TWN Info Service on Health Issues (Mar25/04)
26 March 2025
Third World Network

IP: Delhi High Court clears path for generic risdiplam availability in India

New Delhi, 26 March (Chetali Rao and K M Gopakumar) – The Delhi High Court’s judgment decision of 24 March 2025 paves the way for the introduction of generic risdiplam, offering a potentially more affordable treatment for a rare disease called Spinal Muscular Atrophy (SMA).

The Delhi High Court rejected Roche’s plea for  an interim injunction against Natco Pharma Limited for alleged infringement of its patent (IN334397) in the case of F. Hoffmann-La Roche AG & Anr. vs Natco Pharma Limited (CS(COMM) 567/2024).

The law suit of Roche revolves around the drug risdiplam (marketed as Evrysdi^@) which is critical for the treatment of SMA. Roche claimed that Natco’s activities mentioning risdiplam manufacturing as “under development” infringed its species patent. The court denied the injunction, citing multiple factors including prime facie validity but also kept public interest and balance of convenience at the heart of its judgement.

[In patent law, “species” refer to specific embodiments or variations of an invention within a broader genus or category.]

The Court’s refusal to grant an interim judgement against Natco reflects a balancing act between intellectual property (IP) claims and the broader societal needs for affordable access to life saving drugs.

SMA is a rare genetic neuromuscular disorder, for which there are currently only three treatment options available. Two of these Zolgensma^@ and Spinraza^@ are exorbitantly priced and not registered in India. Risdiplam on the other hand is an oral prescription medicine for SMA patients aged two months and older.

India has an immense burden of both diagnosed and undiagnosed SMA patients. A study indicates an SMA carrier frequency of 1 in 38 within a cohort with no prior positive family history. This suggests that a significant number of persons living with SMA may remain undiagnosed and may tragically die. The potential of underdiagnosis raises the possibility that India has a far greater population of SMA patients than currently recognized.

The high cost of drugs for SMA significantly hinders accessibility and affordability in India. Roche's exorbitant pricing of risdiplam at INR6.2 lakh (USD 7,227) per bottle continues to be a major barrier, limiting access to this vital medication for SMA patients. For patients weighing under 20 kg, one bottle is required each month; those above 20 kg may need up to three bottles per month, pegging the overall price for a month’s treatment to approximately INR18 lakh  (USD 21,861) per month, making the treatment unaffordable.

Public Interest

The judgment lays a significant emphasis on public interest over patent rights, particularly in the context of rare diseases like SMA. Since early 2021, Indian courts have been hearing cases on SMA with a focus on generic or indigenous production and increasing competition. The court acknowledged the exorbitant cost of Roche’s imported drug versus the potentially lower cost of Natco’s generic version. The drug is under development, but would eventually be 80-90% cheaper than Roche’s Evrysdi^@. The stark difference between the originator and generic prices version is a critical factor to ensure affordability and accessibility of drugs like Risdiplam in India.

In this case, the court allowed two interveners – both patients suffering from SMA to make submissions on the aspect of "public interest involved”. The court also noted that the spirit of considering public interest while granting injunctions is well established in the country’s legal jurisprudence. The court aligned with cases like F. Hoffmann-La Roche Ltd. vs. Cipla Ltd.  where access to affordable cancer drugs outweighed patentee rights, emphasizing that SMA patients’ right to life-saving treatment supersedes commercial monopolies at the interim stage. This nuanced approach clearly indicated that the court was cognizant of the need for affordable generic medicines.

The Court opined (paragraph 107) that “in relation to pharmaceuticals, which not just borders on the public good, but brings about the foremost good of the public, i.e. health, is not something that should be dealt with lightly. A drug which is the only one available for treatment in India, for a rare disease, its availability to the public at large at very economical and competitive prices, is a material factor which a Court will consider at the time of dealing with an application for interim injunction. Besides, the plaintiffs can be compensated by way of damages. However, there exists no right for the public to lessen or compensate itself”.

National Policy for Rare Diseases (NPRD): Shortfall to Address the Needs of People Living With Rare Diseases

The judgment also referenced to India’s NPRD which provides financial assistance of INR 50 lakh to patients suffering from rare disease. A total number of only 1,118 patients suffering from rare diseases, in 63 categories, have benefitted under the said policy. However, the court opined that while risdiplam offers a critical treatment option for SMA patients, the financial assistance provided under the policy was insufficient to cover the significant expenses associated with this medication, leaving many patients unable to access the treatment they require.

The ruling thus opens the door for a generic version of risdiplam, which if  priced at 80-90%  lower and made available through the NPRD, could extend the treatment coverage for patients for approximately 13-14 years, a significant improvement over the current policy limitations.  

The court encapsulated the judgment in the case of Union of India and Others Versus Seba P.A. and Others in which the Government of India had voiced its concerns about the financial burden of providing economic assistance to persons suffering from rare diseases, and the Supreme Court in its order dated 24^th February, 2025 in that case where the court instructed the Government to engage with companies that manufacture drugs for SMA, aiming to facilitate more affordable treatment options for patients suffering from this disease.

These clearly reinforces the judiciary’s reluctance to stifle generic manufacturers like Natco, whose entry could alleviate this burden by offering cheaper alternatives. The court noted that the importation-based model of Roche and the intent to “monetize” the drug tilted the balance of convenience in favour of Natco, whose generic production could serve public needs more effectively. This reflects a pragmatic stance on ensuring drug supply over protecting excessive profit margins. Thus, the court concluded that the balance of convenience was granted against Roche.

Genus vs. Species

The case also covered a central issue of the relationship between an International Genus (WO’916) and the Indian “species patent” IN 334397 (IN’397).

[WO refers to patent application filed with the World Intellectual Property Organization while IN refers to applications at the India patent office.]

Roche argued that the genus patent WO’916 did not specifically disclose risdiplam. The species patent IN’397 was an old patent filed in 2016 (with a priority year of 2014) and was granted in 2020. IN’397 claimed risdiplam, a specific compound derived from the genus. Roche asserted its novelty and non-obviousness and also that it had been granted an INN designation and patent grants in more than 60 countries.

Natco challenged the validity of Roche’s patent for risdiplam, arguing that the drug was already covered in WO’916 and its corresponding US patent. Natco stated that both the genus patent WO’916 and species patent IN’397 related to compounds for the treatment of SMA. Natco also claimed that Roche had resorted to patent evergreening and unlawful Patent Term Extension (PTE) in India. It further contended that all statements made by Roche in any jurisdictions including PTE applications were relevant for the assessment of the patentability of the species patent.

The court examined the claim under Sections 64(1)(e) (anticipation by prior publication), 64(1)(f) (obviousness) and 64(1)(j) (misrepresentation) of the Indian Patents Act and found  Natco’s challenge credible enough to question the species patent’s distinctiveness.

[Genus-species patent applications are commonly found in the field of pharmaceutical domain. In patent claims, the relationship between genus and species is hierarchical, with genus representing a broader category and species being more specific examples within that category. The US Patent and Trademark Office’s Manual of Patent Examining Procedure (MPEP 806.04) states: “Where an application includes claims to different species, the claims may be limited to a single disclosed embodiment (i.e., a single species, and thus be designated a specific species claim), or may be generic to a plurality of disclosed embodiments (i.e., a generic or genus claim”.]

During the pendency of the case, Roche had sued Natco in the United States, alleging Natco’s risdiplam has infringed both the US genus US’955/WO’916) and species patent (US’754). The court came down on Roche saying that it “… had misrepresented and made material suppression before the Patent Office with respect to the International Genus Patent”. The court noted that in the ‟admissions towards the coverage of WO”916/US‟955 extending to Risdiplam and claiming infringement of the US Genus Patent, the plaintiffs have put themselves in a position of the Species Patent being susceptible to invalidity. Risdiplam cannot enjoy any protection in a later filed Species Patent, whose novelty is destroyed by the plaintiffs own prior published genus patent family”.  

Judicial-established precedents clearly elucidate that a species patent should not be granted if the prior art already disclosed the species patent. The court observed that “… the intent of the plaintiffs is to monetize the said invention, and in such cases if the plaintiffs succeed, monetary damages are adequate compensation, and interim injunction should not be granted in such cases. The drug is not accessible or affordable to regular patients and the plaintiffs have failed to make the drug accessible and affordable”.

CSO and Patients Welcome the Judgment

Seba P.A and Purva Mittal, two young women battling SMA, had intervened in the case to highlight the urgent need for the court to consider their right to life in the matter and the significant negative impact an injunction could have on access to the drug Risdiplam, given the price disparity between the patented drug and the anticipated low cost of generic versions.

Seba said, “This gives me hope. I believe that the court’s decision will provide relief to SMA patients in our country. I welcome this decision and urge Natco Pharma to supply the generic drug without delay, at a price accessible to patients. I also call on the Ministry of Health, which implements the National Policy for Rare Diseases, to ensure that the life-saving drug reaches all SMA patients in need”.

Echoing similar sentiments, Purva Mittal who has been living with SMA said, “While effective therapies such as risdiplam have been proven to save lives and improve quality of life, their prohibitive costs have kept them out of reach for many patients. We hope this judgement will pave the way for affordable access for SMA patients".

Seba’s lawyer, Mr. Anand Grover, welcomed the Delhi High Court’s ruling, emphasizing that it will prevent many unnecessary SMA-related deaths. He noted that in pharmaceutical patent enforcement cases, public health considerations must take precedence.

Rajeswari Hariharan who appeared for Purva Mittal hailed the judgment saying that the reasoning of the court will go a long way in facilitating affordable access to medicines for rare diseases.

The 24 March judgment marks a significant judicial shift towards interpreting patent disputes through a socio-economic perspective, particularly in the context of rare diseases where treatment costs are prohibitively high. The judgment also marks a step towards a reshaping of the landscape of rare diseases in India. While the government policy has struggled to ensure the accessibility of such drugs, judicial decisions like these can set the precedent for paving the way for generic entry and access to affordable treatments.  

At the time of writing Roche has approached the Division Bench against the decision and the Division Bench will hear the appeal today (26 March).+