India's National IPR Policy 2016: Impact on Patent Practice

India’s adoption of a comprehensive National Intellectual Property Rights Policy on 12 May 2016 marked an inflection point in the country’s engagement with the knowledge economy. For the first time, the government brought all forms of intellectual property – patents, trademarks, copyrights, geographical indications, industrial designs, semiconductor integrated circuit layout designs, trade secrets and plant varieties – under a unified policy vision articulated through the tagline “Creative India; Innovative India.” This was not a mere administrative reorganisation. The Policy represented a deliberate philosophical shift: from a defensive, compliance-oriented posture rooted in India’s TRIPS obligations under the Agreement on Trade-Related Aspects of Intellectual Property Rights, toward a proactive, innovation-first framework that treated intellectual property creation as an instrument of national economic development. For patent practitioners, applicants and the broader ecosystem of IP professionals operating in India, the Policy’s downstream consequences have been far-reaching, touching prosecution timelines, administrative infrastructure, substantive law, judicial doctrine and the practical experience of securing and enforcing patent rights.

The statutory framework governing patents in India remains the Patents Act, 1970, as comprehensively amended by the Patents (Amendment) Act, 2002 and the Patents (Amendment) Act, 2005. The 2005 amendment was itself a direct consequence of India’s TRIPS obligations under Article 27, which mandated patent protection for inventions in all fields of technology, including pharmaceutical products a category that India had deliberately excluded from product patent protection under the 1970 Act’s original architecture. The National IPR Policy did not alter the Patents Act, 1970 itself, but it set in motion a cascade of administrative, procedural and structural reforms that have reshaped how the Act operates in practice. Understanding the Policy’s impact on patent practice requires engaging not only with its seven stated objectives but also with the institutional mechanism it created, the regulatory amendments it generated and the judicial landscape against which all of these reforms have been measured.

The Patenevo readership patent agents, advocates, in-house counsel and IP-informed business owners encounters the consequences of this Policy every time a patent application is filed, every time a First Examination Report must be answered, every time a compulsory licence is contemplated and every time a client asks whether an Indian patent is worth pursuing. This article provides a systematic analysis of how the National IPR Policy 2016 has reconfigured each of these dimensions of patent practice, drawing on the Policy’s stated objectives, the Patents (Amendment) Rules, 2024, leading judicial decisions and the empirical data on patent filings that now constitute part of India’s public record.

The Architecture of the National IPR Policy 2016 – Seven Objectives and an Institutional Nerve Centre

The Policy’s seven interconnected objectives were formulated following consultation with nearly three hundred organisations and individuals convened by an IPR Think Tank and they cover IPR awareness and outreach, stimulation of IP generation, strengthening of the legal and legislative framework, modernisation of IP administration, commercialisation of IP assets, enforcement of IP rights and human capital development. For patent practitioners, the objectives of greatest operational significance are the third, fourth and fifth relating to law, administration and commercialisation respectively but the first objective concerning awareness has had an indirect but demonstrable effect on filing volumes, particularly among startups and domestic entities. The Policy established the Cell for IPR Promotion and Management, universally known as CIPAM, as a single nodal agency under the Department for Promotion of Industry and Internal Trade to implement, coordinate and monitor the Policy’s execution. CIPAM has since become the institutional nerve centre of India’s IP modernisation programme, responsible for outreach, simplification of processes, commercialisation facilitation and stakeholder engagement. Its creation signalled that IP policy in India would henceforth be treated as a matter of industrial and economic strategy, not merely legal administration.

The Architecture of the National IPR Policy 2016 – Seven Objectives and an Institutional Nerve Centre

The Administrative Transformation – Patent Office Modernization and the Reduction of Pendency

Prior to the Policy’s adoption, the Indian Patent Office suffered from chronic understaffing and a structural backlog that severely impaired its ability to examine and grant patents within commercially meaningful timelines. As at 31 March 2016 the date from which the Policy’s impact is conventionally measured patent applications pending examination stood at approximately 1,97,934. The Policy’s fourth objective mandated the modernisation and strengthening of service-oriented IP administration and the government responded with a substantial augmentation of technical manpower, recruitment of additional examiners and the digitisation and streamlining of office systems. E-filing portals were upgraded, online hearings became common and real-time tracking of application status was enabled through the Indian Patent Office’s digital infrastructure. By 31 October 2022, the pendency of applications pending examination had reduced to approximately 1,39,274 a reduction of more than fifty-eight thousand applications in six years, achieved primarily through examiner recruitment and procedural digitisation. The capacity for expedited examination, permitted on certain specified grounds under Rule 24C of the Patents Rules, 2003, became genuinely operational in this period, with the shortest time from filing of a request for examination to grant recorded at eighty-one days a figure that would have been inconceivable in the pre-2016 regime.

The Patent Office’s Annual Report for 2024–25 records 1,10,375 patent applications filed during the financial year, marking approximately a 19.7 percent year-on-year increase and the first time India crossed the one-lakh-ten-thousand threshold in a single financial year. This trajectory from roughly 42,951 filings in 2013–14 to over 1,10,000 in 2024–25 represents a growth of more than 150 percent across the decade and it reflects the compounding effect of the Policy’s awareness, facilitation and administrative reforms on the propensity of both resident and non-resident applicants to engage with the Indian patent system. According to WIPO’s World Intellectual Property Indicators 2025 report, India recorded 63,217 resident patent applications and 41,940 non-resident applications in 2024, placing it sixth globally in terms of patent applications received a significant advance from its earlier position outside the top ten. Resident filings, which stood at approximately 24.8 percent of total applications in 2013, had increased to 55.2 percent by 2023, indicating a structural shift in domestic innovation activity, not merely volume inflation through foreign filings.

The Patents (Amendment) Rules, 2024 – Prosecution Reform as Policy Execution

The most consequential regulatory intervention traceable to the National IPR Policy’s administrative modernisation objective is the Patents (Amendment) Rules, 2024, notified on 15 March 2024 by the Ministry of Commerce and Industry through the Department for Promotion of Industry and Internal Trade. These amendments, which entered into force on the date of publication in the Official Gazette, comprehensively reformed several procedural aspects of patent prosecution and represent the most significant revision to the operational framework of the Patents Act, 1970 since the Rules were last substantially revised.

The most immediately impactful change for practitioners is the reduction in the timeline for filing a Request for Examination under Section 11B of the Patents Act, 1970. Under the pre-amendment regime, an applicant had forty-eight months from the priority date or the date of filing whichever was earlier to file this request, failing which the application was treated as withdrawn. The 2024 Amendment reduced this period to thirty-one months. For applicants who have filed conventional applications, the effect is direct: the window within which prosecution must be initiated has been compressed by seventeen months, requiring applicants and their agents to advance their readiness for examination significantly. For PCT applications entering the Indian national phase, the amendment introduced a complexity, since the international filing date is used to calculate the deadline rather than the actual date of national phase entry in India an asymmetry that the patent profession has noted and which creates a need for careful docketing, particularly for applications that entered the national phase close to the pre-amendment forty-eight-month limit.

The 2024 Amendment also modified the Form 3 compliance regime governing disclosure of corresponding foreign applications under Rule 12 of the Patents Rules, 2003. Previously, applicants were required to file Form 3 disclosures within six months of filing the Indian application and to update the Controller every six months with new prosecution developments in foreign jurisdictions. The amended framework simplifies this to a single updated Form 3 submission due within three months of the issuance of the First Examination Report. This reform reduces the burden of continuous disclosure compliance and aligns the Indian requirement more closely with the prosecution-focused disclosure model operative in other jurisdictions. The amendment simultaneously introduced flexibility on certain previously non-extendible deadlines, permitting extensions for filing the response to a First Examination Report for up to three months beyond the standard six-month period on payment of an official extension fee a significant practical concession to applicants managing complex prosecution timelines.

The handling of pre-grant oppositions was also reformed. The 2024 Amendment introduced a prima facie maintainability filter, requiring the Controller to first determine whether an opposition makes out a prima facie case before admitting it to the full opposition procedure. An official fee of approximately INR 20,000 was imposed for filing a pre-grant opposition. If a prima facie case is established, the application is then examined under the expedited examination procedure under Rule 24C, ensuring that opposed applications receive accelerated rather than prolonged treatment. This addresses what practitioners had long identified as an abuse of the pre-grant opposition mechanism, which had been used as a dilatory tactic to delay grant and impose collateral pressure on applicants.

Substantive Patent Law and the Policy’s Calibrated Approach – Section 3(d) and the Public Interest Dimension

The National IPR Policy is notable for what it chose not to disturb as much as for what it sought to reform. The Policy explicitly commits to balancing the interests of rights owners with larger public interest particularly in the areas of healthcare, food security and access to essential technologies. This commitment is legally operationalised through several provisions of the Patents Act, 1970 that the Policy declined to propose amending, the most significant of which is Section 3(d), which excludes from patentability the new form of a known substance unless it differs significantly in properties with regard to efficacy.

The constitutional and jurisprudential architecture of Section 3(d) was settled definitively by the Supreme Court of India in Novartis AG v. Union of India, (2013) 6 SCC 1, a judgment of foundational importance to both pharmaceutical patent practice and the broader question of how India’s TRIPS compliance obligations are to be reconciled with public health imperatives. In that case, Novartis sought patent protection in India for the beta crystalline form of imatinib mesylate the active ingredient of its cancer drug Gleevec on the basis that this form exhibited superior bioavailability as compared to the base compound. The Indian Patent Office had rejected the application on the ground that the claimed subject matter did not satisfy Section 3(d) and the rejection was upheld by the Intellectual Property Appellate Board. The Supreme Court, through a judgment authored by Justice Aftab Alam, confirmed that Section 3(d) imposes a standard of therapeutic efficacy distinct from and more demanding than the general novelty and inventive step requirements under Sections 2(1)(j) and 2(1)(ja) of the Patents Act, 1970. The Court held that demonstrable enhancement in therapeutic efficacy as distinct from physicochemical properties such as bioavailability or solubility was required for a known pharmaceutical substance to be patentable in its new form. The National IPR Policy, enacted three years after this judgment, preserved this framework entirely, signalling that the government regarded Section 3(d) not as an impediment to innovation policy but as a structural feature of India’s calibrated approach to pharmaceutical patents that serves the country’s public health objectives and its role as the global supplier of generic medicines.

The compulsory licensing framework under Sections 84 to 92 of the Patents Act, 1970 was similarly preserved and, in some respects, contextually reinforced by the Policy’s insistence on access to healthcare as a policy priority. The first compulsory licence ever granted in India under Section 84 was issued on 9 March 2012 by the Controller of Patents, Mumbai, in Natco Pharma Ltd. v. Bayer Corporation the Nexavar case. Bayer held a patent for sorafenib tosylate, marketed as Nexavar for the treatment of kidney cancer and had priced the drug at Rs. 2,80,428 per month. Natco applied for a compulsory licence after Bayer refused to grant a voluntary licence and the Controller held that each of the three grounds under Section 84(1) of the Patents Act, 1970 was independently established: the reasonable requirements of the public had not been satisfied, the drug was not available at a reasonably affordable price and the patented invention was not being worked in the territory of India. The compulsory licence was granted at a royalty of six percent, subsequently revised to seven percent by the Intellectual Property Appellate Board on Bayer’s appeal. The Bombay High Court upheld the IPAB’s order in Bayer Corporation v. Union of India, 2014 (60) PTC 277 (Bom), confirming that the conditions under Section 84 had been met and rejecting Bayer’s contention that importation of the patented drug constituted “working” within the meaning of the Act. The National IPR Policy, by declining to amend the compulsory licensing provisions, implicitly endorsed this jurisprudence as consistent with India’s balanced approach to patent rights.

The Start-up and MSME Dimension – Fee Concessions and Facilitation as Patent Policy

One of the most practically significant consequences of the Policy for the domestic patent ecosystem has been the systematic expansion of fee concessions and procedural facilitations for startups, small entities and educational institutions. The patent fee structure has long operated on a graduated scale distinguishing between natural persons, small entities and others a distinction that predates the 2016 Policy but the Policy’s emphasis on commercialisation and the generation of IP by domestic innovators provided the impetus for progressive extension of this framework. The Start-up India initiative, launched concurrently with the broader economic context in which the Policy was formulated, intersected with patent policy through the recognition of DPIIT-recognised startups as entitled to file patent applications under the facilitated examination procedure at reduced fees and with access to the expedited examination track under Rule 24C. The 161st Report of the Parliamentary Standing Committee on Commerce (2021), which constituted the first major legislative review of the Policy’s implementation, noted that patent applications by startups had increased by over one hundred and fifty percent in the five years following the Policy’s adoption a statistic that practitioners in the patent filing ecosystem will recognise as consistent with their experience of increased domestic client activity in technology, pharmaceutical and engineering domains.

The Judicial Ecosystem – High Court Jurisprudence and the Evolving Contours of Patent Practice

The administrative reforms of the post-2016 period have occurred against the background of an evolving judicial doctrine on patent validity, infringement and enforcement. The Delhi High Court has been the primary forum for significant patent litigation, given its Original Side jurisdiction over patent infringement suits. In Merck Sharp and Dohme Corporation v. Glenmark Pharmaceuticals Ltd., CS(OS) 586/2013 (Delhi HC), the Court engaged with questions of claim construction and the role of prosecution history in interpreting the scope of patent claims issues of direct relevance to patent practitioners advising on freedom-to-operate and infringement analysis in the post-Policy regulatory environment. In Roche Products Ltd. v. Cipla Ltd., 148 (2008) DLT 598 (DB), the Division Bench of the Delhi High Court refused to grant an interim injunction in a pharmaceutical patent infringement case, placing public interest in access to affordable medicines the same interest that animates the National IPR Policy’s public health commitments as a relevant consideration in the balance of convenience analysis under Order XXXIX Rules 1 and 2 of the Code of Civil Procedure, 1908. This line of judicial reasoning, now well established in Indian patent jurisprudence, operates as a structural constraint on the enforcement of pharmaceutical patents that practitioners must account for when advising patentees on interim relief strategy.

The abolition of the Intellectual Property Appellate Board by the Tribunals Reforms Act, 2021 and the transfer of its jurisdiction to the High Courts, represents a structural change of considerable importance for patent practice. Appeals from orders of the Controller of Patents under Sections 116 and 117A of the Patents Act, 1970 including appeals against orders on oppositions, compulsory licences and revocation now lie directly before the High Courts. This change, which occurred in the period of the Policy’s implementation, has concentrated appellate patent jurisdiction in forums of greater institutional capacity and legal authority, with the Delhi High Court emerging as the primary venue for significant post-grant challenges and enforcement proceedings.

The Commercialisation Gap – The Policy’s Unfinished Agenda

A candid assessment of the National IPR Policy’s impact on patent practice cannot avoid acknowledging the gap between the Policy’s commercialisation ambitions and the ground reality. The Policy’s fifth objective to get value for IPRs through commercialisation contemplated a regime where patents would be actively licensed, assigned, pledged as collateral and converted into revenue streams. The experience of nearly a decade suggests that while filing activity has grown substantially, the translation of patent portfolios into commercial value remains underdeveloped. The share of resident-owned patents granted to Indian applicants reached approximately 31.9 percent in 2024–25 the highest in the five-year period but the majority of patents granted in India continue to be held by non-resident entities and the commercialisation of Indian-origin patents through licensing and technology transfer remains modest relative to the filing growth. The Parliamentary Standing Committee’s 2021 report noted that profound structural issues regarding innovation capacity, enforcement and commercialisation continued to restrict India’s transformation into a knowledge economy, even as administrative and awareness reforms achieved significant gains. This observation retains its force in 2026, suggesting that the next phase of patent policy development in India must grapple with questions of IP financing, university-industry technology transfer and patent licensing infrastructure that the 2016 Policy addressed only at the level of aspiration.

India’s R&D expenditure as a percentage of GDP estimated at approximately 0.65 percent in recent years remains far below the levels of China, the United States, South Korea and the European Union, each of which dedicates between two and four percent of GDP to research and development. Filing activity can expand on the basis of administrative reform and awareness; genuine innovation capacity requires sustained investment in research infrastructure that no patent policy alone can generate. This structural reality sets a ceiling on what the National IPR Policy can accomplish and defines the terms of the ongoing debate about whether India’s patent filing boom reflects a genuine innovation ecosystem or represents, at least in part, a strategic optimisation of filing metrics without a commensurate deepening of inventive capacity.

The Global Rankings Dimension – GII, WIPO and the Policy’s External Signalling Effect

The National IPR Policy has had a measurable and documented effect on India’s performance in international innovation rankings. India’s rank in the WIPO Global Innovation Index improved from 81st in 2015 to 38th in 2025, among 139 economies a progression that WIPO’s own reporting attributes in part to improved patent filing volumes, knowledge creation and institutional reform. India now hosts four innovation clusters in the top one hundred globally: Bengaluru ranked 21st, Delhi 26th, Mumbai 46th and Chennai entering the top one hundred for the first time in the 2025 edition. In WIPO’s World Intellectual Property Indicators 2025 report, India was identified as among the top twenty origin countries recording double-digit growth in resident patent applications in 2024, with a growth rate of approximately 19.1 percent in resident filings the highest among major filing jurisdictions in that period. These ranking improvements carry commercial significance for patent practitioners: foreign applicants, licensing counterparties and investment funds use international IP rankings as a proxy for the maturity and reliability of a jurisdiction’s patent system and India’s sustained advancement in these metrics has contributed to its emergence as a preferred destination for technology transfer agreements and patent-backed investment.

Conclusion

The National IPR Policy 2016 must be assessed as a document that has delivered unevenly but substantially. Its greatest achievements lie in the domain of administrative modernisation: the reduction of patent pendency, the exponential growth in filing volumes, the operationalisation of expedited examination, the facilitation of startup participation in the patent system and the international repositioning of India as a serious patent jurisdiction rather than merely a jurisdiction of compliance. The Patents (Amendment) Rules, 2024 represent the most direct regulatory expression of the Policy’s administrative reform agenda, compressing examination timelines, streamlining disclosure obligations, rationalising pre-grant opposition procedure and introducing procedural flexibility where the previous rules were rigid. These changes have materially improved the experience of patent prosecution in India and deserve recognition as genuine advances in practitioner experience and systemic efficiency.

The Policy’s engagement with substantive patent law preserving Section 3(d), maintaining the compulsory licensing regime and declining to trade away India’s TRIPS flexibilities in exchange for foreign investment commitments has been equally significant and considerably more contested. The jurisprudence of the Supreme Court in Novartis AG v. Union of India, (2013) 6 SCC 1 and the compulsory licence regime confirmed by Bayer Corporation v. Union of India, 2014 (60) PTC 277 (Bom) define the contours within which pharmaceutical patent practice in India operates and the Policy’s implicit endorsement of this framework ensures that India’s patent system will continue to be distinguished from the EPO and USPTO models in ways that practitioners advising both patentees and generic manufacturers must understand with precision.

The unfinished agenda is commercialisation. Filing growth without a corresponding increase in licensing revenue, technology transfer activity and IP-backed financing represents a patent ecosystem that is expanding in form without a proportionate deepening of economic substance. The second review of the National IPR Policy which falls due in 2026 under the Policy’s own five-year review mechanism presents an opportunity to address this gap: to build the financing infrastructure, university technology transfer mechanisms and enforcement capacity that the 2016 Policy identified but could not fully deliver. For patent practitioners, this trajectory suggests a profession that will need to evolve from primarily prosecution-oriented practice toward advisory roles in IP commercialisation, portfolio strategy and cross-border licensing functions that the Policy’s vision of a knowledge economy ultimately demands.

References

National IPR Policy 2016, Department for Promotion of Industry and Internal Trade, Government of India – https://dpiit.gov.in/sites/default/files/National_IPR_Policy_25May2016_0.pdf
Cell for IPR Promotion and Management (CIPAM), National IPR Policy Overview – https://cipam.gov.in/en/about/national-IPR-policy
Patents Act, 1970 (as amended), Legislative Department, Ministry of Law and Justice, Government of India – https://legislative.gov.in/sites/default/files/A1970-39.pdf
Patents (Amendment) Rules, 2024, Official Gazette Notification, Ministry of Commerce and Industry, Government of India – https://ipindia.gov.in/writereaddata/Portal/IPOAct/1_98_1_patent-rules-2003.pdf
Novartis AG v. Union of India, (2013) 6 SCC 1 – Supreme Court of India – https://main.sci.gov.in/jonew/judis/40212.pdf
Bayer Corporation v. Union of India, 2014 (60) PTC 277 (Bombay High Court) – https://indiankanoon.org/doc/28519340/
WIPO Global Innovation Index 2025, World Intellectual Property Organization – https://www.wipo.int/web-publications/global-innovation-index-2025/en/gii-2025-at-a-glance.html
WIPO – World Intellectual Property Indicators 2025, World Intellectual Property Organization – https://www.wipo.int/edocs/pubdocs/en/wipo-pub-941-17-2025-en-world-intellectual-property-indicators-2025.pdf
Annual Report 2024–25, Office of the Controller General of Patents, Designs, Trademarks and Geographical Indications, DPIIT – https://ipindia.gov.in/annual-reports.htm
161st Report of the Parliamentary Standing Committee on Commerce (2021), Rajya Sabha https://rajyasabha.nic.in/rsnew/Committee_site/Committee_File/ReportFile/3/103/161_2021_10_15.pdf
Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), World Trade Organization – https://www.wto.org/english/docs_e/legal_e/27-trips.pdf
DPIIT IP Annual Report 2023, Department for Promotion of Industry and Internal Trade – https://dpiit.gov.in/publications/annual-report

National IPR Policy 2016 India: Objectives, Reforms & Impact

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National IPR Policy 2016 India: Objectives, Reforms & Impact

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