Granting of patents only to new chemical entities in pharmaceutical sector would not be TRIPS complaint, according to the report of technical expert group headed by Dr R A Mashelkar. The report also called for efforts to make sure that drugs reach the people at affordable prices.
"It would not be TRIPS compliant to limit granting of patents for pharmaceutical substance to New Chemical Entities only. However, efforts must be made to provide drugs at affordable prices to the people of India. Further, care should be made to prevent the grant of frivolous patents and 'ever- greening' of existing patents. Detailed guidelines should be formulated and rigorously used by the Indian Patent Office for examining the patent applications in the pharmaceutical sector so that the remotest possibility of granting frivolous patents is eliminated,'' the report submitted to the Government last week said.
Among its key terms of references, the expert panel was asked to find if it would be TRIPS compatible to limit the grant of patent for pharmaceutical substance to new chemical entity or to new medical entity involving one or more inventive steps. The term "new chemical entity" appears for the first time in International Intellectual Property agreements in the TRIPS Agreement of 1994, under Article 39.3.The term "new medical entity" has neither been used nor defined in the TRIPS Agreement, the report said.
"Restricting patentability just to NCEs or NMEs could have both legal and scientific ramifications. There is a perception that even the current provisions in the Patents Act could be held to be TRIPS non-compliant. Drug discovery research is still finding its feet in India. Though many companies are investing, it will at least be a decade before a critical mass is in place and results start accruing. Thus, restricting patentability to just to NCEs would mean that most of the pharmaceutical product patents would be owned by MNCs,'' the report said.
"Granting patents only to NCEs or NMEs and thereby excluding other categories of pharmaceutical inventions is likely to contravene the mandate under Article 27 to grant patents to all 'inventions'. Neither Articles 7 and 8 of the TRIPS Agreement nor the Doha Declaration on TRIPS Agreement and Public Health can be used to derogate from this specific mandate under Article 27,'' the panel noted.
"The new form of a known substance would not be patentable unless it differs significantly in properties with regard to efficacy,'' the report said, citing the relevant clauses. If the aim of limiting patents to new chemical entities is to prevent a phenomenon loosely referred to as 'ever-greening', this can be done by a proper application of patentability criteria as present in the current patent regime, the report suggested, while strongly recommending encouragement of incremental developments by the patent regime,'' it said.
In case of patenting of drugs, the protection to various forms of same substance (salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixture, etc.) is often seen as 'ever-greening' (extending incremental protection to a subsisting patent) and hence such protection is objected to.
The protection in the form of incremental inventions in respect of known and new molecules or a process potentially provides an added advantage to an inventor or a firm to retain its market share or capture a space in the established market. However, patenting an invention does not imply that a person can practice the invention; he would have to exercise due diligence and ensure that the rights of others are not infringed, the report said.