Opinion ID: $opinion_id
Heading Depth: 2.0
Heading Rank: 2

Heading: $label

Text: A sponsor may hold multiple patents covering the biologic, its therapeutic uses, and the processes used to manufacture it. Those patents may constrain an applicant’s ability to market its biosimilar even after the expiration of the 12-year exclusivity period contained in §262(k)(7)(A).

The BPCIA facilitates litigation during the period preceding FDA approval so that the parties do not have to wait until commercial marketing to resolve their patent disputes. It enables the parties to bring infringement actions at certain points in the application process, even if the applicant has not yet committed an act that would traditionally constitute patent infringement. See 35 U.S. C. §271(a) (traditionally infringing acts include making, using, offering to sell, or selling any patented invention within the United States without authority to do so). Specifically, it provides that the mere submission of a biosimilar application constitutes an act of infringement. §§271(e)(2)(C)(i), (ii). We will refer to this kind of preapproval infringement as “artificial” infringement. Section 271(e)(4) provides remedies for artificial infringement, including injunctive relief and damages.