Post-Grant Proceedings Are Important For Biosimilars
Law360, New York ( March 19, 2015, 9:12 AM EDT) -- Patent certainty is a major goal of generic drug manufacturers — whether small molecule or biologic. However, compared to their small molecule brethren, biosimilar developers potentially face a much more complicated patent thicket because of the complexity of producing a biologic drug. The Biologics Price Competition and Innovation Act introduced one mechanism by which patent certainty may be obtained prior to market approval. But in recent litigations, biosimilar applicants who have sought to circumvent the BPCIA have been unsuccessful in their efforts to obtain early resolution of their patent disputes in district court. Thus, biosimilar applicants will increasingly look to post-grant patent challenges at the U.S. Patent and Trademark Office as a mechanism for obtaining early and fast patent certainty....
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