Amgen v. Apotex – Biosimilar Applicants Must Provide 180-Day Notice Before Marketing Even if They Participate in the "Patent Dance"

On July 5, 2016, the Federal Circuit rendered its decision in Amgen Inc. v. Apotex Inc., further clarifying the provisions of the Biologics Price Competition and Innovation Act (“BPCIA”). In particular, the Apotex court held that “[t]he (8)(A) requirement of 180 days’ post-licensure notice before commercial marketing…is a mandatory one enforceable by injunction whether or not a (2)(A) notice was given.”1

For background, in October 2014, Apotex filed a biologics license application (“BLA”) for its pegfilgrastim product with the FDA under 42 U.S.C. § 262(k), listing Amgen’s Neulasta® as the reference product. The FDA approved Apotex’s BLA application on December 15, 2014. On December 31, 2014, Apotex provided Amgen a copy of the application and information detailing Apotex’s pegfilgrastim manufacturing process, complying with § 262(l)’s paragraph (2)(A), and initiating what has been referred to as the “patent dance”. Amgen provided Apotex its (3)(A) list on February 27, 2015, identifying three patents, and Apotex provided its (3)(B) patent-specific response on April 17, 2015. After negotiation, the parties agreed to an immediate action for infringement, which Amgen filed on August 6, 2015. During this suit, Apotex notified Amgen that it did not believe it was required to, and indeed did not intend to, provide the Notice of Commercial Marketing specified under § 262(l)(8)(A) of the BPCIA. Amgen sought a preliminary injunction, which was issued by the Southern District of Florida requiring Apotex to “provide Amgen with at least 180 days notice before the date of the first commercial marketing of the biological product approved by the FDA.” Apotex appealed that decision to the Federal Circuit.

In the meantime, the Federal Circuit decided Amgen v. Sandoz, holding that “where, as here, a [biosimilar] applicant completely fails to provide its BLA and the required manufacturing information to the [reference product sponsor] by the statutory deadline, the [notice] requirement of paragraph (l)(8)(A) is mandatory.”

Thus, Apotex argued that, unlike Sandoz, they participated in the “patent dance”, distinguishing their case from the court’s decision in Amgen v. Sandoz.

The Apotex court disagreed in a unanimous opinion, authored by Judge Taranto, holding that while the (2)(A) notice given by Apotex created a factual distinction from the Amgen v. Sandoz case, it did not create a legally material distinction. First, the court noted that section (8)(A) “contains no words” that would make the notice requirement turn on whether the earlier (2)(A) notice was given. Moreover, unlike with the notice and disclosure provision of (2)(A), there is no language in 271(e) that would create a specific remedy for non-compliance. The court also explained that the statutory purpose of the Notice of Commercial Marketing provision was to reduce the “reliability-reducing rush that would attend requests for relief against immediate market entry that could cause irreparable injury” — a purpose that would be frustrated if section (8)(A) notice were not mandatory.2

The Apotex court also addressed another unsettled question regarding the BCPIA, although it was not at issue in this case. In describing how patent infringement works in 35 U.S.C. § 271(e) and the BPCIA, the court stated that “[i]f a patent that the reference product sponsor should have included on its (3)(A) list or its (7) supplement ‘was not timely included,’ then the owner of that patent may not sue for infringement under 35 U.S.C. §271 with respect to the biological product at issue. 35 U.S.C. § 271(e)(6)(C).” While a reference product sponsor may argue that this section of the court’s opinion is dicta, it may be difficult for a patent holder to assert a patent against a biosimilar unless the patent “was timely included” in the relevant patent dance disclosures. Thus, any reference product sponsor would be well-advised to be very careful to include any patent that can be reasonably asserted during the “patent dance.”

1. Amgen Inc. v. Apotex Inc., No. 2016-1308 (Fed. Cir. July 5, 2016).
2. Amgen Inc. v. Sandoz Inc., 794 F.3d 1347, 1360 (Fed. Cir. 2015).


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