Patents, a crucial component of India’s intellectual property framework, confer exclusive rights to inventors for their innovative products or processes. Among the types of patent claims that can be prosecuted under the Indian Patent Law, product-by-process claims stand out. These claims define a product based on the method of its production.
A claim directed to a product protects the product as such, regardless of the process by which it is produced. The scope of enforceability of a product claim encompasses all possible methods of making the product, as well as the product itself. For example, a product patent may claim a new drug molecule, regardless of how it is synthesised or formulated.
A process claim protects the process or the method of manufacturing a product. According to section 48(b)1 of the Indian Patents Act, 1970, for patents related to a process, the patentee has exclusive rights to prevent unauthorised use of the process and the use, sale, or importation of products obtained directly from that process in India. This provision grants indirect protection to the final product obtained directly from the claimed process.
Product-by-Process Claims: Pre-2012 Scenario
Before 2012, the landscape of product-by-process claims in India was marked by considerable ambiguity. The Indian Patent Law remained notably silent on the explicit criteria for the allowability of such claims.
Inventors faced a formidable task as the patentability of product-by-process claims became contingent upon the discretionary decisions of Controllers, lacking uniformity in approach. The dearth of specific guidelines in the Manual of Patent Office Practice and Procedure (MPPP), 20112 further compounded the challenges, leaving inventors to navigate uncharted territory.
The limitations were evident, with inventors grappling to safeguard their innovations as the Controller’s discretion played a pivotal role in determining the fate of product-by-process claims. The pressing need for a comprehensive legal framework became apparent, urging an update to align with international standards and provide a systematic approach to evaluating the patentability of such claims.
The pre-2012 scenario underscored the imperative for legal clarity, emphasising the necessity for a well-defined framework to address the nuances of product-by-process patents and foster a conducive environment for innovation within the Indian patent system.
Crucially, it was clarified that product-by-process claims must explicitly define a novel and nonobvious product. The patentability of such claims hinges on the distinctiveness and the demonstration of inventive step of the product itself, and not solely on the novelty and uniqueness of the manufacturing process. If the product in a product-by-process claim is identical to or obvious from a previous product, the claim is ineligible for a patent, regardless of the uniqueness or unobvious nature of the process by which it is obtained.
The Intellectual Property Appellate Board’s (IPAB) 2012 decision3 significantly influences the examination of product-by-process claims in the Indian Patent Office. The guidelines for pharmaceutical patent applications4 affirm that a claim for a product obtained through a process is anticipated by any prior disclosure of the product itself. Substantive examination now adopts a “product identity theory,” focusing on the product’s inherent qualities for novelty and inventive merit. Additional considerations for constructing of such claims emphasise defining the novel technical attributes of the product. Courts may lean towards a cautious “process-limited theory” in the matter of enforcement in patent infringement cases.
Additional considerations for construction of product-by-process claims
In the construction of product-by-process claims in concordance with current standards of Indian Patent practice, it is imperative that the novel and inventive “technical” attributes of the product itself be properly demarcated in the claim. Such technical attributes ought to include distinguishing “structural” and “compositional” features in respect of a compound and composition claims respectively. Also, in a product-by-process claim, a product defined by way of its function or properties despite the process limitation will be objected to.
It is further important that to meet the prerequisites of inventive merit under the provisions of Section 2(1)(ja)5 of the Indian Patents Act, the product per se demonstrates an enhanced technical effect over the prior art product. This is because “inventive step” under Section 2(1)(ja) of the Indian Patents Act means a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both that makes the invention not obvious to a person skilled in the art. Accordingly, in the precedent set by IPAB’s Order No. 200 of 2012, it was found that the product-by-process claims did not qualify for grant since the product itself did not establish any advanced technical effect attributed to its features. It was specifically ruled as follows:
“The case we are dealing with is not the kind which qualify for grant of product by process claim as the Applicant himself admits in Example 2 that the emission characteristics of the entrapped drug is the same as the un-entrapped drug.”
Enforcement of product-by-process claims
A claim directed towards product “X” produced by a process “Y” evaluated under the product identity theory would be considered enforceable against an infringed product “X” although produced by a different process “Z”. Contrary to the examination standards for product-by-process claims based on a ‘product identity theory’, we think the Indian Courts would adopt a rather conservative approach towards granting similar latitude of monopoly to such claims.
Seemingly, the Courts are more inclined to follow the “process limited theory” in ascertaining the scope of enforcement permissible for such claims. This could be because enforcement based on a “product identity theory” may be perceived as imparting to the claim, a scope of coverage that extends beyond the breadth of the enabled subject matter. This perspective was also echoed in the decision issued by the Hon’ble Supreme Court in the Glivec6 matter (Novartis v Union of India & Ors)
“……..we would like to say that in this country the law of patent, after the introduction of product patents for all kinds of substances in the patent regime, is still in its infancy. We certainly do not wish the law of this country to develop on lines where there may be a vast gap between the coverage and the disclosure under the patent…….”
Vifor International Ltd. v. MSN Laboratories Pvt. Ltd
The Delhi High Court on July 24, 2023 passed a detailed order on infringement of ‘product-by-process’ patent claims in Vifor International Ltd vs MSN Laboratories Pvt Ltd.7 echoing similar considerations.
To ascertain whether the product-by-process claims enforced by the Plaintiff (Vifor) was infringed by the defendants, the Court compared Vifor’s process to that of the defendants. The Defendants were claiming for a process of manufacturing FCM by using oxone, an oxidising agent different from aqueous hypochlorite – as claimed by Vifor.
It was held that Vifor while drafting Claim 1 had consciously and knowingly restricted the scope of the claim for obtaining FCM by a process where aqueous hypochlorite is used as an oxidising agent, which is not the oxidising agent used by the Defendants. Therefore, it is not open to Vifor to go outside the limits of its claim and claim infringement against a party whose process is different.
The Court further upheld the binding dictum of the Supreme Court in Novartis AG (supra) in that the grant of patent is restricted to the disclosure in the complete specification. It was held that once Claim 1 has been limited by a particular process, Vifor cannot assert a right to prevent a third party which uses a process/set of processes different and distinct from the claimed process of Vifor and claim infringement. In order to succeed in establishing its claim for infringement even at the prima facie stage, Vifor is required to show that the rival processes to manufacture FCM are identical, which burden Vifor has failed to discharge.
In light of the uncertainty surrounding the enforcement of product-by-process claims in India, it is advisable to exercise restraint in wording claims in this format unless absolutely necessary. It would be prudent to employ such wording strictly under circumstances where the product cannot be defined or distinguished from the prior art except by way of reference to the claimed process. In addition to the product-by-process claims, it is always desirable to include independent process claims too as a fall-back option. It is expected however, that the upcoming decisions from the higher Courts would shed more light on the jurisprudence surrounding the enforcement of such claims in India.
Author: Divya Shekar, Patent Attorney, Branch Head – Bengaluru
- https://ipindia.gov.in/writereaddata/Portal/ev/sections/ps48.html ↩︎
- Manual of Patent Office Practice and Procedure (MPPP), 2011 (Version 01.11) As modified on 22 March, 2011 ↩︎
- IPAB Order No.200/2012 arising out of OA/11/2009/PT/DEL, The Research Foundation of State University of New York vs Asst. Controller General of Patents, dated 10 August, 2012. ↩︎
- Guidelines for examination of Patent Applications in the field of Pharmaceuticals, published on October, 2014, paragraphs 7.9 and 7.10, pages 15-17. ↩︎
- Section 2(1)(ja) of the Indian Patents (Amendment) Act, 2005 – “inventive step” means a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention non-obvious to a person skilled in the art; ↩︎
- Glivec Decision, Novartis vs Union of India, Supreme Court of India, Civil Appeal Nos. 2706-2716 of 2013 (Arising out of SLP(C) Nos. 20539 – 20549 of 2009, paragraph 156, page 81. ↩︎