[Ip-health] What changes does the Indian Patent Act need? View-1

[Ram]

Different perspectives on the proposed changes in the Indian Patent
Act  that appeared in the Economic Times today.

Given below is the view of the Organisation of Pharmaceutical
Producers of India(OPPI)- "Ram" (Prabhu Ram)


What changes does the Indian Patent Act need?

Ajit Dangi
Director General
Organisation of Pharmaceutical Producers of India.

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 =E2=80=94 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 =E2=80=94 as
many developed countries do =E2=80=94 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.

Story Link: http://economictimes.indiatimes.com/articleshow/965905.cms