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FOREWORD
September 2006 Foreword from Dr A D Damodaran
Greetings and
September 2006, Foreword
Dear Sirs/Friend,
Sub: Foreword
www.patentmatics.org, September 2006.
1.The Indo-US Nuclear Deal was becoming curiouser and curiouser over
the months – with US Congress passing with a thumping majority a
Bill which was certainly going to bind India hand-to-head-to-foot in
her future activities and yet the GOI choosing to wait for the “end
product” to even express its views on the legislative steps going on
in the “partner-country”! Then came the big avalanche’, with so much
water flowing down the river Yamuna. With the main opposition party
submitting its representation in writing to Rashtrapathiji against
the Deal and the CPI (M) led Left demanding that parliament alone
set the terms for negotiations, national politics was steadily
taking a totally new turn. Then came the public statement
signed by three retired
AEC
Chairmen and their very senior erstwhile colleagues from BARC, IGCAR
and NPCIL addressed to all parliamentarians demanding that the deal
needed a total dress-down. Thanks to such a political-technological
consensus against the deal, perhaps the first such event ever
happening in post-independent India (?), PM finally agreed for a
detailed discussion in the houses of parliament to be followed by
his own written reply statement.
He also opted to meet the senior scientists and in a bid to allay
apprehensions, the Prime Minister, Dr Manmohan Singh, on Saturday,
August 26, assured them that no changes would be allowed in the
Indo-US civil nuclear co-operation deal and sought their help in
taking advantage of the initiative to end nuclear apartheid. The
Prime Minister's assurance came during a 90-minute meeting with the
country's top nuclear scientists at his residence. "The
scientists reiterated their concerns about the changes being sought
by members of the US Congress to the July 18, 2005 joint statement
issued by the US President, Mr George W. Bush, and the Prime
Minister Dr Singh," a PMO statement said. The Prime Minister in turn
reiterated the assurances he had given to Parliament in this regard.
The Prime Minister also asked the Department of Atomic Energy and
the National Security Advisor to remain in touch with the scientists
and take their advice while negotiating the safeguards agreement and
the India-specific additional protocol with the IAEA” to quote PTI.
2.September Issue of Patentmatics has reproduced many relevant
documents for use by readers engaged in serious study of this
epoch making event in modern India’s S&T history, including
the Joint Statement by the Senior Nuclear Scientists and the very
exhaustive three-part Series by the veteran journalist-cum
politician Arun Shourie published in Indian Express written with
very pain-staking precision on many a crucial issue covered by the
US Congress-approved Bill and PM’s statement in Rajya Sabha. Even at
the cost of repetition, the major points raised therein by the top
nuclear scientists, and which must continue to be put to very close
scrutiny, are:
“(a) India should
continue to be able to hold on to her nuclear option as a strategic
requirement in the real world that we live in, and in the
ever-changing complexity of the international political system. This
means that we cannot accede to any restraint in perpetuity on our
freedom of action. We have not done this for the last forty years
after the Non-Proliferation Treaty came into being, and there is no
reason why we should succumb to this now. Universal nuclear
disarmament must be our ultimate aim, and until we see the light at
the end of the tunnel on this important issue, we cannot accept any
agreement in perpetuity.
(b)After 1974, when
the major powers discontinued cooperation with us, we have built up
our capability in many sensitive technological areas, which need not
and should not now be subjected to external control. Safeguards are
understandable where external assistance for nuclear materials or
technologies are involved. We have agreed to this before, and we can
continue to agree to this in the future too, but strictly restricted
to those facilities and materials imported from external sources.
(c)We find that the
Indo-US deal, in the form approved by the US House of
Representatives, infringes on our independence for carrying out
indigenous research and development (R&D) in nuclear science &
technology. Our R&D should not be hampered by external supervision
or control, or by the need to satisfy any international body.
Research and technology development are the sovereign rights of any
nation. This is especially true when they concern strategic national
defence and energy self-sufficiency.
(d) While the
sequence of actions to implement the cooperation could be left for
discussion between the two governments, the basic principles on
which such actions will rest is the right of Parliament and the
people to decide. The Prime Minister has already taken up with
President Bush the issue of the new clauses recommended by the US
House of Representatives. If the US Congress, in its wisdom, passes
the bill in its present form, the ‘product’ will become unacceptable
to India, and, diplomatically, it will be very difficult to change
it later. Hence it is important for our Parliament to work out, and
insist on, the ground rules for the nuclear deal, at this stage
itself.
(e) We therefore
request you, the Parliamentarians, to discuss this deal and arrive
at a unanimous decision, recognizing the fundamental facts of
India’s indigenous nuclear science & technology achievements to
date, the efforts made to overcome the unfair restrictions placed on
us and the imaginative policies and planning enunciated and followed
in the years after Independence. The nation, at this critical
juncture, depends on its representatives in Parliament to ensure
that decisions taken today do not inhibit our future ability to
develop and pursue nuclear technologies for the benefit of the
nation” (emphasis added – ADD),
to quote from the
joint statement of Former AEC Chairmen and their senior erstwhile
colleagues.
3.Prime Minister in his
reply in Rajya Sabha said: “the proposed US legislation on nuclear
cooperation with India will not be allowed to become an instrument
to compromise India’s sovereignty… No legislation enacted in a
foreign country can take away from us that sovereign right. Thus
there is no question of India being bound by a law passed by a
foreign legislature. …(On the July 18, 2005 Joint Statement and the
March 2, 2006 Separation Plan), I would like to state categorically
that there have neither been nor will there be any compromises on
this score and the Government will not allow such compromises to
occur in the future… We have concerns over both the House and Senate
versions of the Bill…(On Full Civil Nuclear Cooperation), the
central imperative in our discussions with the United State on Civil
Nuclear Cooperation is to ensure the complete and irreversible
removal of existing restrictions imposed on India through iniquitous
restrictive trading regimes over the years. We seek the removal of
restrictions on all aspects of cooperation and technology transfers
pertaining to civil nuclear energy ‑ ranging from nuclear fuel,
nuclear reactors, to re-processing spent fuel, i.e. all aspects of a
complete nuclear fuel cycle. This will be the surest guarantee of
India’s acceptance as a full and equal partner of the international
nuclear community, even while preserving the integrity of our three
stage nuclear programme and protecting the autonomy of our
scientific research and development. We will not agree to any
dilution that would prevent us from securing the benefits of full
civil nuclear cooperation as amplified above…. I had earlier assured
the House that reciprocity is the key to the implementation of our
understanding contained in the July 2005 Statement. I stand by that
commitment. …India and the United States have held one round of
discussions on a proposed bilateral cooperation agreement. India and
the IAEA have held technical discussions regarding an India-specific
Safeguards agreement. Further discussions are required on both these
documents. While these parallel efforts are underway, our position
is that we will accept only IAEA safeguards on the nuclear
facilities, in a phased manner, and as identified for that purpose
in the Separation Plan only when all nuclear restrictions on India
have been lifted. On July 29 last year, I had stated that before
voluntarily placing our civil nuclear facilities under IAEA
safeguards, we would ensure that all restrictions on India have been
lifted. There has been no shift in our position on this point… The
draft Senate Bill requires the US President to make an annual report
to the Congress that includes certification that India is in full
compliance of its non‑proliferation and other commitments. We have
made it clear to the United States our opposition to these
provisions, even if they are projected as non‑binding on India, as
being contrary to the letter and spirit of the July Statement. We
have told the US Administration that the effect of such
certification will be to diminish a permanent waiver authority into
an annual one. We have also indicated that this would introduce an
element of uncertainty regarding future cooperation and is, not
acceptable to us. …. The July Statement had acknowledged that India
should be regarded as a State with advanced nuclear technology
enjoying the same advantages and benefits as other states with
advanced nuclear technology, such as the US. The July Statement did
not refer to India as a Nuclear Weapons State because that has a
particular connotation in the NPT but it explicitly acknowledged the
existence of India’s military nuclear facilities. It also meant that
India would not attract full‑scope safeguards such as those applied
to Non‑Nuclear Weapon States that are signatories to the NPT and
there would be no curbs on continuation of India’s nuclear weapon
related activities. In these important respects, India would be very
much on par with the five Nuclear Weapon States who are signatories
to the NPT. Similarly, the Separation Plan provided for an
India‑specific safeguards agreement with the IAEA with assurances of
uninterrupted supply of fuel to reactors together with India’s right
to take corrective measures in the event fuel supplies are
interrupted. We have made clear to the US that India’s strategic
programme is totally outside the purview of the July Statement, and
we oppose any legislative provisions that Mandate scrutiny of either
our nuclear weapons programme or our unsafeguarded nuclear
facilities…the March 2006 Separation Plan provides for an
India‑Specific Safeguards Agreement with the IAEA, with assurances
of uninterrupted supply of fuel to reactors that would be placed
under IAEA safeguards together with India’s right to take corrective
measures in the event fuel supplies are interrupted. We, of course,
have the sovereign right to take all appropriate measures to fully
safeguard our interests. An important assurance is the commitment of
support for India’s right to build up strategic reserves of nuclear
fuel over the lifetime of India’s reactors. We have initiated
technical discussions at the expert level with the IAEA on an
India‑Specific Safeguards Agreement. Both the Bilateral Nuclear
Cooperation Agreement with the United States and the India-Specific
Safeguards Agreement with the IAEA would be only within the
parameters of the July Statement and the March Separation Plan.
There is no question of India signing either a Safeguards Agreement
with the IAEA or an Additional Protocol of a type concluded by
Non‑Nuclear Weapons States who have signed the NPT. We will not
accept any verification measures regarding our safeguarded nuclear
facilities beyond those contained in an India-Specific Safeguards
Agreement with the IAEA. Therefore there is no question of allowing
American inspectors to roam around our nuclear facilities. …. In my
statement of March 7, 2006, I had assured Parliament that the
Separation Plan would not adversely affect our strategic programme.
I reiterate that commitment today. The Separation Plan has been so
designed as to ensure adequacy of fissile material and other inputs
for our strategic programme, based on our current and assessed
future needs. The integrity of our 3‑Stage nuclear programme will
not be affected. The autonomy of our Research and Development
activity, including development of our fast breeder reactors and the
thorium programme, in the nuclear field will remain unaffected. We
will not accept interference by other countries vis-à-vis the
development of our strategic programme. We will not allow external
scrutiny of our strategic programme in any manner, much less allow
it to be a condition for future nuclear cooperation between India
and the international community…we are not willing to accept a
moratorium on the production of fissile material. We are only
committed to negotiate a Fissile Material Cut-off Treaty in the
Conference on Disarmament in Geneva, a commitment that was given by
the previous government. India is willing to join only a
non‑discriminatory, multilaterally negotiated and internationally
verifiable FMCT, as and when it is concluded in the Conference on
Disarmament, again provided our security interests are fully
addressed…There is provision in the proposed US law that were India
to detonate a nuclear explosive device, the US will have the right
to cease further cooperation. Our position on this is unambiguous.
The US has been intimated that reference to nuclear detonation in
the India-US Bilateral Nuclear Cooperation Agreement as a condition
for future cooperation is not acceptable to us. We are not prepared
to go beyond a unilateral voluntary moratorium on nuclear testing as
indicated in the July Statement. The same is true of other intrusive
non‑proliferation benchmarks that are mentioned in the proposed US
legislation. India’s possession and development of nuclear weapons
is an integral part of our national security. This will remain so….
international negotiation on nuclear energy cooperation particularly
when it involves dismantling restrictive regimes that have lasted
for over three decades is a complex and sensitive exercise. What we
are attempting today is to put in place new international
arrangements that would overturn three decades of iniquitous
restrictions. It is inevitable, therefore, that there would be some
contradictory pulls and pressures. This does not mean that India
will succumb to pressures or accept conditionalities that are
contrary to its national interests. …. I can assure you that there
is no ambiguity in our position in so far as it has been conveyed to
the US. The US is aware of our position that the only way forward is
strict adherence to July Statement and March Separation Plan. I am
hopeful that the bilateral India‑US Civil Nuclear Cooperation
Agreement when concluded will take into account the issues raised
here. However, I must be honest and frank that I cannot predict with
certainty the final form of the US legislation or the outcome of
this process with the NSG, which consists of 45 countries with
divergent views. We are hopeful that this will lead in a direction
wherein our interests are fully protected and that there is a
complete lifting of restrictions on India that have existed for
three decades. Such an outcome if it materializes will contribute to
our long‑term energy security by enabling a rapid increase in
nuclear power. It would lead to the dismantling of the technology
denial regimes that have hampered our development particularly in
hi‑tech sectors…. I will have wide consultations including
with the members of the Atomic Energy Commission, the nuclear and
scientific communities and others to develop a broad based national
consensus on this important matter. I wish to inform members of the
House that I have invited members of the Atomic Energy Commission on
the 26th August for a meeting. That same day I have also invited the
group of distinguished scientists who have expressed concerns to
meet me (emphasis added – ADD). …. Finally, I would only
like to state that in keeping with our commitments to Parliament and
the nation, we will not accept any conditions that go beyond the
parameters of the July 18, 2005 Joint Statement and the March 2,
2006 Separation Plan, agreed to between India and the United States.
If in their final form the US legislation or the adapted NSG
Guidelines impose extraneous conditions on India, the Government
will draw the necessary conclusions, consistent with the commitments
I have made to Parliament…. It is clear that if the final product is
in its current form, India will have grave difficulties in accepting
the bills. US have been left in no doubt as to our position. The
ground rules for our discussions are clear. These are the parameters
of the July Statement and the March Separation Plan and commitments
given by me to Parliament in the three Suo Moto Statements and my
reply to today’s discussions will be the guiding principles of our
position. Parliament has been kept fully informed at every stage of
the discussions. In their final form, if US legislation or the NSG
guidelines impose extraneous conditions on India, the Government
will draw the necessary conclusions consistent with my commitments
to Parliament”.
4.In spite of the
comprehensive policy statement by PM in the Rajya Sabha, Shri Arun
Shourie has raised a number of serious issues in his three-parts
series, some of the most crucial ones of which are as follows:
(a) The most influential
voice has been that of scientists. And in that lies an important
lesson that transcends the nuclear deal…they are the ones who over
the decades built our nuclear capability. They are the ones who
know. That is why what they had to say on the nuclear deal just
could not be ignored…. because they are professionals. Credibility
has passed from the political class to the
professionals…professionals should exercise the authority that has
fallen to them and speak up on issues that are their specialty. When
they fail to do so, they fail the country.
(b) If GOI did everything
consistent with the 18 July agreement, did anyone going through the
18 July statement deduce that such a critical reactor like CIRUS
would be closed down as a consequence? In other words, ambiguous
statements would not do in a case like this, however genuine they
may appear!
© In India, the power to
enter into international agreements and treaties rests solely with
the Executive, Parliament may discuss them, but it can do nothing
about them – short of throwing out the government and the next
government repudiating them, again only on its own authority. But in
US, the Senate has the ultimate authority. President Clinton twisted
the arm of many a government to sign up the CTBT, his own senate
threw it out! In other words, to wait “till the final outcome
becomes available” would be to close all options!
(d)Years earlier the Dabhol agreement
was projected as being vital for Indo-US relations. The nuclear deal
is being translated into concrete specifics in the US Senate and
House Bills, quite iniquitous in the extreme. In these
circumstances, to make the deal the test and symbol for improved
Indo-US relations is “to inject the vinegar that will sour the
relations again”. In a word, what a government does has to be
assessed and defended on merits. And it is this, which had come to
cause the gravest apprehensions.
(e)In Par 2 of the series, Arun Shourie
has analyzed the US approved Bill in great detail from legal points
which must be assessed very carefully when the deal is taken to the
next stage. Details, please see on the patentmatics website under
“publications” and the author strongly contests on what GOI
continues to describe as “parity”.
(f)US Secretary of State Condoleeza’s
repeated proclamations that “India is not and is not going to become
a member of the NPT as a nuclear weapons state. We are simply
seeking to address an untenable situation. …India has never been a
party to NPT…But this agreement does bring India into the
non-proliferation framework and thus strengthen the regime” and “We
do not support India joining NPT as a nuclear weapon state. Rather,
the goal of our initiative is to include India, for the first time
ever, in the global non-proliferation regime. By requiring India to
place two-thirds of the existing and planned nuclear reactors under
the watchful eyes of IAEA, the initiative would be a net gain for
the cause of non-proliferation”. In other words, negotiations on the
India –specific safeguards with IAEA (US Bill insists that it should
be based on the Model Additional Protocol “as set forth in IAEA
Information Circular (INFCIRC) 540”) are not going to be that
“India-friendly” anyway!
(g) While we fantasize about “parity”,
the US aims to acquire us in the form of an “ally”, an instrument,
seeking “energy security” by making herself dependent on imported
reactors and imported uranium.
And many more such serious
India-specific commitments described exquisitely through extensive
quotations from the US approved Bill itself!
6. Dr MR Iyer, one among the
very few retired DAE scientists with also
experience of working in IAEA as a Safeguards Inspector,
adds a few extremely technical issues to the problem. To quote him
on the Deal, “Contrary to what the PM has assured, the (US) bill has
several implicit clauses which will put the country in difficult
times ahead both politically and technically…The bill may also lead
to technical problems, unpleasant situations and by and by lead to
increasing controls on the country’s nuclear options and
independence when it comes down to the level of IAEA inspectors and
those who have to face them. These have to be pre-emptied by strong
diplomatic measures to remove those clauses, which are likely to put
restrictions and ensure that nothing beyond the July 17 agreement is
conceded. Otherwise US will be successful in indirectly making India
a signatory to all the 3 treaties - NPT, CTBT, and FMCT in one
stroke. Even US has not ratified the CTBT and FMCT is still being
discussed. The separation of civilian and strategic facilities in
the Indian atomic energy program is in itself very complicated since
the two are intertwined under the way in which these have evolved.
If some facility under safeguards happens to have some links to an
un-safeguarded facility, it can lead to uncomfortable complications
with the IAEA at a future date. Similarly an R&D institution coming
under safeguards may face unnecessary procedural problems if it
undertakes some fundamental research, which may have some relevance
for strategic applications. There is
another possible complication in arriving at a safeguard agreement
with IAEA. The “Additional Protocols” of a Safeguard agreement could
be sometimes deeply intrusive and uncomfortable! Further, the IAEA
which is an International body with its mandate and statute from UN
and its multi-national governing body, there is no provision to
consider India as a special case having both safeguarded civilian
installations and un-safeguarded weapon related institutions. This
type of treatment under its mandate is reserved only the 5 nuclear
weapon states. In its current protocols IAEA will not consider India
as a weapon country but as a non-weapon country. Dealing with India
thus needs a change in the mandate for the IAEA from its Board. How
practical this will be is to be seen when India tries to hammer a
safeguard agreement with IAEA which is an obligation under the Indo
USA treaty and calls for in depth negotiations. Contrary to what is
being reported, fuel reprocessing and enrichment may not be covered
by the agreement since these will have relevance to strategic
activities and no hardware/technology is likely to be available for
these. By all accounts the US-India nuclear cooperation bill targets
at limiting or even freezing the nuclear weapon production
capability of India which could get enhanced indirectly as a result
of the nuclear civil cooperation either by making available more
indigenous uranium or technology. By offering supply of these
technologies or hardware that purpose will be defeated even if they
are in the civil domain. Sitting on the other side, an IAEA
inspection strategist will demand that how such technology passed on
for civil uses can be prevented to be used in strategic applications
since the stress even after an agreement will be to ensure that the
external assistance is not in anyway utilized in enhancing India's
weapon production capability. And there cannot be a watertight
compartment for technologies and equipments. Both can be easily
copied. It may be noted that a classical IAEA inspection involves
full flow chart with material input output measurement and
accounting at each stage to detect any possible diversion. Why the
scientific community is nervous about placing the fast reactor
program under safeguards is that an essential element of this
program is home grown reprocessing involving thorium cycle in which
there is no other country has interest or expertise. In so far as
the reactors are concerned this fall under 2 categories – the PHWR
type of our own development and the imported PWR (similar to the
Tarapur/Koodamkulam rectors). The first is a heavy water type for
which apart from India only Canada has the expertise. In any case
the blockade for imported items for our Centers such as BARC, IGCAR
etc will continue as at present and being “strategic” institutions
no imported equipment will be available for the programs in these
centers but a large part of their activities will continue to be non
strategic. In effect what we will be gaining is some nuclear power
stations with imported technology and fuel and fuel supply for some
of our own designed power stations. Most probably what we will not
be getting is hardware/technology for the other nuclear fuel cycle
applications and the agreement may result in several restrictions on
adopting our own nuclear cycle options. Even with the addition
of the installation of additional nuclear power capability the
percentage of nuclear power production is expected to be hovering
around 10% for some time to come. Are we not compromising too much
for too little?”(Emphasis added – ADD)
7. Added to these are
factors which question the very economic viability itself of
imported nuclear reactors, spares and accessories and recurring fuel
assemblies, which is yet to be assessed before choosing the imported
nuclear power to solve the nation’s Energy Security Issues,
as repeatedly raised through the yearlong columns of
patentmatics itself including the need for the parliament to amend
1962 Indian Atomic Energy Act and make it TRIPS-consistent and
making nuclear materials and systems as defined therein also
patentable, as and when the Indo US Deal is to be implemented by
India!!
8. Last but not
the least, a quick look at the history and historical transformation
of IAEA itself is significant in today’s context. After the
successful Manhattan Project resulting in the first ever-atomic
explosion in the deserts of New Mexico and the use of the dreadful
weapon against Japan in Hiroshima and Nagasaki, international
politics underwent a totally new reorientation. Such as process was
further accentuated by two more developments. First was the former
Soviet Union testing successfully testing the first nuclear weapon
in 1949 and then in August 1953 its first thermonuclear device. With
China also going over to the socialist world along with Soviet Union
and East Europe, the need for some sort of a nuclear détente was
becoming increasingly felt among the Western powers, thanks to the
growing tension between the dominant political philosophies by the
US and the Soviet Union. And the now famous Atoms for Peace speech
of President Dwight D.Eisenhover in a way reflected the new needs in
international relationships. Quoting from the Lawrence Livermore
National Laboratory publication Science & Technology March 2004,
“On December 8,1953, in
an address to the United Nations General Assembly, President Dwight
D.Eisenhover called upon all world leaders to move toward peaceful
rather than destructive uses of nuclear technology. He said that
nuclear technology ‘must be put into the hands of those who will
know how to strip its military casing and adapt it to the arts of
peace”. He proposed also modest steps “to initiate a relationship
with the Soviet Union which will eventually bring about a free
intermingling of the peoples of the east and the west- the one sure
human way of developing the understanding required for confident and
peaceful relations”. He also proposed, according to the above
source, that an “international atomic energy agency” be created so
that “Experts would be mobilized to apply atomic energy to the needs
of agriculture, medicine and other peaceful purposes (and) a special
purpose would be to provide abundant electrical energy in the
power-starved areas of the worls”. Though thus conceived within such
an “Eisenhower Nuclear Peace Doctrine”, ground reality was not to be
so more or less from the beginning. India under Jawaharlal Nehru was
one among the first to realize the future geopolitical implications
of the nuclear technologies and their potential fall-outs.
Accordingly, to quote from the “This Day That Age” column of The
Hindu dated October 8,2005,
“India has proposed that
the projected International Atomic Energy Agency for developing
peaceful uses of atomic energy should be responsible to the UN
General Assembly. The proposal was tabled in the UN Political
Committee on October 7. India also recommended that the constitution
of the Agency should be approved by the Assembly and based upon
views expressed in the Assembly itself. Both proposals were in
direct conflict with the stated views of the US and other Western
powers, which have already drawn up a statute for the agency. The US
view is that the relationship of the agency of the UN should be
similar to that of a specialized agency, such as World Health
Organization or the Food and Agriculture Organization”.
In other words, IAEA was to be only
that much ‘democratic’ in its operation at least as per its
constitution! All the same it cannot be denied that with all its
limitations, IAEA has worked as a veritable international
organization in its chosen field and from which a number of
developing countries including India has benefited significantly. US
emerging since 1990s as more or less a monopoly superpower, the role
of IAEA has increasingly been getting steadily partisan; and its
image suffered irreparable damage after the role it played in Iraq
and was to do the same again in Iran! In essence, there is every
justifiable apprehension among the minds of many developing nations
that “IAEA Inspection” need not be all that was as originally
envisaged! In other words, when India enters into an agreement with
a superpower like US within well-laid out IAEA-led inspection
schedules, there could be genuine fears as to how much intrusive
those inspection modalities could be, some of which has been hinted
by an experienced Safeguards Inspector like Dr Iyer earlier!
9. Now that the Prime
Minister has assured the nation through its parliament that India’s
interests would not be sacrificed at any cost, we have to await
further developments.
10.
The saga of litigation on Novartis' cancer drug Glivec is far
from over, an issue which has been one of great concern and about
which so much has been highlighted by patentmatics ever since it
became so under the TRIPS-dictated New
IPR Regime. The
company has recently filed multiple writs at the Madras High Court
against the Patent Controller's decision to reject Novartis' patent
application on Glivec, besides seeking an interim stay, among other
things. The writ was filed against the Chennai Patent Office's order
of January 2006 that rejected Novartis' patent application on Glivec,
following the independent pre-grant oppositions filed by the Cancer
Patients Aid Association and a clutch of domestic drug-makers. The
Swiss-based drug major has also contested some of the considerations
based on which the Patent Office rejected Novartis' patent
application. This includes Section 3 (d) of the Patents Act 1970 as
amended by the Patents (Amendment) Act 2005. The Chennai Patent
Office had rejected Novartis' patent application using, among other
parameters, Section 3 (d) of the Indian law. This meant that
Novartis' Glivec was not significantly different in properties from
an existing compound, though there was a 30 per cent increase in the
bioavailability of this drug over the existing version. Another
contention by generic companies (that made similar versions of
Glivec) is that Novartis's Glivec was known before 1995 and hence
did not merit a patent. Glivec or Gleevec is the brand name under
which Novartis' cancer drug `imatinib mesylate' was sold. And,
the drug has been attracting controversy and litigation ever
since it was given an Exclusive Marketing Right in 2003, in a build
up to the product-patent regime in 2005. The drug is used to
treat Chronic Myeloid Leukemia, but its pricing has been a thorny
issue. The international price of Novartis' drug costs a patient
about $27,000 for a one-year course, while the generic price is
about $2,700. That estimates to about Rs 1 lakh a month for Novartis'
Glivec, while the copy-cat versions cost the patient about Rs
10,000-odd per month. Natco, Cipla, Ranbaxy and Hetero are some of
the domestic companies making generic versions of Glivec.
When India adopted
the product-patent regime in January 2005, Novartis obtained a stay
against some of these local companies that were marketing similar
versions of the drug. And when the Patent Controller rejected
Novartis' patent application, these companies set about vacating the
stay on their drug. Novartis' recent writ at the Madras High Court
is the latest in this saga. As Novartis goes though with the legal
procedures in Chennai on August 22, 2006 cancer patient groups and
representatives of non-government organisations held demonstrations
at Novartis' office in Mumbai.
The Glivec case will
set a precedent for several life-saving AIDS and cancer drugs,
observes Mr Y.K. Sapru, Founder-Chairman of the Cancer Patients Aid
Association (CPAA), one of the organisations locked in a legal
battle with Novartis over Glivec. Companies should be discouraged
from re-working an old drug and patenting it, he added. Some of the
domestic players making similar or generic version of Glivec include
Natco, Cipla, Ranbaxy and Hetero. Globally Glivec grossed about $
2.9 billion in sales. Novartis officials, however, point out that
they give Glivec free to needy patients. The company has claimed
that it has given free Glivec, worth over Rs 1,200 crore to about
5,700 patients, as reported by Business Line. CPAA's Ms
Shubha Maudgal points out that the concern further extends to other
drugs. MabThera from Roche costs over Rs 1 lakh and is given in
about six cycles; Roche's Herceptin costs about Rs 1 lakh a month
and so does its Avastin, she said. Taxol from Bristol Myers Squibb
costs about Rs 70,000 per cycle, she added, pointing out the
unaffordability of these drugs. And a drug like Glivec needs to be
taken life-long, she said.
11. The glivec
case has been highlighted only to bring home the crucial issue that
under the New Patent Regime, the costs of many more drugs (and
perhaps agrochemicals too) will go beyond the reach of the most,
affected by such dreadful diseases (except for those for whom “India
Shines!). In other words, the national campaign for an
Appropriate Patent Regime must assume far wider effectiveness than
that at present. In line with its cherished task, its September
Issue is publishing a number of patents-related articles for the
benefit of its serious readers.
12. If this is so for
medicines, future effects of IPRs on the food
front, the security of which is increasingly to be met from now
onwards through import-based “ship-to-mouth strategy”, to quote Prof
M S Swaminathan himself, also could be challenging, if
adequate steps are not taken in time and effectively. New
and better varieties of wheat plants are being developed and
patented abroad. Research teams from the International Rice Research
Institute (IRRI) in the Philippines and the University of
California's Davis and Riverside campuses have discovered a rice
gene that allows the crop to survive complete submergence in water,
with no compromise to yield. This discovery will pave the way to the
development of rice varieties that can withstand flooding, a common
problem in many rice-growing countries. Although rice is grown in
standing water, it will die if it is completely submerged for more
than a few days. However, weed populations decreased if rice is left
in water. The isolated gene, designated
Sub1A,
can therefore buy farmers time and reduce herbicide use. The
research team is now trying to identify all the genes that are
regulated by
Sub1A, to
use this information to further improve tolerance to flooding and
other stresses.
13. Last but
not the least, the warning words of none other than Shri Narayana
Moorthy need not be mind-boggling: "I keep telling my
colleague Nandan (Nilekani, CEO of Infosys) that it's funny in this
country that we can buy whatever BMWs. We can have 800 channels on
TV," the Chairman and chief mentor of Infosys said.” But the real
progress in India has not taken place simply because the reforms
have not touched the poor people," he said at a book release
function.
14.Thanks to the
major Indo-US Nuclear Issue, the foreword has turned out to be
unusually long; kindly bear with it.
With best wishes and
looking forward to your continued encouragements,
Yours truly,
A D Damodaran.
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