries. But the Plaintiff failed to disclose the details about its patent applications, if any, in any of the patent offices across the world such as United States Patent and Trademark Office (USPTO), European Patent Office (EPO), Japan Patent Office (JPO), etc.

Section 8 of the Act has been reproduced below:

Information and undertaking regarding foreign applications

(1) Where an applicant for a patent under this Act is prosecuting either alone or jointly with any other person an application for a patent in any country outside India in respect of the same or substantially the same invention, or where to his knowledge such an application is being prosecuted by some person through whom he claims or by some person deriving title from him, he shall file along with his application or subsequently within the prescribed period as the Controller may allow—

 (a) a statement setting out detailed particulars of such application; and

 (b) an undertaking that, up to the date of grant of patent in India, he would keep the Controller informed in writing, from time to time, of detailed particulars as required under clause (a) in respect of every other application relating to the same or substantially the same invention, if any, filed in any country outside India subsequently to the filing of the statement referred to in the aforesaid clause, within the prescribed time.

(2) At any time after an application for patent is filed in India and till the grant of a patent or refusal to grant of a patent made thereon, the Controller may also require the applicant to furnish details, as may be prescribed, relating to the processing of the application in a country outside India, and in that event the applicant shall furnish to the Controller information available to him within such period as may be prescribed.

2- Despite repeated requests made by the Indian Patent Office for submission of mandatory documents, the Plaintiff failed to comply with the said requirements, hence, the High Court held that the validity of the Patent Suit is vulnerable for non-compliance of Section 8 (2) of the Act. But the Court refused to delve further into the issue of invalidity of Patent Suit, as this was a Suit for Interim Injunction only.

3- That the prima facie vulnerability of the validity of Suit Patent has outweighed the balance of convenience and irreparable loss caused to the Plaintiff.

Thus, based on the aforesaid grounds, the Delhi High Court has held that the Defendants have prima facie laid a credible challenge to the validity of the Patent Suit on the ground of non-compliance of Section 8(2) of the Patent Act. Therefore, the Delhi High Court refused to grant interim injunction in favor of the Plaintiff and therefore, dismissed the Suit.

Harini Daliparthy

Senior Legal Associate

The Indian Lawyer