The Union Cabinet on Wednesday decided to refer the Patents Amendment Bill to a group of ministers. The government is seeking amendments to the Patents Act to fulfill India's obligations under the commitment to the World Trade Organisation of having in place product patents by 2005.
Official sources said the Cabinet wanted to study the implications of some of the contentious issues in the third Patents Amendment Bill before approving it.
The group of ministers on patents includes Defence Minister Pranab Mukherjee, Health Minister Anbumani Ramdoss, Human Resources Minister Arjun Singh and Commerce and Industry Minister Kamal Nath.
Some of the key issues the Bill is expected to address include the definition of inventions, objection to pre-grant of patents, granting patents for unknown molecules and data protection to pursue R&D in India.
Section 3 of the Patents Act defines inventions that are not patentable. The amendment seeks 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.
The amendments dealing with pre-patent objections seek to remove the right of hearing and provide the facility only after the grant of a patent. Pre-enforcement effectively means that the patents will not be granted until the patents office is completely satisfied with the validity of the case.
A section of the Indian pharmaceuticals industry believes that applications will be under endless scrutiny and the only beneficiaries will be patent lawyers who will try to pick holes at every stage, to stop granting of patents.
On the contrary, under the post-enforcement regime, patents will be granted after basic scrutiny and left to the industry to challenge.
Sources in the pharmaceuticals industry said this was more transparent and competition would take care of frivolous or invalid patents.
Pharmaceuticals companies with a strong R&D base and clinical testing capabilities are also fighting for allowing data protection. There are understood to be sharp differences among the Indian Pharmaceutical Alliance, the Indian Drug Manufacturers Association and the Organisation of Pharmaceutical Producers of India on the issue of data protection.
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