On June 12, 2017, the U.S. Supreme Court ruled that biosimilar makers can give 180-day notice of commercial marketing prior to obtaining license from the FDA. Sandoz Inc. v. Amgen Inc., 582 U.S. __ (2017). The Biologics Price Competition and Innovation Act of 2009 (BPCIA) provides an expedited pathway for obtaining FDA approval for a biosimilar to an already licensed biological product under 42 USC 262(k). Under 262(l)(2)(A), within 20 days of receiving notice from the FDA that an application has been accepted for review, the applicant must provide its application and manufacturing information to the manufacturer of referenced products (sponsor). Section 262(l)(3) triggers exchange of information between the applicant and sponsor and Section 262(l)(8)(A) requires the applicant to provide sponsor a notice at least 180 days prior to commercial marketing of the biosimilar.
Sandoz filed a 262(k) application for a biosimilar of Amgen's Neupogen. After receiving the FDA notice, Sandoz informed Amgen of the application but failed to provide a copy of the application or information on its manufacturing process. Amgen sued Sandoz for violating the BPCIA. During the pendency of the law suit, and after FDA's approval of its application, Sandoz notified Amgen its intent to launch commercial marketing. The district court granted Sandoz's partial judgment on the pleadings finding that Sandoz wasn't required to provide Amgen with a copy of the application or manufacturing information, and that the 180-day notice is effective even if it is provided prior to FDA's approval of the application. The Federal Circuit affirmed the dismissal of claim based on violation of section 262(l)(2)(A) holding that Sandoz did not violate the BPCIA in failing to disclose the application and manufacturing information but it enjoined Sandoz from marketing the biosimilar until 180 days after the date of notice as the notice requirement is mandatory under section 262(l)(8)(A).
The Supreme Court affirmed in part the holding that the requirement to provide information on application and manufacturing information was not enforceable by injunction and that the sponsor may bring a DJ action of patent infringement for an applicant's failure to provide such information. As to the 180-day rule, the Court held that the plain language of the statute and its context confirms a single timing requirement (180days before marketing) rather than two requirements posited by the Federal Circuit (after licensing, and 180 days before marketing) and accordingly, reversed the Federal Circuit's on that ground.
Full text of the opinion is available here.
Sandoz filed a 262(k) application for a biosimilar of Amgen's Neupogen. After receiving the FDA notice, Sandoz informed Amgen of the application but failed to provide a copy of the application or information on its manufacturing process. Amgen sued Sandoz for violating the BPCIA. During the pendency of the law suit, and after FDA's approval of its application, Sandoz notified Amgen its intent to launch commercial marketing. The district court granted Sandoz's partial judgment on the pleadings finding that Sandoz wasn't required to provide Amgen with a copy of the application or manufacturing information, and that the 180-day notice is effective even if it is provided prior to FDA's approval of the application. The Federal Circuit affirmed the dismissal of claim based on violation of section 262(l)(2)(A) holding that Sandoz did not violate the BPCIA in failing to disclose the application and manufacturing information but it enjoined Sandoz from marketing the biosimilar until 180 days after the date of notice as the notice requirement is mandatory under section 262(l)(8)(A).
The Supreme Court affirmed in part the holding that the requirement to provide information on application and manufacturing information was not enforceable by injunction and that the sponsor may bring a DJ action of patent infringement for an applicant's failure to provide such information. As to the 180-day rule, the Court held that the plain language of the statute and its context confirms a single timing requirement (180days before marketing) rather than two requirements posited by the Federal Circuit (after licensing, and 180 days before marketing) and accordingly, reversed the Federal Circuit's on that ground.
Full text of the opinion is available here.
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