Don't trip on patents

The Indian patent regime will undergo seminal change if the country manages to meet the January 1 deadline set under the TRIPS (trade related intellectual property rights) agreement to switch over to product patenting.

With the group of ministers (GoM), constituted by the UPA government to revisit the provisions of the draft Bill circulated by the previous NDA government, clearing the Bill with some changes, the way has been paved for the Patents (third amendment) Bill to be introduced in the winter session of Parliament in December.

But there is no guarantee of its hassle-free passage, despite the BJP's assurance of support for the measure. As could well be expected, the Left parties have already aired their reservations and demanded that the Bill be referred to a joint select committee.

They view the proposed new law as detrimental to the development needs of domestic industry and the health care sector""though industry itself seems to think differently.

Regardless of the validity of the Left parties' disquiet, there are some issues concerning the new enactment that need to be carefully considered. For one thing, the very concept of "patentability" requires unambiguous and carefully conceived definition.

Otherwise, the danger of "ever-greening" of patents through stratagems like the modification of the form of the molecule, say from solid to crystal, will persist and thereby help perpetuate monopolies.

It is necessary also to prevent the needless patenting of generic products, in the wider public interest.

Indeed, the bulk of the patent applications currently lying in the mail box (created as a transitional measure) are said to pertain to products like salts, distillates, isomers and the like, many of which may not deserve to be protected by patent.

Meanwhile, the issue of whether the new law should provide for pre- or post-patent challenge has been sought to be resolved by the GoM by allowing both, but some problems on this count still persist.

For, marrying the merits of the two approaches carries with it their demerits as well.

What is important here is to fix a judiciously perceived time limit for entertaining opposition to a patent application. Otherwise, such a provision could be used as a delaying tactic.

Besides, the new law needs to make full use of some of the flexibilities allowed under the TRIPS accord, and further emphasised in the Doha Declaration, to protect community interests.

The proposed shift from process patents to product patents, however carefully handled, cannot be free of adjustment problems for various sectors.

In the pharmaceutical sector alone, drugs worth an estimated Rs 3,000 crore are expected to go out of the market once a new law is in place. But this change had to come about, sooner or later, and industry has had the best part of a decade to prepare for a new regime.

Indeed, some of the infrastructure required for adjusting to the new regime has already come up. It will be put to the test after the amendment of the law.