Roche v. Natco Dispute

The Delhi High Court’s recent decision in F. Hoffmann-La Roche Ag & Anr v. Natco Pharma Limited (“Roche v. Natco”) [1] is a significant development in India’s pharmaceutical patent jurisprudence, particularly for innovation-driven pharmaceutical investment and enforcement certainty. In 2024, F. Hoffmann-La Roche AG (“Roche”) filed a suit against Natco Pharma Limited (“Natco”) to prevent the launch of a generic version of the active pharmaceutical ingredient called Risdiplam (marketed by Roche under the brand name Evrysdi) [2]. Roche asserted that Risdiplam is a novel chemical entity, and not a mere extension or modification of any earlier compounds, that is protected by patents in over 80 jurisdictions [3], and the only oral treatment for spinal muscular atrophy (“SMA”), a rare genetic disorder which causes progressive muscle weakness and severe respiratory difficulties. Roche argued that it has made significant investments in research and development, including extensive global clinical trials, reflecting the high-risk, capital-intensive nature of rare-disease innovation, and that Natco’s proposed generic would infringe its exclusive patent rights.

Natco, however, challenged Roche’s species patent on multiple grounds, alleging evergreening, contending that Roche had already patented the same invention under the International Genus Patent WO’916 [4] (“IGP WO”), thereby Roche was attempting an unlawful extension of monopoly through a species patent, which did not constitute a novel invention but rather a reassertion of the genus patent in the Indian context. Natco argued that the patent lacked novelty and inventive step under Sections 64(1)(e) and (f) of the Patents Act (“the Act”), pointing to prior art including the genus patent, and further alleged violation of Section 8 of the Act, non-disclosure of information pertaining to foreign applications. Intervening SMA patients highlighted the prohibitive annual cost of Risdiplam (where a single bottle can cost ₹6.2 lakh and the annual treatment can cost ₹1.48 crore), arguing that public interest and accessibility must prevail over Roche’s exclusive patent rights.

In March 2025, the Single Judge Bench of the Delhi High Court order [5], refused Roche’s plea for an interim injunction relief, holding that Natco had raised a credible challenge to the patent’s validity for Risdiplam. The Court reaffirmed that the mere patent grant does not create a presumption of validity, especially where questions of novelty and inventive step arise. Natco’s contention that Risdiplam was anticipated or rendered obvious by Roche’s earlier IGP WO was found prima facie persuasive. The Court noted that both patents shared nitrogen-based heterocyclic structures, indicating substantial overlap between the genus disclosure and the claimed species compound. In this light, Risdiplam appeared to be an obvious modification within the broad Markush framework of the genus disclosure.

The Court emphasized that patent law cannot operate in isolation from human realities. In the context of life-saving drugs, accessibility and affordability are integral components of the public interest test. Roche’s high pricing was viewed as tipping the balance of convenience towards wider patient access, particularly at the interim stage, especially since allowing Natco’s generics launch would expand SMA treatment options without causing Roche irreparable harm. The Court therefore refused interim relief, holding that questions of validity and infringement should be resolved at trial rather than through interlocutory relief, preserving final adjudication on merits.

On appeal, the Division Bench of the Delhi High Court re-evaluated the question of inventive step using the “person in the know” test put forth in the Division Bench judgement of AstraZeneca AB v. Intas Pharmaceuticals Ltd. [6], finding that when the same inventors create both the genus and species patents, the standard person-skilled-in-the-art test must be replaced by the perspective of someone already familiar with the prior patent disclosure, along with its technical scope. For such inventors, modifications that may not appear obvious to an ordinary skilled person can be self-evident extensions of prior work.

Applying this reasoning, the Court noted that several inventors common to Roche’s IGP WO and the Indian species patent for Risdiplam were already acquainted with Compound 809 disclosed in the earlier patent. It held that these inventors, seeking a compound with Risdiplam’s therapeutic properties, would logically substitute a nitrogen (-N) for a carbon-hydrogen (-CH) group in Compound 809. The species patent was therefore considered an obvious derivative of the genus disclosure rather than a distinct inventive step.

On 9th October 2025, the Division Bench affirmed the refusal of interim relief, and the Supreme Court declined to intervene, thereby reinforcing judicial deference to reasoned patent adjudication at the interim stage, enabling Natco to proceed with its generic product launch. The underlying dispute relating to patent validity and alleged infringement remains sub judice pending final adjudication.

Why is this dispute of broader importance?

This dispute has yet again sparked discussion on the high-cost of patented medicines, simultaneously highlighting the importance of legal certainty for pharmaceutical innovators. It underlines the continuous tug in India’s pharmaceutical jurisprudence between patent protection as a driver of innovation and the imperative to ensure affordable access to life-saving medicines. Following the landmark Novartis AG v. Union of India [7] decision, which tightened patentability standards under Section 3(d) of the Act and reaffirmed India’s public-health-oriented intellectual property (“IP”) framework, cases like Roche v. Natco continue to probe how far the law can reconcile exclusivity with accessibility without undermining incentives for research and development. Natco, as a recurrent party in several high-profile patent disputes, has significantly influenced Indian jurisprudence on Trade-Related Aspects of Intellectual Property Rights (“TRIPS”) compliance, evergreening, compulsory licensing, and generic drug entry, thereby shaping business strategies in the pharmaceutical sector.

From Exclusivity to Equity: Mapping the Judicial Approach to Patents

A consistent judicial philosophy has emerged in India’s patent jurisprudence, one that seeks to calibrate, rather than dilute, patent exclusivity with the imperatives of public health and equitable access. Courts have consistently ruled that genuine innovation deserves protection; however, this protection cannot extend to cover minor modifications that fail to demonstrate meaningful therapeutic benefit. It also cannot be enforced in a way that makes life-saving medicines inaccessible. This balanced approach combines legal requirements, TRIPS obligations, and the constitutional goal of social welfare, contributing to a predictable and rule-based patent regime.

Roche v. Cipla [8], involved Roche’s Erlotinib Hydrochloride (marketed as Tarceva) for lung cancer treatment against Cipla’s generic (marketed as Erlocip). The Single Judge Bench held after expert consultation that Roche’s patent covered a mixture of Polymorphs A and B, whereas Cipla’s product contained only Polymorph B [9]. Since Roche’s separate application for Polymorph B had been rejected under Section 3(d) of the Act for lack of enhanced efficacy, no infringement was found. On appeal, the Division Bench held the claim was broad enough to encompass all polymorphic forms, including Polymorph B and thus found Cipla liable for infringement, but awarded only nominal damages of ₹5,00,000 and denied an injunction relief, citing public health considerations and the need to avoid disrupting access to an affordable cancer therapy for patients.

In Bayer v. Union of India [10], Bayer held a patent for Sorafenib Tosylate [11] (marketed as Nexavar), a liver and kidney cancer drug. After Bayer refused a voluntary license, Natco sought a compulsory license under Section 84(1) of the Act, offering a generic at fraction of the cost. Natco argued Bayer had not met public demand, had not priced the drug at a reasonably affordable price, and failed to adequately “work” the patent in India. The Controller of Patents granted the compulsory license, finding all statutory grounds satisfied; the Intellectual Property Appellate Board upheld the order, raising the royalty to 7% and the Bombay High Court affirmed. The courts stressed that TRIPS-compliant patent protection must be balanced with India’s public-health obligations, emphasizing that life-saving drugs must remain accessible and affordable.

Later compulsory license applications by BDR Pharmaceuticals International Private Limited (for Bristol-Myers Squibb Company’s cancer drug Dasatinib [12] in 2013) [13] and Lee Pharma Limited (for AstraZeneca India Private Limited’s diabetes drug Saxagliptin [14] in 2015) [15] were rejected for failing to meet statutory thresholds or show sufficient efforts at obtaining voluntary licenses, confirming that Indian courts employ compulsory licensing sparingly and only when patentees evidently neglect public interest.

In Novartis v. Union of India [16], the Supreme Court rejected Novartis’s patent application for the beta crystalline form of imatinib mesylate (marketed as Glivec) under Section 3(d) of the Act, holding it to be a new form of a known substance, without enhanced therapeutic efficacy. The decision preserved generic availability, significantly reducing treatment costs for Chronic Myeloid Leukemia (“CML”), enabling exports of affordable generics of imatinib mesylate across developing countries and benefiting an estimated half a million CML patients over five years. The judgement established Section 3(d) of the Act as a strong protection against evergreening and it reaffirmed India’s legislative intent to tie pharmaceutical patents to clear therapeutic advancement.

Government Initiatives for Affordable and Accessible Medicines

Making sure people can access essential medicines has been a key focus of India’s healthcare and regulatory system. An important instrument in this effort is the National List of Essential Medicines (“NLEM”), issued by the National Pharmaceutical Pricing Authority (“NPPA”). NLEM identifies medicines that address the population’s priority healthcare needs, using standards of efficacy, safety, and cost-effectiveness. It also provides the foundation for government purchasing, subsidy allocation, and price regulation under the Drugs (Prices Control) Order, 2013 (“DPCO”). The latest iteration, NLEM 2022 lists 384 drugs across 27 therapeutic categories, [17] underscoring the government’s commitment to ensuring affordability and continuous availability of critical drugs, primarily within the essential and generic medicines segment. In parallel, the NPPA exercises broad supervisory and price-regulatory powers, monitoring and fixing retail and ceiling prices for almost 4,500 drug formulations. [18] Through this oversight, coupled with the statutory mechanisms under the DPCO, the regulatory regime enables price ceiling, periodic price revisions, and market-linked adjustments.

Complementing these statutory mechanisms is the Jan Aushadhi Scheme, which runs through the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (“PMBJP”). The scheme makes it easier to afford quality generic medicines, offering them at prices 50 to 80% lower than branded options. As of June 2025, more than 16,000 Jan Aushadhi Kendras (“JAKs”) are operating across the country. This initiative provides wide-ranging treatment options for both urban and rural populations. The PMBJP product basket includes over 2,000 drugs and 300 surgical items, which further improves public access to affordable healthcare. [19]

Although these government initiatives have substantially improved access to essential and generic medicines, high-cost patented medicines continue to remain financially inaccessible for a significant section of patients. That said, there are specific mechanisms under present framework that exist to enable more affordable access to such patented medicines.

Mechanisms to Ensure Affordable Access to Patented Medicines

The Act enables wider access to patented medicines by allowing both voluntary licensing (Section 70) and compulsory licensing (Sections 84-92) when affordability or availability concerns arise. Meanwhile, Paragraph 19 of the DPCO grants the government the power to impose price controls on even non-scheduled drugs under extraordinary circumstances for public interest, for example to curb unreasonable pricing or maintain supply. Yet, the broad scope of “extraordinary circumstances” creates room for varied and inconsistent interpretation; misapplication of this discretion could undermine regulatory stability and deter pharmaceutical investments, making policy predictability a critical consideration for innovators and investors. While these mechanisms reflect a commitment to public access, the potential for ad-hoc intervention highlights the urgent need for a structured, transparent and balanced policy framework that ensures equitable access to life-saving patented treatments without compromising a favorable business environment for innovation and investment.

Towards a Patent Medicine Access Scheme

A dedicated, government subsidized scheme for high-cost patented medicines would serve as a logical extension of India’s public-health and IP-policy framework. This scheme could be modeled on the National Policy for Treatment of Rare Diseases, 2021 [20] (“NPTRD”), which establishes criteria for financial assistance and patient eligibility. Under the NPTRD, the government provides financial assistance up to ₹50 lakh per patient at designated Centres of Excellence, for diagnosis and treatment of rare diseases. [21]

Under this scheme, the government could maintain a registry of patients who require specific patented therapies, this would help improve transparency and efficiency. The government could negotiate bulk procurement or fixed pricing with patent holders to lower costs. Alternatively, the scheme could offer direct subsidies, limited subsidies, or insurance reimbursements for patients who qualify for patented medicines. This would apply whether the treatment is a one-time cure or a long-term treatment for rare or serious conditions. Eligibility criteria could focus on life-threatening or rare conditions, much like the NPTRD. Distribution could use existing infrastructures such as JAKs or hospital-based specialty pharmacies to ensure nationwide access.

This scheme could help balance affordability and innovation, allowing patent holders to recover their research and development costs, thereby maintaining incentives for innovation while also protecting public health. By combining negotiated pricing and targeted subsidies, the scheme could offer predictable, structured and equitable access to patented medicines.

Balancing Innovation and Access: Our Perspective

The trajectory of India’s pharmaceutical patent jurisprudence, illustrated most recently in Roche v. Natco, reflects a nuanced and pragmatic approach. Patents have a vital role in fostering innovation, but their enforcement must be carefully balanced with the needs of public health and equitable access. Courts have emphasized that patent exclusivity should not block access to life-saving treatments. However, over-reliance on access-driven outcomes at the expense of patent certainty could discourage investment and affect India’s attractiveness as a destination for pharmaceutical innovation. Furthermore, litigation-driven outcomes remain case-specific and reactive, highlighting the limitations of relying solely on litigation to resolve long-term access issues.

We believe that a proactive, government-facilitated scheme for patented medicines, complemented by existing initiatives such as NLEM, PMBJP, NPPA, NPTRD, and DPCO, represents a logical next step. In our view, this approach not only aligns with India’s constitutional and public health commitments [22] but also strengthens investor confidence by demonstrating that innovation and access can coexist within a stable, TRIPS-compliant framework.

References:

  1. 2025 SCC OnLine Del 6390.
  2. Indian Species Patent No. IN 334397 (valid until May 2035).
  3. https://www.roche.com/media/releases/med-cor-2022-05-31#:~:text=Evrysdi%20is%20approved%20in%2081%20countries.
  4. Genus Patent WO 2013/119916.
  5. 2025 SCC OnLine Del 1826/ 2025 DHC 1907.
  6. 2021 SCC Online Del 3746/ (2021) 87 PTC 374 (DB).
  7. 2013 6 SCC 1/ 2013 SCC OnLine SC 271.
  8. F. Hoffmann-La Roche Ltd. v. Cipla Ltd., 2015 SCC OnLine Del 13619.
  9. Patent Application Bearing No. IN 507/DEL.
  10. Bayer Corporation. v. Union of India, 2014 SCC OnLine Bom 963.
  11. Indian Patent No. IN. 215758.
  12. Indian Patent No. IN. 203937.
  13. Compulsory License Application (C.L.A.) No. 1 of 2013.
  14. Indian Patent No. IN 206543.
  15. Compulsory License Application (C.L.A.) No. 1 OF 2015.
  16. Novartis AG v. Union of India, (2013) 6 SCC 1.
  17. https://www.pib.gov.in/PressReleasePage.aspx?PRID=1858931#:~:text=384%20drugs%20have%20been%20included,categorized%20into%2027%20therapeutic%20categories.
  18. https://nppaipdms.gov.in/IMCS/hissso/loginLogin.imcs.
  19. https://janaushadhi.gov.in/pmbjb-scheme.
  20. https://rarediseases.mohfw.gov.in/uploads/Content/1624967837_Final-NPRD-2021.pdf https://cdnbbsr.s3waas.gov.in/s31177967c7957072da3dc1db4ceb30e7a/uploads/2023/05/2023051269.pdf.
  21. In Paschim Banga Khet v. State of West Bengal ((1996) 4 Supreme Court Cases 37), the Supreme Court noted the ‘constitutional obligation of the State to provide adequate medical services to the people to preserve human life’. In Mohd. Ahmed (Minor) v. Union of India (2014 SCC OnLine Del 1508), the Delhi High Court has observed that the ‘core obligations under the right to health are non-derogable’.
  22. https://mohfw.gov.in/sites/default/files/9147562941489753121.pdf.

Authors:

Taskeen Pirani, Associate Partner

Sohail Vij, Trainee Associate

Disclaimer:

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.