The amended rules, apparently published in the official gazette on June 2, contain certain highly "objectionable" clauses which, experts say, go much beyond the TRIPS requirements and even supersede the basic Patents (Amendment) Act, 1999.

Industry sources say that the ministry of industrial development and patent experts from the industry (represented by the Indian Drug Manufacturers' Association (IDMA)) held discussions on the "objectionable" clauses on May 31. However, just 48 hours after the meeting, the rules were notified, raising doubts on whether the objections cited were looked into at all.

Industry 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 thebasic 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 others, dilute the powers of the government to intervene and sell/distribute a patented invention in "public interest", virtually limits the period of use of compulsory licences and even leaves gaps to facilitate misuse in the cut-off date for the grant of patents in India. The IDMA had in May sought amendments in the draft rules.

Leading patent advocate and high court lawyer NB Zaveri 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". This, experts add, rules out cases where prolonged short supplies lead to high prices or the national health plans for tuberculosis, malaria, etc, which may not strictly fit thenational emergency criteria.

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, Zaveri added.

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.

Ahmed is new controller general of patents

The joint secretary at the ministry of industrial development, AE Ahmed, is believed to have taken additional charge as the controller general of patents. Ahmed takes charge from HD Thakur, though there is no official confirmation on the newappointment or the reasons thereof.

It is also believed that joint secretary at the ministry of industrial development, P Rai, has moved on to the WIPO (World Industrial Property Organsation). This, again, could not be confirmed.