By Terry Mahn and Gina Nellesen ( May 17, 2017, 11:56 AM EDT) -- When Congress enacted the Biologics Price Competition and Innovation Act of 2009, it created an artificial act of infringement for the submission of a biosimilar application but was silent as to how patent term extension would apply to these large-molecule drugs. Language from the patent statute as interpreted by courts extends patent protection for a drug's "active ingredient,"[1] a term that is not commonly applied to biologics. Biologic manufacturers, therefore, should be made aware that the scope of patent rights for large-molecule drugs under an extended term is at best unclear, given that the statutory language developed under Hatch-Waxman must now be "overlaid" onto the BPCIA....
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