Effects Of Biosimilars Legislation On Patent Litigation

Law360, New York (October 7, 2009, 11:06 AM EDT) -- Intellectual property protection may not immediately come to mind when one considers health care reform, but it should.

Those interested in patent protection should pay special attention to provisions in this pending legislation that would authorize the Food and Drug Administration to approve follow-on versions of biotech medical products (“biosimilars”).[1]

These provisions would establish a complex dispute resolution scheme for biotech medicine patents that departs significantly from the rules of civil litigation.

If enacted, the legislation threatens to convert the U.S. patent system into a two-tiered...
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