Healthcare Matters

(Source: Reuters) – India’s Supreme Court will soon rule in a case that could change the game in the country’s healthcare sector. Novartis AG –pretty much playing Big Pharma’s hand in this instance– has gone after India’s patent office for being overly protective of its country’s global role as a supplier of  low-cost generic medicines. Specifically, the Indian patent office has refused to grant Novartis a patent on the company’s cancer drug, called Glivec. Novartis claims that the drug embodies more than enough new and unique intellectual property (IP) to qualify for protection. But the Indian patent office claims that Glivec is nothing more than an amended version of a known compound. Haven’t we heard this before?

If the patent office sides with Novartis, it will be regarded as a blow to the country’s generic drugmakers who supply medicine to 1.2 billion Indians and to other poorer nations across the world. India takes pride in its reputation as “pharmacy to the developing world,” but Big Pharma aims to put a stake in the ground, as it is wary of what it sees as “lax protection” for its IP.

“The stakes are very high on both sides,” said Leena Menghaney, a manager in New Delhi for Medecins Sans Frontieres (MSF), which relies on Indian-made generic drugs to treat AIDS and other diseases in Africa and many poor countries. By the way, Glivec, known as Gleevec in the United States, was approved in 2001 and can cost $70,000 a year. Discount programs mean it is available for a lot less in poor countries and in India more than 95 percent of patients receive it free of charge under a company donation scheme, so if you’re asking what’s the big deal here, well…

“The patent for Glivec is not really the issue here. It is just an example of us wanting very clear legal clarity about what kind of innovation is patentable,” Paul Herrling, head of the Novartis Institute for Tropical Diseases, told Reuters. The institute is a unit of the pharmaceutical company that focuses on diseases in the developing world. In contrast to other countries, India’s patent law prohibits patents on a newer form of a known drug unless it offers a significant advance in efficacy. The aim is to prevent “evergreening”, or adding new patents that tweak a product to extend exclusivity. Novartis argues this does not apply to Glivec, since the initial patent was for a version of the drug that needed a major re-design to make it effective. Emerging market economies are increasingly wary about ceding too much market power to Western drug-makers who are targeting their expanding middle classes as an important growth market at a time when their U.S. and European sales are flagging.

This is all about balancing patents against patients, Menghaney of MSF believes. Frankly, I don’t like that argument much at all, but she may be right. It reminds me a of the logic behind the recent SCOTUS ruling. Apparently, Courts don’t make decisions simply based on the merits, legality or precedents supporting one of the arguments being made. Rather, they look at the entire context, account for public opinion, marry the two and sets out to rule in a way that can be tied back.

This case should be about what is/isn’t patentable in the drug-making world –that’s all. But the highest courts in the developing world have paid attention to the way we’ve “done it” in the developed world. And they think they can do a better job. Are they wrong?

—Tom Finn