Dapagliflozin – India

Dapagliflozin – India

On July 20, 2021, Delhi High Court dismissed the appeals of Astrazeneca in an interim injunction case.

 

Plaintiff (Astrazeneca) owns IN 205147 (genus patent) & IN 235625 (species patent) covering dapagliflozin (DAPA) compound. IN 147 expired on Oct. 02, 2020 & IN 625 will expire on May 15, 2023. Plaintiff filed suit against many defendants (Intas / Alkem / Zydus / Eris / USV / Torrent / MSN / Micro labs / Ajanta) based on both patents to restrain them from manufacturing or selling the DAPA in India. In Nov. 2020, Court (single judge) in two separate proceedings denied the interim injunction. Plaintiff appealed.

 

This is a typical case of disclosure (patentability) v. coverage (infringement). Plaintiff sued defendants on both, IN 147 & IN 625 patents. Also, in Form-27 (working requirement) of IN 147, Plaintiff mentioned DAPA product. Defendants argued that, as Plaintiff claimed infringement of IN 147 patent, DAPA was disclosed therein. Hence, there is credible challenge to later IN 625 patent based on various grounds. Plaintiff argued that IN 147 genus patent covers DAPA product but did not disclose it specifically.

 

Court said that once the plaintiff claimed infringement of IN 147 also, it necessarily followed that DAPA was subject matter thereof and once it was the subject matter thereof, how it could be the subject matter of subsequent patent IN 625. Court further said that, with respect to one invention, there can be only one patent. The plaintiff herein however, while claiming one invention only i.e. DAPA, are claiming two patents with respect thereto, with infringement of both, by the respondent(s)/defendant(s). It strikes at the very root of the claim of the plaintiff and disentitles the plaintiff from any interim relief.

 

Court further said that at least at this stage we are unable to, in the face of the pleadings of the plaintiff, find any difference between IN 147 and IN 625. The plaintiff are found to be pleading DAPA to have been disclosed generally in IN 147 and specifically in IN 625. In the face of the said pleading, no case for injuncting the defendant(s) during the pendency of the suits is made out. Also, from the field of the invention subject matter of the two patents at this stage, it also appears that there is no enhancement of the known efficacy, within the meaning of Section 3(d) of the Act, between the product subject matter of IN 147 and the product subject matter of IN 625. Moreover, once the plaintiff, before the USPTO applied for and agreed to the validity period of US patent equivalent of IN 625 ending on the same day as the validity period of the US patent equivalent to IN 147, the plaintiff, in this country are not entitled to claim different periods of validity of the two patents.

 

Thus the appeals are dismissed, with costs of Rs.5,00,000/- to the defendants.

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