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Biologics patent owners should consider the US International Trade Commission as a supplement (or alternative) to district court litigation, say Filko Prugo, Charlotte Jacobsen, Matt Rizzolo and Henry Huang of Ropes & Gray.
For manufacturers of biologics and biosimilars, the Biologics Price Competition and Innovation Act (BPCIA) imposes a complex statutory scheme that restricts the timing and control of patent litigation in district court. Biosimilar applicants who find themselves on the receiving end of a potential patent infringement complaint in district court have the advantage of (and have utilised) patent challenges at the Patent Trial and Appeal Board (PTAB).
However, another option also exists for biologics patent owners—one that proceeds at a fast pace using specialised rules and judges and that eschews stays pending PTAB challenges: the International Trade Commission (ITC).
The ITC provides a potentially robust supplement to BPCIA litigation in federal court—with distinct strategic considerations and powerful potential remedies for patent owners. Most significantly, the ITC may permit earlier resolution of ‘second phase’ BPCIA patent disputes and avoid the need for a preliminary injunction to prevent an at-risk biosimilar launch.
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Biologics, patent infringement, biosimilar litigation, US International Trade Commission, patent invalidity, Biologics Price Competition and Innovation Act