The Delhi High Court recently commented on the need for 'claim mapping' while seeking injunctive reliefs in such cases involving allegations of patent infringement [F-Hoffmann-La Roche AG & Anr. vs. Zydus Lifesciences Limited].
‘Claim mapping’ is the process of comparing elements of a patent’s claim to other similar patents to ascertain if there is any infringement.
Justice Saurabh Banerjee observed that to secure a temporary injunction in patent cases, apart from establishing (i) a prima facie case, (ii) balance of convenience and (iii) likelihood of irreparable harm, the applicant also has to establish a fourth limb of ‘claim mapping.'
The Court explained that claim mapping is an essential step, and forms the very fulcrum for patent litigation. It further noted that the mere registration of a patent in favour of a patentee is not by itself sufficient for seeking a temporary injunction under the Patents Act, 1970.
“When a party ... approaches a Court of law in a suit for infringement of patent which is accompanied by an application under Order XXXIX rules 1 & 2 CPC (temporary injunctions) wherein also the said party ... is seeking an ad interim injunction, there is a fourth limb as well i.e. ‘claim mapping’ or like whereby it is necessary for such a party to establish and cross the hurdle of showing that the impugned product ... of the defendant ... is likely to and/ or is actually infringing their suit patents", the Court said in its October 9 ruling.
The Court made these observations while rejecting a plea by Swiss company F-Hoffmann-La Roche AG (Roche). Roche had sought a temporary injunction to restrain Indian pharma company, Zydus Lifesciences Limited from selling the product "Sigrima."
Roche claimed that Sigrima was biosimilar to the Pertuzumab (a medicinal drug used to treat breast cancer and known by the brand name Perjeta) product sold by Roche. Roche said that it held the patent for "Pertuzumab Variants And Evaluation Thereof."
Roche claimed that Zydus had procured few vials of Pertuzumab from the plaintiff’s Indian affiliate. Thereafter, Roche got to know that Zydus had applied for permission to manufacture a new drug from Pertuzumab and had even received regulatory approvals. Roche sought to restrain Zydus from selling the drug so derived.
The Court, however, rejected Roche's plea for interim injunction after noting that the Swiss company had not demonstrated or shown 'claim mapping' in its suit.
“Granting an injunction merely on the basis of a registered patent to a/any/every patentee like the plaintiffs (Roche) without putting it to the test of ‘claim mapping’ or like, cannot be the intention of the legislature. In such circumstances, allowing the present application of the plaintiffs would amount to an ad-interim injunction to them simply because they have two suit patents IN ‘646 and IN ‘632 subsisting in their names. The same shall render the purpose of the existence of the provisions of the Patent Act, 1970 otiose," Justice Saurabh Banerjee observed.
The Court proceeded to dismiss Roche's plea without commenting on the merits of the case.
“Without any ‘claim mapping’ there is no basis for this Court to render any finding and/ or draw any final conclusion against the defendant (Zydus) As such, without commenting on the merits involved, even though the plaintiffs may have set out a good case based on the conduct/s of the defendant as recorded in the order dated 09.07.2024, however, since there is no ‘claim mapping’ qua the two patents IN ‘646 and IN ‘632 of the plaintiffs with the impugned product ‘Sigrima’ of the defendant, this Court is unable to pass any order in favour of the plaintiffs merely because the composition comprising Pertuzumab is same or they are biosimilar," the Court said.
Senior Advocates Sandeep Sethi and Arvind Nigam, with Advocates Pravin Anand, Shrawan Chopra, Archana Shankar, Devinder Rawat, Prachi Agarwal, Achyut Tewari, N. Mahavir, Riya Kumar, Shreya Sethi and Agnish Aditya appeared for Roche.
Senior Advocate Dushyant Dave, with Advocates Bitika Sharma, Aadarsh Ramanujan, Vrinda Pathak, Sandhya Kukreti, Rajnish Kumar, Vanshika Puri and Ahaana Singh Rana, Rupali Bandopadhya and Abhijeet Kumar represented Zydus.
[Read judgment]