[Ip-health] New York Times editorial: India’s Novartis Decision
thiru at keionline.org
Fri Apr 5 23:29:41 PDT 2013
India’s Novartis Decision
By THE EDITORIAL BOARD
Published: April 4, 2013
The Supreme Court in India ruled on Monday that Novartis, the pharmaceutical company, should not be given a patent for a cancer drug because it was too similar to Novartis’s earlier version. The decision, which is the culmination of a high-profile, seven-year legal battle, should help protect the availability of cheap generic drugs for poor patients.
The ruling has attracted global attention because it concerns the drug Gleevec, a highly effective treatment for leukemia, and because India is the world’s largest supplier of generic medicines and, as a result, its policies potentially affect billions of people around the world.
In many ways, the decision against Novartis is the result of a quirk of history. India began granting patents for medicines in 2005 when it changed its laws to comply with a global intellectual property agreement, but only for drugs created after 1995. The original chemical that forms the basis of Gleevec, imatinib, was discovered in the early 1990s and was not patentable in the country. The court ruled that Gleevec was not eligible for a patent because it was not demonstrably more effective than its predecessor.
When it changed its patent rules, India decided to prevent drug companies from getting monopoly protection on updated drugs that did not represent a major advance over previous versions — a practice often referred to as “evergreening.” The Gleevec case is the first big test of that principle.
Novartis protests that this is not a case of evergreening because the new version is significantly superior in that it is 30 percent easier for the body to absorb than the earlier compound. But the court found that Novartis did not convincingly show that the drug offered “enhanced or superior efficacy” as Indian law requires. The court noted that the decision should not be read as prohibiting patents on all incremental innovation.
The ruling will allow the sale of generic versions of Gleevec in India and other countries where it is not patented at less than one-20th of the roughly $70,000 a year it costs in the United States. It will not affect the price of the drug in America.
This case is unique because it concerns an innovative and useful drug whose creation happened to straddle the change in Indian patent law. The ruling is important, nonetheless, because it establishes a limited precedent that requires drug companies to show real improvements in efficacy before they can get patent protection on updates to existing drugs in India.
That could help poor patients get drugs at prices they can afford while preserving an incentive for true innovation.
Knowledge Ecology International (KEI)
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