India’s Supreme Court Denies Patent to Novartis for Minor Change to Drug

The Supreme  Court of India denied Novartis AG’s request to overrule a 2006 decision of the Indian Patent Office denying a patent to Novartis for Gleevec, a drug for treatment of leukemia. Bloomberg reports  that scientists  believe that Gleevec “turns the deadly blood cancer into a chronic disease.”  Gleevec was Novartis’ best-selling drug in 2012, with sales of $4.7 billion, according to Bloomberg.

Evergreening

Novartis challenged a segment of Indian patent law that restricts multiple patents for a drug and denies patent protection for newer versions of known substances already patented in medicines, according to a Washington Post report.  The Washington Post reported that Pratibha Singh, a lawyer representing three Indian drug companies in the case, said, “the Supreme Court has said that product was known prior to 1995, and a new patent cannot be granted because it is just a little modification on the old one.”  Singh continued, “the court held that merely because it [the new version] is more soluble or more stable, it does not qualify by itself for patent protection.”

Bloomberg reported that Novartis argued that the molecule imatinib, on which Gleevec is based, required years of research and modification to make it an effective, safe leukemia treatment. Justices Aftab Alam and Ranjana Prakash said “repetitive patent is not permissible on the same drug,” and that “the drug is neither new nor complies” with provisions of patent law, Bloomberg reported.

Other drug and pharmaceutical manufacturers are facing similar issues in India. The Washington Post reports that the Indian Patent Appeals Panel allowed a cheaper generic version of Bayer AG’s anti-cancer drug, Nexavar, to enter the market. It also revoked the patent of Pfizer’s cancer drug, Sutent; the company has appealed.

The New York Times reports that “in the United States companies can get a new patent for a drug by altering its formula or changing its dosage.”  Even minor changes,  such as changing the dosage of a medicine from once a day to twice, qualify for a new patent in the U.S.. As an example the Times pointed to AstraZeneca, which got new patent protection when it made slight alterations to the chemical structure of Prilosec and renamed it Nexium.

International Action

Other countries are adopting  an approach similar to India’s, the New York Times reports. “Argentina and the Philippines have passed laws similar to the one enacted in India,” and Brazil and Thailand have been compelling brand name manufacturers of AIDS drugs to accept competition from generics, on the ground that the public health requires the generics to be available.

Reuters reported that the U.S. Trade Representative’s Office is looking into the decision of the Indian Supreme Court.  In the United States, which is in the process of negotiating the terms of a new Pacific Rim trade agreement, the pharmacy industry is lobbying to require the other countries that want to participate in that agreement to enforce tough patent requirements, the New York Times reported.

Costs

Indian exports of generic medications amount to about $10 billion per year according to the New York Times, and the Washington Post reported that “80 percent of the world’s nearly 8 million HIV-infected patients rely on Indian generic medicines.” In India the generic version of Gleevec costs $175 for 30 pills, while the same dose for the brand name Gleevec costs $2,200, according to the Washington Post.  Novartis said in the Washington Post article that it has programs to distribute medications to patients who cannot afford them, pointing out that 16,000 patients in India receive Gleevec free of charge.