NGOs working on patent issues in the country have asked the government to reject the recommendations of the Mashelkar Committee on the twin issues of 'evergreening of patents' and 'excluding micro-organism from patentability'. Instead, the NGOs have asked the government to accept the recommendations of Department Related Parliamentary Standing Committee which has recommended that the patentable pharmaceutical product should be restricted only to 'new drug molecules'.
"Apparently, the recommendations of the Parliamentary Committee should take precedence over those of the Mashelkar Committee on the two issues under consideration, and, therefore, the recommendations of the Mashelkar Committee should be disregarded and appropriate amendments introduced in the amended Patents Act 1970," National Working Group on Patent Law (NWGPL), an NGO of decades of standing, said in its letter to Union commerce minister Anand Sharma.
"Regarding..… whether it would be TRIPS compatible to exclude micro-organisms from patenting, there is a provision for patentability of micro-organisms in the Patents Act, 1970.Micro-organisms as such occur in nature and should be considered as discoveries and not inventions. Genetically modified micro-organisms perform certain activities. The viable proposition would be to patent only specific activity under process patent. It may be equally important to define 'micro-organism' so that there is no confusion about the scope of their patentability. The issue of patenting of micro-organisms is a subject of mandated review by the WTO. WTO has been examining this issue since 1999, but they have not come to any conclusion. The Committee are of the view that the Government should take an early and unequivocal decision with regard to patentability of micro-organisms per se or their specific activities. If needed, necessary amendments should be expeditiously carried out in the Patents Act," the Parliamentary Committee in its report to the government said.
"Article 27 of TRIPS stipulates that patent shall be available for any inventions, whether products or process. The terminology of patentable invention needs to be defined, so that the frivolous claims are not filed. It would be appropriate to define the invention as 'patentable basic invention'. Similarly, the patentable pharmaceutical product should be restricted only to 'new drug molecules'," the Parliamentary Committee in its report noted on the issue of evergreening of patent.
The government set up a Technical Expert Group with Dr R A Mashelkar as its chairman and four other members, on April 5, 2005 when senior Members of Parliament pressed for amendment to sub-Section (ta) of Section(2) and sub-Section(j) of Section(3) of the Patents Act 1970 during a debate in Parliament in April, 2005 on Patents (Amendment) Bill. The Members urged that the definition of 'pharmaceutical substance' should be changed to limit the grant of patent for 'pharmaceutical substances to include only chemical entity or medical entity involving one or more inventive steps'. The other issue pressed by the Members was about 'excluding micro-organism from patentability'.
The Technical Expert Group submitted its Report to the Government on December 29, 2006.There was strong criticism of the report by public interest groups and others on the ground that important parts of it were plagiarized from a submission before the Technical Expert Group by the representative of MNCs. The criticism was so strong that Dr. Mashelkar, the chairman of the Committee resigned. However, the Ministry persuaded him to re-examine the issues and submit a revised report. The Revised Report hardly brings out any new substantive arguments. The conclusions arrived at by the Group are exactly the same as were derived in the original report.
During the debate in the Parliament in April, 2005 on Patents (Amendment) Bill 2005, a large number of MPs demanded that the Bill should be referred to a Joint Parliamentary Committee. However, this demand was not conceded as the Minister pointed out the urgency to pass the Bill. Subsequently, the Department Related Parliamentary Standing Committee on Commerce, as reconstituted on August 5, 2005, decided to examine the Patents Act 1970, Trade Marks Act 1999 and the Design Act 2000.
The committee was briefed by the senior officials of the concerned Departments of the Government. It also received written submissions as well as oral submissions from a number of individuals and organizations. Among the issues examined by the Department Related Parliamentary Standing Committee on Commerce were included the two issues which were referred to the Technical Expert Group headed by Dr Mashelkar. The Committee submitted its Report to both the Houses of Parliament in October, 2008.
The National Working Group on Patent Laws was established more than 20 years ago in 1988 under the chairmanship of eminent scientist Dr Nitya Nand when the Uruguay Round of GATT Negotiations was in the thick of negotiations. The members comprise of legal experts, academicians and senior experts from various NGOs. The Group had established four People Commissions on Patent Law issues. The first two Commissions were chaired by Justice V R Krishna Iyer and other two were chaired by I K Gujral, former prime minister of India.