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Articles

Major Changes Ahead

July 6, 2009

Articles

Major Changes Ahead

July 6, 2009

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John D. Garretson article in BioForum Europe

After years of discussion, the U.S. patent system is poised for sweeping reform.  Congress is now considering two bills (both titled “The Patent Reform Act of 2009,”  S. 515 and H.R. 1260) that, if enacted, would represent the most significant changes to patent law since 1952.  Federal legislation is also pending to create a follow-on biologics approval process within the Food and Drug Administration (FDA).  Two “bio-similar” bills have been introduced within the last several months (H.R. 1427 and 1458), and a third is expected shortly.

There is significant momentum for both of these initiatives.  Many expect Congress to act this year, despite the challenges (and distractions) posed by the current economic crisis.  The Obama administration is also seeking to prioritize health care reform.  As part of that process, access to medication, regulatory procedures and pioneer exclusivity are all being hotly debated.

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