Saturday, August 25, 2007

Novartis in Pain!

A court in Chennai stood up to a pharmaceutical giant and in major setback to the company ruled against it.

No prescriptions and a little change would buy you almost any medication at the local drugstore in India. That seemed all set to change in 2005 when India amended its patent law to fall in line with WTO requirements. Until then India allowed pharmaceutical patents only on the manufacturing processes used to produce drugs, not on the end products themselves. So Indian pharmaceutical companies were able to manufacture generic versions of expensive and valuable medicines by just changing the manufacturing method. This system encouraged companies to compete in low-cost manufacturing, developing the nation's industry and making medicines widely available at low prices. It also seemed to be of great public health value. Bringing India’s patent law in step with that of the European and US laws seemed a logical and rational move in the direction of modernization and globalization. Or at least that is what the pharmaceutical companies and the developed world attempted to convince the detractors of the amendment. With little or no parliamentary debate the amendment became law in 2005. Even the communist party of India voted for it acknowledging the major reservations it had with the change. The people at greatest risk are those needing HIV/AIDS medication and cancer chemotherapy. With the patenting of these medications the drugs would become unaffordable for most creating a public health crisis.

As disconcerting as the new patent law was it seems that the authors did put in a few clauses that serve protectionism and to make it less destructive. One such clause is allowing patenting of only those drugs that were invented after 1995. But in the ruling against Novartis, its Section 3(d) that saved the day. It was effectively used to prevent this hugely profitable company from making yet another life saving drug unattainable to India’s poor.

Section 3(d) is a clause in India's patent law that states that modifications or new uses for existing substances are not grounds for a patent unless they significantly increase its effectiveness. Novartis' challenged this section attempting to have it removed. This was its response to the rejection of the company's patent application for the cancer drug Gleevec in January 2006. The patent was rejected on grounds that the company had modified the drug with little if any change or improvement in efficacy or effectiveness.

Bravo Chennai!

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