The Government had, in early June, notified the amendments to the Patents Rules 1972 following the enactment of the Patents (Amendment) Act, 1999.

The petition, it is believed, challenges various allegedly "objectionable" clauses laid down in the rules. Broadly speaking, the drug body claims that the amended rules go much beyond the TRIPS requirements and even supersede the basic Patents (Amendment) Act, 1999.

IDMA may have also raised doubts over the sincerity of the hearing accorded to industry, days after the gazette notification (on the Patent rules) had gone to print. The ministry of industrial development and patent experts from the domestic industry (represented by the Indian Drug Manufacturers' Association) held discussions on the "objectionable" clauses on May 31, even as the rules had gone to print apparently on May25.

Moreover, just 48 hours after the meeting, the rules were notified, raising doubts on whether the objections cited were looked into at all. The IDMA petition has, however, yet to be admitted.

Experts also say that since the patent rules are meant to carry out the provisos in the Patents Act, there is no justification, at this stage, to make drastic changes that supersede the basic act. Moreover, this is being viewed as a wasteful exercise given that the Patents Act 1970 is due for major changes for compliance under TRIPS before 2000.

Patent experts say that the rules, among other things, dilute the powers of the Government to intervene and sell/distribute a patented invention in "public interest" and virtually limits the period of use of compulsory licences.

The Indian Drug Manufacturers' Association (IDMA) had, in May, sought various amendments in the draft rules. The industry body had said that while Section 24 (D) (1) of the amended Patent Act leaves the scope of the term "public interest"open, the draft rules (No 33 (o)) restrict this safeguard clause to cases of "national emergency or other circumstances of extreme urgency".

In the case of the compulsory licence provision, Section 24 C provides for the issue of licence only two years after the grant of exclusive marketing rights for five years. The three-year period left for the use of the compulsory licences is again restrained by incorporating a scheme of "prima-facie rejection" by the patents controller.

Patent experts also point to Rule 33 G, which allows "tests to be conducted either in whole or part" thereby creating difficulties in the enforcement of the cut-off date of January 1, 1995. This rule, experts say, leaves the door open to claim benefits for tests conducted before the cut-off date and even products already in public domain.