1st Biosimilars Act Ruling May Limit Patent Challenges

Law360, New York (November 13, 2013, 7:24 PM EST) -- The ability of biosimilars makers to make early challenges to biologic drug patents may be curtailed by a Tuesday ruling throwing out Sandoz Inc.'s suit to invalidate patents for Amgen Inc.'s biologic arthritis drug Enbrel, the first time a judge has interpreted the litigation provisions of the Biosimilars Act.

Sandoz, which is working on a biosimilar version of Enbrel but has not yet sought government approval, filed suit in June seeking declaratory judgment that its version would not infringe and that the patents are invalid....
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