By Devanssh Mehta
Patent law sits at the intersection of science, commerce, public health and national strategy. For a nation aspiring to convert scientific talent into societal value, India’s patent regime must balance two competing priorities: strong incentives for innovation, and equitable access to knowledge and essential technologies. This article examines the present statutory and regulatory architecture, recent reforms and draft guidelines, judicial influences, sectoral pressures (notably pharmaceuticals and digital/AI), and plausible future directions for patent policy in India. Throughout, I analyse implications for researchers, industry, healthcare, and national competitiveness — and conclude with pragmatic policy recommendations.
Background — the legal scaffolding
The present statutory backbone is the Patents Act, 1970 (as amended), which sets out patentability criteria, term and rights conferred, limitations (e.g., compulsory licensing), and remedies. The Act is implemented and interpreted through the Patents Rules (2003, as amended) and examination/guideline documents issued by the patent office and the executive. The Office of the Controller General of Patents, Designs & Trade Marks (CGPDTM) is the statutory administrative body that conducts examination and grants patents, while the Department for Promotion of Industry and Internal Trade (DPIIT) sits at the policy level and notifies rules and amendments. The judicial branch — from High Courts to the Supreme Court — has played an outsized role in shaping doctrinal contours, particularly in pharma-related cases that implicate public health. Office of the Controller General of Patents, Designs & Trade Marks Department for Promotion of Industry and Internal Trade
Key statutory features that remain central today are:
- Patentable subject matter and exclusions (Sections 3 and 4 of the Act).
- Novelty, inventive step and industrial applicability as gatekeeping standards.
- Term of monopoly (20 years from filing).
- Compulsory licensing (Section 84) and government-use provisions as statutory safeguards for access.
- Pre-grant and post-grant opposition procedures that allow third-party challenges.
(For a consolidated version of the Act as currently available online, see the official compilation of the Patents Act.)
Recent and ongoing reforms — what changed, what’s being debated
1. Procedural modernization — Patents (Amendment) Rules, 2024
Beginning in 2024 the government undertook a package of amendments aimed primarily at simplifying procedures, accelerating prosecution timelines, encouraging indigenous innovation and reducing administrative friction for applicants. These amendments modify fees, introduce procedural streamlining and update forms and timelines intended to reduce pendency and improve ease of doing business for domestic innovators. Multiple practitioner notes and official summaries were published after March 2024 when the Rules were notified.
2. Computer-Related Inventions (CRI) — Draft Guidelines 2025
Recognising the growing volume of AI- and software-related filings, the patent office produced revised draft Guidelines for Examination of Computer-Related Inventions (CRI) in 2025 and solicited stakeholder comments. These drafts aim to clarify the borderline between excluded subject-matter (pure algorithms, mathematical methods) and patentable technical contributions, and to give examiners a structured test for inventive step in AI/ML contexts. The public consultation process and iterative versions (including a Version 2.0 in mid-2025) show an ongoing attempt to create a balanced, predictable framework for digital-era inventions.
3. Policy conversations on access and compulsory licensing
India’s statutory compulsory licensing regime (Section 84) continues to be a policy focal point, especially after high-profile disputes in pharmaceuticals. The debate is two-sided: public-health advocates call for robust use of compulsory licences to ensure affordable medicines, while industry cautions against undermining incentives for R&D. The statutory three-year waiting period before a compulsory licence can be sought remains in place, and legal commentary continues to explore its operationalisation and evidentiary thresholds.
4. AI, data, and IP — nascent regulatory experiments
The DPIIT has been actively consulting stakeholders on AI-related IP and copyright policy, including “One Nation, One Licence” style proposals for training-data licensing and mechanisms for rights clearance. These consultations (into early 2026) indicate a future where questions of data ownership, training-data licences and attribution will migrate into patent-adjacent territory (e.g., when models enable or embody inventions). Such policy work signals that India’s IP system will likely be at the forefront of reconciling AI, copyright and patent concerns.
Judicial influence and interpretative trends
Indian courts have shaped patent doctrine through several landmark rulings — especially in pharmaceuticals and biotechnology — where access to medicine and public interest arguments intersect with patent exclusivity. Recent High Court rulings have emphasised the need for technical proof and reasoning when patentability is denied on morality or public-order grounds; courts have pushed the patent office to ground refusals in cogent technical findings rather than subjective assessments. This trend strengthens procedural fairness in examination and pushes the office toward more robust, transparent reasoning.
Analysis — strengths, weaknesses and strategic tensions
Strengths
- Mature statutory framework with flexible safeguards. The Patents Act balances exclusivity with public-interest tools (compulsory licensing, government non-commercial use, pre/post-grant oppositions). This modularity allows targeted interventions without wholesale legal overhaul.
- Administrative modernisation. The 2024 Rules and ongoing guidelines (e.g., CRI drafts) reflect proactive governance: procedural simplification, stakeholder consultation, and technical upskilling of examiners can materially lower pendency and increase grant quality.
Weaknesses and frictions
- Pendency and resource constraints. Despite reforms, examination backlogs and uneven technical expertise across patent branches slow prosecution — particularly in high-volume fields like pharmaceuticals, biotech and AI. This is a systemic capacity issue requiring sustained investment in examiners and domain expertise.
- Legal uncertainty for software/AI inventions. Global uncertainty on patenting AI-created or AI-assisted inventions complicates prosecution and litigation strategy. The CRI guidelines (draft) are promising but still in flux; unclear standards risk inconsistent grant rates and forum shopping.
- Access vs incentives — an unresolved trade-off. Compulsory licensing remains politically salient and legally available, yet its threat may chill private investment if applied unpredictably. Conversely, restrained use may compromise affordability and public health goals. The policy challenge is to operationalise access safeguards transparently and predictably.
Sectoral dynamics
- Pharmaceuticals and public health. India’s legacy as the “pharmacy of the developing world” makes pharmaceutical patent decisions geopolitically visible. Patent denials, compulsory licences or patent thickets in this sector have outsized implications for access and trade.
- Digital & AI economy. Patent protection faces tension with rapid innovation cycles, open-source models and data-centric value creation. India must decide whether to lean toward permissive protection (to catalyse local AI firms) or tighter rules that prioritise data commons and open innovation. DPIIT’s AI consultations suggest the government recognizes these stakes.
International considerations
India’s treaty obligations — notably under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) administered by the World Trade Organization — set minimum standards but also afford flexibilities. The global debate on TRIPS flexibilities, compulsory licensing for public health, and differential treatment for developing countries continues to influence India’s domestic choices. India’s diplomacy needs to manage trade partner expectations while defending policy tools for public health and technological catch-up.
The future — plausible scenarios (next 5–10 years)
I outline three plausible trajectories India could follow; each blends legal reform, administrative action and policy orientation.
Scenario A — Balanced modernization (most desirable)
- The patent office scales examiner capacity and specialised technical units (AI, biotech, pharma).
- CRI examination guidelines are finalised with clear tests for technical contribution, leading to predictable outcomes for software/AI filings.
- Compulsory licensing is applied narrowly and transparently — with clear, evidence-based criteria and compensatory mechanisms — preserving investor confidence while safeguarding access.
Policy outcome: increased domestic patents in high-value sectors, predictable enforcement and continued access to essential medicines.
Scenario B — Access-first legalism
- Aggressive use of compulsory licensing and expansive interpretations of Section 3 exclusions (e.g., broad public-interest refusals) to secure access to medicines and technologies.
- Short-term benefits for affordability; long-term risk of reduced foreign R&D investment and bilateral trade pressures.
Policy outcome: equity gains but possible erosion of private R&D incentives.
Scenario C — Protection-maximising drift
- Emphasis on stronger exclusivities, faster grant rates and industry-friendly interpretations, perhaps to attract multinational R&D.
- Risk: constrained access to essential technologies, higher drug prices, and domestic innovation concentrated among large firms.
Policy outcome: potential short-term investment flows but socio-political backlash and increased regulatory scrutiny.
Policy recommendations — pragmatic, India-centric
Drawing on the analysis above, I recommend the following calibrated steps to evolve India’s patent ecosystem effectively:
- Invest in examiner specialisation and infrastructure. Create dedicated technical benches (AI, biotech, pharma) with continual upskilling and cross-posting from academia/industry on temporary secondments. This is the single highest-leverage administrative reform to improve grant quality and reduce pendency.
- Finalize CRI Guidelines with measurable tests. Publish concrete examination checklists for “technical effect” and “technical contribution” in AI-driven inventions to reduce discretion and litigation. Solicit a final round of targeted stakeholder testing involving AI firms, universities and civil-society groups.
- Operationalise transparent compulsory-licence protocols. Define ex ante criteria, minimum evidentiary thresholds and an expedited hearing timeline for CL requests; create a compensation formula and appellate fast-track so rights-holders and the public perceive the system as fair and rule-based. Reference cases and international practice should guide this.
- Harmonise IP policy with AI/data governance. Ensure DPIIT’s AI consultations translate into cross-cutting rules that coordinate copyright, data access and patenting — for example, standardised licences for training datasets that preserve research access while enabling commercialisation.
- Promote pro-innovation financing and tech transfer. Create matched-funds for early-stage translational research, tax credits for R&D, and strengthened university-industry tech-transfer offices to convert patents into products and economic value.
- Strengthen adaptive public-interest clauses. Keep accessible statutory flexibilities (e.g., government-use) but pair them with clearer procedural safeguards and timelines to avoid ad hoc use that damages investment climate.
Practical guidance for stakeholders
- For inventors and startups: Prioritise early demonstration of technical contribution and utility in software/AI filings; maintain clear invention records and seek expedited examination if commercial timing matters.
- For pharmaceutical firms: Engage proactively in collaborative licensing models (e.g., voluntary licences, tiered pricing), and maintain readiness for evidence-based hearings on compulsory-licence petitions.
- For policy-makers: Use pilot projects (e.g., AI patent fast-track) before nationwide rollouts; measure impacts on grant quality, litigation and R&D investment.
Conclusion — towards a resilient, equitable patent regime
India stands at a pivotal juncture: its patent system must simultaneously nurture high-technology industries, protect access to essential goods (notably medicines), and adapt to the paradigm shifts brought by AI and data-driven innovation. The legislative and administrative momentum — seen in the 2024 Rules, the CRI consultations of 2025, and active DPIIT engagement on AI policy — is promising. Success, however, depends less on one-off rule changes and more on sustained capacity-building, transparent use of public-interest tools, and cross-sectoral policy coherence that aligns IP law with health, industrial and digital strategies. If executed with discipline and foresight, India can craft a patent ecosystem that is both innovation-friendly and socially conscious — generating new science, new industries, and equitable public value.
Selected authoritative sources and further reading
- The Patents Act, 1970 — consolidated (official PDF).
- Patents (Amendment) Rules, 2024 — official notifications and summaries.
- Draft / Revised Guidelines for Examination of Computer-Related Inventions (CRI) — Draft 2025 (Version 1 & 2): stakeholder consultation documents.
- Analysis and commentary on compulsory licensing and public-health implications.
- DPIIT generative-AI and copyright/public consultation updates (early 2026).