New Delhi: Once again, the Supreme Court has shown that affordability always wins over profits, as it has refused to interfere with the Delhi High Court’s interim order restraining Natco Pharma from producing a copycat generic version of Swiss drug maker Roche’s Risdiplam. This is the latest development in the long-running legal tussle between the two companies, where Roche has accused Natco of infringing on its patent to treat Spinal Muscular Atrophy(SMA), a rare disorder that affects about 1 in every 7,744 live births in India.
Roche has developed, and marketed the drug under the brand name Evrysdi, the only oral drug for the treatment of this disease. However, the drug remains out of reach for most Indians, with a price of about ₹6 lakh per bottle . Hyderabad-based Natco pharma’s proposed version, on the other hand, is priced at ₹15,900 per bottle, reducing the treatment costs by upwards of ₹5 lakh.
The Swiss firm argues that it holds a genus patent for Risdiplam, meaning it encompasses related inventions, and not just a specific one. They have asserted that they hold the patent unchallenged in over 60 jurisdictions, and both the Indian Patent Office (IPO) and the International Search Authority (ISA) have acknowledged the novelty and non-obviousness of its genus patent, though not explicitly mentioning Risdiplam.
Natco has countered this by questioning Roche’s claims about the novelty and non-obviousness of the drug, saying that the US patent infringement suits filed against it by Roche contradict the acknowledgements received from the IPO and ISA, as they didn’t explicitly mention Risdiplam. In the US, Roche had admitted that Risdiplam originated from the genus patent, countering its stand in India.
“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.” Roche said in a press statement, following the decision.
It added, “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.”
The SC has also directed the Delhi High Court to expedite the hearing on this case, even as this can have wide-ranging ramifications for companies developing critical pharmaceutical products and the healthcare industry as a whole in India.
