Roche lost its bid at India's top court to halt Natco Pharma from selling a drastically cheaper generic of the SMA drug, Risdiplam, until a trial on a patent infringement suit is decided.
F Hoffmann-La Roche, suffered a setback as India's top court dismissed the Swiss pharmaceutical giant's petition to block Natco Pharma from manufacturing and selling the generic version of Risdiplam.
The Supreme Court of India on Friday refused to interfere with the Delhi High Court's interim order made last week, thereby opening the doors to allow the sale of the generic and much cheaper version of Roche's drug Risdiplam. Risdiplam is a crucial drug for the treatment of Spinal Muscular Atrophy (SMA).
The Supreme Court's dismissal prioritizes judicial procedure in terms of concurrent interim findings over immediate protection of the patent.
The Supreme Court's decision to uphold the interim relief granted to Natco highlights the ongoing tension between patent monopolies and access to essential medicines. The Indian pharma company is allowed to continue manufacturing and selling its generic version of Risdiplam until a final decision on the main patent infringement suit is decided.
In response to Roche's plea, the Supreme Court directed the Delhi High Court to expedite hearing the patent suit against Natco. The high court will have to decide on the validity of Roche's patent or Natco's alleged infringement, which could include the "reverse engineering" claim.
The high court is where the arguments made by both sides will be tested on evidence. Intellectual property lawyer Aman Sinha said "that's when the things on merit will go into play."
The Supreme Court bench explicitly said that its observations were solely for the disposal of the appeal and will not have any bearing on the final decision of the suit.
During the hearing on Friday, Roche's lawyer, Neeraj Kishan Kaul, argued on grounds that millions of dollars had been invested in research of the patent and the unfairness use of the public interest argument to defeat a patent holder's right under the Patent Act.
Arguing against the generic entry, Roche said that after years of R&D and participation in the National Rare Drug Policy, it was unfair that the "public interest element" was easily invoked to defeat their patent right, saying, "We have cooperated on millions of drugs," Kaul said.
The immediate implication of the Supreme Court ruling is that Natco Pharma is now cleared to sell its generic version for approximately 15,900 rupees($181.00) per bottle,97 percent lowerthan Roche's imported price of around 600,000 rupees per bottle, a difference in cost that would make the life-saving medication vastly more accessible.
The immense price drop is critical, especially since the rare disease often requires treatment over many years, Sinha said. This development makes the drug, which stabilizes the degeneration caused by SMA, accessible to thousands of Indian families previously priced out of hope, he added.
The ruling by the Indian top court may also open the floodgates for increased competition in the Risdiplam market, promising greater affordability and accessibility for patients.
Source: MLex
