The Patent (Third) Amendment ordinance clears the air on one of the most contentious issues in recent years: the changeover in our patent regime. The amendment (the most significant to date) heralds the transition from a process to a product patent regime for pharmaceuticals, chemicals and food by January 1, 2005. This is in line with our obligations under the WTO’s Trade-Related aspects of Intellectual Property Rights (TRIPS). The government had little choice but to adopt the ordinance route to ensure compliance with international obligations once the winter session of Parliament ended without the amendment bill being passed. The ordinance, therefore, was not wholly unexpected. To be sure this is not the best and most democratic way to effect such a far-reaching change in our statute books. But given the Left’s strident political opposition to changes in the existing law, the government had little choice in the matter.
Indeed, the ordinance tries to address many of the concerns voiced by the Left and domestic industry, which had a stake in the earlier regime. For instance, it fixes a time-bound (90 day) period for all pre-grant opposition. Such opposition, moreover, will only be allowed on grounds of ‘patentability’. Post-grant, a patent can be opposed before the patents controller as well as in a court of law. The rights of mailbox applicants (those who had submitted their patent applications under the Mailbox Facility established after the 1999 amendment) will be operational only from the date of the granting of the patent and not retrospectively. This takes care of a major concern of generic producers in the country who feared that they would be hauled to court for patent violations in case the benefit is extended retrospectively.
Contrary to widespread anxieties, the new regime is unlikely to see drug prices shoot through the roof, since an estimated 97 per cent of all drugs sold over the counter are off-patent. The other safeguards include retention of 13 compulsory licensing provisions, including one for enabling grant of compulsory licensing for export of medicines to countries which have no manufacturing capacity. Additionally, a compulsory licence — a facility to sidestep patents under specified circumstances — can now be issued within the grace period of three years from the grant of patent. The transitional arrangement of EMRs has been dropped. Embedded software can now be patented. This should come as a major source of relief to the Indian software industry at a juncture when it is slowly moving up the value chain and developing potentially patentable software. The ordinance also gives the government much needed breathing space. It can only be hoped that the Left will see reason on the issue and stop tilting at windmills. The bill — whenever it comes up in Parliament — needs to be supported.