Better now, but...

The government has done well to make substantial amendments to the patents Bill before getting it passed by Parliament. All was not well with the patents amendment Ordinance that was issued in December in order to meet the deadline agreed upon internationally, and the Bill that was drafted to replace it had the same deficiencies.

In the last few weeks, criticism of the proposed law had begun to mount, and it was clear that the critics (which included the Left parties) had a point. The main opposition, in the form of the NDA, had also come round to the view that the Bill could not be passed in its original form, though it was the NDA government that first mooted the Bill.

So the government had no choice other than to listen to the critics, since without support from the NDA or the Left, the Bill would have been defeated. The end product, which has now met with parliamentary approval, stands improved in both drafting and substance. Nevertheless, some concerns remain unaddressed or inadequately addressed.

On the positive side, the official amendments have excluded embedded software from the ambit of the product patent regime and curbed the ever-greening of patents by clarifying the concept of patentability in unmistakable terms.

Ever-greening would have allowed a patent holder, nearing the end of the 20-year life of a patent, to renew the patent for a fresh 20-year period""as many pharmaceutical companies had been preparing to do. The mere discovery of a new form of a known substance, which does not result in enhancement of the known efficacy of that substance, can no longer be held as grounds for patenting.

Besides, the new Bill has also addressed the issue of needless patenting by re-defining a patentable pharmaceutical substance as any new entity involving one or more inventive steps.

Going further, the inventive step has been properly defined to reduce the scope for misinterpretation. Such clarifications were essential to avert possible chaos in the industry due to fraudulent and excessive patenting.

These concerns stemmed from the unusually large number (about 7,000) of applications in the "mail box" awaiting patents. What is surprising is that about 2,500 applications that were being seriously pursued claimed to be for newly discovered chemical entities. This strained credulity since it meant that an average of 250 new entities have been invented in India every year, against the annual global average of a mere 10!

However, as noted, some lacunae, in even the amended statute, can pose problems, especially in the case of essential drugs. The general perception is that the flexibilities on drugs patenting and manufacturing, allowed under Article 30 of the Trade-Related Intellectual Property Rights (TRIPs) agreement, have not been fully used.

As such, the new law may limit the scope for producing affordable versions of life-saving medicines. This is not a view shared by all, but has been argued by patent experts from the African countries, many of which rely heavily on the supply of cheap generic drugs from India for the treatment of millions of people suffering from ailments like HIV/AIDS.

Though the government claimed in the Lok Sabha that it had enormous powers to deal with any unusual rise in drug prices, these too are not adequately reflected in the Bill that has been passed. On the contrary, it bars the government from over-riding any patent for at least three years""a provision not required under the WTO agreement on trade-related intellectual property rights (or TRIPs).

Thus, it might have been prudent to refer the Bill to a parliamentary committee for further review, as suggested by the BJP. That this has not been done testifies to the state of hostility between the two main political formations. Nevertheless, the new patents law is better put together than seemed possible a month or two ago.