IU Maurer School of Law
FOR IMMEDIATE RELEASE
Jan. 15, 2010
BLOOMINGTON, Ind. -- As sweeping health care legislation moves through Congress, new laws would provide data exclusivity to innovator companies that introduce new biologic drugs and an expedited regulatory approval process for companies that introduce follow-on (generic) biologic drugs. Such changes could have a significant impact on the pace of innovation in the drug industry.
In view of the importance of the topic, the Indiana University Maurer School of Law's Intellectual Property Program has organized a conference, "Intellectual Property Rights and Health Care: Perspectives on Follow-on Biologic Drugs," to be held from 1:15 p.m. to 4 p.m. on Thursday, Jan. 21.
Mark Janis, IU Maurer School of Law professor and Ira C. Batman Faculty Fellow, said the effects of the pending legislation could hit particularly close to home.
"The health care debate affects everyone, of course," Janis said. "But on top of that, Indiana is home to a thriving life sciences community. We need to care deeply here about the innovation climate for biologic drugs."
Unlike traditional drugs, biologics are highly complex molecules derived from tissue, antibodies, viruses, or other living entities. While there is legislation in place to balance the rights of pharmaceutical patent holders and generic drug manufacturers, it is not clear that those rules will work well in cases involving biologic drugs. Thursday's conference will bring together leading intellectual property experts to debate the merits of the proposed rules.
Several notable panelists are expected to participate, including:
Michel and Munck will talk about the ways in which pending rules might affect the competition in the market for biologic drugs, while Norman will provide perspective from a leading pharmaceutical company.
"We are going to hear quite an array of views on the best ways to use intellectual property rules to promote innovation in biologic drugs," Janis said.
Thursday's event will take place in the Moot Court Room of the Maurer School of Law, 211 S. Indiana Ave. It is free and open to the public.