Amgen v. Apotex Decision

By: Sandra King  |   July 18, 2016

Amgen v. Apotex – Patent Dance Participation Does Not Obviate the Need for Post-Licensure Notice

On July 5, 2016, the Federal Circuit issued its decision in Amgen v. Apotex affirming an order preliminarily enjoining Apotex from launching its version of Neulasta (pegfilgrastim). Unlike Sandoz in the previously decided post-licensure case, Amgen v. Sandoz, Apotex had properly engaged in the “patent dance” outlined in 42 U.S.C. § 262(l). As such, Apotex contended that they were not required to provide post-licensure notice to viagra sans ordonnance Amgen and that such requirement may not be enforced by an injunction. The Court held that the post-licensure notice provision is mandatory and enforceable by injunction even for those biosimilar applicants that properly participate in the patent dance.


Apotex had previously filed an application with the FDA under the Biologics Act seeking permission to begin marketing its biosimilar version of Amgen’s Neulasta. Apotex and Amgen had proceeded several steps into the “patent dance” laid out in § 262(l). Apotex had provided Amgen with a copy of their application and information detailing Apotex’s manufacturing process per § 262(l) paragraph 2(A). Amgen then provided its own patent list under paragraph 3(A) identifying three patents and Apotex provided a paragraph 3(B) response. In the response, Apotex certified that it did not intend to begin commercial marketing before expiration of two of the cited patents and asserted non-infringement and invalidity arguments against the remaining cited patent. On the same day, Apotex also sent a letter to Amgen providing notice of future marketing pursuant to paragraph 8(A).

Shortly thereafter, Amgen filed a motion asking the district court to issue a preliminary injunction that would require Apotex to provide 8(A) notice if and when it receives a license and further delay commercial marketing for 180 days from that notice. The question presented was whether the 8(A) notice requirement is a mandatory one enforceable by injunction as to an applicant who had properly provided 2(A) notice to launch the information-exchange process.


The CAFC ultimately held that the 8(A) requirement is a mandatory one enforceable by injunction whether or not 2(A) notice is provided. The CAFC noted that, in Amgen v. Sandoz, the Court did not say that the 8(A) requirement was mandatory only in no-2(A)-notice circumstances. The Court also noted that the language of 8(A) is categorical and contains no words that make the applicability of commercial-marketing notice turn on whether 2(A) notice was provided.

Apotex, like Sandoz, argued that giving 8(A) its plain meaning would effectively extend by six months the 12-year exclusivity period afforded to reference product sponsors. In response to this policy argument, the Court interestingly offered the following analysis:

…as time passes, more and more of the reference products will be newer, and a biosimilar-product applicant, entitled to file an application a mere four years after licensure of the reference product, … can seek approval long before the 12-year exclusivity period is up. In such circumstances, we have been pointed to no reason that the FDA may not issue a license before the 11.5-year mark and deem the license to take effect on the 12-year date—a possibility suggested by § 262(k)(&)(A)’s language about when the FDA approval may ‘be made effective.’ And we read (8)(A) as allowing the 180-day notice of commercial marketing acheter viagra to be sent as soon as the license issues, even if it is not yet effective, because it is at the time of the license that ‘the product, its therapeutic uses, and its manufacturing processes are fixed.’

With these statements, the Court appears to be implying that 8(A) notice will be considered acceptably filed once the FDA grants tentative approval of the biosimilar product. Whether this will effectively prevent extension of the exclusivity period beyond the 12-year limit remains to be seen and will depend on how the FDA chooses to issue licenses. However, at this point in time, applicants are encouraged to file 8(A) notice only on receipt of tentative approval from the FDA to avoid additional litigation.