Developments in IP Regime (Complied by Sunil Jose)
(a)Botswana Conference rekindled debate on Generic drugs

A conference held in Gaborone, Botswana, on 29-30 March 2004 rekindled the debate on generic drugs on HIV/AIDS. AIDS activists alleged that the Conference was used by United States to question the quality, safety and effectiveness of cheaper generic fixed-dose combinations (FDCs) of anti-retroviral drugs used in AIDS treatment.

However the officials attending the meeting failed to reach an agreement on global guidelines for low-cost generic HIV/AIDS drugs. (IRIN Plus News, 1 April 2004)

FDCs of anti-retrovirals combine three medicines in one pill. According to advocates of FDCs, patients need to take only two pills a day thereby make it easier for them to stick to their treatment regimen while Branded drugs involve taking six pills a day. They are much cheaper than branded drugs.

Generic drugs meet the stringent WHO standards and are an integral part of the WHO's recently announced "3 by 5" initiative - a plan to ensure access to HIV/AIDS medicines for at least 3 million persons with AIDS by end-2005.

Generic drugs recommended through WHO's technical review process includes Triomune and Triviro, generic anti-retrovirals manufactured by Cipla Ltd. and Ranbaxy Ltd. respectively which combine stavudine, lamivudine and nevirapine into one pill that is taken twice a day.

Generic drugs have not been approved by the U.S. Food and Drug Administration (US FDA). Therefore they would not be procured under the US Government's Emergency Plan for AIDS Relief (PEPFAR) (the $15 billion five-year initiative -announced in President Bush's 2003 State of the Union address). (PEPFAR require drugs to be approved either by FDA or through a mechanism established by PEPFAR.)

NGOs pointed out that up to 4 times as many people could gain access to life-saving treatment if US Emergency Plan used generic versions of patented AIDS drugs.

According to AIDS activists the US government was using the conference to undermine the case for generic drugs. The Human Rights watch said in a statement, "The drugs in question meet the stringent standards of the WHO technical review for generic drugs, but have not been approved by the US FDA. The United States, under pressure from pharmaceutical companies selling the brand-name equivalents, claims instead that 'There are no uniform principles, guidelines or international standards addressing the development' of generic drugs - an assertion that calls into question the WHO's widely accepted review process."

William Haddad, chairman of Brogenerics, a U.S.-based generic AIDS drug manufacturer, alleged, "US want to add a new level of approval, so that United States brand name companies can sell their products, and generic companies cannot use United States money [to produce drugs for developing countries]."

US officials had dismissed allegations that they used the meeting to question the approval process of generic drugs and to protect the interests of US Pharmaceutical giants who produce expensive AIDS drugs. Dr. Mark Dybul, Deputy Chief Medical Officer of US Emergency plan for AIDS Relief claimed that US wanted to ensure that internationally accepted standards would be used in evaluation of these drugs.

John Lange, deputy coordinator at the US Department Office of the Global AIDS Coordinator, speaking at a meeting organized by the Global Business Coalition on HIV/AIDS and the Council on Foreign Relations, said, "If we were to purchase antiretroviral drugs that do not meet quality standards, they could build up resistance and do more harm than good".

On 30 August 2003, WTO member states had reached an agreement that made it easier for poorer countries to import generic drugs if they are unable to manufacture the medicines themselves. (This is not allowed under the original provisions of TRIPS Agreement).

Source: African Action Press Release 29 March 2004; IRIN Plus News, 30 March and 1 April 2004 ; TheBody, HIV/AIDS News Room. March 31, 2004; Botswana conference sparks debate on generics" BRIDGES Weekly Trade News Digest, Vol. 8, Number 12, 31 March, 2004

(b)The International Seed Treaty is to become law.

On March 31, 2004. The International Treaty on Plant Genetic Resources for Food and Agriculture (The International Seed Treaty) administered by Food and Agricultural Organization of United Nations (FAO) crossed the stipulated number of ratification (40). The Treaty will enter into force on June 29, 2004. India had signed the Treaty on June 10, 2002.

The Treaty will provide an international legal framework that will be a key element in ensuring that plant genetic resources for food and agriculture, which are vital for human survival, are conserved and sustainably used and that benefits from their use are equitably and fairly distributed.


The Treaty recognizes and protects the rights of farmers whose experience and knowledge gained over many generations resulted in the development and conservation of thousands of agricultural crop varieties which otherwise would have been lost forever.

The Treaty will institute, for the first time, a multilateral system of facilitated access and benefits-sharing for the crops and forages most important for food security. Scientists, international research centres and plant breeders from public and private organizations will benefit from enhanced access to genetic biodiversity.

The multilateral system will also ensure the fair sharing of benefits derived from the use of genetic resources, in particular for farmers in developing countries that have for centuries contributed to the conservation of genetic resources.

The system also provides for the obligatory sharing of monetary benefits arising from utilisation, including from commercialisation of new varieties by the private sector.

Source: "Treaty on biodiversity to become law," FAO Press Release, 31 March 2004;
 

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Hungary protests planned extension of data exclusivity period for pharma products in EU Budapest. (Interfax-Europe)

Hungary, along with other countries set to join the European Union in May 2004, is petitioning planned EU legislation to extend data exclusivity protection periods in the pharmaceutical industry from six to ten years, the Budapest Business Journal reported.

According to current rules, member states' registration authorities cannot approve generic drugs whose application refers to original drugs that were authorized less than six years ago. The planned modification, under discussions in the European Parliament since June, would extend this period to ten years, and would be applicable to new member states as well once they enter the EU next May.
Imre Czinege, a member of the Hungarian parliament's health care committee and also part of Hungary's observer delegation in the European Parliament, told the BBJ that the change would raise health care costs in Hungary by an annual HUF 15 billion due to the ensuing limited availability of generic alternatives. Of this, HUF 12 billion would have to be covered by the National Health Care Fund (OEP), which is already under considerable budgetary constraints.

Czinege added that the change would also hurt local producers by limiting the number of additional products they can copy. In addition, the long period of protection would also take away incentives for innovative producers, who are otherwise the main proponents of the change, to create new molecules.
However, the Association of Innovative Pharmaceutical Manufacturers in Hungary (AIPM) is arguing that the budgetary impact of the extension of data protection periods for manufacturers of original products would be considerably less, at around HUF 3 billion a year, as only a handful of low-turnover products would be affected. This would be "a small price to pay" for the social benefits of medical innovation, AIPM chairwoman Krisztina Szekely said.

Extending the data exclusivity period could create better conditions for innovation, Szekely said, adding that research and development of a new product normally costs an innovative producer USD 600-800 million over a typical period of 10-15 years. "Sooner or later, Hungarian producers will also have original products; then, they will have the loudest voice defending patents," Szekely noted.
 

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NGO opposes EMR for Bayer's Gatifloxacin
P.T. Jyothi Datta , Business Line
Mumbai , April 5

CAMPAIGNERS for affordable medicines have now trained their guns on Bayer's antibiotic drug gatifloxacin, sold under the Tequin brand name. Bayer has sought an exclusive marketing right (EMR) for gatifloxacin and the application lies at the Indian Patent office, pending a decision.

However, Affordable Medicines and Treatment Campaign (AMTC), a platform of non-governmental organisations, has contested Bayer's application on the grounds that "gatifloxacin is not a new molecule and is a pre-1995 invention." Gatifloxacin is used to treat bacterial infections of the lungs, sinuses, skin and urinary tract.

In its letter to the Controller General of Patents, AMTC points out that the "US patent office Web site states that the patent for this product was originally filed on January 21, 1986. Hence, we (AMTC) feel that the compound per se is not eligible for the grant of an EMR." Granting an EMR, which would give the company exclusive rights for five years, would affect the availability of the drug at "reasonable prices," AMTC added.

Despite efforts to reach the company, no official response was available from Bayer on the issue.
Meanwhile, lawyers specialising in Intellectual Property Rights (IPR)-related issues told Business Line that more hair-splitting was in the offing on the validity of patent and EMR applications.

"Pharma companies are eligible to apply for product patents and EMRs only for a new drug or a post-1995 discovery. However, drug firms try to keep a monopoly on their products by tweaking the patent, changing its delivery system or dosage form and claiming an additional period of exclusivity on existing drugs. When a product is new, companies are given a 20-year period to get their return on investments made in research. But after that, competition should be allowed, as it brings prices down and is good for the consumer," they point out.

AMTC said that globally Bayer's Tequin has two dosage strengths, 200 and 400 mg - both are priced at about $252 (Rs 11,030) for 30 tablets and $736 (Rs 32,214) for 90 tablets. This works out to about Rs 367 per tablet.

A clutch of Indian companies including Emcure, Aristo Pharma, Wockhardt Ltd, Nicholas Piramal, Ranbaxy and Cipla make the same drug. Prices for the 200-mg tablets range from Rs 18.5 for five tablets to Rs 50, that is, about Rs 3 to Rs 10 per tablet, point out industry representatives.
Prices for the 400-gm dosage varies from Rs 28 for five tablets up to Rs 350. This works out to Rs 5 to Rs 70 per tablet.

"Given that an average antibiotic course is taken over five days or a week, the cost to a patient increases," said AMTC representatives.

Further, AMTC officials point out that the Indian Patent Act is silent on the procedure for the opposition of EMR applications. "There should be a procedure of pre-grant opposition, where even civil society can go through the data published and express their objections, if any," they point out.

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Drug companies warn of rocky IPR road ahead
P.T. Jyothi Datta , Business Line
Mumbai , April 9

DOMESTIC drug companies have sounded a note of caution on the hassles that could surface in the details of the legal framework that is being laid out for the product-patent regime, come January 2005.
The recent legal entanglements that have followed the country's first exclusive marketing right (EMR) granted to Novartis is just an indication that intellectual property rights (IPR) related issues are set for a rocky road ahead, making it all the more necessary to have clarity in the rules that will finally prevail.
The pharma industry will soon be governed globally by TRIPS or trade related intellectual property rights, the detailed, multilateral agreement on IPR.

Given this reality, India should implement `TRIPS-minimum requirements and maximum permitted flexibilities', according to the Indian Drug Manufacturers' Association (IDMA).

Against the backdrop of recent patent-related wrangles, IDMA has stressed the need for clarity in The Patent (Third Amendment Bill) that will govern the industry when product patents are respected in the country.

In its presentation to the Government, IDMA has stated that patents granted to "foreign patent holders" will result in Indian manufacturers being asked to give up manufacture of the same drugs through injunctions received from Indian courts.

"When this involves Indian manufacturers and over 50 essential molecules and thousands of brands sold across India, it is bound to create shortages, price rise disruption of the distribution trade, retrenchment of employees and possible rush of spurious substitutes by unsocial elements."
The reference is to the EMR granted to Novartis's blood cancer drug, Glivec, which resulted in local manufacturers being restrained from producing knock-off versions and selling them at a tenth of the cost.

Only earlier this week, Natco Pharma's case against Novartis's EMR for Glivec was dismissed by the Delhi High Court, leaving Natco with the option of taking the case to the apex court.

IDMA is a forum of 500-odd Indian pharma companies of all hues and from across the country, including Dr Reddy's Laboratories, Orchid, Shasun, Sun Pharma, Dabur, Cadila Pharma, Torrent and Cadila Healthcare.

During the period between 1995 and 2004, the Government has approved and Indian manufacturers have produced new drugs, investing in facilities for the same."Since process patents are applicable till date, new drugs have been made and the turnover of these is about Rs 5,000 crore," IDMA said.
During the same period, about 7,000 patent applications were filed in India, some which may relate to the drugs being made by local companies. If product patents are granted on existing drugs, it could lead to a "chaotic situation", the forum said.

IDMA has also underlined the need for "advance notification" or pre-grant opportunity to anyone to oppose EMR or patent applications, in an effort to avoid difficulties to consumers and "wasteful litigation" by companies.

Referring to the Bill's definition of "patentable invention" as being a " new product" and involving an "innovation", the IDMA presentation said that there is no mention of "derivatives, polymers, etc., ... and their patentability is debatable".

In other words, if a patent application is for an existing drug where the company has merely changed the dosage form - say, from tablet to crystalline form - it should not be treated as a new drug.

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NATIONAL WORKING GROUP ON PATENT LAWS AND PUBLIC INTEREST LEGAL SUPPORT AND RESEARCH CENTRE
A - 388, SARITA VIHAR, NEW DELHI - 110 044

Phone Nos. 681-3311, 694-7403, Fax No. 681-3311 E.Mail: <wgkeayla@del6.vsnl.net.in>

PRESS RELEASE

Sub: Fourth Peoples' Commission on Review of Patent Legislations amending Patents Act 1970.
 

1. This Press Release pertains to a critical issue of public importance which is going to affect the future of India and the welfare and health of the peoples of the world. Although seemingly concerned with technical changes in the time honoured Indian Patents Act, 1970, it deals with matters of fundamental importance.

2. Parliament has already enacted Patents (Amendment) Act, 1999, Patents (Second Amendment) Act, 2002 and the government has since introduced Patents (Amendment) Bill, 2003, in the Lok Sabha on 22nd December, 2003. By this legislative process according to government they have fulfilled their obligation to bring the Patents Act 1970 in conformity with the patent system as provided in the Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement. However, a preliminary examination of the three legislations, reveals that several important issues relevant to the patent system have been ignored in the amendment process. This is a cause of serious concern. The National Working Group on Patent Laws (NWGPL) and Public Interest Legal Support and Research Centre (PILSARC) have therefore been prompted to initiate a review of all the three legislations with the help of eminent persons.

3. In the past also eminent legal luminaries, economist, scientists and other experts in India have expressed through three Peoples' Commissions the need for a cautious and careful approach being adopted in regard to changing our national legislation on patent laws. The First Commission was established in 1993 on 'Constitutional Implications of the Final Act Embodying the results of the Uruguay Round of Multilateral Trade Negotiations'; the Second Commission established in 1998 looked into the obligations during the transitional period of TRIPS and the Third Commission on Patent Laws for India established in 2002 made a comprehensive study of the patent system and suggested crucial amendments within the frame work of binding commitments under the TRIPS Agreement. It is observed that in framing the draft legislations the government has ignored all important recommendations made by the three Commissions for reasons best known only to the government.


4. Internationally the Commission on Intellectual Property Rights established by the UK government in its Report of September, 2002, UNDP Report of 2003 on 'Making Global Trade Work for People and the Report of the Royal Society Working Group of 2003 on 'Keeping Science Open : Effect of IP Policy on Conduct of Science' have also cautioned about the need for a careful approach in implementing the TRIPS Agreement in the national legislations of the developing countries. The Doha Declaration on the TRIPS Agreement and Public Health of November 2001 has also clarified the flexibilities and freedom available to protect public health in developing countries. It has also recognized the gravity of public health problems afflicting many developing and least developed countries.


5. Keeping the above in view the NWGPL and PILSARC have decided to constitute a Fourth Peoples' Commission of eminent persons to review the three legislations keeping in view the Doha Declaration on the TRIPS Agreement and Public Health, Fundamental Rights guaranteed to our citizens in the Constitution of India, the implications of TRIPS in realization of economic, social and cultural rights as guaranteed by the International Human Rights Laws and cautious approach supported by various national and international commissions mentioned above. The Commission will also examine the issues which aught to be taken up the Government with the TRIPS Council.

6. Hon'ble Shri. I.K. Gujral former Prime Minister of India has agreed to chair this Commission. He was Chairman of a Parliamentary Committee which had warned of the social implications of patent in its Report on Dunkel Draft Text in 1993. He was also Chairman of the Third Peoples' Commission on Patent Laws for India which had studied in depth the relevant and crucial provisions to be incorporated in the Indian patent system.

7. The following eminent persons have been pleased to agree to sit, discuss and consider with an open mind the crucial issues involved relating to patent laws will constitute the Fourth Peoples' Commission on Review of Patent Legislations Amending Patents Act 1970 :

Chairman :
Hon'ble Shri. I.K. Gujral
Former Prime Minister of India

Members :

Prof. Yashpal
Former Chairman, University Grants Commission

Shri. S.P. Shukla
Former Member, Planning Commission

Prof. Muchkund Dubey
Former Foreign Secretary and currently
Chairman, Council for Social Development

Shri. B.L. Das
Former India's Ambassador to GATT

Prof. Ashok Parthasarathi
Former Secretary to the Government of India and currently
Professor, Centre for Studies in Science Policy
Jawaharlal Nehru University

Prof. Prabhat Patnaik
Prof. of Economics
Jawaharlal Nehru University

Dr. Rajeev Dhavan
Senior Advocate,
Supreme Court of India

Member Secretary :

Dr. Biswajit Dhar
Prof. & Head of Centre for WTO Studies
Indian Institute of Foreign Trade

Convenor :

Shri. B.K. Keayla
Former Commissioner of Payments and currently
Convenor, National Working Group on Patent Laws.


8. The Commission will be free to decide the procedures and modalities of its work. The Commission may co-opt additional members as, it will also be free to constitute sub-committee to take evidence and hold discussions. The Report of the Commission will be to the people of India, hoping that Parliament and Government of India will consider the views expressed. The Commission is requested to submit its Report as soon as it deem fit perhaps within a period of 2/3 months. Shri. B.K. Keayla will assist the Commission as the Convenor. The Commission's mailing address will be A-388, Sarita Vihar, New Delhi - 110 044

For and on behalf of the For and on behalf of the
National Working Group on Public Interest Legal Support and
Patent Laws Research Centre

(B.K. Keayla) (Dr. Rajeev Dhavan)
Convenor, NWGPL Executive Director, PILSARC


(Prof. Ashok Parthasarthi)
Co-chairman, NWGPL

New Delhi :
February 03, 2004
 

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Thembalami will manufacture efavirenz

Tamar Kahn
Cape Town
April 8, 2004

Pharmaceutical company Merck, parent company of South African subsidiary MSD, said yesterday it intended to give local drug manufacturer Thembalami Pharmaceuticals a nonexclusive licence to make generic copies of its patented AIDS drug efavirenz, branded Stocrin.

Thembalami is a joint venture between India's largest pharmaceutical company, Ranbaxy, and Adcock Ingram, the pharmaceutical arm of JSE Securities Exchange SAlisted Tiger Brands.

Stocrin is one of the key antiretroviral medicines specified in government's HIV/AIDS drug rollout plan, and will be given to an estimated 70% to 80% of patients on state treatment.

Although Thembalami has not secured Medicines Control Council registration for its version of efavirenz a requirement for marketing any drug in SA the agreement will enable Thembalami to bid alongside MSD in the state tender for efavirenz.

It is understood that the health department has told generic manufacturers that they may bid for the antiretroviral contracts prior to the council's approval, provided they have secured voluntary licences.

There are nine patented antiretrovirals on the tender list, three of which still require licences to be issued for local generic manufacture. These are Abbott's ritonovir (Norvir) and lopinavir (Kaletra), and MSD's indinavir (Crixivan).

"We are trying to support government's objective of promoting local production, and hope (local firms) will sell (the drugs) at prices that consumers can afford," said MSD director for legal and corporate affairs Seara Macheli yesterday.

MSD had signed a letter of intent with Thembalami and was considering licence applications from a further seven companies, including Aspen Pharmacare, she said.

The licence that MSD is poised to issue Thembalami is royalty free, and covers sale to both public and private sector patients throughout the Southern African Development Community (SADC).

Thembalami is currently negotiating manufacturing licences for generic versions of Boehringer Ingelheim's nevirapine and GlaxoSmithKline's lamivudine and stavudine, according to Dr Jonathan Louw, MD of Adcock Ingram's pharmaceuticals division.

He said Thembalami had five antiretrovirals registered with the council, and a further seven products, including efavirenz, were in the registration process.

Adcock Ingram CEO Mike Norris said the margins in the company's AIDS drug business would be extremely low.

"However, we will realise significant factory savings through increased volumes and we have the capacity to manufacture most dosage forms, including liquids, without any immediate additional investment.

MSD CEO Chirfi Guindo said that in the poorest countries and those hardest hit by the HIV/AIDS epidemic, including SA, MSD provided Stocrin and Crixivan at prices at which the company did not make a profit.

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Asian countries in race for nuclear power

REUTERS[ SUNDAY, APRIL 11, 2004 09:43:35 AM ]
 

SINGAPORE: From India to China, energy-deficient Asia is spending billions of dollars to build nuclear power plants, sparking fierce competition among global equipment makers for the bonanza.

The blossoming of nuclear power in Asia, where 18 of the world's 31 units under construction are located, is dubbed by some as a renaissance of the sector and has become a massive magnet for European, Canadian and Russian suppliers.

The lure is so strong that the United States may relax in 2004 its curbs on the sensitive technology transfer to select Asian nations as China has other sources of nuclear expertise.

"Nuclear power will certainly continue to increase as a share of the region's capacity and that's mainly driven by activities in China and India," said Charles Chang, Asia power and gas analyst at rating agency Fitch.

Nuclear fuel makes up 1.4-3.7 per cent of the power output in Asia's two most populous nations, below the 35-40 per cent for Japan and South Korea and 78 per cent for France.

Few projects have broken ground in the West in the past few years as environmental, health and security concerns have persisted since the Chernobyl accident in 1986. A growing number of aging nuclear plants in Europe are reaching their expiry dates and it has not been decided if they would be replaced.

To clinch the lucrative contracts in Asia, nuclear equipment suppliers have focused on their safety records as well as competitive investment and production costs, analysts said.

Suppliers also have to convince their own governments to let them export such sensitive technologies. The governments must also build good ties to win such deals, industry experts said.

The suppliers include Framatome ANP, a venture between France's Areva and Germany's Siemens, Electricite de France, and Atomic Energy of Canada Ltd, an unlisted global nuclear equipment maker, and Russia.

Framatome said on its Web site it "is ready to take part in the new development phase of the Chinese nuclear program" and "is ready to issue the most suitable proposal to allow the Chinese industry to become more and more self-sufficient."

Washington bars firms such as Pittsburgh-based Westinghouse Electric Company, a unit of state-owned British Nuclear Fuels Ltd, and General Electric, from building reactors in China.

But industry sources said Washington was expected to ease its control on China in September.

"U.S. firms are not allowed to provide a whole set of equipment to China, let alone signing contracts and providing loans to build the plants for us. But this September the restriction is expected to be lifted," said Liu Changxin, deputy secretary general with the Chinese Nuclear Society in Beijing. China is about to build four 1,000-megawatt (one million kilowatt) plants costing $6 billion as part of its drive to quadruple nuclear  Westinghouse would bid to supply its latest reactors, known as AP 1000s. The projected cost for the AP 1000, scheduled to get design approval in September, will be $1,000-$1,200 per kilowatt.

 
Framatome would also make a bid, said the WNA, which represents nuclear companies and organizations.