Vifor (International) Limited v MSN Laboratories Pvt Ltd (2024)

Summary

“These appeals have been preferred against the order dated 24 July 2023 passed by a learned Single Judge disposing of the interim injunction applications” ... “and refusing interim relief in terms as prayed for by the appellant.” (para 1) “The appeals raise an issue of significant import, namely, product- by-process claims and their scope as liable to be construed under the provisions of the Patent Act” (para 2). “IN'536” (“Indian Patent No. 221536”) “is described to be an invention used for intravenous treatment of iron deficiency and iron deficiency anaemia, when oral iron preparations are rendered ineffective.” (paras 12, 96) The Single Judge had held that “the scope of Claim 1 of IN'536 is limited to a product obtained through a specific process feature identified therein and cannot cover any and all processes that may be used by a third party to produce FCM” (“Ferric Carboxymaltose”) “and it is thus held that Claim 1 is a product-by-process claim and not a pure product claim.” (paras 9, 12) “At the very outset it becomes pertinent to note that the suit patent expired on 20 October 2023” (para 11).

The Bench held that “product-by-process claims primarily pertain to a product although the claim may have chosen to describe the invention with the aid of process terms” and that “What we have been unable to countenance are two sets of standards being employed depending upon whether it be the stage of grant or infringement analysis.” (para 179) “In our considered opinion as long as the product-by-process claim pertains to a product which is novel and inventive and unknown in the prior art it would remain a product which would fall within the ambit of Section of 48(a).” (para 143) “It is this foundational and conceptual mistake which renders the impugned judgment unsustainable.” (para 180) “We accordingly allow the present appeals and set aside the impugned judgment dated 24 July 2023. While an interim injunction would not be warranted at this stage, the suit proceedings may be taken forward bearing in mind the legal position as enunciated above.” (para 184)

What the court decided

1. Procedure. Appeal heard after expiry. “In our considered opinion, the importance of the issues which were canvassed coupled with the fact that the questions posited requires us, as the first High Court of the country, to enunciate the law with respect to product-by-process claims merits the appeal being considered on merits notwithstanding the expiry of the suit patent.” (para 11)
2. Obiter. Earlier interim orders. “Interim injunctions though not strictly binding precedents, constitute material of relevance when a prayer for interim injunction in respect of the same product comes to be laid. While granting or refusing to grant injunction in infringement actions, courts should not be selective and if choosing to refuse injunction, ensuring that adequate grounds are disclosed and which would indicate why the views expressed or taken in the earlier orders are not liable to be followed.” (para 97)
3. What a product-by-process claim is. “A product-by-process claim is an amalgam which ‘straddles’ the otherwise recognised distinction between products and process patents per se. A product-by-process patent is 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.” “It would be wholly incorrect to hold that products must necessarily and invariably be described by their composition and structure or at least recognise it to be an inflexible precept.” (para 183, A–B)
4. Novelty of the product. “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 is that a product-by-process claim would be accepted and accorded statutory protection, only if the product itself be novel.” “The guidelines as well as the judgments rendered in the context of product-by-process claims speak in unison when they state that for assessing novelty one must disregard the process terms and discern whether the product possesses novelty. We are reminded that a product is not rendered novel merely by virtue of the fact that it is produced by a new process.” (paras 181, 183, D–E)
5. The rule of necessity. “We are also of the considered view that the rule of necessity as articulated in different jurisdictions and noticed hereinabove must guide the acceptance of such claims. It would thus be factors of inability, of structures being indefinable at the time of patent filing and where an applicant is constrained to resort to process terms in order to render sufficient clarity on the inventive qualities of the claimed product which would define and regulate the grant.” (paras 168, 181)
6. “Obtained by” and “obtainable by”. “Section 48(b), however, does not adopt the ‘obtainable by’ language while referring to a process claim. In our opinion, a process claim and the extent of protection that can be claimed in respect thereof would have to draw colour and content from Section 48(b) and which embodies the phrase ‘obtained directly by that process’. We would thus draw and acknowledge the existence of a distinction between ‘obtained by’ and ‘obtainable by’ language embodied in the claim.” “Consequently, an ‘obtained by’ claim tested whether on the anvil of Section 48(b) or the canons of claim construction would lead us to the same conclusion, namely, the patentee having intended to restrict the scope of the claim to the recited process.” (para 142)
7. Section 48(a), not section 48(b). “Ultimately, and as we have held hereinbefore, a product-byprocess claim would have to meet the test of pertaining to a novel and inventive product as opposed to a mere process. It will thus be wholly incorrect to abridge or truncate a product-by-process claim to fall within the ambit of Section 48(b).” “Ultimately, courts when faced with such claims would have to discern from the language of the claim and the specifications whether the claim pertains to an inventive product or merely a novel process. The difficulty in discerning the scope of such claims would not constitute a valid basis to deprive a true invention of the protective cover which the Act confers.” (para 143)
8. One standard for grant and infringement. “We fail to discern any logic in recognizing distinct tests of novelty being applicable at the stage of patentability and those that may be relevant for deciding a question of infringement. It is pertinent to observe that both at the stage of grant as well as while considering an allegation of infringement the terms and the language of the claim remain unaltered. Claims and specifications do not change hues but remains static.” (para 183, J) “What we have essentially held is that the product attribute of such a patent cannot be effaced or ignored merely because the question stands raised in an infringement action.” (paras 179, 183)
9. Sections 107 and 64. “Sections 107 and 64 constitute an added ground which convinces us to reject this contention. If grounds of revocation which constitute a foundational ground impacting the validity of the grant itself be a ground which can be validly urged as a defence in an infringement action, there exists no justification to countenance a different set of rules being employed.” (para 183, M)
10. Abbott Laboratories not followed. “We are thus of the firm opinion that the learned Judge clearly erred in appreciating the scope of product-by-process claims and manifestly erred in propounding the theory of distinct principles being applicable to infringement actions. We for reasons aforenoted have found ourselves unable to accept the line postulated by the majority in Abbott Laboratories.” (para 167) “There cannot be shifting lines of protection-one which would imbue the examination process and another completely distinct and discordant test for infringement. If the product is discernible, unobvious and novel, it cannot be ignored in the course of trying an infringement action.” (paras 167, 183)
11. Hospira explained. “In any event, as is evident from a close reading of that passage, Hospira UK Limited merely holds that a claim to a product ‘obtained by’ a process would confine the scope of the claim so far as infringement and sufficiency are concerned.” (para 139) “Further, a holistic reading of Hospira UK Limited shows that the said decision cannot be recognized to be an authority for the proposition that the principles of claim construction which may apply while answering a question of patentability would not be relevant in actions for infringement.” (paras 139, 183)
12. Claims, not products, compared. “Undoubtedly, courts would construe and interpret claims as opposed to comparing two rival products while evaluating an allegation of infringement. Our explanation of product-by-process claims in the preceding parts of this decision is not founded on an understanding of claims being either ignored or relegated to a secondary position while interpreting such patents.” “The principle that we have enunciated clearly does not result in a comparison between products nor was such a precept propounded.” (para 179)
13. Applied to the suit patent. “In our considered opinion, once IN'536” (“Indian Patent No. 221536”) “was recognised and accepted to be a product-byprocess claim, the question of infringement was necessarily liable to be answered on the basis of product attributes and de hors the process of manufacture.” (para 166) “Once we accept that the inventive attribute of the patent was the chemical compound titled FCM” (“Ferric Carboxymaltose”) “, a modulated process would still be infringing as long as the end product was the same.” (paras 12, 96, 166, 169)
14. The International Nonproprietary Name. “Insofar as the question of allocation of an INN” (“International Nonproprietary Name”) “to chemical formulation is concerned, we only observe that the question of patentability is to be examined and evaluated independently. The conferral of an INN cannot be accepted as constituting irrefutable evidence of an invention. It could at best be viewed as corroborative of an assertion of a patentable product having been obtained.” (paras 12, 175)
15. Prosecution history and divisionals. “As we read that opposition which appears at page 1118 of our record we find ourselves unable to construe it to be an admission of IN'536 being a process claim.” (para 176) Of the contention that the appellant “had failed to follow the route of filing divisional applications”, the Bench held: “We find ourselves unable to countenance this contention bearing in mind the indubitable fact that the suit patent came to be granted on 25 June 2008. The decision in Abbott came to be pronounced only thereafter and more particularly on 18 May 2009.” (paras 176–177)
16. Procedure. Appellate interference and disposition. Of “the rule of deference as propounded in Wander”, the Bench held: “We are of the firm opinion that the legal position as enunciated by the learned Judge suffers from patent and manifest illegalities as explained in the body of this decision and thus clearly warranting interference in appeal.” (para 182) “We accordingly allow the present appeals and set aside the impugned judgment dated 24 July 2023. While an interim injunction would not be warranted at this stage, the suit proceedings may be taken forward bearing in mind the legal position as enunciated above. 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.” (paras 182, 184)

What the court did not decide

Of Corona’s assertion “that its product was different and distinct from FCM” (“Ferric Carboxymaltose”), the Bench held: “Since this was not the basis on which the matter appears to have proceeded before the learned Single Judge, we desist from rendering our opinion on those contentions bearing in mind the fact that the suits are still pending and it would thus be open for the defendants including Corona to address submissions touching upon the validity of the patent.” (paras 12, 170) “Having already examined the issue on merits, we also desist from considering the submissions which were addressed by the appellants based on the opinion of the expert.” (para 175) “Though needless to state we deem it appropriate to clarify that we have only enunciated the legal position with respect to product-byprocess claims and why the prima facie reasons assigned in the impugned judgment were rendered unsustainable. Thus all other objections and defences taken by the respondents are open to be addressed in the pending suits.” (para 185)

Subsequent treatment

No later judicial treatment and no further appeal traced as of 16 October 2026.