The Delhi High Court has ordered Natco Pharma to pause the launch of a generic version of Roche’s rare disease drug, Risdiplam, amid a patent dispute. The court has restrained Natco Pharma from launching the generic version of the drug, which is used to treat spinal muscular atrophy (SMA), a genetic disorder that affects the nervous system and causes progressive muscle weakness and loss of muscle mass.
Natco Pharma had earlier been granted permission by the court to manufacture and market the generic version of Risdiplam, but Roche had subsequently moved the court to block the launch, citing patent infringement. Roche had claimed that its patent for the drug was still valid, while Natco Pharma argued that the patent had expired.
The court has now allowed Natco Pharma to manufacture and market the generic version of Risdiplam, but has stayed its launch to allow for further proceedings. This decision is seen as a significant victory for Natco Pharma, as it will help to make the drug more affordable for patients in India, where access to healthcare is a major challenge.
The court’s decision is also seen as a setback for Roche, as it had hoped to maintain its monopoly on the market for the drug. However, the court’s ruling is in line with the Indian government’s efforts to increase access to affordable and essential medicines for patients in the country.
The decision is also seen as significant for the pharmaceutical industry, as it highlights the importance of intellectual property protection and the need to balance this with the need to ensure access to life-saving medicines. The case is likely to have implications for the industry as a whole, as it navigates the complex issue of patent protection and public health.