Delhi High Court: The appeals were preferred against the decision dated 24-07-2023 passed by a Single Judge disposing of the interim injunction applications and refusing interim relief in terms as prayed for by appellant. The appeals raised an issue of product-by-process claims and their scope as liable to be construed under the provisions of the Patent Act, 1970 (‘the Act’). The Division Bench of Yashwant Varma* and Dharmesh Sharma, JJ., opined that the Single Judge’s decision failed to correctly appreciate the well settled principle of product-by-process terms being an established and recognised mode of drafting claims and such a method being adopted in cases where products resist definition except by resort to process terms. The Court thus held that the legal position as enunciated by the Single Judge suffered from patent and manifest illegalities and thus clearly warranted interference in appeal.
Background
Appellants claim to be part of the Vifor Pharma Group of Companies founded in 2008. IN‘536 (‘the suit patent’) was an invention used for intravenous treatment of iron deficiency and iron deficiency anaemia, when oral iron preparations were rendered ineffective. Appellants submitted that Ferric Carboxymaltose (‘FCM’), which was the International Non-proprietary Name (‘INN’) accorded to the product in dispute, was formulated to meet the requirement of an intravenous iron therapy which would be non-toxic, easily administrable in a variety of clinical conditions and capable of being quickly sterilized. It was submitted that IN‘536 was a novel water-soluble iron carbohydrate complex of iron and oxidation product comprising of one or more maltodextrins. It was also submitted that IN‘536 was principally a product claim, which could also be acknowledged as being a product-by-process claim, a practice which was common and well known in claim drafting.
As far as the suit patent was concerned, it was asserted that the patent had not been challenged or questioned in pre-grant opposition in India. The suit patent was granted in 2008 and although it had expired upon completion of its full term of 20 years in October 2023, appellant submitted that they were able to exploit the monopoly flowing from the grant of the suit patent for 12 of its 20-year term. Appellant submitted that FCM was a new and novel man-made product which was unknown in the prior art.
Appellant submitted that as per ‘Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals’, a product-by-process claim was not unknown in the Indian patent system and that patentability of a product-by-process claim, as the Indian Patent Office (‘IPO’) holds, rested fundamentally on the product itself and was not dependent upon a method of production. It was further submitted that product-by-process claims must define a novel and unobvious product and not be limited by its description in the form of a process.
The primary challenge which appellants raised against the impugned order was that the Single Judge had failed to either notice or deal with its submissions relating to novelty of FCM and inventive qualities of that product especially when the same had never been questioned by respondents.
Analysis, Law, and Decision
The Court observed that the Single Judge had misconstrued and failed to appreciate the essence of the stand as taken by appellants. The Court noted that the averments in the plaint, the reliance placed on the IPO guidelines, and the orders passed by the European Patent Office (‘EPO’), all unerringly tend to indicate and establish that appellant had placed FCM in the category of a product-by-process patent and this stand would clearly be incompatible with the understanding of the Single Judge that appellant sought to assert that product-by-process claims were an unknown concept in Indian Patent law.
The Court noted that the Single Judge appeared to have taken the principled position that product and process claims operate in distinct silos and thus losing sight of the undisputed fact that an amalgam of the two, and which represented what product-by-process claims essentially were, and opined that the position taken by the Single Judge could not be accepted. The Court further noted that the Single Judge’s decision was premised firstly, on the suit patent being a product-by-process claim and secondly, the principle that the process terms limited the scope of the claim and patent protection thus being extendable only to the process and not the product. Thus, the Court opined that the Single Judge had proceeded on the incorrect premise that appellant had contended that the Indian patent regime did not recognize or contemplate product-by-process claims.
The Court opined that “the Act undoubtedly conferred patent protection to both products and processes. The fact that novelty and inventive characteristics or qualities were key attributes for a patent could not be doubted. Section 48(a) of the Act enabled a product patentee to restrain a third party from making, using, or selling that product. Thus, the Act acknowledged that both product and processes might be imbued with inventive qualities and thus be patentable.”.
The Court relied on Kirin Amgen Inc v. Hoechst Marion Roussel Ltd., [2004] UKHL 46 (‘Kirin Amgen’), wherein a product-by-process was understood by the House of Lords of having the advantage of enabling the inventor of a new process to prosecute not only a manufacturer who infringed its claimed process but additionally by virtue of a product-by-process claim to also proceed against one who had dealt in a product which had been made by the process. Kirin Amgen (supra) also recognized the principle adopted by the EPO of accepting a claim to a product defined in terms of its process where the product itself was new and its attributes not being capable of being described in chemical or physical terms.
The Court thus opined that “once product-by-process claims were conceptually accepted and acknowledged, it would be incorrect to hold that products must necessarily and invariably be described by their composition and structure. That would go against the very grain of product-by-process claims as understood in patent jurisprudence.”. Thus, the Court concluded that even in the case of product-by-process claims, it was the novelty of the product which must be established shorn of the process terms that might accompany such a claim. The Court held that the Single Judge erred in holding that a claim to a product must necessarily and inviolably be explained by its structure. The Court opined that appellants had placed on the record copious material to establish that respondents were claiming FCM albeit manufactured by deployment of a process different from that of appellant or with the use of different oxidizing agents.
The Court opined that the fundamental fallacy flows from the understanding of a distinction between a “product by process claim” and a “pure product claim”. It was this foundational and conceptual mistake which rendered the impugned judgment unsustainable. The Single Judge had fundamentally erred in understanding product-by-process claims as “limited to a product obtained through a specific process feature”. The Court opined that the Single Judge’s decision failed to correctly appreciate the well settled principle of product-by-process terms being an established and recognised mode of drafting claims and such a method being adopted in cases where products resist definition except by resort to process terms. The Court noted that the IPO guidelines accepted product-by-process claims principally and such claims would only be entertained when the applicant was able to establish that a novel product unknown in the prior art had come to be invented. The Court further opined that claims once entertained must be informed by the rule of necessity and it being impracticable to fully describe the inventive attributes and characteristics of the invention except by resort to process terms.
The Court held that the legal position as enunciated by the Single Judge suffered from patent and manifest illegalities and thus clearly warranted interference in appeal. The Court thus, concluded the following:
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A product-by-process claim was an amalgam/hybrid which straddles the otherwise discernible and recognised distinction between products and process patents per se.
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As understood by the IPO Guidelines, product-by-process patents were neither unconventional nor unknown and the Indian patent regime itself contemplated product-by-process claims.
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Product-by-process claims pertained to a product which was novel and inventive and unknown in the prior art. It would thus remain a product which would fall within the ambit of Section 48(a) of the Act.
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One principle which finds resonance across jurisdictions and stands embodied even in the guidelines framed by the IPO, EPO and the USPTO was that a product-by-process claim would be accepted and accorded statutory protection, only if the product itself be novel.
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The statute confers a right upon the patentee to restrain the making or using of a product or a process.
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Section 48(b) of the Act was concerned with a process patent per se, and the Act proceeded to create a statutory bar and prevented 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, did not adopt the “obtainable by” language while referring to a process claim.
The Court opined that “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) of the Act.”. Thus, the Court allowed the present appeals and set aside the impugned judgment dated 24-07-2023.
[Vifor (International) Ltd. v. MSN Laboratories (P) Ltd., 2024 SCC OnLine Del 784, decided on 07-02-2024]
*Judgment authored by: Justice Yashwant Varma
Advocates who appeared in this case :
For the Appellants: Neeraj Kishan Kaul, Sandeep Sethi, Senior Advocates; Pravin Anand, Vaishali Mittal, Rohin Koolwal, Hersh Desai, Ira Mahajan, Pritha Suri, Siddhant Chamola, Advocates
For the Respondents: Chander M. Lall, Senior Advocate; G. Nataraj, Shashikant Yadav, Rahul B., Kunal Vajani, Kunal Mimani, Shubhang Tandon, Prashant Alai, Rajeshwari H., Tahir AJ., Garima Joshi, Advocates
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