Pharma Company Roche Approaches Supreme Court Against Delhi High Court Allowing Natco To Make Generic Drug For Spinal Muscular Atrophy

Swiss pharmaceutical giant F Hoffmann-La Roche AG has approached the Supreme Court against the Delhi High Court's order allowing Natco Pharma to manufacture and sell a generic drug of Risdiplam, a drug used to treat Spinal Muscular Atrophy (SMA).

The counsel for Roche mentioned the matter before Chief Justice of India for urgent listing. CJI agreed to list the matter.

On October 9, a division bench of the Delhi High Court had refused to pass an injunction against Natco Pharma in a patent dispute. A Division Bench of Justice C Hari Shankar and Justice Ajay Digpaul dismissed Roche's appeal against a Single Judge's decision, which had allowed Natco to continue manufacturing and selling the drug in India. Roche had argued that Natco's product infringed its suit patent IN'397, valid until 2035, which claimed compounds for treating spinal muscular atrophy.

The case arose out of Roche's claim that Natco's manufacture and sale of Risdiplam infringed its Indian patent containing compounds for treating SMA.

Natco invoked the statutory defence under Section 107(1) of the Patents Act, 1970, claiming that the patent was invalid under Section 64(1)(e) (lack of novelty) and Section 64(1)(f) (obviousness).

The High Court division bench found “no reason to interfere with the findings of the learned Single Judge that Risdiplam is vulnerable to invalidity in terms of Section 64(1)(f) of the Patents Act, as being obvious vis-à-vis prior art in the form of the claimed Compound 809 in WO'916/US'955,” and held that “no case for interference with the said decision, within the parameters of Wander, can be said to have been made out.”