DHC reaffirms “Access to Medicine” to be prioritised and restrains “Evergreening”
Decided on: March 24, 2025
Coram: Mini Pushkarna
Citation: 2025 SCC OnLine Del 1826
Introduction
The Delhi High Court recently delivered a critical judgment highlighting significant developments in India’s patent jurisprudence, especially in pharmaceutical patents. This case is concerned with a patent infringement suit over a species patent for a drug calledRISDIPLAM and marketed in India by the brand name of EVRYSDI, which is an approved oral drug for the treatment of SMA (Spinal Muscular Atrophy), a rare and life-threatening neuro-muscular disease.
The dispute began when the Roche “plaintiff” sought an interim injunction to prevent patent infringement against the Natco “defendant” for developing and manufacturing a generic version of the medicine. Roche also claimed patent validity till 2035, and an unopposed patent was granted in more than 60 jurisdictions. On the other hand, Natco, the “defendant”, challenged plaintiff’s patent validity on multiple grounds under Section 64 of the Patents Act, highlighting obviousness and lack of inventive step in plaintiff’s patent claim.
In this case, the Court tried to balance the competing interests of rewarding innovations and the right to accessible healthcare. The Court considered Natco’s claims a credible challenge against Roche’s patent and refused any interim relief.
Facts of the case
The disputed patent suit “IN’397”, which is a species patent for RISDIPLAM medicine, used for treating SMA (Spinal Muscular Atrophy), was filed by the plaintiff company “Roche” in 2015. The patent was granted in 2020 with a validity till 2035 with corresponding patents in over 60 jurisdictions, including the USA, Canada, and Australia.
The plaintiff company discovered that Natco has listed RISDIPLAM as an “Active pharmaceutical ingredient under development” on their website. They have already filed a patent application for “Improved process for preparation of Risdiplam” in 2022, following which the plaintiff “Roche” filed this suit for infringement, seeking an interim injunction to restrain the defendant “Natco”.
The plaintiff company argued that RISDIPLAM is a clearly new compound which involved rigorous and costly research & development. And it is not covered under WO’916, which is a genus patent. At the same time, the defendant claimed that RISDIPLAM is already covered under WO’916 and made allegations that the plaintiff is trying to indulge in evergreening by claiming RISDIPLAM to be a new compound, especially when their patent claim carries obviousness and lacks any inventive step. Defendant also argued that under Indian laws, Patents lack any presumptive validity and raised concerns regarding the unaffordability of Roche’s drug and the inaccessibility of their patient support programme.
Court Analysis
Justice Mini Pushkarna of the Delhi High Court dismissed the plea for an interim injunction, considering the defendant’s challenges against the patent “IN’397” to be credible, and made several significant observations that have broad implications for the pharmaceutical industry.
The Court observed that under Indian law, at an interim stage of a dispute, a patent already granted is not presumed valid or invalid; the defendant is required only to make a credible challenge to the patent, not to prove patent invalidity. Thus, any interim relief the plaintiff claims is not an automatic right.
The Court noted that the defendant company created a credible challenge about RISDIPLAMbeing covered by the prior genus patent WO’916, the plaintiff failed to prove their invented compound to have enhanced efficacy over the genus disclosure and also couldn’t establish novelty or any enhanced effects in their species patent. Hence, the development in the genus structure of RISDIPLAM appeared obvious to a person skilled in the art, which raised doubts about any inventive steps involved.
While considering the public interest, the Court highlighted the importance of access to affordable medicines and noted that RISDIPLAM costs around Rs. 1.48 cr. annually and opined that the patient support programme by Roche is available to a minimal number of patients only.
The Court didn’t find Roche to have established a strong prima facie case; the Court dismissed the plea for any interim injunction, observing that Roche can be compensated in future, but patients would suffer irreparable harm if Natco is restrained, which will result in a lack of access to medicine for SMA patients.
How the judgment impacts IP law in India
This ruling reinforces the well-settled principles of intellectual property law in India, which state that public health or interest outweighs monopoly IP rights for pharmaceutical companies, prioritising patients’ rights in rare diseases and aligning well with our values of the Indian Constitution.
This judgment reiterated that it is possible to challenge the patents already granted in India. They do not have any presumed validity and may require one to prove a genuine inventive step. The Court reaffirmed that patents cannot be exclusive only on grounds of coverage; instead, there must be a clear disclosure for a species patent. Thus, this judgment stands against and discourages evergreening attempts by companies that file multiple overlapping patents to maintain exclusivity and monopoly. The stand taken by the Court signals that IP rights in India operate under a constitutional framework, where incentives for innovation are kept in balance with the public interests.
Conclusion
The Delhi High Court, acknowledging the seriousness of any credible challenges to the validity of a patent, did not allow any interim injunction to the plaintiff and prioritised public interest over the claim for monopoly. In this ruling, the Court reaffirmed the right of access to medicines, aligning with the constitutional values in the patent jurisprudence followed in India, alongside balancing innovation incentives for such cases in future.
Author: Akshi Seem, Associate partner