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Novartis tests the law, again

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Nature reports:

Pharmaceutical giant Novartis goes to the Indian Supreme Court next week, aiming to weaken the country’s drug-patent law by challenging a clause that prevents ‘evergreening’, a practice in which pharma companies continuously extend the life of a patent by tweaking the drug slightly.

Evergreening keeps drugs out of the reach of generic manufacturers, and therefore, say critics, out of the hands of patients who cannot afford some brand-name drugs. Novartis is also seeking a 20-year patent on a new version of its 11-year-old anticancer drug imatinib mesylate (Gleevec), which costs roughly US$30 for one 100-milligram pill. A generic version of the drug sells for as low as one-tenth of that cost.

When India signed up in 2005 to the World Trade Organization’s agreement on trade-related aspects of intellectual property rights (TRIPS), designed to ensure patent protection, the country included a clause, 3(d), that states that a drug must show a marked difference in efficacy from previous versions to be patentable.

In 2006, the Chennai patent board ruled that Novartis’s variation of Gleevec was not novel enough to be patentable, and in 2007, the Chennai High Court dismissed Novartis’s challenge that clause 3(d) did not fall in line with the TRIPS agreement. However, in 2009, India’s Intellectual Property Appellate Board overturned the 2006 ruling and deemed the drug to be novel and inventive, but said that because the new version didn’t meet the criterion of enhanced efficacy required by 3(d), it still did not merit a patent.

Now Novartis is challenging 3(d) once more and trying again for a new patent on Gleevec. Anand Grover, co-founder and project director for the Lawyers Collective HIV/AIDS Unit in Mumbai, which is battling Novartis alongside the Indian generic-drug manufacturer Natco, says that Novartis is now arguing that section 3(d) relates to “discoveries” (of things already in existence but not previously found) and so doesn’t apply to its patent application, which is an “invention” (the creation of something new) under the Indian patent law.

A blow to India’s generic industry would also create a ripple effect throughout the developing world, says [Brook Baker, a professor in the Program on Human Rights and the Global Economy at Northeastern University School of Law in Boston, Massachusetts]. “India is a major exporter of generic medicines to developing countries, including 80% of the medicine now used to treat over 6.6 million people living with HIV/AIDS. India’s status as the pharmacy of the poor and of the developing world is actually under attack.”

An earlier background story from Nature claimed:

India’s generic drugs industry, which has boomed since the country abandoned patent protection in 1970, has long been a lifeline to poor countries, supplying HIV drugs that have saved millions of lives, for example. Now India is aiming to become a drugs factory for rich countries such as Japan.

But at the same time as India’s drug companies look East, health advocates are concerned that the European Union’s (EU’s) demand for stricter patent rules on generics will hamper the country’s ability to act as a pharmacy for the developing world.

Japan is keen to use more generic drugs as a way of curbing its skyrocketing health-care costs: the country spends some 36 trillion yen (US$450 billion) a year on health care, and this could rise to 93 trillion yen by 2035. This April, Japan signed a free-trade agreement with India that should make it easier for Indian companies to reach the Japanese market.

Generics account for just 18% of Japan’s $97-billion drug market, compared with 70% in the United States. Japanese doctors are mainly responsible for this, says Ludwig Kanzler, a partner at the Tokyo office of consultancy firm McKinsey, as they have “resisted any significant changes to the health-care system, and certainly all changes that restricted the freedom of doctors”.

In a bid to raise the share of generics to 30% by 2013, the Japanese government brought in reforms last year, including encouraging hospitals to prescribe generics and promoting the use of the drugs among patients. Now, several blockbuster drugs, such as the anticholesterol agent Lipitor (atorvastatin) and the antidepressant Paxil (paroxetine), are about to go off-patent in Japan, says Kanzler.


Written by Arhopala Bazaloides

March 23, 2012 at 5:15 am

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