Federal Circuit Weighs in on Abbreviated Biosimilar Applications

July 23, 2015
Post by Blog Staff

The Biologics Price Competition and Innovation Act (BPCIA) establishes an abbreviated pathway for regulatory approval of follow-on biological products that are highly similar to a previously approved product (the reference product).  The general structure of the abbreviated pathway, referred to as "biosimilar" licensure , is similar to that used for Abbreviated New Drug Applications (ANDA) under the Hatch-Waxman Act:  u nder the abbreviated pathway, an applicant may file a biologics license application with the the Food and Drug Administration (FDA) asserting that the product is biosimilar to an FDA approved reference product.  Because the biosimilar Applicant is able to rely on the license of the reference product, the application proceeds much faster. In addition, as part of the application, the biosimilar Applicant is permitted to begin commercial marketing within a specified time frame.

There are some limitations onto the abbreviated pathway. The reference product enjoys a twelve-year exclusivity, and the biosimilar application cannot even be submitted until four years after the reference license is granted. The Act also establishes that assertion of biosimilarity effectively constitutes patent infringement, allowing for patent infringement suits prior to FDA approval and marketing. As part of this system, there is an elaborate information exchange process between the applicant and the holder of the reference product. The Act requires the biosimilar Applicant to send the reference holder the biosimilar application and manufacturing information within twenty days of the FDA accepting the application, and for the parties to exchange lists of patents for which they believe claims of infringement could reasonably be asserted by the reference holder. The parties then negotiate to form a list of patents subject to an immediate infringement action. The reference product holder then has the right to immediately sue the biosimilar Applicant for infringement on the listed patents. The Act also requires the biosimilar Applicant to give 180 days' notice of commercial marketing to the reference product holder.

The recent Amgen v. Sandoz case has tested the operation of the biosimilar application system.  In the Amgen litigation, Sandoz filed a biosimilar application, referencing Amgen's FDA approved product. However, Sandoz opted not to provide Amgen with Sandoz's biosimilar application within twenty days of the FDA's acceptance of the application, and Sandoz provided the 180 days' notice of commercial marketing prior to the FDA approval. After Sandoz's biosimilar application was approved by the FDA, Amgen brought suit asserting that Sandoz infringed its patent covering the reference product, and violated the BPCIA by failing to disclose the required information and by giving a premature, ineffective, notice of commercial marketing. Sandoz counterclaimed for declaratory judgment that it was permitted to act as it did under the BPCIA, and that Amgen's patent was invalid and not infringed by Sandoz's biosimilar product. 

In a split decision, a three judge panel of the Federal Circuit determined that providing the biosimilar application to the owner of the reference product within twenty days of filing is not an absolute requirement for obtaining approval.  The court concluded that even though the Act uses the strong language of "shall provide"when referring to submission of the application to the reference product holder, the Act also provides a remedy for the reference product holder. A failure to submit allows the reference product holder to bring an action for declaration of infringement, validity, or enforceability of any patent that claims the biological product or use of the biological product. The Act specifies this is the "only remedy."The Court found that by virtue of providing this remedy, the information disclosure is not a true requirement, and the reference product holder has the ability to get the application and manufacturing information in discovery if it files suit.

The panel also determined that the 180 days' notice before commercial marketing may only be given after FDA approval of the application. In reaching this conclusion, the court notes that the statutory language requires 180 days' notice before the date of commercial marketing of the "licensed"biological product. This "licensed"language makes the notice of commercial marketing only applicable after the FDA approves the application. 

While this decision does provide some much needed clarity to what the actual requirements are for biosimilars application, it is likely that the case will be taken up for en banc rehearing by the Federal Circuit.  Filewrapper® will continue to tack this case and provide updates.

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