Ajit Dangi
Director General
Oppi*

With the nearing of TRIPS' deadline, the pharmaceutical industry in India is moving towards a TRIPS-compliant patent regime and the stage is now set to usher in a new era.

Having enjoyed the fruits of a weak Intellectual Property Rights (IPR) regime for over the past 30 years, India's pharmaceutical sector should now use the skills it has acquired during that period as foundation - and look at the new IPR regime as a strategic tool to grow globally and view it as an opportunity, not a threat.

The question then comes up whether we can have, adequate safeguards to protect our national interest in the IPR regime? The fact is that the TRIPS agreement already provides enough flexibility to do so. It, for instance, allows compulsory licensing of a patented product in case of national emergency (e.g. HIV/AIDS).

There is also an apprehension that medicine prices are going to go through the roof in the product patent regime. This is a myth propagated by some sections of industry.

Over 95% of the drugs in World Health Organisation's (WHO) list of essential drugs are already out of patent, and will continue to be available at current prices. And there are several therapeutic equivalents available for the rest. There are, for example, over a dozen categories of anti-hypertensives.

Also, the National Pharmaceutical Pricing Authority (NPPA) will keep on monitoring medicine prices.

As such, medicines contribute to only about 15% of healthcare expenditure. The bulk of the expenditure (85%) comes from diagnostic tests, hospitalisation, doctor's consultation fees, etc.

Therefore, this obsession with medicine prices in India is not warranted. One of the ways to resolve this issue is to aggressively privatise health insurance so that the public can be reimbursed for the medicines they buy.

The taxes and duties on medicines are also quite steep and amount to about 37% to 40% of their total price. These taxes need to be drastically cut, so as to make medicines affordable.

A debate is also being raised about the criteria for patentability. This, again, is a needless controversy. Apart from the new chemical entities (NCEs), Novel Drug Delivery Systems (NDDS), polymorphs, chiral molecules, etc. should also be patentable.

In fact, drug discovery is a very expensive, lengthy and risky process and India's strength lies in such incremental innovations.

Hence, if the invention meets the criteria of novelty, non-obviousness and utility, it should be patentable. Many of our large, and mid-size, companies have successfully taken out patents in the US on incremental innovations like these, and they should be encouraged

Another issue is about pre-grant vs post-grant opposition. As of now, after the patent controller's examination for patentability any member of the public has the right to make objections. And the objector is treated as a party and has a right to participate in all the proceedings in the grant of the patent.

In contrast, most of the developed world honours only post-grant opposition. This is because it has been found that pre-grant opposition often results in frivolous objections delaying the patent process.

Even in developed countries, only a small percentage (7% to 8%) patents have been opposed. India, therefore, should opt for post-grant opposition. That would ensure that the granting of patents, and hence the introduction of new medicines, is not delayed on frivolous grounds .

India is also becoming a destination of choice for outsourcing many pharmaceutical processes such as clinical trials, custom synthesis, bio-informatics, research & development (R&D), etc.

For this process to gain momentum it is important that the data generated in such activities needs to be protected from unfair commercial use as it is an integral part of IPR. India should, therefore, opt for a minimum of five years of data protection - as many developed countries do - to increase comfort levels.

If India is aspiring for 8% to 10% of GDP growth, which is doable, and is poised to play its rightful role in the knowledge economy, there is no better way to achieve this goal than to honour IPRs.