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Patent Law

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Representatives Send Letter to FDA to Explain Data Exclusivity Provisions of Biosimilars Legislation

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

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By Kevin E. Noonan -- Members of Congress (Rep. Anna G. Eshoo (D-CA) (at right), Rep. Jan Inslee (D-WA), and Rep. Joe Barton (R-TX)) who sponsored the follow-on biologics portion of the comprehensive health care reform bill past year (Patient Protection and Affordable Care Act (H.R. 3590, now P.L. 111-148)) have sent a letter to the Food and Drug Administration, purportedly to explain the "legislative intent" of the data exclusivity provisions of the bill. Those provisions read as follows: SEC. 7002. APPROVAL PATHWAY FOR BIOSIMILAR BIOLOGI CAL PRODUCTS. (a) LICENSURE OF BIOLOGICAL PRODUCTS AS BIO- SIMILAR OR INTERCHANGEABLE.?Section 351 of...

Full post as published by Patent Docs on January 10, 2011 (boomark / email).

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