In a patent infringement case involving patent claims relating to ferric carboxymaltose (FCM) filed by Vifor International, the Single Judge of the Delhi High Court denied an injunction by constructing patent by process claims as process claims. The Single Judge stated that the product claimed was limited by the process by which it was claimed, and that the defendants would be liable for infringement only if they made FCM using the same process. As the defendants in the case, MSN Labs, Corona Remedies, and Dr Reddys Labs, were using different processes, the Judge denied the grant of an injunction.
Vifor International appealed to the Division Bench, which reversed the Single Judge’s decision on the ground of it being patently and manifestly illegal. The Division Bench stated that product by process claims are drafted for inventions that cannot be defined by their composition, structure, or by any physical or chemical characteristic, and by rule of necessity, they have to be defined by their process of manufacture. Simply put, product by process claims describe inventions by the process of making them because they are so complex that they cannot be defined in any other way. These claims are normally drafted for natural products and macro molecules that are undefinable.
According to the Division Bench, as product by process claims are used to define products using the process of making them, they are product claims and not process claims. Because they are product claims, they are patentable only if they satisfy the novelty and inventive step requirements. Though they are drafted in process language, they have to be treated as product claims for patentability and infringement analysis.
The Court differentiated between products obtained by a process, which is the language used in Section 48(b) of the Patents Act, and products obtainable by a process that fall within the scope of Section 48(a). It stated that a known product that is made by a novel and inventive process falls within the scope of Section 48(b) that grants patent rights to processes and products made by such processes. But a novel and inventive product that is defined by a process falls within the scope of Section 48(a), which grants patent rights to products. Therefore, for products ‘obtained by process’ claims, process comparison is critical, but for products ‘obtainable by process’ claims, it is sufficient if the products are the same to prove infringement.
Excerpt from the Judgment
The relevant para of the Judgment that outlines the principles laid down by the Court is as follows:
“183. We would thus record our conclusions in the following terms:-
A. 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.
B. 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. That would go against the underlying compulsions which govern product-by- process claims. Patent Registries and courts globally acknowledge and accept the possibility of structurally indefinable products and have propounded the ―rule of necessity‖ with respect to product-by-process claims. As understood by the IPO Guidelines, product-by-process patents are neither unconventional nor unknown and the Indian patent regime itself contemplates product-by-process claims.
C. Product-by-process claims are foundationally referable to a novel or unobvious product and the patentability of that product not being dependent upon the mere novelty of the process adopted. A product is not rendered novel merely by virtue of the fact that it is produced by a new process, because if novelty is claimed only in respect of a process, it would be treated and granted as a process patent.
D. One principle which finds resonance across jurisdictions and stands embodied even in the guidelines framed by the IPO, EPO and the USPTO 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.
E. 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.
F. The statute confers a right upon the patentee to restrain the making or using of a product or a process. However, and as was observed in Hospira UK Limited, the dichotomy between a product and a process is not liable to be viewed as operating in a water tight compartment. Hospira UK Limited eloquently explains the raison de‟ etre for the acceptance of product-by-process claims as being founded on the needed imperative of striking a balance between “clarity and fairness” and according a limited leeway in that “limited class of cases” where the patentee is unable to identify a characteristic or parameter disclosed in the patent except by way of an “obtainable by” process definition. It thus formulates the tests to be borne in mind while evaluating such a claim to be whether a characteristic or attribute is discernible from claims structured in product-by-process terms. Viewed in that light, it is manifest that the decision propounds a reasoned, just and balanced threshold for examination of product-by-process claims.
G. The contention that process features serve as a limitation during infringement proceeds on the incorrect and untenable premise that notwithstanding the product being novel, it must be presumed that the patentee sought and claimed protection only over the process and thus the same acting as a limitation. More fundamentally, such an interpretation ignores the undisputed fact that such a claim may in fact have been recognised at the stage of grant as a novel product.
H. Product-by-process claims pertain to a product which is novel and inventive and unknown in the prior art. It would thus remain a product which would fall within the ambit of Section of 48(a). 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.
I. Product-by-process claims, although employing process terms, are fundamentally concerned with an inventive product and the reference to a process being only to aid in explaining the novel attributes of a new product unknown in the prior art. Thus, it would be unjust and incorrect to prune down a claim pertaining to such a patent as being confined to merely a process. That would clearly be doing violence to well established tenets of claim construction. According such an interpretation firstly proceeds on the premise that notwithstanding the product being novel, it must be presumed that the patentee sought and claimed protection only over the process and thus the same acting as a limitation. More fundamentally, that interpretation commands us to ignore the undisputed fact that such a claim may in fact have been recognised at the stage of grant as a novel product.
J. The primary concern of the Act is an invention as is evident from Section 2(1)(j) of the Act and which may relate not just to a new product but even a process both of which may involve an inventive step. 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. We thus principally find ourselves unable to countenance the submission that separate or distinct tests of novelty should apply between the grant of a patent and the examination of an allegation of infringement.
K. Since the terms and the language of the claim remain unaltered and consistent both at the stage of grant as well as while considering an allegation of infringement, separate or distinct tests of novelty should not apply between the grant of a patent and the evaluation of an infringement allegation. 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 in our opinion remain unchanged.
L. There is no justification to hold or recognise the law to be that while an inventive characteristic of a product sets it apart from the prior art, the same should be disregarded when it comes to infringement analysis. Acceptance of the proposition that the patentability and novelty of a product becoming triable based upon two separate and distinct set of rules would invariably result in the creation of an incongruous and anomalous situation. It would essentially lead to a position where while the patent may validly be accepted to be a product at the stage of grant, it becomes confined to a process for the purposes of examining infringement. This would clearly amount to propagating a double standard approach and which would be unjust and untenable.
M. 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.
N. Turning back to our statute, it becomes pertinent to observe that Section 48(b) on its plain language is concerned with a process patent per se. It is with the aforesaid objective that the Act proceeds to create a statutory bar and prevents third parties from either using the patented process or employing the same for the purposes of manufacture of a product which could be said to have been directly obtained from that process. Section 48(b), however, does not adopt the “obtainable by” language while referring to a process claim.
O. 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. The words “obtainable by” would appear to convey a descriptive process by which the claimed product could be manufactured or produced. However, that process in itself need not and invariably be the inventive element of the patent.
P. The expression “obtained by” on the other hand would be intended to convey a direct linkage between the product and the process. However, in the context of our statute, the latter would in most situations be concerned with a process claim referable to Section 48(b) and ultimately liable to be construed accordingly be it for patentability or infringement analysis. 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. This would also follow when examined from the eye of the notional audience.
Q. Section 48(b), however, does not adopt ―obtainable by‖ language while referring to a process claim. The words ―obtainable by‖ convey a descriptive process by which the claimed product could be manufactured or produced. The usage of ―obtainable by‖ language is identical to what occurs in Section 48(a) of our Act and extends to products claims per se.
R. Ultimately, a product-by-process claim would have to meet the test of pertaining to a novel and inventive product as opposed to a 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). 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).
S. Consequently, 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. In any event, it would be wholly incorrect and unjust to postulate a rule that product-by-process claims must be inevitably curtailed by process terms.
T. Hospira UK Limited was principally dealing with an ―obtained by‖ claim. It also recognised Kirin Amgen as being an authority for the proposition that infringement of ―obtained by‖ claims would be answered in the affirmative only if it were found that the infringing product had actually been made “by the relevant process”. Hence, on merits, since Hospira UK Limited related to an “obtained by” claim, it would clearly fall within the scope of Section 48(b) of our Act.
U. 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. Whether the product-by-process claim relates to or does not relate to an inventive product and is confined to a novel process, would essentially turn upon the facts of each case. Only where the claim is discerned and found to be confined to a novel process would we be justified in recognising the claim as falling squarely within the ambit of Section 48(b) of the Act.
V. The position which has been taken by the majority in Abbott Laboratories¸ i.e., process features serving to limit the product-by- process claim, was a departure from a host of precedents (Scripps and SmithKline) and also does not appear to have found acceptance in any other jurisdiction. Even the Japanese Supreme Court in 2012 (Ju) 1204, Minshu Vol.69 No.4 did not accept that process terms are limiting or that they remove the focus from the inventive product itself and rejected the “double standard” approach with respect to tests for patentability and infringement.
W. There is an imperative necessity to assess novelty and the scope of the patent right based on a consistent and unchanging criterion. The acceptance of the argument canvassed by the respondents would compel us to recognise the examination process being subject to a set of rules distinct and contrary to the principles which would apply to infringement analysis. The patentability and novelty of a product thus becomes triable based upon to two separate and distinct set of rules.
X. We thus find ourselves unable to concur with the Abbot rule of process terms limiting the scope of protection that can be claimed in an infringement action. 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.
Y. The submissions based on Abbott Laboratories proceed on the premise that a product-by-process claim would render the notional audience incapable of discerning the true intent of the patentee. That, however, is a question which relates to claim construction. The aforenoted submission also fails to bear in consideration that the onus of proving infringement lies on the patentee. It would thus be incumbent upon the patent holder to establish that what was claimed was in fact a product and the claims read together with the specifications lead us unerringly towards that conclusion. In any case, the apprehended confusion or lack of clarity would not justify accepting the principle that for the purposes of evaluating an allegation of infringement one must necessarily proceed on the basis that process terms limit or deprive product-by-process claims of their essence. We are thus of the firm opinion that the theory of a distinct set of rules being applicable to infringement actions is wholly incorrect and untenable.
Z. We find that whether it be a question of validity or infringement, the patentability of a product can always be assailed irrespective of the process terms. In fact, if a defense of invalidity were to be raised in a suit for infringement, it would be open for a defendant to assert that the patent has been wrongly granted either on the ground of a lack of novelty or otherwise being unpatentable. This in light of the right unambiguously conferred by Section 107. Such a challenge would itself be addressed upon the product itself. That challenge would not rest upon the process terms at all. It would be incumbent upon such a defendant to prove that the claim does not relate to a novel or inventive product and that assertion would clearly not be influenced by the mere recitation of the process terms.
AA. Therefore, and in our considered opinion, 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 Act. It would inevitably have to be tested on principles enshrined in Section 48(a). Mere usage of process terms cannot be accepted as limiting nor is there any justifiable rationale to accept the advocated distinction between validity and infringement. If the rule of necessity were to compel the applicant to submit an application embodying a product-by-process claim, there would appear to be no justification to stultify the extent of protection.
BB. The question of patentability is to be examined and evaluated independent of the allocation of an 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. CC. The fundamental fallacy in the judgment flows from the learned Judge’s understanding of a distinction between a “product by process claim” and a “pure product claim”, an aspect which is alluded to in para 71. 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.”
Citation: Vifor (International) Limited & Anr. vs Msn Laboratories Pvt Ltd & Anr., Decided by the Delhi High Court on 7 February, 2024, FAO(OS) (COMM) 159/2023 & CM APPL. 39177/2023, rules the Delhi High Court.
Disclaimer
The case notes in this blog post have been written by IP attorneys at BananaIP Counsels based on their review and understanding of the Judgments. It may be noted that other IP attorneys and experts in the field may have different opinions about the cases or arrive at different conclusions therefrom. It is advisable to read the Judgments before making any decisions based on the case notes.
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