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Mumbai, Apr 14: In a strategic move to thwart the increasing number of challenges to patents that multinational pharma firms face, the Organisation of Pharmaceutical Producers of India (OPPI), an association of research-based international and large pharma companies in India, has recommended the filing of pre-grant opposition within six months of publication and disposed off within 12 months of commencement of pre-grant proceedings. Currently, there is no timeframe for filing oppositions, which has resulted in indefinite delays in the granting of patents.
With April 15 being set as the deadline for submitting recommendations against the draft manual released by the Indian Patent Office seeking recommendations from the healthcare fraternity in India, OPPI is learnt to have submitted recommendations last week on issues like Section 3(d) of patentability, regulatory data protection and compulsory licensing, besides pre-grant opposition. In February, the Indian Patent Office had released a 368-page new draft manual of patent practices and procedures, which is followed by patent offices across the country in order to grant patents.
Tapan Ray, director general of OPPI, told FE, “To ensure that innovation is not put to undue disadvantage for delay in pre-grant proceedings, the need to introduce statutory time-limits for setting up hearings and disposing off pre-grant matters for accountability by the patent controller, are of utmost importance.” If the patent-oppositions proceedings are not concluded within 12 months, OPPI suggests an equivalent term of patent restoration. OPPI recommends that Section 3(d) of the Patent Act should focus not on only “properties with regard to efficacy” for patentability. Ray said, “Incremental innovations generally result in better outcomes, not only by increasing efficacy, but also by reducing the side-effects profile. This makes administration easier for the patients which results in improved compliance, more stable molecules ensuring better storage conditions, etc.” On the issue of compulsory licences, Ray said, “Issue of compulslory licence (CL) should be restricted to emergencies and public non-commercial use only.”
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