Supreme Court Dismisses Roche Plea on Natco Pharma Generic SMA Drug, Urges Delhi HC for Speedy Trial

The Supreme Court of India has dismissed the plea filed by Swiss drugmaker F Hoffmann-La Roche AG seeking to restrain Natco Pharma from manufacturing a generic version of Risdiplam, a drug used to treat Spinal Muscular Atrophy (SMA). 

The top court declined to intervene in the Delhi High Court’s interim order and urged a speedy trial in the ongoing patent suit.

SC Refuses Interim Relief, Upholds Delhi HC’s Concurrent Findings

A bench comprising Justice PS Narasimha and Justice AS Chandurkar stated that it was not inclined to interfere with the Delhi High Court’s interim order, noting that both the single bench and division bench had issued concurrent findings. 

The bench clarified that its observations would have no bearing on the merits of the ongoing civil suit, which it directed the High Court to dispose of expeditiously.

Roche’s Patent Claim vs Natco’s Generic Defence

Senior Advocate Neeraj Kishan Kaul, appearing for Roche, argued that the company held a valid patent for Risdiplam (IN’397), protected until 2035, developed after years of research and significant investment. He contended that Natco’s generic product was created using reverse engineering and infringed Roche’s intellectual property. Kaul also argued that public interest should not override Roche’s statutory rights under the Patents Act.

Natco, represented by Senior Advocates Kapil Sibal and Gopal Subramanium, invoked defences under Section 107(1) of the Patents Act, claiming the patent lacked novelty and was obvious under Sections 64(1)(e) and 64(1)(f).

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Delhi HC Observed Vulnerability of Patent

The Delhi High Court had earlier found no grounds to restrain Natco from selling the drug in India. The court concluded that the Roche patent was vulnerable to invalidity under Section 64(1)(f) for being obvious in light of prior art. The division bench ruled there was no basis to interfere with the single judge’s decision, applying the principles from the Wander case to assess interim injunctions in patent disputes.

Conclusion

The Supreme Court’s refusal to grant interim relief to Roche reinforces judicial restraint in interfering with concurrent findings. The case now moves forward at the Delhi High Court, which has been directed to resolve the patent suit without delay, keeping in view the critical healthcare and legal implications.

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