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GM's first R&D hub outside US in Bangalore |
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ECONOMICTIMES.COM[ MONDAY, MARCH 15, 2004 05:47:11 PM ] |
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NEW DELHI :
General Motors has set up a research and development centre in Bangalore , its first outside the US . The company has invested $21 million in the centre which it plans to make its Asian R&D hub. The centre currenly employs 230 engineers, which will increase to 400 by the year-end. As part of its drive to augment R&D efforts in the country, the company has also tied up with 21 institutes, including IITs and IISc. GM India President and Managing Director Aditya Vij said, "the centre in Bangalore , which is the first science lab outside the US , will be a design and engineering centre, which will ultimately support an auto manufacturing presence not only in India but also the Asian region." GM currently has a miniscule presence in the Indian auto market. It has a plant in Halol in Gujarat where it produces several variants of the German-engineered Opel Astra, Corsa, Swing, and the Chevrolet Opra sedan..
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Global drug sales up 9 p.c. to $500 b
NEW YORK, MARCH 16. Global pharmaceutical sales approached the $500 billion mark in 2003, and Pfizer's cholesterol fighter Lipitor became the world's first $10 billion drug, according to an annual survey by IMS Health.
Worldwide drug sales grew 9 per cent to $491.8 billion last year, according to IMS, a provider of information to the healthcare industry that tracks about 90 per cent of all prescription drugs as well as certain medicines sold over the counter in more than 80 countries.
North America accounted for nearly half of all sales tracked by IMS, with $229.5 billion, up 11 per cent over 2002, led by cholesterol treatments with $26.1 billion in sales.
European Union countries racked up a quarter of all drug sales at $115.4 billion, an 8 per cent growth rate.
Pfizer, the world's largest drugmaker, had two of the top four best-selling drugs last year.
Lipitor once again held the top spot as sales rose 14 per cent to $10.3 billion, while Pfizer's Norvasc for high blood pressure was fourth at $4.5 billion, up 7 per cent.
Merck and Co. Inc's cholesterol drug Zocor was again second, despite a 4 per cent decline in sales, at $6.1 billion, and Eli Lilly's schizophrenia drug Zyprexa was third with sales of $4.8 billion, up 13 per cent.
AstraZeneca had the fastest growing drug among the top ten as heartburn and acid reflux medicine Nexium saw sales rise 62 per cent to $3.8 billion — seventh on the list.
Those figures demonstrate AstraZeneca's success in getting physicians to switch patients from the company's older drug Prilosec, which last year became available in the U.S. without a prescription. Prilosec had been the world's third best-selling prescription drug.
"The global pharmaceutical industry continued to grow at a solid pace in 2003, despite difficult economic conditions and continued pressure on the sector from regulators and the media,'' Graham Lewis, IMS vice president for strategic consulting, said in a statement.
- Reuters
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Sowmya Sundar,
Suresh Krishnamurthy
"This
milestone in the history of the PCT heralds a new era in the
operations of the PCT, which is the cornerstone of the
international patent system", said Mr. Francis Gurry, WIPO
Deputy Director General who oversees the PCT. "The availability
of secure electronic filing using PCT-SAFE will ensure timely
receipt and processing of international applications and will
translate into significant efficiency gains both for users of
the system and for WIPO", he added.
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Meet against generic AIDS drugs may hurt pharma majors
P.T. Jyothi Datta ,Business Line |
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Mumbai , March 26
THE Doha Declaration, a virtual global treatise that put health on top of the agenda for Governments, may just be shaken from its roots on Monday. An old battle will be re-visited in Botswana next week, when the merits of generic anti-AIDS drugs are going to be put through the grind yet again.
Indian pharma majors Cipla and Ranbaxy sell their anti-AIDS drugs in African markets and stand to be impacted by this meeting despite the endorsement of their anti-AIDS drugs by the World Health Organisation (WHO).
Expressing concern over the US-initiated conference on Fixed-Dose Combination (FDC) drugs, slated for March 29 and 30, to discuss issues of safety and efficacy, non-governmental organisations (NGOs) allege that "the meeting has been shrouded in secrecy and multinationals would seek to arm-twist countries into not buying generic drugs."
Given that US lobbyists have made it clear that no funds would be forthcoming if African countries would purchase FDC anti-AIDS drugs, Cipla's Joint Managing Director Mr Amar Lulla said: "It is up to individual countries to stand up and be counted. The anti-FDC AIDS drugs argument is redundant, as they are endorsed by the WHO."
For Cipla it will be déjà vu, a case of been there and done that, as about three years ago Cipla had unsettled MNCs selling in Africa by offering anti-AIDS drugs at one-thirtieth the original price.
This time around, Cipla's representatives will not be in Botswana, but Cipla supporter, Mr Bill Haddad, a generic drug manufacturer who volunteered three years ago to help Cipla's Dr Yusuf Hamied organise the campaign to reduce the price of AIDS medicines, will be there.
Ranbaxy's HIV Project Head, Mr Sandeep Juneja, said representatives from the company's South African base would represent the company at Botswana.
Mr Juneja feels that the campaign to retain turf was expected as "generics have the potential to affect the business of originator companies (who originally made the medicine)."
Pointing out the innovation done by Indian companies on the AIDS drugs, he said, "A fixed-dose combination (FDC) involves taking one pill twice a day, as opposed to taking three pills in the morning and evening, respectively. The three individual drugs are made by different companies, but we innovated to have the FDC. The benefits of FDC are that it reduces the number of pills an individual has to take and enhances the chance that patients stick to their regimen. If patients do not take their pills on time or in the right dosage, it creates the dangerous situation of drug resistance. And these were the reasons why WHO and NGOs such as Medecins Sans Frontieres endorsed our drugs."
The Botswana meeting would see the participation of UN agencies, WHO and US government representatives, and Ranbaxy's Mr Juneja feels that FDCs will only come out stronger from the debate.
Analysts say the export of anti-AIDS drugs to Africa from India would be about Rs 50 crore, but the potential is about $300 million per annum (about Rs 13,000 crore). Only last year, former US President Mr Bill Clinton struck a deal with a clutch of Indian companies to supply select anti-AIDS drugs at $140 per year per patient. Other generic anti-AIDS drugs are priced at about $300 per year, and even this is less than the estimated cost of $562 for the same combination of drugs, but in a dosage of six pills, made by brand-name companies, point out NGOs.
Ms Joanne Carter with Washington-based advocacy organisation Results International told Business Line that NGOs would be at Botswana in full-strength to support generics. "There is concern that the US government may look to push US FDA regulatory standards on anti-AIDS drugs sold in Africa. This would undermine global trade meetings that have sought to prioritise health. This meeting would put pressure on countries accessing funds, forcing them to use it in a way that would not save the most number of lives."
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`Patenting of seeds by MNCs likely to hit Indian farmers'
Our Bureau ,
Business Line
Mangalore , March 26
PATENTING of seeds may lead to the emergence of multi-national
companies (MNCs) in the seed market, according to Dr N.S. Shetty,
former senior consultant of Food and Agricultural Organisation.
Delivering the keynote address at the inauguration of the
two-day workshop on "Intellectual Property Rights" organised by
Sri Dharmasthala Manjunatheshwara College of Business Management
in Mangalore on Friday, he said that farmers believe in breeding
the seeds, and in saving and replanting them. In India, research
on plant breeding and seed production is not protected by
intellectual property rights (IPRs). Research is done in public
domain with public funds.
Stating that the situation is different in developed countries,
he said that more than 90 per cent of biotechnological research
there took place in private sector. Farmers in these countries
depend on the private seed industry for supply.
He said that the strategy of MNCs is to develop and market seeds
with patent protection throughout the world. Most of the
patented seeds in India are owned and traded by MNCs. Most of
these can be used for one crop only. Ultimately the farmer has
to depend on MNCs for the supply of seeds. India, which has a
majority of small and marginal farmers, cannot afford to use
these seeds on payment, Dr Shetty said.
He expressed fear that the patented seeds may replace a wide
diversity of traditional local varieties and endanger Indian
biodiversity.
He said that huge germplasm stock in the country should be
recognised as the property of the country of the origin and paid
for like any other resources of private enterprises.
He suggested that there be different IPR systems for different
countries than the uniform international IPR system.
On the Trade-Related Intellectual Property Rights (TRIPS)
agreement, he said that it was planned, designed and formulated
by the US and G-7 countries in consistent with their patent
acts. It will facilitate market for their technological products
and increase the flow of royalties from developing countries to
the developed countries.
Dr Shetty said that TRIPS and the amendments proposed in the
Indian Patent Act may have far reaching implications for Indian
pharmaceutical industries and agriculture. India could have
tried to retain the balance between the public interest and
private interest of IPR-holders while amending the Indian Patent
Act to comply with TRIPS, he added.
The President of the Kanara Chamber of Commerce and Industry, Mr
R.D. Kini, presided over the function.
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THE MONDAY INTERVIEW ‘R&D Is The Lifeblood Of The Pharma Industry’ |
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Financial Express |
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The
Rs 22,000 crore Indian pharmaceutical industry is in the
throes of structural changes. A quest for quality medicines
at affordable prices to the poor remains its major
challenge. But the most important task is in leveraging the
vast pool of intellectual capital to bring out quality
medicines at affordable prices. Cooperation between the
pharma industry— both multinationals and domestic
companies—and government can help alleviate the problem.
Ranjit Shahani, vice-chairman and managing director,
Novartis India, and president, Organisation of
Pharmaceuticals Producers of India feels that the task of
making quality medicines accessible to Indians living in
rural areas is gigantic. But he believes that Indian
industry is capable of tackling critical issues as well as
taking up challenges arising out of the post 2005 patent
regime. He spoke to S R Kasbekar of FE. Some excerpts:
It is often said that drug prices in India unaffordable
for the poor. Do you agree?
This is an unfair statement. In fact, the drug prices in
India are among the lowest in the world and 70% of the
Indian population has no access to medicine for other
reasons. But let me put the issue in a global context. Out
of a global population of 5.5 billion, 2.8 bn people earn
less than $2 a day of which 1.2 bn people earn less than $1
a day. India bears a fair amount of the global disease
burden. Today, we have 16% of the world population but 20%
of the global mortality and 18% of the worldwide morbidity
with only 2% of the worldwide GDP and a mere 1% of the
worldwide investment in healthcare. There is clearly a
yawning gap between the investment and the challenge we
face. We have patients in villages who have to trudge miles
to get para-cetemol. If a Coke or Pepsi is available in the
smallest of shops in these villages, I see no reason why we
cannot distribute simple OTC medicines in these areas. The
real task, therefore, is to get the key stakeholders to
ensure quality medicine is available.
Do you think the existing environment is conducive for
investment?
Yes, I think the environment is significantly changing for
the better. India is entering the product patent regime from
January 2005. However, the cost of bringing out a new
molecule, including marketing and development, is globally
around $1.2 bn. This is beyond the reach of domestic pharma
companies. Global MNCs take, on an average, eight years to
come out with a new molecule. R&D productivity is
decreasing, commercial costs are in-creasing. That is why
coop- eration between MNCs and domestic pharma companies can
optimise costs. The industry is going through a period of
consolidation, pressures of the financial market, forces of
globalisation and the impact of NGOs has made the framework
for the global and national pharma industry complex. There
is currently a consolidation phase globally and India is no
exception. The period of exclusivity of new products is
significantly shortened to six months from 10 years. Also,
there are pressures from regulatory authorities and, of
course, the challenges of cost containment. R&D is the life
blood of the pharmaceutical industry and is central to
progress. We have come a long way from serendipity to
genomics to stem cells resea-rch. Indeed, this is a move
from art form to experience-based to evidence-based
research.
Why then do chronic diseases continue to pose major
challenges?
It’s a pity that diseases like tuberculosis, malaria and
AIDS claim nearly six mn lives each year but they don’t get
the ink space which some other diseases get. For example,
avian flu so far has claimed 19 lives worldwide, Creutzfeld-Jacobs
disease 139 lives, West Nile virus 500, SARS 908 and Ebola
1,000. But these deaths have caused major headlines across
the globe.
Recent clinical trial deaths have raised questions over
the use of humans as guinea pigs. Your comments?
All pharma companies follow global protocols in clinical
trials. Each patient gives an informed consent. Prior app-rovals
from the drugs controller and an independent ethics
committee are prerequisites for clinical trials on humans.
By not having our population in this process, we will be
eliminating our genetic pool and this does not augur well
for patients from India as all the new medicines would have
been approved on patients whose genetic pool would be
different from ours. All companies should follow global
protocol in clinical trials to ensure a foolproof process.
Would you agree that recently Indian companies have
outperformed MNCs?
When the product patent law was in place in 1970 and before,
MNCs accounted for 80% of market share. Curren-tly, it’s
only 20%. That’s be-cause global companies don’t launch new
products as there is a lack of patent protection whereas
Indian companies aggressively launch products based on the
process patent laws. Much will depend on the post-2005 era.
India has around 300 large and over 5,500 small pharma
companies. I feel we have the largest intellectual capital
in the world and should be ready to take on challenges of
the WTO regime. Global firms are keen to enter India as a
favourable product patent regime is expected to be in place
in January 2005. The beneficiary will be the Indian patient.
What do you think of opportunities and challenges before
the Indian pharmaceutical industry?
The Indian pharmaceutical industry has significant
opportunities but a few barriers need to be overcome. The
irrational fear of Intellectual Property Rights should be
eliminated and we need to put in place a world-class patent
regime. This will ensure flow of FDI into R&D as well as
manufacturing and would also provide new medicines from MNCs.
The number of patents granted to Indian companies by the US
patent office has gone up from 27 in 1997 to 307 in 2003.
Out of 855 patents, 93% have come from 10 companies,
including two institutes the Council for Scientific &
Industrial Research and National Institute of Immunology.
We, therefore, need some depth in filing of patents. I also
feel that a business environment that encourages innovation
and research will create opportunities for national
research-based pharma companies to ally with global MNCs.
Opportunities also exist for marketing alliances so that
medicines can reach the remotest corner of the country.
However, I’d like to point out that the scale of the
operation has to significantly change in R&D for the Indian
industry. Today, on an average, the top five Indian pharma
companies spend about 4.25% of their sales on R&D against
20% by MNCs. This is an opportunity as well as a challenge.
Today, the market for drugs in India is $6 bn. Mckinsey
estimates this would rise to about $25 billion by 2010,
provided the product patent regime is in place, the business
environment is made more friendly and innovation and
research are encouraged. There are opportunities for export
of generics and bulk drugs by Indian industry as well as
Active Pharmaceutical Ingredient, and there are innovative
R&D as well as IT-led sales. Add to that the potential from
mass domestic markets and you have a picture of a very
dynamic pharmaceutical industry in the future.
How do you look at the future relationship between MNCs
and Indian firms?
I feel globalisation and liberalisation will change the
corporate landscape of the Indian industry. Global changes
that affect pharma companies will also have differing
implications for Indian firms. Expect-ations of stakeholders
have been raised and meeting stock market expectations is
likely to become more difficult for Indian players as
transforming to a fundamentally innovation-led R&D company
takes time and cost. In the interim, there are operations
for both domestic and global companies to ally in the area
of R&D.
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Developments in Intellectual Property Law
I.
International trademark registration in 2003
The World Intellectual Property Organization (WIPO) has released
the International Trademark Registration statistics for the year
2003. WIPO received 23,872 trademark applications in 2003 under
a procedure that facilitates the process of seeking trademark
protection in several countries, known as the Madrid System for
the International Registration of Marks.
This represents a 3% increase over 2002. 21,847 trademark
registrations and 6,637 trademark renewals were recorded in the
International Trademark Register in 2003.
Germany topped the list of largest users for the eleventh year
running with 4,999 international registrations (22.9%), followed
by France (3,281 or 15%), Switzerland (2,204 or 10.1%) and
countries of the Benelux—Belgium, Luxembourg, Netherlands (2,104
or 9.6%).
The top ten users of the Madrid System in 2003 were: Henkel
(Germany), Novartis (Switzerland), Sanofi (France), Unilever
(Netherlands), Janssen Pharmaceutica (Belgium), L’Oréal
(France), Nestlé (Switzerland), Bayer (Germany), Siemens
(Germany), ITM (France).
The USA joined the Madrid Protocol on November 2, 2003. Three
other countries, namely Cyprus, Iran and the Republic of Korea,
also acceded to this treaty in 2003, and Croatia, did so in
January 2004, bringing the number of countries party to the
Protocol to 62 and total current membership of the Madrid System
to 74 (statistics as on 1st February 2004)
In 2003, the Madrid Union Assembly also adopted Spanish as a
working language of the Madrid Protocol, making the system more
attractive, especially for Latin American nations, which are
largely absent from its membership today. Trademark owners will
be allowed to file international applications under the Protocol
in Spanish as from April 1, 2004.
Source: WIPO Press Release 376/2004 dated March 1, 2004
II. The International Design System in 2003
The WIPO-administered International Design System governed by
the Hague Agreement concerning the International Registration of
Industrial Designs recorded 2,474 new deposits (each deposit can
include up to 100 designs) and 3,463 renewals in 2003. The total
number of industrial designs for which protection was sought
under the Hague Agreement in 2003 was 13,512.
The International Design System (Hague System) offers owners of
industrial designs a simplified, quick and cost-effective means
of applying for protection in any of the member countries by
filing a single international application, at a reduced cost.
Six countries (Belize, Estonia, Gabon, Georgia, Iceland and
Kyrgyzstan) joined the Hague Agreement in 2003 and a seventh,
Croatia, joined on February 12, 2004, bringing the total current
membership up to 37 countries.
The top ten users of the Hague System in 2003 were: Swatch
(Switzerland), Interior’s (France), Daimlerchrysler (Germany),
Hermès (France), Unilever (Netherlands), Nokia (Finland),
Hansgrohe (Germany), Salomon (France), Volkswagen (Germany),
Philips Electronics (Netherlands).
The Geneva Act of the Hague Agreement, which entered into force
on December 23, 2003, introduces a number of new features that
make the system more attractive such as the possibility of
deferring publication of a design for up to 30 months, and of
filing samples of the design rather than photographs or other
graphic reproductions. These features are of particular interest
to the textile industry.
The Geneva Act, which will become operational on April 1, 2004,
also provides for the possibility of establishing a link between
the International System and regional systems such as the
Registered Community Design System of the European Community, by
providing that intergovernmental organizations may become party
to that Act. So far, 13 countries have signed the Geneva Act.
Since the Hague System began operations in 1928, some 2,000,000
designs have been deposited with the International Design
Register.
Source: WIPO Press Release 376/2004 dated March 1, 2004
III. European Parliament
adopts Directive on the enforcement of Intellectual Property
Rights
On 9th March 2003 the European Parliament has adopted Directive
on the enforcement of intellectual property rights. The
Directive would require all Member States to apply effective,
dissuasive and proportionate remedies and penalties against
those engaged in counterfeiting and piracy and so create a level
playing field for right holders in the EU.
The Directive will be officially adopted once it has been
approved by the Council of Ministers. Once adopted, the Member
States will have two years to implement it through national
legislation. The new Directive would bring national legislation
on sanctions and remedies closer into line across the EU. Member
States are free to go further than the proposed Directive.
According to the European Union’s Internal Market Commissioner
Frits Bolkestein the draft Directive was an important step
forward in the fight against counterfeiting and piracy while
keeping the emphasis on catching "the big fish" rather than the
"tiddlers" who commited relatively harmless acts like
downloading a couple of tracks off the Internet for their own
use.
The draft Directive includes procedures covering evidence and
the protection of evidence and provisional measures such as
injunctions and seizure. Remedies available to right holders
would be the destruction, recall or permanent removal from the
market of illegal goods, as well as financial compensation,
injunctions and damages. There would be a right of information
allowing judges to order certain persons to reveal the names and
addresses of those involved in distributing the illegal goods or
services, along with details of the quantities and prices
involved.
The draft Directive contains the necessary safeguards and
limitations to protect the interests not only of the defendant
but also of potentially innocent offenders, who have unknowingly
been involved in illegal practices.
One important element is missing from the draft is the provision
on criminal sanctions. On this Commissioner Bolkestein said that
it would propose “in due course” further measures providing for
criminal sanctions in this field. Moreover the Directive would
not prevent Member States from applying criminal sanctions if
they wished to.
The Commission claimed that the provisions represented an
appropriate balance among all interests involved, including
right holders, commercial users, consumers and intermediaries.
Source: European
Commission Press Release IP/04/316 on 9th March 2004
IV. Harmonisation of TRIPS and CBD: India-led group submitted
Check list of issues in TRIPS Council
The Doha Ministerial declaration adopted at the fourth WTO
ministerial meet in November 2001 says that work in the TRIPS
Council on the reviews of the Article 27.3(b) or the whole of
the TRIPS Agreement under Article 71.1 of TRIPS Agreement or any
other implementation issue should also look at the relationship
between the TRIPS Agreement and the UN Convention on
Biodiversity and the protection of traditional knowledge and
folklore and other relevant new developments that member states
raise in the review of the TRIPS Agreement.
Since then there were several discussions in the TRIPS Council
to determine what measures need to be taken within the framework
of the TRIPS Agreement to prevent misappropriation of
traditional Knowledge and folklore and to support the objectives
and implementation of the CBD.
India and 7 other developing countries (Bolivia, Brazil, Cuba,
Ecuador, Peru, Thailand and Venezuela) submitted a checklist of
issues in TRIPS Council, held on 7th March, to assist and
expedite the discussions on this subject. The document develops
earlier proposals on disclosure of source and country of origin
of the biological resource and of the traditional knowledge used
in the invention and disclosure of evidence of prior informed
consent and of benefit sharing.
While the EC did not necessarily agree with all three points,
such as evidence of prior informed consent, it was willing to
pursue the discussions along those lines. It also stressed that
in order to avoid duplication, the TRIPs Council's work on TK
should await the outcomes of the WIPO Intergovernmental
Commission on Intellectual Property Rights and Genetic
Resources, Traditional Knowledge and Folklore. Switzerland and
Norway also signaled their openness to discussions.
In contrast, the US opposed the checklist, arguing that there
was no conflict between the TRIPS Agreement and the CBD and that
the CBD should not be enforced through patent law. The US, along
with Japan, called for the discussions to take place in WIPO. In
response, the India-led group, supported by other developing
countries, insisted that discussions should continue in the
TRIPs Council pursuant to the mandate set out in Paragraph 19 of
the Doha Declaration.
Sources: ’Renewed calls
for moving ahead on biodiversity’, BRIDGES Weekly News Digest,
24 March 2004; WTO Document IP/C/W/420, 2 March 2004 and
information from WTO site.
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