INDIA Trends and Developments Contributed by: Mohit Goel, Sidhant Goel, Deepankar Mishra and Mehr Bajaj, Sim and San, Attorneys at Law
export activities subject to certain safeguards, after finding a credible challenge to the validity of the asserted patent. • Similarly, in F . Hoffmann - La Roche AG & Anr . v Natco Pharma Ltd . (2025: DHC:1907), concerning the Risdiplam patent for treatment of Spinal Mus- cular Atrophy (SMA), the Delhi High Court refused interim injunctions against generic entry while simultaneously grappling with the implications of access to an otherwise prohibitively expensive rare-disease therapy. These disputes underscore the degree of judicial sen- sitivity increasingly visible in Indian pharmaceutical patent litigation, particularly where intellectual prop- erty enforcement intersects with rare diseases, afford- ability concerns, therapeutic access and broader con- stitutional considerations relating to public health. The result is not an anti-patent system, as India is sometimes simplistically portrayed internationally. Rather, it is a jurisdiction constantly attempting to balance innovation incentives against affordability, healthcare realities, and public interest considerations. A recurring feature of these disputes is the close judi- cial scrutiny of patent validity at the interim stage itself. Indian courts have shown a willingness to examine credible challenges to validity, including allegations of evergreening and want of inventive step, before granting injunctive relief that would foreclose gener- ic competition. This approach reflects the statutory architecture of the Patents Act, which embeds public interest safeguards through provisions on patentabil- ity standards, pre- and post-grant opposition, and compulsory licensing. For innovator companies, the practical implication is that the strength of the under- lying patent, rather than the mere fact of registration, increasingly determines the availability of early relief. For businesses operating in the life sciences sector, the practical takeaway is one of strategic calibration rather than pessimism. Innovators are increasingly advised to anticipate validity challenges, to prepare robust technical and economic evidence early, and to structure portfolios around genuinely inventive contri- butions rather than incremental modifications. Generic and biosimilar manufacturers, in turn, must weigh the
prospect of refused injunctions against the residual exposure created by the courts’ growing readiness to award substantial damages and direct interim depos- its where infringement is ultimately established. The result is a litigation environment that rewards care- ful evidentiary and commercial preparation on both sides, and in which neither exclusivity nor access can be assumed as a default outcome. The rise of “e-infringement” Perhaps the most important structural shift within India’s IP ecosystem is that modern infringement increasingly operates through digital infrastructure rather than conventional counterfeit networks. This evolution has given rise to what practition- ers increasingly describe as “e-infringement” – ie, infringement that is not merely committed online, but is amplified, facilitated or commercially sustained through digital platform architecture itself. Counterfeit goods today may move simultaneously through marketplace listings, sponsored advertise- ments, warehousing systems, payment gateways, recommendation algorithms, and logistics networks. In many instances, infringement is no longer hidden from consumers. It is integrated directly into main- stream platform ecosystems. Indian courts are increasingly examining not only the conduct of individual infringers, but also the role played by intermediaries and digital platforms them- selves. There is growing judicial willingness to scruti- nise marketplace participation and platform-enabled visibility in infringing activities. The Information Technology (Intermediary Guidelines and Digital Media Ethics Code) Rules, 2021 have fur- ther strengthened expectations surrounding interme- diary due diligence, grievance redressal and compli- ance obligations. For businesses operating in India, intellectual property strategy increasingly overlaps with platform governance, digital compliance and online risk management. Domain names have become digital trust assets Domain name disputes are also evolving rapidly within India’s enforcement architecture. Historically, domain
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