Amendments to patents law on course

The group of ministers (GoM) on patents today finalised its recommendations for undertaking amendments to the Patents Act. The amendment Bill is expected to be introduced in the winter session of Parliament.

"Both pre and post-grant opposition facility will be there, but the provision will be made in a way that the whole purpose of the law is not defeated," Commerce and Industry Minister Kamal Nath told reporters after a meeting of the GoM.

The issue of including a provision to contest a patent, which has already been granted, had been one of the contentious issues with the domestic pharmaceuticals industry.

The scrapping of the pre-grant objection provision in the Patent Amendment Bill 2003, caused a lot of heartburn among the domestic pharma companies, which were of the opinion that it would lead to the grant of frivolous patents.

Sources said the GoM had decided that an opposition to the grant of a patent would not hold up the processing of the patent application.

The government will adhere to the January 1, 2005, deadline for the product patent regime, he said. A modified Bill, incorporating the decisions of the GoM, would now go to the Union Cabinet.

In September, the Cabinet had referred the Bill to the GoM as it wanted it to study the implications of some of the contentious issues.

Government officials said that the amendments being proposed, have incorporated the concerns of all other departments, including security concerns and issues pertaining to patentability of embedded software in hardware.

In addition to this, the time frames for disposal of patent applications have also been streamlined and modified. Officials said that the amendments would also seek to exclude the patentability of new forms of previously patented compounds so that marginal changes which merely serve to delay the entry of generics cannot be patented.

Officials said that the amendments to the Patent Act was not likely to include the issue of compulsory licensing.

"There is a view that the issue has been dealt with in the second amendment and the Joint Parliamentary Committee set up to examine the issue had 40 sittings on this. There are 27 occassions when the issue of compulsory licensing has been referred to in the act. There is a strong licensing regime and there is no need to make it stricter," an official said.

MNCs in the pharma sector want a stricter compulsory licensing regime while the small units want a more relaxed licensing regime. Pharmaceutical companies with strong R&D base and clinical testing capabilities are also fighting for allowing data protection.