Article on use of Bayh-Dole March-In rights to control the price of pharmaceuticals

Posted by J. Matthew Buchanan

September 30, 2004

Link: Chemical & Engineering News (C&EN) has a recent article (September 14, 2004) on the attempts by consumer groups to use the Bayh-Dole Act to control drug prices. The article provides background and summary information on the Act, and details recent attempts by Essential Inventions to get NIH to exercise march-in rights to control the price of Norvir (Abbott) and Xalatan (Pfizer).

The article also discusses the legislative history of Bayh-Dole and the Congressional intent behind the provisions that require the patent holder to make the invention available to the public on “reasonable terms.” Under the act, the government can march-in and grant licenses to others if any of four conditions are not met regarding availability of the invention.

It appears that, in the past, people tended to view the legislative intent behind the Act as focused on utlilization (e.g., the patent holder couldn’t shelf an invention for which a demand exists), and not availability (e.g., cost of product). Now, however, some say its not so clear.

Both of Essential Inventions petitions have been denied (see this prior PTP post), but it seems as if they have succeeded in getting people to think differently about the Act itself.

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