You are on page 1of 1

OPPOSE PATENT (AMENDMENT) BILL---WHY??

The Bill totally ignores the flexibility available within the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) and compromises accessibility and availability of medicines, agrochemicals, seeds, pesticides, etc. If the bill in its present form becomes law, it will seriously compromise the right to food and health. The Bill proposes to extend the scope of patentability beyond the TRIPS requirements by amending Section 3(d) of the Patents Act to provide patents to new use of known medicines. There is no obligation under TRIPS to provide a patent to either new use or new dosage of known medicines. The product patent should be given only to new chemical entities and not to either new use or dosage forms or any other forms of known molecules. This will limit the number of patent protected drugs. The Bill proposes to do away with the pre-grant opposition procedure. Currently, there are approximately 6000 applications pending in the mailbox protection. In the absence of pre-grant opposition, these 6000 applications would escape public scrutiny. Public scrutiny is crucial in light of the fact that less than 500 drugs have been granted marketing approvals in India between 1995-2004. Hence, pre-grant opposition is absolutely essential for blocking trivial patents. It is also part of natural justice to give an opportunity to interested parties, including civil society, to be heard before granting a monopoly. The Bill has not properly incorporated the August 30th Decision of the TRIPS General Council, which permits the grant of compulsory licenses for export purpose to countries with no or insufficient manufacturing capacity in the pharmaceutical sector. The Bill proposes to permit compulsory licensing to a country with no or insufficient manufacturing capacity in the pharmaceutical sector if there is a corresponding patent in the importing country. This ignores the fact that in many instances, there may not be any patent protection in the importing country because the deadline for Least Developing Countries (LDCs) to comply with TRIPS is 2016. In this case, the Indian drug companies would not be able to export to LDCs in the absence of a compulsory license granted by the LDC. Lastly, the compulsory license regime within the present Patents Act contains cumbersome procedures without any time line for the final disposal of the application. This renders the compulsory license system ineffective to curb abuse of patents because procedural requirements take away the deterrent element of the compulsory license mechanism. The other safeguards in the present Patent Act, e.g. parallel importation, Bolar provision, and experimental exception, should be amended to make use of the TRIPS flexibility in its full extent.