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Vol.
XXIX No. 14
April 03,
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Patents
Amendments & The International NGOs
Prabir
Purkayastha
THE
criticism emanating from the global activists and international NGOs regarding
the Indian Patents Amendments Act seems to lack certain clarity. Are they
arguing that India should have rejected unilaterally the flawed Trade Related
Intellectual Property Rights (TRIPS) framework that mandates product patents and
continued with its process patent regime? Or are they arguing that India has put
in a particularly bad Patents Act within the TRIPS framework?
From
Medicines Sans Frontiers (MSF) and Oxfams talk of Indias betrayal of the
global poor, the uninitiated might conclude that the recently amended Indian
Patents Act is the culprit, while what perhaps they really wanted was for India
to continue with process patents and step out of TRIPS. While this is a
perfectly legitimate demand, not to state it as such is either ignorance or
deliberate obfuscation. These international NGOs also seem not to have
registered the number of Amendments that the government was forced to
incorporate under the pressure of the Left parties in Parliament. Without
addressing either the TRIPS framework or examining the amendments that have now
been put in place, general criticism of the revised Patents Act comes easy but
does not help shed much light.
BROAD
PICTURE OF PATENT AMENDMENTS
Let
us first take the broad picture about the Patents Amendment Bill. It was the
third and final step (earlier amendments were in 1999 and 2002) in ending Indias
35-year old process patent regime and changing over to a product patent one.
This was the result of the 1995 WTO agreement of which TRIPS is a part. That the
world is now accepting the importance of the Indian process patent regime in
building a domestic industry that produced cheap, life saving medicines is
unfortunately belated wisdom. It would have been far more useful if this wisdom
had dawned during the 1986 to 1995 period when the TRIPS agreement was being
negotiated. Even though the Indian left and activist groups had mounted a fierce
campaign during this period (virtually without any support from the
international NGOs or the health activist community), India finally succumbed to
the pressure of the rich countries. Once TRIPS was accepted, India had
abandon the process patent regime that had served it so well, the only saving
grace being the 10-year grace period that the agreement allowed the developing
countries. The impact of TRIPS is now visible worldwide: the AIDS epidemic has
brought home, even if belatedly, the cost of putting MNC profits above human
lives.
The
issue is not that Indian generic drugs manufacturing will be harmed by the new
Patents Act as is being argued, but India finally accepting the product patents
regime and changing the Patents Act accordingly. Otherwise, it might appear that
we in India have put in place a Patents Act that is somehow far more restrictive
than what other countries allow, thus threatening the export of Indian generics,
so important in the fight against AIDS in Africa. This way of posing the problem
lets off the hook the real instigators of the global patents regime. And
obscures from the simple fact that India was the last holdout in the
product patents regime forced down the throat of the developing countries by big
pharma and the club of the rich.
TWO
CHOICES
The
question is what should have been the strategy of the activist groups and the
Left those who have been fighting against the products patents regime
once the 10-year grace period ended. Once the WTO agreement was put in place, India
had two choices: either stay put and not change its Patents Act facing the
consequences in WTO. Or try and fight a battle on two fronts: squeeze whatever
advantage it can of the limited safeguards in TRIPS and at the same time, fight
for the removal of TRIPS from WTOs ambit. It might be noted that these
flexibilities were not given as a charity by the rich countries, but exist
solely due to the pressure put by the developing countries during the long
1986-95 Uruguay Round negotiations.
If
we believe in the first, then there are obvious consequences. India would be
held to be a violator of the TRIPS agreement and would, as a first step, have
invited sanction on its pharmaceutical exports, and later, possibly cross-sectoral
sanctions. India would then also
have lost the ability to intervene in the larger WTO agenda where it has played
such a central role on behalf of G20 and G90 countries. Well-meaning
international NGOs need to ponder that finally, it would have also meant India
being unable to export its drugs to any country. Otherwise, the cynical might be
tempted to conclude that the international NGOs wanted India to walk out of
TRIPS so that its cheap, generic medicines would not threaten the worldwide MNC
markets.
The
second position fighting within WTO against TRIPS and using whatever
TRIPS provisions exist is a more complex strategy. It involves mounting an
attack on TRIPS itself using the review process that has now been committed in
Doha, while at the same time taking TRIPS to the edge. Let us also
recognise that the flexibilities within TRIPS is an open issue precisely because
very few countries have chosen to exercise them. Expanding their scope is an
important political task within TRIPS, for which the Indian Patent Amendments
provided an opportunity.
For
the Left, to reject the Patents Act would have been quite simple. The problem
for the Left and the groups involved in the struggle over the Intellectual
Property Rights regime is that an outright rejection of the Patents Amendments
would have meant a failure to expand on the limited flexibilities of TRIPS. The
Left could not argue for a rejection of the Product Patents regime and yet move
amendments to a Product Patents Bill. If
the Left had rejected the Ordinance and referred it to the Parliamentary
Committee, the chances are that the BJP and Congress would have combined as they
had in 2002 when the Left was forced to walk out of the Joint Parliamentary
Committee. Once BJPs grandstanding was over, it would certainly have reverted
to its earlier pro-patent stance. Therefore, the only window of opportunity of
extracting concessions from the UPA government was in passing an Amended Patents
Act incorporating as many changes as possible from those that the Left had been
advocating for the last five months. And this is the more difficult option that
the Left chose to exercise instead of the more knee-jerk, comfortable one of
outright rejection.
Here,
it must also be noted that earlier, the government had virtually refused to talk
about the patent amendments with the Left. Theirs was an obdurate stand that no
negotiations were necessary and they knew best what had to be done. It was only
the twin embarrassment of Goa and Jharkhand, and the realisation that the defeat
of the Patent Amendments in Parliament would be seen as another failure that
forced the government into a U-turn and grudging negotiations with the Left.
CONCESSIONS
TO THE LEFT FROM THE GOVT
Once
we accept that the arena of forcing a change in TRIPS and WTO is Geneva and not
New Delhi, we then need to examine whether the Left did succeed in extracting
major concessions from the government. Some of the changes that the Left wanted
incidentally pertain to the 2002 Amendments to the Patents Act introduced by the
NDA and not the current ones. The key issues were limiting what can be patented,
protecting the export of drugs such as retrovirals to Africa, the ability to
compulsorily license drugs if and when required, protecting the continued
production of drugs for which the drug companies have put in mailbox
applications, etc. A glance at the changes that the government has been forced
to accept will make clear that the Left has won major gains on all these counts.
These are:
-
Restrictions
on patentability
to prevent
the MNC tactics of ever-greening of patents: It is well known that big
pharma continues its patent monopoly beyond 20 years by introducing minor
modifications to the original pharmaceutical entity. Various restrictions
have now been put in the Patents Act to prevent such attempts.
No
software patenting: The Ordinance had provided for software patenting for any
computer program that has industrial application or is used in combination
with hardware. In the global struggle against software patenting, the Indian
Patents Act would have been a heavy blow. This has now been deleted from the
Act.
Restoration
of pre-grant opposition to patents: The Ordinance had shifted pre-grant
opposition of patents to a post grant one. This would have meant that patents
can be challenged by others only after it has been granted, in line with US
patenting procedures, which routinely grant frivolous patents such as on neem,
haldi, etc. The original provisions of pre-grant opposition has now been
restored.
Export
to other countries: Though the Ordinance had provided for allowing exports of
Patented drugs produced through compulsory license in the country to
developing countries with no manufacturing capacity, this clause had been
circumscribed by a provision that the importing country would have to obtain a
compulsory license. The amendments now clarify that the country concerned
would not require a compulsory license and can import from India through a
notification or if an export market for India already exists there.
Continued
manufacture of mailbox drugs: Possibly the biggest concern expressed was that
after the passing of the Ordinance, drugs which are being produced by Indian
companies and for which patent applications are pending in the mailbox, would
have to go off the market. Instead, the Amended Act has granted a virtual
compulsory license for all the 7,500 drugs in the mailbox that will allow
their continued manufacture with paying a “reasonable royalty”.
Strengthening
compulsory licensing provisions: There have been widespread concerns that the
process of grant of compulsory licenses to counter the monopoly of patents may
take too long and thus defeat the whole purpose for the same. This has been
addressed by the amendments by specifying that the “reasonable” time
period “shall not ordinarily exceed six months.”
In
addition, the government has also accepted the setting up a technical committee
to examine the issue of patenting of microorganisms and what constitutes new
entities under the Patents Act, after which more amendments can be put in place.
Perhaps more could have been extracted: there is after all always scope for
improvement. There are still major gaps that need to be plugged. The compulsory
licensing procedures need to be strengthened. But these are not insignificant
gains. Already, the European Commission is readying itself to take India to the
WTO Disputes Settlement on these issues. Similar moves are afoot in the US as
well. We would have to see what the global activist community then does. Will
they keep quiet on the moves of their Governments or line up with India on this
one? Or was their concern merely of taking India out of WTO and not the larger
one of taking TRIPS out of WTO?
We
need a global movement against TRIPS now that there is widespread acceptance
that it has been disastrous for the poor. This demands that the focus comes back
on where it should have been from the beginning the nature of the TRIPS
agreement and the completely unequal WTO regime. The most we can expect out of
an Indian Patents Act is the best of a bad TRIPS bargain. It is the bargain
itself that needs to be challenged.
