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FOREWORD
Dear Sirs/Friend,
Sub: Foreword, September 2005.
"INDIA should try to improve its maintenance of intellectual
property rights (IPR) if it wants to attract more American
investment in the biotechnology, pharmaceutical and clinical
research sectors, Dr David C. Mulford, US Ambassador to India", has
said. This was one area that required concerted action, he said,
addressing members of the Indian Chamber of Commerce and the
Indo-American Chamber of Commerce on Thursday. He said both India
and the US shared a major interest in science and technology and
India had proved itself to be a world-class player in these sectors.
"As IPR protection improves, US companies will become major
investors, contributing capital, top quality science and technology,
global management expertise, and new jobs," Dr Mulford said.
According to a recent interview of this year’s Magsasay Award
winner Dr S Shantha of the celebrated Adayar Cancer Institute,
around 800,000 new cases are being added to the list of cancer
patients annually in India and that too with the existing facilities
totally inadequate to meet the situation. Added of cource are the
new threats of cancer drugs going out of bounds of the needy common
and the poor under the new TRIPS dictated patents regime, whatever
be the claims of the authorities in being "fair" in the 2005 Act –
remember that the well known anticancer drug glivec is still not
available to the patients except through the courtesy/mercy of its
inventor Novartis, since the case is still resting with the Supreme
Court for its final decision even after the lapse of nearing two
years!
In between, the health activists, nay, even the Indian drug
companies, are getting increasingly weary of the 2005 Act itself as
things unfold. Whatever might have been their earlier views on TRIPS
and the "need for a compliant IPR regime", domestic pharma majors
are now increasingly led to fear that the new negative list on
patenting substances will only discourage even the ongoing
indigenous R&D for years to come. Since they are far from launching
a new chemical entity of their own, some of India’s largest pharma
companies are focussing on novel drug delivery systems (NDDS) for
the time being. According to the 2005 Act, these modifications will
be deemed to be the same substance unless they differ significally
in efficiency. While TRIPS treats invention as ‘patentable’ if it is
‘new’, ‘capable of industrial application’ and ‘involves an
inventive step’, the 2005 Act has limited the definition to only new
chemical molecule. Not surprisingly even companies such as Ranbaxy,
Biocon and Nicholas Piramal working on NDDS reportedly are worried
on this score! Is it that the 2005 Act is to be amended again to
allow ‘patent greening’ to offer IP protection to the NDDS ?
Obviously the issues continue to baffle all those
in the field. The article by the veteran BK Keayla highlights the
issues once again in his characteristically cogent manner
(Conclusion: The originators of inventions should get their just
reward by way of suitable royalties and there should be no grudge in
providing the same. Simultaneously the doors should be opened for
obligatory licensing involving the domestic enterprises in the
production of patented drugs. The profit driven model of the TRIPS
is not suited to the health needs of the developing and poor
countries. The amended Patents Act 1970 as in the present form is a
super profit driven Act. The suggestions made in this Paper are
within the framework of the TRIPS Agreement and crucial from the
public interest and role of domestic enterprises. A judicious and
careful implementation of TRIPS Agreement is needed for its smooth
application and balancing of rights and obligations of the patent
holders in a manner conducive to social and economic welfare as
stipulated in Article 7 of TRIPS Agreement. India can play an
effective role in the region about the availability of generic drugs
at reasonable prices by the pharmaceutical industry only after the
ignored issues are provided through further suitable amendments to
the Patents Act 1970. If the damage to the amending process of the
Patents Act is not undone, the public sufferings will soar to a
unimaginable extent.) and the one by Gopakumar et.al. summarises the
suggestions submitted to the RA Mashelkar Committee studying the
‘residual issues’ emanating from the 2000 Act as referred to by the
government arisining out of the discussions in the houses of
parliament during the approval of the said Act (Conclusion: We
suggest the limiting the scope of patentability is absolutely
necessary for India not only to address the public health concerns
but also for the survival of the domestic pharma industry. To
effectively limit the scope of patentability, the criteria of
novelty, inventive step and industrial application should be defined
as per national interests. This is to be done by amending the
definitions of patentability criteria in the present Patents Act.
Further, the definition of pharmaceutical substance to be replaced
with a new definition and this definition should then be linked to
the provisions and exclusions mentioned in Section 3 of theAct).
Interested readers would find the article "Inventions: A New
condition for Patentability" in TIFAC/IPR Bulletin as very
beneficial. A well researched paper from NBER on "Institutions and
Technological Innovation During the Early Economic Growth: Evidence
from the Great Inventors of the US, 1790 – 1930" champions adoption
of the then practice of US of requiring that applications be
examined for novelty by technical experts for the design of IP
institutions in contemporary developing countries – a very
exciting thought to see that qualifying words such as ‘noveltry’ are
less misinterpreted by nonexperts. In other words, the whole
matter is totally in a flux with none seemingly happy of the Act
which was rushed through and passed in great hurry as if to meet a
deadly date deadline! Incidentally, according to a report in
Financial Express, PFIZER Inc's Viagra and Eli Lilly and Company's
Cialis are competing with each other neck-and-neck in the US
markets. In India too, increased competition, leading to price cuts,
has impacted sales of sildanefil citrate and tadalafil (generic
versions of Viagra and Cialis used for the treatment of erectile
dysfunction (ED.). Such ‘good things’ happen for the ED drugs,
not for those belonging to the life-saving category! Again,
according to available data, the prices of about 94 per cent of
medicines remained unchanged, according to official sources. "The
Government had taken adequate precautionary measures in the Patent
(Amendment) Act, 2005 and there had been virtually no impact on the
drug prices with the product patents coming into force from January
this year," Mr Paswan said, briefing newspersons after the meeting
of the consultative committee attached to the Ministry of Chemicals
and Fertilisers. He also said that an independent agency was
assigned the task of monitoring the impact of introduction of the
product patent regime and whether it has resulted in raising prices
of medicines and "It has been found that out of the about 31,000
formulations surveyed, prices of 29,047 remained unchanged, prices
in case of 833 formulations went up by less than five per cent and
in case of 233 drugs prices have actually came down," he said.
Such a conclusion is certainly not of much value. Majority of the
current formulations being only based on the generic drugs,
obviously there cannot be any immediate price rise solely to be
attributed to the onset of the 2005 Act. Equally worrying ,FE
reports that The government is considering introducing a mechanism
that will enable a harmonised global patent search. The move will
allow India’s patent examiners to act in concert with their
counterparts in the West and do away with the need to file for
patents separately in different countries. The World Intellectual
Property Organisation (Wipo) has offered India technical and
financial support to institute the search mechanism.
Is this part of a plan to push India to accept wholesale
to an International Patents System, one truly shudders at the very
thought itself!
The September Issue has republished as a continuation a further
number of articles which appeared in the press on the new Indo-US
Agreement on nuclear technology. This
is to enable the readers to see at one place a total summary of the
crucial development . While giving great importance to the policy
views of the PM and other distinguished political leaders, those
given by the AEC Chief Dr Anil Kakodkar and as reported by PTI are
summarised as below:
a.India will closely watch the Nuclear Suppliers’ Group (NSG)
regime and how the US change its laws with regard to dismantling
restrictions and lifting embargo on civil nuclear technology before
it starts reciprocating by segregating civilian and military nuclear
facilities.
b.The act of identification and segregation of the civilian and
military nuclear facilities in India will be taken up in a phased
manner and is going to be purely on reciprocal basis. ..It will be
purely an Indian decision and every time we do, we will take
totality into account. The decision on the method of segregation
will be purely Indian and not dictated by anyone. It would not be a
one-time job but will be in the light of India’s growing energy
requirements.
c. we are looking for external inputs as an additionality to
existing and growing indigenous nuclear programmme.
d.Any external cooperation that is forthcoming will be put under
specific safeguards, this is consistent with our national policy.
e. With India’s capability and impeccable track record on safety
and export control, there is a definite change in mindset among
developed nations about India and the joint Indo-US cooperation
statement was the result
f.India’s growing economy needs large energy inputs…Nuclear power
is important in this context….import of nuclear power plants and
nuclear fuel would help realise energy security.
This statement has tremendous clarity and, taken along with the
suggestions of a former AEC Chief Dr MR Srinivasan that from
hereafter discussions must be conducted between only experts, the
issue should be crtically evaluated from the following points as
well:
- India will be able to go for a 20-30,000MW plan only based
on massive imports of nuclear reactors and fuel loads. Import of
natural uranium is feasible provided the suppliers assure life
time supply. Present reserves in the country are adequate only
for generating 10,000MW, to quote the AEC Chief from his recent
statement to the press.
- In this task massive , DAE will have to bring in perhaps the
private sector industries as well.
- In the US, the Congress passed the Atomic Energy Commission
Act 1954 allowing private companies the right to build and
operate nuclear power plants. It took the yeomen efforts of the
best among the latter ones to take over the new opportunities.
In its exciting volume "Building A Century, Bechtel 1898 –
1998", the celebrated construction company says "The Board
agreed to an aggressive "Triple Ten Strategy". Bechtel would
commit to 10 percent of its pretax profits and 10 percent of its
management and engineering capability for 10 years to learning
the technology of nuclear power – an investment in technology in
positioning ourselves in an industry that we were convinced was
going to be very big. It joined with Pacific Gas and Electric
and six major eastern and midwestern untilities to form the
Nuclear Power Group(NPG)….". It was based on such a massive plan
and support efforts including the necessary R&D back-up that
enabled even Bechtel to construct the nuclar power plants, first
at Dresden, then at Humbolt Bay, Big Rock Point and so on.
Incidentally, Bechtel established the first ever turn key plant
at Tarapur for GE also by late sixties. If DAE has to make this
strategy possible, the Atomic Energy Act 1962 will have to be
amended by the parliament and in a determined and systematic
mode, a couple of selected state-of-art and forward looking
private companies may have to be brought in and their
capabilities adequately built up to make the diversification
plan feasible.
- Bringing in the private sector and import of nuclear
reactors with fuels will certainly need amendment so that the
special protection of nonpatentability is withdrawn for nuclear
materials, processes and systems. Is DAE in a position to face
this IP challenge?
- Last but not the least, will it be economical to import
nuclear reactors and fuels, with additional recurring
expenditure also to be met for imported replacements and spares?
Obviously all such crucial issues will have to be examined by
experts within the accepted ‘political/strategic policy guidelines’
befor one can ‘count the chickens’ in the efforts of securing the
so-called Energy Security. Not an easy task, perhaps feasible only
from a long term point of view, that too involving very systematic
and expeditious planning.
The Issue continues its "Challenges…." Series for Engineered
Materials as applied for metallic alloys. Inclusion of alloys as a
chemical compound in the 1970 Patents Act enabled Indian R&D
personnel to undertake systematic indigenisation of selected alloys
of strategic interests, e.g., zirconium alloys for nuclear
applications, titanium/aluminium alloys for space and defence
applications, shape memory alloys for critical devises, etc. The
epoch making program as applied to the launch vehicle grade Maraging
Steel is described in the "Lab to Launch" by the pioneer of the task
Dr PP Sinha of VSSC/ISRO. Incidentally he also could invent an
Indian Maraging Steel, now available for all to use! Let us hope
that more such inventions would be made during the Post TRIPS regime
as well.
Last but not the least, the article on "Changing Challenges"
presented before a distinguished gathering of public men on the
occasion of the 2005 Independence Day Eve concludes as below:
Facing challenges is integral with societal changes. It
was Karl Marx who said with great emphasis that change is the only
thing which is permanent! It was indeed tremendous challenge for the
leaders of our independence movement to free this mautireligious
multicultural ancient land to freedom from the yoke of the greatest
empire on earth. It was equally challenging for our post-independent
rulier to put the country along a development path. We are now at
another state of challenge in the twentyfirst century when the
aspirations of our citizenry have been awakened to world standards,
but which needs new strategies and new challenges. I have never been
a cynic. Let me conclude with these great lines of Faust:
"Who so ever strives,
There is salvation".
A Faustian Alternative indeed and a very worthwhile message to
remember. Undoubtedly we have to face them "not madly or badly, but
through incessant strivings" to quote repeatedly the celebrated
words of late Jawaharlal Nehru.
Kindly keep sending your contributions through articles and
suggestions.
Yours sincerely,
A D Damodaran.
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