Summary
This year-in-review brings together Intellepedia’s most-read patent law articles of 2025, capturing how Indian courts and the Patent Office addressed issues from CRI guidelines to public health and SEP licensing. For practitioners, the compilation offers a practical snapshot of principles shaping patent prosecution and enforcement in India.
As intellectual property practitioners and innovators would readily acknowledge, patent law in India operates at the intersection of technological advancement, public policy, and commercial interests. The year 2025 proved particularly eventful, with Indian courts and the Patent Office addressing matters ranging from public health considerations in pharmaceutical patent disputes to Standard Essential Patent licensing, from procedural fairness in patent examination to the scope of infringement after patent expiry, and from updated guidelines for computer-related inventions to the boundaries of claim amendments.
This compilation brings together some of the most significant patent-related articles from Intellepedia that resonated with our readers over the past year. Each addresses principles and precedents that patent applicants, litigants, and practitioners would do well to understand, as they continue to guide decision-making in patent matters. The articles are presented below with expanded summaries to provide practitioners with substantive reference material.
Featured Patent Articles
Indian Patent Office Issues Draft CRI Guidelines 2025 – Version 2.0: Key Additions and Changes
Published: 1 July 2025 | Author: Gaurav Mishra
On 29 June 2025, India’s Patent Office published Draft Guidelines for Examination of Computer-Related Inventions (CRI), Version 2.0, marking a significant expansion from the March 2025 draft. The updated guidelines have grown to 62 pages from the previous 47-page version, accompanied by a comprehensive 73-page annexure providing non-exhaustive examples under Section 3(k) of the Patents Act. These additions reflect the Patent Office’s sustained effort to clarify examination standards for inventions involving artificial intelligence, machine learning, blockchain, and quantum computing technologies.
A notable enhancement includes newly integrated case law from 2019-2024, such as the Microsoft Technology Licensing case from Madras High Court (2024), which clarifies that ‘the presence of a mathematical formula alone does not render a claim unpatentable.’ The guidelines emphasise that examiners must evaluate the actual technical contribution rather than applying automatic exclusions based on the presence of computer programs or mathematical methods. For practitioners filing computer-related patent applications in India, these guidelines represent essential reading, as they provide detailed procedural guidance and illustrative examples that can inform claim drafting strategies.
Risdiplam – Spinal Muscular Atrophy Case: Delhi HC Favours Public Health Over Roche Patent
Published: 21 April 2025 | Author: Neetha Mohan
The Delhi High Court rejected Roche’s request to stop Natco Pharma from manufacturing a generic version of Risdiplam, an oral treatment for Spinal Muscular Atrophy (SMA). The ruling emphasised that public health interests outweigh patent protections when life-saving medications remain financially inaccessible to patients. SMA affects approximately 1 in 7,744 Indian births, and Roche’s branded Risdiplam costs Rs. 2.2-7.2 million annually—a sum prohibitive for most families requiring this treatment.
The court found that Natco had raised credible challenges to the patent’s validity, particularly regarding novelty and inventive step, noting that Roche had taken contradictory legal positions across jurisdictions. The judgment scrutinised whether Risdiplam was sufficiently novel compared to Roche’s broader genus patent. The court determined that Natco had raised a prima facie credible challenge regarding anticipation by prior publication, weakening Roche’s monopoly claims. This decision carries significant implications for pharmaceutical patent litigation in India, reinforcing the judiciary’s willingness to balance patent rights against accessibility of essential medicines.
Dolby v. Lava: INR 20 Crore Deposit Ordered in SEP Patent Infringement Case
Published: 23 July 2025 | Author: Gaurav Mishra
The Delhi High Court directed Lava International Limited to deposit approximately Rs. 20.08 crore or provide an equivalent bank guarantee as temporary security in a patent infringement dispute involving Dolby International AB. The case centres on allegations that Lava infringed eight of Dolby’s Standard Essential Patents (SEPs) related to Advanced Audio Coding (AAC) technology. These patents span various audio processing techniques, with some remaining valid through 2030-2031 whilst others have already expired.
According to the court’s findings, Lava exhibited conduct characteristic of an unwilling licensee. The company had dragged licensing negotiations from 2018 onward, providing delayed responses, making no pre-suit counteroffers, and demanding confidential data without substantively questioning patent validity. The court characterised this as ‘classic holdout’ behaviour—a term increasingly relevant in SEP licensing disputes worldwide. This decision provides important guidance on how Indian courts view negotiating conduct in FRAND (Fair, Reasonable, and Non-Discriminatory) licensing contexts, and signals that implementers cannot indefinitely delay licensing discussions without consequence.
Products Made During Patent Term are Infringing Even After Expiry
Published: 8 September 2025 | Author: Dr. Kalyan Kankanala
In a significant ruling, India’s Himachal Pradesh High Court clarified that interim injunctions protecting patent rights cannot continue after a patent expires, even if the infringing products were manufactured during the patent’s validity period. The case involved Boehringer Ingelheim’s patent for Empagliflozin, which expired in March 2025. Though the company sought to maintain an injunction against competitor Femilab Healthcare beyond the patent term, the court held that the purpose of granting interim relief stands satisfied and the interim cannot be allowed to continue thereafter.
However, the court made a critical distinction between ending the injunction and preventing sales of infringing inventory. It ruled that defendants cannot commercially exploit infringing goods manufactured while the patent was active. The court emphasised that infringement occurring during the patent’s lifetime cannot simply fade away, thereby preventing infringers from profiting post-expiry by selling stockpiled products made unlawfully during the protected period. This ruling provides clarity for patent holders seeking remedies against infringers who may attempt to wait out the patent term whilst accumulating infringing inventory.
Cannot Raise New Ground While Refusing Patent, Rules Delhi High Court
Published: 28 August 2025 | Author: Gaurav Mishra
The Delhi High Court invalidated a patent refusal order in Proprietect L P v. Controller of Patents, establishing important procedural protections in patent examination that applicants can rely upon. Proprietect L P submitted a 2011 patent application for a foam laminate product. After examination and a hearing where amended claims were presented, the Patent Office rejected the application in July 2020 on multiple grounds including lack of novelty, inventive step, and claim clarity—plus a new objection regarding sufficiency of disclosure that had never been raised previously.
The court identified three critical violations of procedural fairness. First, the Controller introduced a new objection under Section 10(5) only in the final refusal order, never raising it during the hearing. The court found this breached natural justice principles by denying the applicant the opportunity to respond. Second, the Controller failed to meaningfully address the amended claims submitted post-hearing. Third, the refusal order merely restated earlier objections without substantive analysis, rendering it a non-speaking decision. This judgment reinforces the requirement that patent applicants must receive fair notice of all objections and an opportunity to respond before applications are refused.
Court Awards Rs 50 Lakh to GSP Crop Science in Patent Infringement Case Over Agrochemical Formula
Published: 30 July 2025 | Author: Gaurav Mishra
The Delhi High Court ruled in favour of GSP Crop Science against BR Agrotech Ltd., awarding damages in a patent dispute over an agrochemical formulation. GSP’s patent (No. 394568) covered a suspension-emulsion combining Pyriproxyfen and Diafenthiuron, commercialised as SLR 525 since 2018. The defendants produced an identical product called Roxyfin with the same chemical composition. GSP discovered the infringement in 2022-2023 and filed suit, obtaining an interim injunction in February 2023.
The court found that sellers are liable for patent infringement even if they are not directly involved in manufacturing the infringing product. The ruling established that Section 48 of the Patents Act prohibits making, using, offering for sale, or selling patented products. Beyond the Rs. 50 lakh damages award, the court also imposed an additional Rs. 2 lakh penalty for court costs. This decision reinforces the principle that distributors and retailers cannot escape liability by claiming ignorance of the manufacturing process.
Squibb Secures Interim Injunction Against Zydus in Nivolumab Patent Dispute
Published: 18 August 2025 | Author: Neetha Mohan
The Delhi High Court issued an interim injunction preventing Zydus from launching its biosimilar version of Nivolumab, a monoclonal antibody used in cancer treatment. The court found that Squibb’s patent (IN 340060) remained valid and that Zydus’s product would likely infringe it. Nivolumab works by blocking PD-1 receptors on T-cells, thereby restoring immune function to fight cancer. The drug’s therapeutic specificity depends on six unique complementarity-determining regions. Squibb markets the treatment globally as Opdivo, with the Indian version sold as Opdyta.
When Squibb learned in 2024 that Zydus was preparing to commercially introduce ZRC-3276, it filed an urgent suit seeking to block the launch. Zydus countered by arguing the patent lacked novelty and that biosimilar development constituted permissible experimental activity under patent law’s research exemption. The court disagreed on all fronts, determining the patent was enforceable. This ruling carries significant implications for biosimilar manufacturers in India, clarifying the boundaries between legitimate research activities and commercial preparation that may constitute infringement.
AbbVie’s Patent Refusal Upheld over Impermissible Shift from Treatment to Product Claims
Published: 21 May 2025 | Author: Intellepedia
The Delhi High Court upheld rejection of AbbVie’s patent application for an anti-cMet antibody-drug conjugate (ADC) used in cancer treatment. The court found the original claims focused on therapeutic methods, which are explicitly excluded from patentability under Section 3(i) of India’s Patents Act, 1970. The applicant attempted to overcome this restriction by amending claims to shift focus from treatment methods to the product itself.
However, the court determined this modification constituted an impermissible broadening of claim scope that introduced new subject matter beyond what was originally disclosed. The judges emphasised that Indian patent law prohibits artificially broadening claims through strategic redrafting. This case illustrates the tension in pharmaceutical patenting: whilst product claims generally receive broader protection than method claims, applicants cannot simply reframe rejected applications to escape statutory exclusions. Practitioners must carefully consider claim strategy from the outset of prosecution.
Revocation is Distinct from Invalidity Defence and Survives Patent Expiry, Rules Delhi High Court
Published: 29 April 2025 | Author: Neetha Mohan
The Delhi High Court clarified important distinctions in patent law regarding revocation petitions and invalidity defences. In Macleods Pharmaceuticals Ltd. v. Boehringer Ingelheim Pharma GmbH & Co. KG, the court held that a revocation petition under Section 64 is distinct from an invalidity defence under Section 107 and remains maintainable even after patent expiry. The case involved Macleods’ challenge to a patent for the anti-diabetic drug LINAGLIPTIN.
Whilst Boehringer argued that raising invalidity as a defence in an infringement suit rendered a separate revocation petition redundant, the court disagreed. A revocation petition seeks complete removal from the patent register, whereas an invalidity defence only applies to disputes between specific parties. The court emphasised that findings in infringement suits operate between contesting parties, whilst revocation orders have broader effects. This distinction is particularly relevant for generic manufacturers who may wish to clear patents from the register even after expiry to avoid future claims.
Amgen’s Lyophilised Peptibody Patent Upheld by Madras High Court
Published: 4 September 2025 | Author: Neetha Mohan
The Madras High Court set aside a patent application refusal for Amgen’s lyophilised therapeutic peptibody formulations, determining that previous objections were unjustified. The application concerned romiplostim, a thrombopoietin receptor agonist used to stimulate platelet production, combined with four specific excipients at defined concentrations to improve stability. The patent office had rejected the application citing lack of inventive merit, non-patentability grounds, and insufficient disclosure.
However, the court found these objections unsustainable and directed the application to proceed to grant following claim amendments. A key finding addressed the specificity of excipient selection. The court observed that excipient selection is highly protein-specific and requires empirical optimisation, making the claimed combination non-obvious and inventive. This decision provides guidance for pharmaceutical applicants seeking to patent formulation innovations, confirming that carefully optimised combinations can meet the inventive step threshold even when individual components are known.
Looking Ahead
The patent-related developments of 2025 reflect the continuing evolution of India’s patent system as it addresses contemporary challenges. From clarifying examination procedures for computer-related inventions to balancing patent enforcement against public health considerations, Indian courts and the Patent Office have provided guidance that practitioners must incorporate into their strategies. However, it is worth noting that these developments build upon established principles whilst responding to the specific circumstances of each case.
For patent applicants, litigants, and practitioners, staying informed of these developments is essential for effective practice. The principles laid down in these cases have direct implications for how patents are drafted, prosecuted, and enforced in India. We at Intellepedia remain committed to providing comprehensive, accessible, and timely coverage of patent law developments, and we are grateful to our readers for their continued engagement with our work.
In order to stay updated on future patent law developments, readers may consider bookmarking Intellepedia and visiting regularly for our latest posts. As always, the articles are intended for informational purposes, and specific legal advice should be sought from qualified professionals for individual matters.