Patent Dance Developments: A Tale Of 2 Antibodies

By Ted Mathias, Stacie Ropka and Nisan Zaghi (October 26, 2018, 3:44 PM EDT) -- The Biologics Price Competition and Innovation Act of 2009 outlines a series of steps, commonly referred to as the "patent dance," for resolving patent disputes involving biologic drugs. The patent dance is similar in some respects to the now-familiar Orange Book listings and notice letters that precede a Hatch-Waxman litigation for small molecule drugs. The patent dance is different, however, in that parties face more strategic choices. Whereas the presuit Hatch-Waxman process is essentially mandatory, an abbreviated biologic license applicants might elect to forgo the patent dance.[1] For parties that do engage in the patent dance, recent litigations for the antibodies trastuzumab and adalimumab point to the different approaches parties can take....

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