180 days post-licensure notice before commercial marketing for all Biosimilar Products is mandatory
Introduction
The Present case relates to biologic product Amgen’s pegfilgrastim and legal action under Biologics Price Competition and Innovation Act of 2009 (Biologics Act or BPCIA) (BPCIA or Bio-similars Act, which was enacted on March 23, 2010, as a component of the Patient Protection and Affordable Care Act)
The Bio-similars Act was designed to create an abbreviated approval pathway for producers of biological products that are known to be sufficiently bio-similar, or interchangeable, with a therapeutic biological product that has already been approved by the FDA.
The BPCIA, along with the abbreviated approval process, introduced a scheme for resolving patent disputes for bio-similar products. Commonly referred to as the “patent dance”, 42 U.S.C. §262(l) creates a schedule whereby the bio-similar applicant and the reference product sponsor exchange information regarding the application for the bio-similar; specifically, the parties exchange information regarding patents that may be the subject of litigation regarding the proposed bio-similar product.
Summary and background of case:
In the present case of Apotex (Biosimilar applicant) filed a Biologic License Application (BLA) under 42 U.S.C. § 262(k), listing Amgen’s Neulasta® as the reference product seeking FDA approval to market a biosimilar version of Neulasta® (pegfilgrastim)
Apotex’s application was accepted for review by the Federal Drug Administration (“FDA”) on December 15, 2014. Two weeks later, Apotex engaged in the patent information exchange process pursuant to § 262(l)(2)(A) by sending Amgen a copy of its application and information detailing its manufacturing process. On February 27, 2015, Amgen sent Apotex its § 262(l)(3)(A) list of patents. On April 17, 2015, Apotex provided its § 262(l)(3)(B) response. On the same day, Apotex also sent Amgen a letter stating it was providing notice of future commercial marketing pursuant to § 262(l)(8)(A). Amgen interpreted this letter as an attempt to initiate the 180 day notice period, even though Apotex’s proposed product had not received an FDA license.
In October 2015, Amgen filed a motion for a preliminary injunction requiring Apotex to provide an (8)(A) notice to Amgen only after Apotex receives a license and thereby delay Apotex’s commercial marketing of its pegfilgrastim product for 180 days from that notice.Resolution of the motion turned on whether the 180 day commercial marketing notice of (8)(A) is mandatory. The District Court held that it was mandatory and granted Amgen’s preliminary injunction. Apotex appealed.
Conclusion of court of appeal (Appeal from the United States District Court for the Southern District of Florida in No. 0:15-cv-61631-JIC); Decided on July 5, 2016
Court of Appeals for the federal circuit affirmed district court decision by concluding that an applicant must provide a reference product sponsor with 180 days’ post-licensure notice before commercial marketing begins, regardless of whether the applicant provided the (2)(A) notice of FDA review.
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