Product-by-process patent claims are based on novelty of product: Delhi High Court

The Delhi High Court recently pronounced a detailed judgment enunciating the law and legal position on product-by-process patent claims [Vifor (International) Limited & Anr v. MSN Laboratories Pvt Ltd & Anr]..A Bench of Justices Yashwant Varma and Dharmesh Sharma held that product-by-process claims are founded on a claim relating to a novel product whose unique attributes are sought to be explained by reference to its manufacturing process.“These patents owe their genesis to cases where new products could not be fully described by their structure compelling the patent applicant to rely upon and refer to the process features,” the Court said..The Court said that product-by-process patents are neither unconventional nor unknown, and that the existing Indian patent regime contemplates such claims.“One principle which finds resonance across jurisdictions and stands embodied even in the guidelines framed by the IPO [Indian Patent Office], EPO [European Patent Office] and the USPTO [United States Patent and Trademark Office] is that a product-by-process claim would be accepted and accorded statutory protection, only if the product itself be novel. Irrespective of the language in which such a claim may be couched, it is necessary that such a patent application speak of a novel product. It is this foundational precept on which product-by-process claims are tested,” the judgment stated..The Bench further said that product-by-process claims pertain to a product which is novel and inventive and unknown in the prior art and thus, it would remain a product which would fall within the ambit of Section of 48(a) of the Patents Act.“The difficulty in discerning the scope of such claims would not constitute a valid basis to deprive a true invention of the protection which the Act confers. It would be incorrect to rule that product-by-process claims must be inevitably curtailed by process terms.” .The Court went on to make the following important observations:Claim protection over process does not act as a limitation on a product in a product-by-process claim;Any reference to process in a product-by-process claim acts as an aid to explain the novel attributes of a new product unknown in the prior art;Separate tests of novelty do not apply between grant of patent and the examination of an allegation of infringement;As long as a product-by-process claim pertains to a product which is novel and has no parallel in the prior art, the mere fact that the patentee chooses to describe the invention more exhaustively by reference to process terms, and in light of the difficulties of expression alluded to above, the tests should remain unchanged;A product-by-process claim would necessarily have to be examined on the anvil of a new and unobvious product irrespective of the applicant having chosen to describe the invention by referring to a process of manufacture. The mere adoption of the product-by-process format would not result in a novel product being downgraded to Section 48(b) of the Patents Act. It would inevitably have to be tested on principles enshrined in Section 48(a);The question of patentability is to be examined and evaluated independent of the allocation of an International Non-proprietary Name (INN) to a chemical formulation. Conferral of an INN cannot be accepted as constituting irrefutable evidence of an invention and could at best be viewed as corroborative of an assertion of a patentable product having been obtained..The Bench rendered the judgment while dealing with an appeal filed by Vifor International Limited against a single-judge’s order dated July 24, 2023 refusing to injunct pharma companies from making Ferric Carboxymaltose (FCM), which is used to treat iron deficiency.Vifor held the patent over FCM and it was their case that other entities were making the compound during the term of the patent.The defendants were companies like MSN Laboratories, Corona Remedies and Dr Reddys laboratories. They claimed that they are not infringing the patent because their process for making FCM was different from the process described in the claims of Vifor’s patent..The Division Bench set aside the single-judge’s order.It held that the fundamental fallacy in the single-judge’s judgment flows from the judge’s understanding of a distinction between a product by process claim and a pure product claim. “It is this foundational and conceptual mistake which renders the impugned judgment unsustainable. The learned Judge has fundamentally erred in understanding product-by-process claims as “limited to a product obtained through a specific process feature”. The view taken is rendered further untenable since it appears to have been the uncontested position before the learned Judge that FCM was not known in the prior art.”The Court finally said the suit proceedings before the single-judge may be taken forward bearing in mind the legal position enunciated in this judgment.“We also leave it open to the appellants to press their claim for deposit of percentage of sales at the appropriate stage and subject to further orders being passed in the pending suits. All rights and contentions of respective parties in that respect are kept open.”.Senior Advocates Neeraj Kishan Kaul and Sandeep Sethi along with Advocates Pravin Anand, Vaishali Mittal, Rohin Koolwal, Hersh Desai, Ira Mahajan, Pritha Suri and Siddhant Chamola appeared for Vifor International.Advocates G Nataraj, Shashikant Yadav and Rahul B appeared for respondents MSN Laboratories, Dr Reddys Laboratories and Corona Remedies.Senior Advocate Chander M Lall along with Advocates Kunal Vajani, Kunal Mimani, Shubhang Tandon and Prashant Alai appeared for intervener BDR Pharmaceuticals..[Read Judgment]