Global pharmaceutical major F. Hoffmann-La Roche AG has approached the Supreme Court of India challenging a recent Delhi High Court decision that permitted Natco Pharma Ltd. to manufacture and sell a generic version of Risdiplam, a drug used for treating Spinal Muscular Atrophy (SMA) — a rare, genetic neuromuscular disorder.

Counsel for Roche mentioned the matter before Chief Justice of India B.R. Gavai, seeking urgent listing. The CJI agreed to list the plea for hearing.

The challenge comes after a Division Bench of the Delhi High Court, comprising Justice C. Hari Shankar and Justice Ajay Digpaul, on October 9, declined to grant an injunction restraining Natco from producing or selling the generic version. The Bench dismissed Roche’s appeal against a Single Judge’s order, which had earlier allowed Natco to continue manufacturing and marketing Risdiplam in India.

Roche had contended that Natco’s product infringed its Indian Patent IN’397, which it claims is valid until 2035, covering compounds used in the treatment of SMA. Natco, however, invoked Section 107(1) of the Patents Act, 1970, asserting that its actions were not infringing since the patent itself was invalid under Section 64(1)(e) (lack of novelty) and Section 64(1)(f) (obviousness).

After reviewing the scientific material and prior art, the High Court’s Division Bench found no reason to overturn the findings of the Single Judge, holding that Risdiplam was vulnerable to invalidation under Section 64(1)(f) due to obviousness when compared to Compound 809, disclosed in prior art documents WO’916/US’955.

The Court observed:

“No case for interference with the learned Single Judge’s decision, within the parameters of Wander Ltd. v. Antox India P. Ltd., can be said to have been made out.”

With the High Court refusing to restrain Natco, Roche has now sought urgent intervention from the Supreme Court, contending that the lower court’s order undermines patent protection for innovative drugs and could discourage pharmaceutical research and investment.

The Supreme Court is expected to hear Roche’s plea shortly.

Roche developed Risdiplam as a novel oral medication for Spinal Muscular Atrophy, marking a significant shift from previous injectable treatments. Natco’s version, according to Roche, infringes its patented compound. Natco, on the other hand, maintains that its product is based on publicly known prior art and does not violate any valid patent rights.