The Buzz, published by the American Intellectual Property Law Association featured Laura Smalley’s article on The Biologics Price Competition and Innovation Act.
The Biologics Price Competition and Innovation Act (“Act”) provides an abbreviated pathway for obtaining Food and Drug Administration (“FDA”) approval of a drug that is biosimilar to an already-licensed biological product (reference product). 42 U.S.C. § 262(k). The Act also provides procedures for resolving patent disputes between biosimilar manufacturers (applicants) and manufacturers of reference products (sponsors). 42 U.S.C. § 262(l). The Act treats the submission of a biosimilar application as an “artificial” act of infringement, enabling parties to bring patent infringement actions at certain points in the application process even if the applicant has not committed a traditional act of patent infringement, such as making or using an infringing product. 35 U.S.C. § 271(e)(2)(C)(i),(ii). The Act “facilitates litigation during the period preceding FDA approval so that the parties do not have to wait until commercial marketing to resolve their disputes.” Sandoz Inc. v. Amgen Inc., Nos. 15–1039, 15–1195, 2017 WL 2507337, at *6 (Sup. Ct. June 12, 2017)(“Decision”).
On June 12, 2017, the Supreme Court decided important issues governing the Act’s mechanisms for resolving patent disputes in Sandoz Inc. v. Amgen Inc. The Supreme Court held that Act’s requirement for the applicant to provide its application and manufacturing information (42 U.S.C. § 262(l)(2)(A)) is not enforceable by an injunction under federal law, but that an injunction under state law may be available. The Supreme Court also held that an applicant may provide notice of commercial marketing under 42 U.S.C. § 262(l)(8)(A) before obtaining an FDA license. While the Supreme Court did not expressly determine the issue, its rationale makes clear that noncompliance with other provisions of the Act’s information exchange procedures cannot be remedied by an injunction under federal law, but instead must be remedied by the immediate declaratory judgment action expressly authorized by the Act.
The Requirement to Provide the Biosimilar License Application and Manufacturing Information is not Enforceable by an Injunction under Federal Law, but State Law Remedies May be Available.
This article was originally published in the June, 2017 Biotech Litigation section of Biotech Buzz, published by the American Intellectual Property Law Association. Read the full article: "The Supreme Court Interprets the Biologics Price Competition and Innovation Act in Favor of Biosimilar Applicants"