India must sign IPR accord for defence cooperation: Russia

 Moscow, Nov. 30. (PTI): Ahead of President Vladimir Putin's visit, Russia today said it was not going to move further in sharing sophisticated military technologies with India until New Delhi signs an agreement on the protection of Intellectual Property Rights. "In our military-technical cooperation we have come to a stage when, without signing of the agreement on the protection of Intellectual Property Rights (IPR), we cannot look ahead," Russian Defence Minister Sergei Ivanov said here ahead of his trip to New Delhi to prepare the groundwork for Putin's three-day visit. During his stay in New Delhi, Ivanov will co-chair the fourth session of the Indo-Russian inter-governmental commission on military co-operation along with his Indian counterpart Pranab Mukherjee to finalise defence agenda for talks between Prime Minister Manmohan Singh and Putin on December 3. Ivanov, who is a close confidant and personal friend of Putin and is seen by many as his possible successor, underscored that the absence of IPR protection agreement has become an "obstacle" in the development of defence co-operation involving the cutting-edge technologies. "It has become something of an obstacle if we think of future, we can fulfil our previous obligations without this, but we cannot move ahead in high technology cooperation," Ivanov said. He noted that Russia had submitted the draft of the agreement to India two years ago, but the Indian side has not even given its suggestions or proposals on it.

Brazil to Break Foreign AIDS Drugs Patents

Reuter, Nov 30, 2004 

By Andrew Hay

BRASILIA, Brazil (Reuters) - Brazil will break patents on some foreign AIDS drugs next year to escape the control of multinational firms holding developing countries "hostage," the government said on Tuesday.

Brazil, which has a much-copied universal free AIDS program, has for years threatened to break patents in its drive to cut the cost of foreign drugs used in its 15-drug anti HIV-AIDS cocktail.

It will make the move in 2005 when it begins domestic production of three to five drugs without permission from the companies that hold the patents, Pedro Checkr, head of the government's AIDS program told reporters.

Checkr did not say which patents would be broken.

Under Brazilian law, and based on World Trade Organization rules, a nation can break drug patents by applying a "compulsory license" on a product if it is a case of national emergency or national interest.

Brazil says it can no longer afford to run its free anti-AIDS program using imported drugs.

"We determined that we have to move to a situation of self-sufficiency through compulsory licensing," Checkr said. "If we don't move toward self-sufficiency the program will collapse."

He said, "We see mergers of multinationals, regional monopolies, its all a big agreement to keep developing nations hostage to the multinational industry."

In the mid 1990s AIDS experts expected millions of Brazil's young, sexually-active population to fall prey to the disease.

Brazilians threaten to breach patents on Aids drugs
By Raymond Colitt in São Paulo (Financial Times) December 3 2004

The Brazilian government is threatening to break several patents of international pharmaceutical companies in order to produce cheaper anti-AIDS drugs locally.

The move is part of Brazil's long-standing programme to distribute anti- retroviral drugs free of charge to all HIV-infected patients. Next year it plans to break patents on as many as five of the 15 drugs that it uses to make up its anti-Aids cocktail.

"If we don't move towards self-sufficiency the programme will collapse," said Pedro Chequer, head of the government's Aids programme. "It is not only a legal but above all an ethical commitment."

Over the past three years, Brazil has repeatedly threatened to break patents as a way to negotiate price reductions with mostly international pharmaceutical companies. Yet so far, it has not broken any patent. Negotiations over next year's supply contracts have just begun.

Pharmaceutical companies say prices in Brazil are already among the lowest.

Merck, the US drug company, has been in talks since September 2003 over the possibility of giving the government a licence to manufacture and sell its drug.

Roche, the Swiss health care company, says it has reduced its price by 73 per cent since it began supplying the Brazilian government several years ago.

Under regulations of the World Trade Organisation, a country can issue a "compulsory licence" that allows it to manufacture a product in a case of national emergency or interest.

The issue has been one of Brazil's main battle cries in trade negotiations within the WTO and in talks on the Free Trade Area for the Americas (FTAA), which have been stalled for a year.

In 1997, Brazil became the first developing country to adopt a free antiretroviral drugs programme.

In its first five years, this programme helped halve the number of Brazilian deaths from Aids. This year it spent R$567m ($209m, €157m, £108m) and benefited 151,000 patients.

Similar programmes were adopted last year in South Africa and elsewhere, in part with Brazilian help to set up local manufacturing of generic Aids drugs.

Brazil's infection rate is considerably lower than in many other developing countries, particularly in Africa. Non-government agencies say as many 600,000 people out of a population of 180m could be unknowingly infected with the HIV virus. By comparison, South Africa has 5m infected people or more than 11 per cent of the population.

Brazil produces some generic medicines domestically and imports others. Last year, it fine-tuned its legal procedures to make it easier to import generic versions of drugs.

GlaxoSmithKline contests patent plea rejection before HC

Our Legal Correspondent (BL)

Kolkata , Dec. 15

GLAXOSMITHKLINE plc, the pharmaceuticals major, on Wednesday moved an application before Mr Justice Pinaki Chandra Ghose of the Calcutta High Court, contesting the refusal of a patent application by the office of the Controller of Patents & Designs sometime ago.

The company had applied to the Controller for a patent on a pharmaceutical product, Rosiglitazone Maleate tablet and a solvent under the provisions of the P&D Act. After considering the application, the Controller rejected the application of Glaxo, which had sought a patent for the product, which was claimed to be a researched and invented one. The Controller, however, refused to accept this as the same is already in the markets of the US and Brazil, having been patented thereof. The product is a conventional one and not invented, the Controller had pointed out. Glaxo, in its application today, submitted before the court that the order of the Controller refusing grant of patent was illegal.

Countdown to product patent regime Pharma MNCs in India in consolidation mode
P VINOD KUMAR (FE) December 16, 2004 at 0000 hours IST

CHENNAI, DEC 15: Barely two weeks to go for the product patent regime to come into force, multinational pharmaceutical firms are in the process of consolidating their Indian operations.

Two major pharma companies, Glaxo SmithKline and Sanofi Aventis, have already consolidated their Indian operations, while others are in the queue to follow suit.

According to industry insiders, the director board of Glaxo SmithKline Consumer Healthcare has recently finalised a Rs 123 crore buyback offer to enhance their stake in the company from 40% to 47%.

According to the director board’s decision, the company, through the tender route, would buy back 33.25 lakh equity shares of Rs 10 each, accounting for 7.33% of its paid-up equity capital, at a rate of Rs 370 per share. The tender route was preferred due to the thin trading volume in the stock.

Similarly, Sanofi Aventis is in the process of merging its Indian subsidiaries, Sanofi Lab and Aventis Pharma to consolidate its Indian operations. The French pharma giant would also enhance its stake in the merged entity to over 70%.

The company has already got the go ahead from the authorities concerned and is expected to complete the process by the end of current fiscal. Sanofi Lab is a pure play marketing company while Aventis manufactures a range of products.

According to industry sources, the consolidation of Indian operations by multinationals is in view of the new product patent regime which would come into force from January next. The consolidation would bring synergy among different siblings of the pharma majors and would also give the advantages of an enhanced size.

“With a lot of generics currently manufactured by Indian companies expected to do a vanishing act from the pharma shelf and replaced by the original patented versions, consolidation would give companies a more focussed business strategy. It would also give them enough headway against competition,” industry insiders said, adding, “With almost all multinationals expected to either set up their facilities in India or start marketing their patented products, competition would become intense. Marketing cost for multi-national drug companies are normally higher compared to local firms due to competition.”

Malaria Herb Now Turns Top Cash Crop

The Nation (Nairobi)

December 16, 2004

Nairobi

Kenya is set to emerge a major source of artemesinin, an important ingredient in the new generation of anti-malarials which the World Health Organisation says are the key to fighting the killer fever.

Artemesinin is an extract from the shrub, Artemisia annua, or sweet wormwood, which is currently mostly grown in China and Vietnam.

A natural anti-malarial to which no resistance by the malaria parasite has been recorded, artemesinin is used to formulate the so-called Artemesinin Combination Therapies (ACTs), currently the most effective treatments for malaria.

In April this year, Kenya's ministry of health adopted an ACT drug, Coartem, to be the first line treatment for malaria in the country, joining 40 other countries which had already done so following recommendations by the WHO.

Coartem, which is highly effective against Plasmodium falciparum, the strain of malaria parasite that causes the disease in Kenya, is the only fixed dose combination of artemesinin and the anti-malarial ingredient called lumefantrine. The wide usage of the drug in Kenyan public hospitals is expected to start from next year following commitments by donors to fund its roll-out.

According to Mr Phillip McLellan, the managing director of Nakuru - based East African Botanicals Ltd., Kenya is today well-placed to take advantage of a surging global demand for ACTs such as Coartem, which has led to a shortage of artemesinin.

"We have successfully grown Artemesia annua on both an experimental and commercial basis in both Kenya and Tanzania, and we can confirm that our soils and climate are suited for the crop," Mr McLellan told Horizon. "Kenyan farmers are renown for their expertise in the horticultural industry, and there is no reason why they should not excel in farming artemesia."

Already, Mr McLellan said, his company has contracted farmers in Naivasha, Meru, Eldoret, Thika and Mwea to grow the crop, which takes about seven months to mature. EAB supplies the farmers with six week seedlings.

EAB, which is itself getting support from the Kenya Agricultural Research Institute, GTZ, USAid and TechnoServe, is already exporting artemesinin to Europe from locally grown artemesia, Mr McLellan added.

"Although we too are still on a learning curve, we can say that all a farmer needs is a fair-sized piece of land, at least a hectare, with good soils and regular water," Mr McLellan said. "Our experience is that the returns from artemesia can compete favourably with those from such traditional crops as wheat and maize."

Kenya's entry into artemesia farming could not have come at a better time, with the WHO affirming last month that rising global demand of ACTs had led to an artemesinin shortage. The WHO notice followed communication by the drug giant, Novartis Pharma, which supplies the UN agency with Coartem at cost price, that they had only been able to get artemesinin supplies to satisfy 80 per cent of its requirements.

According to a recent press release by Novartis, the artemesinin shortage was inevitable given the rising demand for ACTs.

"The worldwide demand for the drugs - which include Coartem and several other products - is estimated by WHO and Roll Back Malaria partners to have quadrupled from 2003 to 2004," the release said. "At the time of the Artemisia annua crop harvest in July/August 2003, the extent of the increase in demand was not predictable."

Novartis, the release said, could consider sourcing artemesinin from countries such as Kenya if the ingredient was proven to be of the required quality.

"We are working on identifying additional sources of artemesinin, but this process takes time as Novartis strictly adheres to good manufacturing practices in its production," Novartis said. "We follow a rigorous process of ensuring that our suppliers comply with the high quality standards we expect."

According to Mr McLellan, Kenya's adoption of Coartem as first line treatment for malaria should encourage local farmers to start cultivating artemesia.

"Since we will be using the drug in increasing quantities in the near future, it is only right that we benefit from growing one of its key ingredients," Mr McLellan said.

Other than EAB, the other major Kenyan institutions which currently grows artemesia is the Kenyatta University's Centre for Complementary Medicine and Biotechnology Research.

HC remits back Glaxo patent issue

Our Legal Correspondent (BL)

Kolkata , Dec. 17

MR Justice Pinaki Chandra Ghosh of the Calcutta High Court on Thursday remitted back the issue of patent sought by GlaxoSmithKline Plc claiming Rosiglitazone Maleate tablet as its research invention product, which the Controller of Patents & Designs has refused to accept.

As the order of the Controller is not appealable, Glaxo moved in writ jurisdiction against the order of the Controller. Earlier, a writ petition was filed in the Delhi High Court on the same issue, but was withdrawn in 2002. Glaxo wanted to get an exclusive marketing right for the product.

It was stated that the Controller has not examined the case under the perspective of Section 24A of the Patent Act.

The contentions of Glaxo were opposed by counsel of the Controller, stating that the product in question is not inventive, but a conventional product, as the US and Brazil have already granted patent.

After hearing the parties, the court directed the Controller to expedite the hearing without granting adjournment because after December 31, the force of the application shall not remain. So, the Controller has been directed accordingly.

Cervical Cancer Epidemic in Poor Countries

By Stephanie Nebehay

GENEVA (Reuters) - Health agencies on Thursday called for tackling cervical cancer which has taken on epidemic proportions in developing countries from Brazil to India due to a lack of screening.

An alliance launched a manual to help authorities develop good, low-cost detection and treatment programs for the second most common cancer among women worldwide after breast cancer.

About 80 percent of the 500,000 new cases of cervical cancer each year occur in poor countries, mainly in Latin America, Sub-Saharan Africa and the Indian sub-continent. The global caseload is projected to jump to 750,000 by 2020, it warned.

"You could say it is a developing epidemic of cervix cancer," Peter Boyle, director of the International Agency for Research on Cancer (IARC), one of five agencies forming the Alliance for Cervical Cancer Prevention, told a news briefing.

Cervical cancer, caused by a sexually transmitted virus, is both preventable and treatable as it takes many years to develop from detectable precursor cancerous lesions.

About 230,000 victims die every year, according to the manual, based on a five-year study financed by a $50 million grant from the Bill & Melinda Gates Foundation.

In rich countries, women routinely undergo examinations and pap smears in which a smear of cervical cells is taken and evaluated at a laboratory to detect any abnormality.

Such screening lowers risk by 50-90 percent, but is costly and requires a reliable laboratory for analysis, according to Sankarana Rayanan of the IARC, which is based in Lyons, France.

"Such a luxury is not possible in low-resource settings, where we would emphasize that women between 30 and 49 years be screened at least once or twice in their lifetime," he said.

The simplest method is visual inspection, after acetic acid, basically vinegar, is applied to the cervix, turning precancerous lesions white, or iodine, which turns them yellow.

NEW OPTIONS FOR RICH WOMEN

In wealthy countries, women have access to a new technology, the HPV DNA test to detect whether types of cancerous human papillomavirus (HPV) are present.

"It is an effective test that can find women at high risk ... It is certainly something that holds out a lot of hope," said Boyle of the IARC, which has recommended it as a screening test.

But the test, by the U.S.-based company Digene, costs $20 to $40 -- out of the reach of poor countries which also lack technicians and laboratories, according to Sankarana.

The world's first preventive vaccines against cervical cancer are also in sight, with GlaxoSmithKline and Merck and Co. Inc conducting phase three clinical trials.

"Both have been shown to be safe and effective," Boyle said.

On Tuesday, Merck said it plans to seek approval next year for its Gardasil vaccine, while GlaxoSmithKline said it believes it has a winner in its experimental cervical cancer vaccine Cervarix, due to be filed for regulatory approval in 2006.

GSK chief executive officer Jean-Pierre Garnier estimated that there are more than 400 milllion women in Europe and the United States who could be vaccinated, potentially making the new treatments the biggest-selling vaccines ever.

 

Novartis' Glivec story: A sign of things to come?

P.T. Jyothi Datta (BL)

Mumbai , Dec. 20

A LITTLE more than a year ago, a significant step towards establishing a product patent regime was taken in India.

Novartis was granted the country's first exclusive marketing right (EMR) for its blood cancer drug Glivec.

But today the Glivec story evokes emotion-filled reactions from several quarters. It stands mired in litigation and pharma industry representatives say in `I-told-you-so' tones that seeking the refuge of the law was bound to happen when it concerned access to life-saving drugs.

The concern stems from the fact that an EMR gives Novartis the right to be the only company in the country legitimately marketing the drug for a period of time. And local companies making the me-too version of the same drug would have to stop producing it with immediate effect.

Bottomline, feared non-government agency representatives, cancer patients would find the drug too expensive. A year's course of Glivec internationally costs about $27,000, while local copies from India sell at $2,700.

Novartis, meanwhile, initiated legal steps to keep other Indian companies such as Cipla, Ranbaxy and Sun from making similar versions of Glivec.

It also began to give Glivec for free to patients. At last count, about 3,000 cancer patients benefited.

The Glivec story gives us a key-hole view into what is in store when India goes in for product patents in January. Product patents will give companies 20-year monopolies on their innovative products. And concerns abound over whether medicines would see a shortage or a price increase as a result of this.

But for multinational companies looking into India, is the Glivec experience off-putting? Or does the slow trot towards product patents instil confidence to invest in India?

"The Government is likely to bring product patent protection through an Ordinance. But there is still no clarity on what is patentable, whether pre-grant opposition before patents are granted and the triggers for compulsory licencing," said Mr Kewal Handa, Executive Director (Finance) with Pfizer.

Foreign direct investment is connected to patent protection in a knowledge-based industry and one will bring in the other, he adds.

On the "human side", he clarifies: "Companies are donating drugs, others are looking at differential pricing. Bring in patent protection with checks and balances in the interest of consumers."

Mr Rajiv Gulati, Chairman and Managing Director with Eli Lilly in India, says: "Lilly will more than double investment in clinical research, if patents are protected."

It currently invests about Rs 10 crore in research in India. Other MNCs too, such as Merck and GlaxoSmithKline, are waiting in the wings, he adds.

Waiting and watching how the patent regime will be implemented on the ground, as indicated by the Novartis Chairman and Chief Executive Officer, Dr Daniel Vasella, during his recent visit to India. The Glivec experience in India, notwithstanding.