Category: Health

India’s Supreme Court is to rule Monday on a landmark patent case involving Swiss drugmaker Novartis AG that focuses on demands by major companies that their investments be protected, against Indian companies that say they should be allowed to continue producing cheaper generic versions of many lifesaving medicines.

A decision in the seven-year legal battle is keenly awaited by the two most interested parties— big pharma companies and health aid groups — with both sides saying the outcome will set a precedent with far-reaching consequences for the future availability of the drugs.

“Across the world, people rely on India for supplies of affordable versions of expensive patented medicines,” said Leena Menghaney of Doctors Without Borders. “This case will have fundamental consequences.”

The case goes back to 2006 when Novartis’ application for a fresh patent in India for its cancer drug imatinib mesylate was rejected by the Indian patent office.

The patent authority cited a legal provision in India’s 2005 patent law aimed at preventing companies from getting fresh patents for making only minor changes to existing medicines — a practice known as “evergreening.”

The drugmaker has argued that its leukemia drug Gleevec, known in Europe and India as Glivec, was a newer, more easily absorbed version that qualified for a fresh patent.

The company filed an appeal, but India’s patent appeals office turned it down in 2009 on the grounds the company was unable to show significant increase in efficacy of the drug.

Novartis then approached the Supreme Court in August 2009, which heard arguments seeking to challenge the interpretation and application of India’s patent law in the case.

Gleevec, used in treating chronic myeloid leukemia and some other cancers, costs a patient about $2,600 a month. Its generic version was available in India for around $175 per month.

“The difference in price was huge. The generic version makes it affordable to so many more poor people, not just in India, but across the world,” said Y.K. Sapru, of the Mumbai-based Cancer Patients Aid Association.

The case once again pits big pharmaceutical companies against health activists and aid groups with both sections arguing that the judgment would be an important milestone for the future of the pharmaceutical industry worldwide.

“The Novartis verdict is important because it will determine whether India gets to limit patents to genuine new drugs, or whether drug companies get to “evergreen” their patents until eternity, simply by re-patenting a slightly modified version of a known substance,” said Ellen ‘t Hoen, a pharmaceutical law and policy consultant.

Western pharmaceutical companies have warned that a rejection of Novartis’ application would discourage investment in research and innovation, and would hobble drugmakers’ efforts to refine and improve their products.

The international drug majors have been pushing for stronger patent protection in India to regulate the country’s $26 billion generic drug industry, which they say often flouts intellectual property rights.

In a statement sent to The Associated Press late last year, Novartis said patent protection was important to ensure effective protection for innovation.

“Knowing we can rely on patents in India benefits government, industry and patients because research-based organizations will know if investing in the development of better medicines for India is a viable long-term option,” the company said.

Groups such as Doctors Without Borders say cheaply made Indian generics are a lifesaver for millions of patients in poor countries who cannot afford to pay Western prices to treat diseases such as cancer, malaria and HIV.

India, which has emerged as the world’s pharmacy for the poor, has come under intense scrutiny from pharmaceutical giants who say India’s 2005 Patent Act fails to guarantee the rights of investors who finance drug research and development.

The country’s recent decision to allow a local manufacturer to produce a generic version of Bayer’s patented cancer drug Nexavar, to make the drug available to the public at a reasonably affordable price, has also not gone down well with Western pharmaceutical companies.

Health and aid groups were clearly nervous before the top court rules on the Novartis case.

“Generic companies depend on the freedom to operate. If there are too many intellectual property-related challenges, then the companies very quickly withdraw from making that drug,” said Menghaney.

The groups fear that a ruling in favor of Novartis would lead to a proliferation of patents — some based on a minor tweaking of formulation and dosages —on dozens of other generic medicines that Indian companies have been producing and supplying to needy nations at far lower costs than those charged by Western drug manufacturers.

And the fallout of the judgment will be felt across the world, says Menghaney. “It’s not just about India.”

“If generic competition on many crucial medicines ends, then prices for these medicines will increase, both in India and across the developing world. This would be devastating for millions who rely on India for affordable medicines.”

Associated Press

There has been another confirmed case of a mysterious new SARS-like virus.

The Saudi health ministry informed the World Health Organization that a 39-year-old man was hospitalized with the novel coronavirus on February 28 and died two days later.

So far, WHO has recorded 15 confirmed cases of the novel coronavirus, including nine deaths, since the fall.

The Saudi patient did not appear to have had any contact with anyone who was already infected. As a result, WHO is investigating other potential exposure sources.

Symptoms

The novel coronavirus is in the same family as SARS.

SARS, or Severe Acute Respiratory Syndrome, virus sickened 8,000 people and killed 774 between 2002 and 2003.

Symptoms of the novel coronavirus include an acute respiratory infection, fever and a cough. And it could lead potentially to pneumononia and kidney failure.

The first cases were found to have occurred in an Amman, Jordan, hospital, according to the Centers for Disease Control and Prevention.

Cases

Most of the people who’ve caught the virus have been in the Middle East.

But there have been cases reported in the United Kingdom as well.
One of the U.K. patients had traveled to Saudi Arabia. Upon return, he infected two other family members.

“Once it gets you, it’s a very serious infection,” said Dr. William Schaffner, an infectious disease specialist at Vanderbilt University Medical Center in Nashville.

Fortunately, he added, the virus is “very difficult to acquire.”

While the SARS epidemic was going on, many of those caring for patients were infected too.

The fact that this hasn’t been seen with these cases so far is a good sign, Schaffer said.

Origin

It’s suspected that, like SARS, the virus originated in animals.

A study published in November found that genetically, the new coronavirus was most closely related to viruses found in bats.

While no cases have popped up in the United States, doctors say they won’t be shocked if it did.

“It could happen,” said Dr. Susan Gerber, a medical epidemiologist in the CDC’s Division of Viral Diseases.

“That’s why the CDC is working closely with the World Health Organization and other international partners.”

Spread

WHO has asked member states to keep an eye out for severe acute respiratory infections and review them for unusual patterns.

It did not recommend travel or trade restrictions for countries where the virus has been found.

Dr. Susan Gerber, a medical epidemiologist in the CDC’s Division of Viral Diseases, agrees.

There’s no evidence of sustained human-to-human transmission, she said, “where you see a chain of many cases going person to person to person.”

“People shouldn’t freak out,” she added. “There’s no evidence that this virus is easily spread, say, across a room.”

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