NEWS OF THE W EEK
INDIA FORCES DRUG LICENSE DRUG PRICING: Official rules that too few
patients can afford a Bayer medication
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N A RARE MOVE with potentially broad implica-
tions for Western drugmakers, India’s controller general of patents has authorized a compulsory license for a Bayer cancer drug. The decision allows the Indian drug company Natco Pharma to make and sell a generic version of the drug Nexavar without Bayer’s consent. The decision marks the first time that an Indian company has successfully petitioned for the compulsory licensing of a patented drug. Under the controller’s ruling, Natco must pay a 6% royalty to Bayer and make the drug available at no cost to 600 needy patients per year. Bayer may appeal the ruling. “We are disappointed by the decision of the patent controller in India to grant a compulsory license for Nexavar, and we will evaluate NEWSCOM
The average Indian citizen’s annual income is far less than the monthly cost of Bayer’s Nexavar.
PUSHING ADVANCED MANUFACTURING GOVERNMENT: President unveils details of new $1 billion initiative
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PRESIDENTIAL PROPOSAL to create 15 Insti-
tutes for Manufacturing Innovation is drawing support from industry groups but criticism from some in Congress for its $1 billion price tag. The National Network for Manufacturing Innovation, which is part of the President’s 2013 budget request, aims to bring companies together with universities and community colleges, as well as federal, state, and local governments, to tackle important research challenges facing manufacturers. “These are going to be institutes of manufacturing excellence where some of our most advanced engineering schools and our most innovative manufacturers collaborate on new ideas, new technology, new methods, new processes,” President Barack Obama said on March 9 when rolling out the initiative’s details. The full network needs congressional approval, but a pilot project will start immediately with $45 million from the DeAP/STEVE H ELBER
The President announced his manufacturing initiative at a Virginia factory run by Rolls-Royce, which participates in a local research center akin to that Obama proposes.
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our options to further defend our intellectual property rights in India,” spokeswoman Kerstin Crusius says. The patent controller found that Bayer was pricing Nexavar—a liver and kidney cancer drug known generically as sorafenib tosylate—too high for most Indians and that the company was not distributing it effectively throughout the country. The regulator estimates that 29,000 Indian patients could benefit from Nexavar, but most are unable to afford its $5,600-per-month price. Compulsory licensing is permitted under international trade rules if certain conditions are met, but only a few countries have resorted to it. In a statement, the health charity Doctors Without Borders saluted the Indian decision and expressed hope that the precedent would lead to the compulsory licensing of other expensive drugs. “Bayer was not able to do much justice to the product; they priced it like idiots,” says Madineedi Adinarayana, Natco’s general manager of corporate and legal affairs. Natco plans to sell the drug for $175 per month. “We are doing this on humanitarian grounds and in sympathy with people who are facing these types of cancers,” Adinarayana says. Bayer is currently suing the Indian drug producer Cipla for selling a generic version of Nexavar without permission for about $600 per month.—JEANFRANÇOIS TREMBLAY
partments of Defense, Commerce, and Energy, as well as NSF. DOD will run the pilot program. Nonprofit research centers, with support from industry, can apply to host an Institute for Manufacturing Innovation focused on a specific research area, says Michael F. Molnar, chief manufacturing officer at NIST and the director of the Advanced Manufacturing National Program Office. For the full-scale program, the federal government proposes to put about $100 million into each project in the first year, with industry partners gradually taking over funding. Winning projects will be chosen through a competition. “These centers could provide small and midsized companies with ideas, approaches, best practices that could be used to ask the question, ‘How could I move my business from just a U.S.-focused market to a global market?’ ” explains Fred Wentzel, executive vice president of the National Council for Advanced Manufacturing. A focus on small and midsized companies “is the only way to expand exports—the biggies are already doing it.” But some in Congress are skeptical. “I have initial concerns about the program’s cost, as well as the potential for overlap and duplication with other federal initiatives,” says Rep. Benjamin Quayle (R-Ariz.), chair of the technology subpanel of the House of Representatives Science, Space & Technology Committee. He is also troubled that the Administration would launch the pilot project without congressional approval.— ANDREA WIDENER
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