India to seek a patent and generic model

New Delhi, 9 may 2007. - The Brazilian decision to use a generic anti-AIDS made ​​in India has reaffirmed the Asian country's leadership in the production of these drugs, and has opened a new front for discussion of patent law .
A generic drug is simply an unbranded product containing the same components as the patented, priced lower than the latter because it includes the costs of research, security and marketing.
And, on day 4, the price difference led Brazil to suspend the patent on an AIDS drug by the multinational Merck and announce the import of a generic manufactured in India almost four times cheaper than the original.
The drug is "Efiravenz" offered by Merck, which owns the patent, to 1.69 cents per unit, compared to 0.45 of the generic manufactured by three laboratories relying on a loose Indian patent law in force since 1970.
That rule reduced the term of patents to a range of 5 to 7 years and imposed restrictions on registration in the pharmaceutical sector, which allowed Indian companies to copy the formulas of medicines through reverse engineering.
India thus became the world leader in production of generics and their companies dedicated to the export of medicines to least-developed, sensitive to the possibility of paying a lower cost treatments.
But according to Doctors Without Borders, the role of India as "pharmacy for the Needy" is in danger following the adoption in 2005 of more generous with patents, to harmonize intellectual property legislation in line with the Organization World Trade Organization.
"When patents are warranted, generics become illegal. We are concerned that India is the only source of cheap drugs and the law in the country enter the patent system, "he told Efe a spokesman for the organization, Leena Menghaney.
The controversy between patent and generic and lies, firstly, that if granted a patent for a drug to a company producing cheaper versions becomes illegal, resulting in tragedy for patients in poor countries.
"Patents have two problems, says Menghaney. First, the price of medicines is high because it hides a patent monopoly. And besides, patented drugs are not available in poor countries, because companies do not sell where anyone can buy. "
But on the other hand, drug companies claim that the effect of the economic benefits associated with patents is the incentive that allows further research toward better treatments and new drugs for diseases without a cure.
"For patients to have access to appropriate medications, the first step is to bring to market new and innovative products," defended the Swiss pharmaceutical firm Novartis said in a statement.
"The best way to encourage innovation is to encourage respect for intellectual property," it added.
The duel between patent and generic is set and the dilemma of privileging economic benefits as a way to reach new medicines, or give preference to the necessary health protection at affordable prices.
"Drugs are not luxuries, but essential. Neither the citizens must be in the hands of companies and poor countries have treatments, so you have to balance the scales "concludes Menghaney.
In India itself the swords are at the top: a court of Madras (south) will sentence, possibly in June, a case filed by Novartis in order to achieve a patent for a drug against leukemia, advocates the repeal of some aspects of the 1970 Act.
While NGOs have used a media campaign and mobilization, worried about the consequences of the case, Novartis, which according to his spokesman is "optimistic" with the ruling, has trusted his luck Shanthi Bhushan's lawyer, former Indian Minister of Justice.
The outcome of this case not only be a replay of the tension between intellectual property rights and reasonable access to medicines, but could prolong the life of the "pharmacy of the poor" or mitigation.

Novartis and NGOs, optimistic about the verdict in patent case

New Delhi, Mar 6, 2007. - The Swiss company Novartis and the NGO Doctors Without Borders today expressed optimism about the upcoming announcement of the verdict of the trial in a Court of Chennai facing the pharmaceutical with the Indian government to prevent a drug patent leukemia.
The Tribunal adjourned the meeting scheduled for today because the trial judge was ill, and summoned both sides to hold another hearing on March 26, a date that could finally produced the announcement of the date of the judgment.
"The next 26 the Court will decide when is the verdict. Here we discuss, first, the constitutionality of the law, and on the other, the decision on patents. Anyway, whoever wins now, the case will end with an appeal to the Supreme Court, "said Leena Menghaney Efe, MSF spokeswoman in India.
Novartis has claimed a section of Indian law prohibits the patenting of drugs that are not strictly innovations, a clause that the Government of New Delhi introduced years ago as a result of pressure from activist groups.
The drug for which the Swiss company decided to go to court is the "Glivec", a drug used to treat a type of leukemia and in India is manufactured as a generic.
According to Novartis, patents are crucial to create incentives for research and development of better medicines, hence calls into question the validity of section 3d of the Indian patent law, by which new licenses only get the products differ significantly from substances already registered.
From the Novartis headquarters in Bombay, spokeswoman Svetlana Pinto said by telephone Efe that the company, defended the case by former Indian Minister of Justice Shanthi Bhushan, is "optimistic" with the outcome.
However, Novartis's request has raised strong opposition from organizations such as MSF, who have warned that if the court rules in favor of the drug, the more difficult to manufacture generic drugs that are treated with many people in the Third World .
"A decision in favor of Novartis would affect many developing countries studying to pass similar laws in India, with a logical interest in drug development sustainable," said Menghaney.
NGOs in Chennai had reported the low profile of the representatives who defend the government's position in the case, in contrast to experts who defend Novartis, which the representative of Doctors Without Borders blamed today that the government "not serious about the case. "
"The drugs were reported in India as" an essential good ", and so far we were happy with the position of the country. Patent law is an opportunity for countries to save their people, because the molecules are patented and innovation, "said Meghaney.
Although, according to Indian television network NDTV, a favorable ruling would affect Novartis increased prices of 9,000 medicines, MSF spokeswoman was, as the representative of Novartis, "optimistic" about the next outcome of case.
India, where a quarter of the population lives below the poverty line, is one of the few developing countries able to produce quality essential medicines, and these drugs are among the cheapest in the world.
In the case of Glivec, patients pay about 120,000 rupees a month (about 2,100 euros) for treatment, in contrast to the 8,000 rupees (135 euros) per month cost of treatment with generics.
In a statement released Feb. measured, Novartis had claimed that the "Glivec" is offered free to 99 percent of Indian patients who need it, while generic versions reach in India "a price about 4.5 times the average annual salary. "

NGOs denounce Indian government indifference to defend their case against Novartis

New Delhi, 15 Jan 2007. - The trial pitting the Swiss drugmaker Novartis with the Indian government to prevent patenting a drug for leukemia was resumed today in Chennai (South) amid criticism from NGOs, who reported EFE disinterest of the Indian government to defend the case.
The sessions were resumed today in the High Court of Chennai in the southern Indian state of Tamil Nadu, and was preceded yesterday of new occurrences of several NGOs, including Doctors Without Borders, to require Novartis to withdraw its lawsuit against the Indian government .
In the room, "while Novartis was challenging the Indian Constitution, there was no government expert to refute their arguments, other than a local attorney who is conducting a serious defense," said Gopa Kumar EFE, the NGO Center for Trade and Development India (CDTI, an acronym in English).
For its part, the pharmaceutical company issued a statement that hailed the beginning of the new view as an opportunity to "gain clarity on the status of intellectual property and patents assurance" in India.
"The new view has started today, but the court only heard the arguments of the parties. Although it is impossible to predict what will happen, tomorrow will be important for the development of the case, "he told Reuters from Mumbai a company spokesman.
Novartis has claimed a section of Indian law prohibits the patenting of drugs that are not strictly innovations, a clause that the Government of New Delhi introduced years ago as a result of pressure from activist groups.
The drug for which the Swiss company decided to go to court is the "Glivec", a drug used to treat a type of leukemia and in India is manufactured as a generic.
According to the company, patents are crucial to create incentives for research and development of new and better medicines.
However, Novartis's request has raised strong opposition from organizations such as Doctors Without Borders (MSF), who have warned that if the court rules in favor of Swiss pharmaceutical giant, will be easier for other companies to obtain patents for drugs now made ​​generically and those who are treated many people in the Third World.
From Chennai, the spokesman was pessimistic CDTI for the development of the eye and said that it was "strange" absence of government representatives qualified to defend the law.
"If the government is still not properly defend this case will be patients who will lose," lamented the spokesman.
Kumar's view is similar to the executive director of Oxfam International, Jeremy Hobbs, who said yesterday in a statement that, if a victory for the company, many drugs will be patented "at prices unaffordable for poor people."
The NDTV television network picked up today for a man with leukemia in the northern region of Bihar, which pays 8,000 rupees (about 135 euros) per month for their treatment based on generic, a figure that contrasts with the 120,000 rupees (about 2,100 euros) per month would cost the drug from Novartis.
India, where a quarter of the population lives below the poverty line, is one of the few developing countries able to produce quality essential medicines, and these drugs are among the cheapest in the world.
A ruling in favor of Novartis would affect the price increase of about 9,000 drugs, according to NDTV.
In a statement, the company had tried to defend against the charges, ensuring that the "Glivec" is offered free to 99 percent of Indian patients who need it, while generic versions reach in India "a price about 4.5 times higher than the average annual salary. "