Drugs for Indian Poor Spark Pfizer Anger at Lost Patents

Posted: Published on March 28th, 2013

This post was added by Dr P. Richardson

In trying to get sophisticated medicines to its neediest citizens, India is increasingly pitting its generic-pharmaceutical industry against international drugmakers, threatening their growth in emerging markets.

An Indian regulatory board this month upheld a ruling that allows Natco Pharma Ltd. (NTCPH) to make a low-priced copy of Bayer AG (BAYN)s Nexavar cancer treatment. The drug is one of at least four that have had their patents weakened, revoked or rejected in India in the past year. The country also has refused a patent for Novartis AGs (NOVN) Gleevec leukemia medicine, and the Supreme Court will rule April 1 on the companys appeal of the decision.

Those steps are needed to put modern medicines into the hands of Indians, according to aid groups and doctors. Western drugmakers including New York-based Pfizer Inc. (PFE) say the country, which has a $30 billion drug market thats growing 13 percent a year, is abusing international law and allowing domestic companies to profit from products discovered at Big Pharmas expense.

The dispute illustrates how emerging markets are turning out be less lucrative than drugmakers expected. London-based GlaxoSmithKline Plc (GSK) has warned that so-called compulsory licensing of patented products may hurt profit growth. One advocacy group now is pushing stricken Western countries such as Greece to follow Indias lead, raising the prospect of further pressure on drug prices.

Emerging markets are extremely important for drugmakers because they cant grow in Europe, plain and simple, Michael Leuchten, an analyst at Barclays Plc in London, said in a telephone interview. The effect isnt quantifiable, but it is a stumbling block and companies will suffer.

India in 1995 agreed to meet intellectual-property standards set out by the World Trade Organization. The country says those standards allow it to invalidate patents and issue compulsory licenses to local generics companies to ensure its citizens have access to medicine.

Indian officials also may be motivated by boosting the domestic drug industry, said Wim Leereveld, who heads the Access to Medicines Foundation, a non-profit group that ranks drug companies on how well they make products available to poor and middle-income countries.

This is not only about access to medicines; they are also protecting their own businesses, said Leereveld, whose group doesnt take funding from drug companies.

An e-mail requesting comment sent to 12 officials at Indias Department of Pharmaceuticals wasnt answered. Three phone calls to the office of the department secretary, Dilsher Singh Kalha, werent answered.

Generic-drug companies Natco and GM Pharma Ltd. won their 2006 effort to contest AstraZeneca Plcs patent protection in India for its lung-cancer drug Iressa, a decision upheld in November 2012 by the countrys Intellectual Property Appellate Board.

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Drugs for Indian Poor Spark Pfizer Anger at Lost Patents

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