Summary
In a landmark case, the Delhi High Court denied Roche's plea to restrain Natco from producing a generic version of Risdiplam, prioritizing public health and drug affordability. The ruling scrutinized the novelty of Roche’s patent and emphasized that monetary damages could suffice if Roche later prevails. The case reflects the growing tension between patent enforcement and healthcare access in India.
The Delhi High Court, in a significant ruling dated March 24th, 2024, rejected the interim injunction application of F Hoffmann-La Roche AG (“Roche”) against Natco Pharma Ltd. (“Natco”), over the unauthorised manufacturing of Risdiplam, an oral drug for the treatment of Spinal Muscular Atrophy (SMA). The Court held that public interest outweighs the need for an injunction, as Risdiplam is the only approved treatment for SMA in India and remains unaffordable for most patients.
Background
SMA is a rare neuromuscular disorder, which affects approximately 1 in 7,744 live births in India. Risdiplam, developed and marketed by Roche under the brand name Evrysdi, is the only oral drug for the treatment of SMA. However, with an annual cost ranging from ₹2.2 million to ₹7.2 million, the drug remains out of reach for most patients.
Risdiplam is protected under Indian patent IN 334397, titled “Compounds for Treating Spinal Muscular Atrophy” (hereafter referred to as “suit patent”), valid until May 11, 2035. Due to the drug’s prohibitive cost and limited accessibility, patients, advocacy groups, and lawmakers have been calling for a more affordable generic alternative.
Roche filed a patent infringement suit against Natco, which had included Risdiplam in its pipeline of active pharmaceutical ingredients (APIs) under development. Natco had also filed a patent application (IN 202241055182) for an improved synthesis process of the drug. Alleging that Natco’s activities infringed its patent, Roche sought an interim injunction to restrain Natco from initiating production of the drug.
In response, Natco challenged the validity of the suit patent on multiple grounds, including anticipation by prior publication [Section 64(1)(e)], obviousness [Section 64(1)(f)] and misrepresentation [Section 64(1)(j)] based on Roche’s international genus patent (WO 2013/119916 A2 or WO’916) and its US counterpart (US Patent No. 9,586,955 or US’955).
Two SMA patients, Purva Mittal and Seba P. A, intervened in the case, arguing for affordable access to treatment.
Hoffmann-La Roche’s Arguments
Roche argued that Natco had effectively admitted infringement by acknowledging their plans to launch Risdiplam, which alone is sufficient to warrant an injunction. They asserted that the suit patent enjoys a strong presumption of validity and has remained unchallenged in over 60 jurisdictions. They also submitted that both the Indian Patent Office (IPO) and the International Search Authority (ISA) have confirmed the novelty and non-obviousness of the suit patent over the genus patent, which does not explicitly disclose Risdiplam.
Roche clarified that its patent term extensions (PTEs) in foreign jurisdictions did not amount to an admission that the genus patent specifically disclosed Risdiplam. They also highlighted the global coexistence of genus and species patents to reinforce the independent patentability of Risdiplam.
Further, Roche underscored the need for a fair balance between pharmaceutical innovation and affordability, highlighting their R&D investments and clinical trials to bring Risdiplam to market, while Natco had made no such contributions. They accused Natco of being a habitual infringer and warned that permitting generic competition by denying patent protection would discourage research for developing life-saving treatments. They claimed that their Patient Assistance Program and discounts to the Indian government had benefited many SMA patients in India.
Roche urged the Court to grant an injunction, arguing that allowing Natco’s generic version would undermine drug development for rare diseases.
Contentions by Natco Pharma
Natco argued that the genus patent (WO’916) had fairly disclosed Risdiplam’s structure and that minor modifications would have been routine for a skilled person, rendering the suit patent obvious.
Natco also pointed out that Roche had filed a patent infringement suit in the U.S. against them under the U.S. genus patent (US’955), effectively admitting that it covered Risdiplam. They contended that if Roche could enforce its genus patent abroad, the same genus patent should serve as prior art to invalidate the suit patent in India. Furthermore, they pointed out that Roche had obtained a PTE in the U.S. by admitting that Risdiplam originated from the genus patent, which contradicted its stance in India.
Natco further argued that a species patent cannot be granted unless it demonstrates significant technical advancement, which Roche had failed to establish. They accused Roche of misrepresenting and suppressing material facts before the IPO regarding the genus patent. Since Roche never filed a genus patent in India, Natco argued that Risdiplam had already entered the public domain before the suit patent was filed.
Additionally, Natco alleged that Roche had not adequately worked the patent in India, as it was only importing Risdiplam instead of manufacturing it locally. In contrast, Natco intended to manufacture the drug domestically, ensuring greater accessibility. They asserted that since Roche prioritized monetization over accessibility, any potential infringement could be compensated through monetary damages, negating the need for an injunction.
Finally, Natco highlighted the massive price difference between Roche’s Risdiplam and the proposed generic version, arguing that public interest and the balance of convenience favoured the generic drug. They contended that restricting access to an affordable alternative solely to uphold Roche’s patent monopoly would undermine India’s public health priorities.
Submissions by the intervenors
The intervenors emphasized the urgent need for affordable access to Risdiplam and urged the Court to consider public interest over patent enforcement. They pointed out that Roche’s Patient Assistance Program had benefited only 75 patients in India and the drug remained unaffordable despite discounts. They maintained that generic competition would significantly reduce drug prices and improve accessibility and pleaded the Court to balance public interest and the right to health against Roche’s patent rights to ensure affordable treatment in India.
Analysis and Findings by the Court
Anticipation by prior publication
The Court determined that the key issue was whether Risdiplam was disclosed in the genus patent, which Natco cited as prior art. Citing legal precedents, the Court stated that disclosure can be implicit or inherent and need not always be explicit. As per the Court, even implicit disclosure in prior art can invalidate a patent and observed that Natco has raised a credible challenge regarding the anticipation by prior publication.
The Court further stated that Roche cannot selectively adopt different legal positions across different jurisdictions to suit their convenience. Roche enforced the US genus patent against Natco in the U.S., claiming that Risdiplam was covered under it, while in India, Roche argued that the genus patent did not explicitly disclose Risdiplam to defend the suit patent. The Court noted that this contradiction weakened Roche’s novelty claim and raised serious doubts about the suit patent’s validity.
The Court observed that Roche had secured Patent Term Extensions (PTEs) in the U.S. and Australia by linking Risdiplam to the genus patent. Based on its analysis, the Court concluded that Natco had made a prima facie credible challenge to the validity of the suit patent on grounds of anticipation by prior publication.
Inventive step
While addressing inventive step, the Court noted that at least four inventors were common between the international genus and the suit patent. The Court stated that in such cases, the test for obviousness should be from point of view of ‘person in the know’, and not in the context of ‘person ordinarily skilled in the art’. The key question, the Court stated, is whether the inventor, at the time of drafting the genus patent, was already aware of the invention later claimed in the suit (species) patent.
Applying the ‘person in the know’ standard, the Court analysed whether Risdiplam was an obvious modification of Compound 809 in the genus patent. The Court observed that the key difference between Risdiplam and Compound 809 in the genus patent was the substitution of a Carbon-Hydrogen (CH) group with a Nitrogen (N) atom. Given that Nitrogen and CH are bioisosteres, commonly interchanged in medicinal chemistry, this modification was deemed routine optimization rather than an inventive step. The Court stated that Natco had made a prima facie case for obviousness, making the suit patent vulnerable to revocation based on lack of inventive step.
Aspect of Balance of Convenience and Irreparable Damage
The Court noted that Roche imports Risdiplam into India, while Natco intends to manufacture the drug domestically at 80-90% lower costs. The Court also found that Roche’s Patient Assistance Program benefitted only a small fraction of patients and failed to address broader affordability concerns. Given the stark price difference, the Court asserted that permitting Natco to sell its generic version of the drug would benefit more SMA patients. The Court observed that Roche’s losses, if any, could be compensated with damages, whereas denying generic competition would deprive patients of a life-saving treatment.
Public Interest
Recognizing SMA as a debilitating, incurable disease, the Court prioritized public health over patent enforcement. The Court stated that since Risdiplam is the only approved treatment in India but remains largely unaffordable, permitting Natco’s lower-cost version would better serve public interest.
Conclusion
The Court rejected Roche’s request for injunction, ruling that Natco had prima facie raised a credible challenge to the validity of the suit patent. It observed that if Roche ultimately prevails at trial, Natco would be liable to compensate for any resulting damages. To ensure compliance, the Court directed Natco to submit details of its assets within four weeks and maintain comprehensive records of manufacturing, sales, and supply, with quarterly and annual financial disclosures. Consequently, the Court dismissed Roche’s application.
However, on March 26, 2025, a Division Bench of the Delhi High Court restrained Natco from launching its generic version of Risdiplam until the next hearing on April 2.
Citation: F. Hoffmann-La Roche Ag & Anr. vs Natco Pharma Limited, CS(COMM) 567/2024 & I.A. 33088/2024, I.A. 44310/2024, I.A. 44384/2024 (H.C. Delhi March 24, 2025). Available at: https://indiankanoon.org/doc/26602359/
Article Review: Dr. Kalyan Kankanala
Accessibility Review: Rakesh Krishnan
