title: Strategic considerations under the Biologics Price Competition and Innovation Act.
abstract: The Biologics Price Competition and Innovation Act provides a pathway for regulatory approval of generic drugs and the associated patent challenge. This article reviews strategic considerations during the patent litigation and injunction phases. Considerations during the initial patent litigation phase include when and whether to exchange a paragraph k application and the listing and exchange of patent information during the volley phase.
authors.forename: John L
authors.initials: JL
authors.lastname: Marquardt
authors.forename: Stephen R
authors.initials: SR
authors.lastname: Auten
mesh_terms: D001688:Biological Products; D059451:Biosimilar Pharmaceuticals; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D016568:Drugs, Generic; D006801:Humans; D010330:Patents as Topic / Q000331:legislation & jurisprudence*; D013810:Therapeutic Equivalency; D014481:United States
chemical_list: D001688:Biological Products; D059451:Biosimilar Pharmaceuticals; D016568:Drugs, Generic