Roche setback in Delhi HC paves way for cheaper spinal muscular atrophy (SMA) drug
NEW DELHI: Delhi High Court division bench has dismissed Swiss major Roche ’s appeal seeking to restrain Hyderabad-based Natco from launching a generic version of Risdiplam , paving the way for the drug’s potential entry at a fraction of the multinational’s price.
The bench comprising Justices C Hari Shankar and Ajay Digpaul on Thursday upheld the single judge’s order of March this year, reaffirming public health must take precedence over monopolistic practices and evergreening, sources told TOI.
The verdict could have far-reaching implications for patient access to high-cost treatments for rare diseases in India.
Sources said that Roche is planning to appeal the order.
Citing public interest, the single bench order had denied Roche an injunction against Natco, stating ``In a patent suit, public interest in terms of availability and accessibility of the drug, is a relevant factor to grant or to refuse the injunction. The price under Roche‟s Patient Support Program in India, is also unaffordable’’.
Roche’s Risdiplam marketed as Evrysdi, the only oral medication for spinal muscular atrophy (SMA) in India, is priced around Rs 6.2 lakh per bottle, taking up the therapy cost to over Rs 1 crore in certain patients. SMA, is a life-threatening, progressive genetic disease, for which medication is to be taken lifelong, the cost makes it unaffordable to most families. As against this, Natco’s generic version is expected to cost around Rs 16,000 per bottle, substantially slashing the price by as much as 97%.
When contacted, a Roche Pharma India spokesperson said ``We are extremely disappointed with this development and are considering our options within the scope of the Indian law. Roche is committed to protecting its innovation. IP protection is a cornerstone for any pharmaceutical innovation. We believe that strong IP protection, including patents, is essential for innovation to thrive in India, drive access to innovative treatments that address the healthcare challenges we face today, and is a critical lever for Viksit Bharat’’.
Roche had filed the case in 2024 after it learnt about Natco’s plans to launch a generic version. The drug’s patent will expire on May 11, 2035.
Subhatosh Majumdar of S Majumdar & Co, the law firm which represented Natco, said ‘’The decision by the Division Bench in dismissing the appeal by Roche from the interim order of the single judge is a landmark in patent jurisprudence in India. There is also public interest involved given that the drug, Risdiplam, is used to treat spinal muscular atrophy’’.
Natco had told the court that it intends to make the product available at a price that is nearly 80-90% lesser than the plaintiffs’ price. It also said that Roche is resorting to ``evergreening and unlawful patent term extension in India''.
``The Court ought to balance the public interest, and the constitutionally protected right to health of patients and balance them against the exorbitant price of the drug. The drug is not accessible or affordable to regular patients and the plaintiffs (Roche) have failed to make the drug accessible and affordable. When a big gap exists in the price of the plaintiffs’ drugs and the defendant’s drugs, balance of convenience will be in favour of the defendant, subject to the defendant establishing a credible challenge to the validity of the patent’’, the March order says.
Further , the Roche spokesperson added: “Since the launch of Evrysdi in 2021, Roche has been actively collaborating with local authorities in India to implement tailored pricing solutions to ensure long-term equitable access. About 300 SMA patients have benefitted from Evrysdi in India since its launch.
The bench comprising Justices C Hari Shankar and Ajay Digpaul on Thursday upheld the single judge’s order of March this year, reaffirming public health must take precedence over monopolistic practices and evergreening, sources told TOI.
The verdict could have far-reaching implications for patient access to high-cost treatments for rare diseases in India.
Sources said that Roche is planning to appeal the order.
Citing public interest, the single bench order had denied Roche an injunction against Natco, stating ``In a patent suit, public interest in terms of availability and accessibility of the drug, is a relevant factor to grant or to refuse the injunction. The price under Roche‟s Patient Support Program in India, is also unaffordable’’.
Roche’s Risdiplam marketed as Evrysdi, the only oral medication for spinal muscular atrophy (SMA) in India, is priced around Rs 6.2 lakh per bottle, taking up the therapy cost to over Rs 1 crore in certain patients. SMA, is a life-threatening, progressive genetic disease, for which medication is to be taken lifelong, the cost makes it unaffordable to most families. As against this, Natco’s generic version is expected to cost around Rs 16,000 per bottle, substantially slashing the price by as much as 97%.
When contacted, a Roche Pharma India spokesperson said ``We are extremely disappointed with this development and are considering our options within the scope of the Indian law. Roche is committed to protecting its innovation. IP protection is a cornerstone for any pharmaceutical innovation. We believe that strong IP protection, including patents, is essential for innovation to thrive in India, drive access to innovative treatments that address the healthcare challenges we face today, and is a critical lever for Viksit Bharat’’.
Roche had filed the case in 2024 after it learnt about Natco’s plans to launch a generic version. The drug’s patent will expire on May 11, 2035.
Subhatosh Majumdar of S Majumdar & Co, the law firm which represented Natco, said ‘’The decision by the Division Bench in dismissing the appeal by Roche from the interim order of the single judge is a landmark in patent jurisprudence in India. There is also public interest involved given that the drug, Risdiplam, is used to treat spinal muscular atrophy’’.
Natco had told the court that it intends to make the product available at a price that is nearly 80-90% lesser than the plaintiffs’ price. It also said that Roche is resorting to ``evergreening and unlawful patent term extension in India''.
``The Court ought to balance the public interest, and the constitutionally protected right to health of patients and balance them against the exorbitant price of the drug. The drug is not accessible or affordable to regular patients and the plaintiffs (Roche) have failed to make the drug accessible and affordable. When a big gap exists in the price of the plaintiffs’ drugs and the defendant’s drugs, balance of convenience will be in favour of the defendant, subject to the defendant establishing a credible challenge to the validity of the patent’’, the March order says.
Further , the Roche spokesperson added: “Since the launch of Evrysdi in 2021, Roche has been actively collaborating with local authorities in India to implement tailored pricing solutions to ensure long-term equitable access. About 300 SMA patients have benefitted from Evrysdi in India since its launch.
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