The Supreme Court agreed to hear Swiss pharma giant Roche’s plea challenging the Delhi High Court’s order permitting Natco Pharma to manufacture and market a generic version of Risdiplam, a drug used in the treatment of Spinal Muscular Atrophy (SMA). The matter was brought before the Chief Justice of India for urgent listing, which was allowed. The Court’s intervention underscores the significance of patent protection and statutory defences in the pharmaceutical sector.
Roche, the original patent holder of Risdiplam, had filed a suit alleging that Natco Pharma’s production and sale of the generic version infringed its Indian patent IN’397, valid until 2035, covering compounds for SMA treatment. Natco, in response, invoked the statutory defences under Section 107(1) of the Patents Act, 1970, arguing that Roche’s patent was invalid on grounds of obviousness under Section 64(1)(f) and lack of novelty under Section 64(1)(e). A Single Judge of the Delhi High Court allowed Natco to continue manufacturing and selling the drug, prompting Roche to appeal.
Roche contended that Natco’s actions directly violated its patent rights and sought an injunction to prevent the manufacture and sale of the generic drug. Natco, on the other hand, relied on the statutory provision permitting manufacture of a patented invention in certain cases, asserting that Risdiplam lacked inventive step and was obvious in light of prior art, specifically referencing Compound 809 in WO’916/US’955.
The Division Bench of the Delhi High Court, comprising Justice C Hari Shankar and Justice Ajay Digpaul, upheld the Single Judge’s findings. The Court noted, “there is no reason to interfere with the conclusions that Risdiplam is vulnerable to invalidity under Section 64(1)(f) of the Patents Act, as being obvious vis-à-vis prior art in the form of the claimed Compound 809. No case for interference, within the principles established in Wander Ltd., has been made out.” The Bench highlighted that statutory defences play a critical role in balancing patent rights and public access to essential medicines.
While the High Court refused to grant an injunction against Natco, the Supreme Court has now agreed to examine Roche’s plea, which could have far-reaching implications for patent enforcement and generic drug manufacturing in India. The matter is expected to address the tension between protecting innovator rights and ensuring availability of affordable medicines for life-threatening conditions like SMA.
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