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Genzyme's Manufacturing Issues with Fabrazyme Prompt Patients to Petition HHS Secretary to Exercise Bayh-Dole "March-in" Rights

By Donald Zuhn, Kevin Noonan, Chris Singer, Sherri Oslick, and Jason Derry

By James DeGiulio -- Genzyme's manufacturing problems with their $300,000 per year drug Fabrazyme have prompted patients who depend on the enzyme replacement drug to ask that Health and Human Services (HHS) Secretary Kathleen Sebelius exercise the government's "march-in rights" under the Bayh-Dole Act. The 1980 law empowers the federal agency funding the research, here the HHS, to abrogate Genzyme's U.S. Patent Nos. 5,356,804 and 5,560,757 on the drug, allowing other companies to fill the demand. The agency is empowered to provide licenses to other interested parties when the "health or safety needs" of the American people are not being...

Full post as published by Patent Docs on August 16, 2010 (boomark / email).