In this update:
– clarifies mapping requirements for standard essential patents
– rejects interim injunction in high-value pharma patent dispute over Risdiplam
Partner: Kirti Balasubramanian, Associate: Paarth Samdani
In a significant ruling, the Delhi High Court has clarified that owners of standard essential patents (SEP) cannot rely solely on the label of “essentiality” to secure injunctive relief in India. Courts will require extensive claim-mapping, paired with technical proof of both infringement and essentiality, supported by cogent and credible evidence.1
In a first substantive non-infringement decision on SEPs, the Delhi High Court refused to grant an injunction in a suit filed by Philips relating to video compact disc (VCD) technology. The Court held that Philips had failed to establish infringement, as it relied on a product-to-product comparison rather than undertaking the required claim-level mapping of the suit patent to the defendant’s product – an essential step for infringement analysis under Indian patent law.
Given Philips’ contention that the suit patent qualified as an SEP, the Court also examined the threshold for establishing essentiality of a patented invention. In doing so, it clarified that a patentee must demonstrate, through credible and cogent evidence:
SEP owners contemplating enforcement in India will need to front-load litigation with detailed technical claim charts, expert analysis, and industry-facing evidence of essentiality, rather than relying on the SEP designation alone.
A recent decision of the Delhi High Court underscores that when granting interim injunctions in pharmaceutical patent disputes, Indian courts consider not only patent strength, but also competition, access, and public health considerations, particularly in cases involving expensive and critical therapies.
The Delhi High Court refused to grant interim injunctive relief to F. Hoffmann-La Roche AG (Roche) against Natco Pharma Limited (Natco) in relation to Risdiplam, an oral drug used to treat spinal muscular atrophy (SMA).2 Risdiplam is globally marketed at a high price point and has raised significant concerns regarding access and affordability in India.
Natco proposed to manufacture and market the drug at substantially lower prices following the expiry of Roche’s earlier genus patents.
The Court declined interim relief after finding that Natco had raised a credible prima facie challenge to the validity of Roche’s suit patent. While acknowledging that mere inclusion of a species compound within a broad genus disclosure does not automatically defeat novelty, the Court held that Roche’s prior genus patents supported a strong obviousness challenge to the species patent, particularly given the overlap in inventorship.
The Court accorded considerable weight to public interest considerations, noting that restraining Natco would adversely affect access to a high-cost, life-saving drug. Roche appealed the Division Bench decision to the Supreme Court of India, arguing that the High Court had erred in denying interim relief and in its reliance on public interest at the interlocutory stage. The Supreme Court declined to interfere, thereby affirming the Delhi High Court’s reasoning.3
The National Company Law Appellate Tribunal (NCLAT) reaffirmed that disputes concerning the exercise and enforcement of patent rights, including issues relating to licensing terms, pricing, and market access, fall primarily within the statutory framework of the Patents Act, 1970 (Patents Act) and that the Competition Commission of India (CCI) lacks jurisdiction to adjudicate patent-related disputes in the facts of the case.4
In reaching this conclusion, the NCLAT relied on the Delhi High Court’s Division Bench ruling in Ericsson v CCI,5 (along with the Supreme Court decision affirming it6) which held that the Patents Act, being a special statute, prevails over the Competition Act, 2002 in matters involving alleged abuse of patent rights. The CCI has challenged the NCLAT’s decision before the Supreme Court.
The Sustainable Harnessing and Advancement of Nuclear Energy Act, 2025 (SHANTI Act), received presidential assent on 20 December 2025, and was subsequently published in the Official Gazette on 21 December 2025. The SHANTI Act marks a significant shift in India’s approach to patent protection for atomic energy and nuclear-related inventions.7
Under the new framework, patents may be granted for inventions relating to the peaceful uses of nuclear energy and radiation, while activities expressly reserved for the State (such as enrichment, reprocessing, spent fuel management, and heavy water production) or inventions that are assessed as sensitive or having national security implications, will continue to remain excluded. The Act also introduces new procedural obligations, including a pre-disclosure requirement for inventions believed to relate to nuclear energy, and a referral mechanism for determining whether an invention falls within reserved or sensitive categories.
For inventors, the SHANTI Act opens the door to patent protection for a wider category of nuclear-adjacent technologies, including safety systems, monitoring and control equipment, medical and industrial radiation applications, materials, and software, subject to a government-led sensitivity review.
The quarter saw a series of distinct regulatory and policy developments across intellectual property and allied areas. On the legislative front, the notification of the amended Geographical Indications (Registration and protection) Rules, 2025, together with the release of draft guidelines on the use of the Geographical Indication (GI) logo, reflects an effort to update procedural requirements, fee structures, and norms governing authorised use within the GI regime.
In parallel, the government released draft amendments to the Patent Rules, 2003 and the Trade Marks Rules, 2017 focusing on procedural changes and the proposed introduction of a code of conduct for patent and trademark practitioners. Notably, the Ministry of Agriculture also invited stakeholder comments on the draft Seeds Bill, 2025, which seeks to introduce a consolidated legislative framework governing seeds, aimed at bringing greater clarity and legal certainty to a regulatory space that has historically been fragmented and overlapping with complementary legislation, including with the Protection of Plant Varieties and Farmers’ Rights Act, 2001.
The Department for Promotion of Industry and Internal Trade released Part I of its working paper on Artificial Intelligence (AI) and copyright, examining the application of existing copyright law to AI-generated outputs and training datasets, and outlining possible licensing-based approaches for use of copyrighted works in AI systems. Part II of the working paper is expected to be released in the coming months.
As these consultations progress, the upcoming quarters are expected to provide clearer direction on how the government intends to manage the interaction between artificial intelligence technologies and intellectual property rights.
[1] Koninklijke Philips N.V. v M. Bathla & Anr, Delhi High Court (CS(COMM) 533/2018)
[2] F. Hoffmann La Roche AG v Natco Pharma Limited, FAO(OS) (COMM) 43/2025
[3] F. Hoffmann La Roche AG v Natco Pharma Limited, SLP(C) No. 29664/2025
[4] Swapan Dey v CCI, 2025 SCC OnLine NCLAT 1698
[5] Telefonaktiebolaget LM Ericsson and Anr. v the Competition Commission of India and Ors., (LPA No.247/2016, LPA No.150/2020, LPA No.550/2016, LPA No.247/2016 along with W.P.(C) 8379/2015)
[6] Competition Commission of India v Monsanto Holdings Private Limited & Ors., (Special Leave to Appeal (C) No.25026/2023), available here.
[7] Inventions related to atomic energy were broadly excluded from being patentable, under Section 4 of the Patents Act, 1999, read with Section 20 of the Atomic Energy Act, 1962.
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