|
Though amendments to the Patents Act, 1970 are likely
to made known only after the government tables it in
the Winter session of Parliament, domestic and MNC players
are warring to preempt provisions that could hurt them.
The latest axe to grind is a letter to Finance Minister
P. Chidambaram by the Indian Pharmaceutical Alliance
(IPA). In a November 24 letter, the IPA has argued against
'evergreening' (evergreening is when patent owners attempt
to extent the patent monopoly by seeking a new patent
that updates the first one before its expiry).
Written by H.F. Khorakiwala, Wockhardt Chairman and
IPA President, it says big pharma players misuse 'evergreening'
to keep modified versions of their patented drugs in
the market, even after the original drug goes off-patent.
IPA says, domestic industry can capture one-third of
the global generics trade - or exports worth Rs 90,000
crore by 2010 - if only India's new TRIPS-compliant
Patents Act keeps 'evergreening' at bay.
''We're saying, we don't need to introduce those drug
patents in India as it could harm consumers and domestic
players,'' says D.G. Shah, IPA Director-General.
But pharma MNCs have reacted angrily to IPA's assertions.
"Yes, generics are a key strength of home-grown
pharmas; but no, exports will not suffer if new forms
of already patented drugs are patentable," is their
refrain.
''Intellectual Property Rights will not have a major
impact on overall revenues in India,'' says S. Ramakrishna,
Senior Director, Corporate Affairs, Pfizer Ltd, citing
an Indian Drug Manufacturers' Association report on
which CMIE, FDA and BCG collaborated.
''Exports are 40 per cent of India's total pharma revenues,
but generics were 90 per cent of total exports in 2000-01.
And 25 of India's top 30 export destinations are WTO
member countries, leaving no more than 10 per cent of
overall export revenues likely to be affected by product
patents,'' says the report.
Ramakrishna says 3 per cent of India's drug market comprises
drugs under patent. So domestic growth is being driven
by patented and older molecules as well as their extensions
- the same growth IPA opposes in its letter, he adds.
''We understand the capabilities of Indian industry
in incremental improvement to drugs. But we're saying,
why introduce these drugs in India. Take them to the
US and EU so that Indian consumers don't suffer,'' says
Shah.
But Ramakrishna voices a common apprehension of MNCs:
That a future Patents Act may not incentivise improvements
on existing and known innovations. ''The Act should
not limit patent protection solely to New Chemical Entities.
India has skills and inventiveness for research that
is fundamentally incremental,'' he says.
The clincher, however, is the 4,200 new patent applications
for modified patented drugs filed by Indian companies
like Ranbaxy, Cipla and Wockhardt, according to the
PCT database. Of these, 55 per cent are for incremental
innovations. Ranbaxy's 239 applications alone have 122
for incremental improvements.
|