The Organisation of Pharmaceutical Producers of India (OPPI), an association of research based large pharma companies in India has recommended the filing of pre-grant opposition within six months of publication and being disposed off within twelve months of commencement of pre-grant proceedings. This recommendation has been made with a view to give a timeframe for filing oppositions thereby curbing the indefinite delays presently faced in the grant of patents. The multinational pharma is also trying to rein in the increasing number of challenges to patents they face.

The OPPI is learnt to have submitted recommendations on issues like Section 3(d) of patentability, regulatory data protection and compulsory licensing, besides pre-grant opposition as a part of the exercise of the Indian Patent Office seeking recommendations on the draft manual released by it recently. 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

The gravity in OPPI’s recommendations can be only gauged from the statement of its Director General when he says that “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.” OPPI also suggests that if the patent opposition proceeding are not concluded within twelve months, an equivalent term of patent restoration should be given.

OPPI’s recommendation on Section 3(d) of the Patent Act is that the sub-section should not focus only on “properties with regard to efficacy” for patentability. Airing his views on incremental innovation the Director General 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, the recommendation pertains to the issue of compulsory licence (CL) should be restricted to emergencies and public non-commercial use only.

A glance at the OPPI’s position on IPR & Indian Patent Act, available on its website, confirms the stance taken by it. The position paper echoes essentially the same as recommendations. OPPI is very critical about the Pre-grant as well as Post-grant oppositions and disapproves them. Similarly with respect to section 3(d) of the Patents Act, it believes that apart from ‘NCEs’, which can only fit into the scale of “differ significantly in efficacy”, all other forms such as salts, esters, isomers and derivatives of known substances should be patentable as long as they meet the criteria of patentability like novelty, non-obviousness and commercial applicability.

The removal of Pre and Post grant oppositions seems a distant idea but as far as the recommendation of a time period for filing Pre-grant opposition is concerned, it can surely bring a significant change or lessen the delay in patent granting process.