FDAnews Device Daily Bulletin

WHO PLAN TO EASE IP ENFORCEMENT MAY CHANGE LICENSING PRACTICES

June 16, 2006
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A World Health Organization (WHO) initiative to loosen diagnostics and drug intellectual property (IP) laws in developing countries could lead diagnostics manufacturers to consider patent restrictions for their products and dampen their financial incentive to develop tests for diseases that are prevalent in poorer nations, an industry consultant suggests.

A report issued in April by WHO's Commission on IP Rights, Innovation and Public Health encourages diagnostics and drug firms to avoid enforcing patents that would inhibit access to medical treatments. The report urges developed countries to grant voluntary licenses to poorer countries for use of their products and facilitate the transfer of medical technology to those countries.

Perhaps the biggest issue for companies in wealthier nations is the issue of compulsory licensing, which allows governments to force patent holders to grant use of their IP to the state or other entities.

One of the main problems with the current situation is that there seems to be no way to limit compulsory licenses to poorer countries alone, David Vogel, president of Intertech Engineering Associates and an expert on device development, safety and regulation, told FDAnews.

Compulsory licensing is meant to protect countries from inventors who may hold hostage potentially lifesaving technology by demanding unrealistic licensing fees, Vogel pointed out.

(http://www.fdanews.com/ddl/33_24/)