On July 5, 2016, the Federal Circuit affirmed a district court's preliminary injunction against proposed biosimilar manufacturer Apotex, holding that Apotex was enjoined from entering the market until Apotex: (1) provides notice to Amgen once the FDA issues a license to manufacture Apotex's biosimilar (which the FDA has not done); and (2) then waits to enter the market until 180 days after providing such notice to Amgen.
Key takeaways include:
- The mandatory 180-day commercial marketing provision of the Biologics Price Competition and Innovation Act (BPCIA) is triggered once the FDA has granted a license to manufacture a biosimilar, regardless of whether the biosimilar applicant begins the 262(l) information exchange process before the FDA grants the license.
- In reaching this conclusion, the Federal Circuit affirmed its decision in Amgen v. Sandoz, 794 F.3d 1347, 1357–58 (Fed. Cir. 2015), that "notice starting the 180-day clock must follow, not precede, the licensure." The 180-day period is tied to FDA licensure because that is when "the [biosimilar] product, its therapeutic uses, and its manufacturing processes are fixed."
- The 12-year exclusivity period for reference product sponsors is not meant to provide the latest date by which a reference product sponsor may maintain exclusivity. Rather, it is the earliest date by which exclusivity may end, and to allow exclusivity to remain 180 days after this is in no way inconsistent with the remaining provisions of the Act.
- The Federal Circuit is taking a hard line in enforcing the BPCIA's notice provisions, creating an uphill battle for any biosimilar applicant who attempts to argue around the 180-day commercial marketing provision.
A complete analysis of Amgen v. Apotex is provided below:
At issue in Amgen, Inc. v. Apotex Inc., No. 16-308 (Fed. Cir. July 5, 2015), was Apotex's 2014 Section 262(k) application with the FDA to create a biosimilar of Amgen's product, Neulasta® (i.e., the "reference product"). Pursuant to 262(l)(2)(A), Apotex provided a copy of its 262(k) application to Amgen, and then sent Amgen a letter providing notice of Apotex's intent to market a biosimilar Neulasta® within 180 days of receiving a license from the FDA, as required by subsection 262(l)(8)(A). Notably, section 8(A) specifically uses the term "licensed" product, but at the time Apotex sent what Apotex deemed to be a section 8(A) notice to Amgen, Apotex did not have an FDA license to sell its potential biosimilar product (nor does it today).
The parties subsequently completed the exchange of information requirements of subsection l, and Amgen filed an action for patent infringement in August 2015.
In the litigation, and in response to Apotex's notice of intent of commercial marketing, Amgen filed a motion for preliminary injunction, requesting that the district court require Apotex to provide notice under subsection (8)(A) if and when it actually receives a biosimilar license from the FDA, and to delay Apotex's marketing of its product until 180 days after this notice. In response, Apotex argued that the requirement that the 180-day notice be given solely after licensure should not apply to it, as it had followed the requirements of section 262(l)(2) by providing Amgen with a copy of its biosimilar application and starting the exchange of information process required prior to litigation. Apotex reasoned that, were the court to find otherwise, it would effectively add an extra 180 days to the 12-year exclusivity period the BPCIA already provides to reference product sponsors (like Amgen).
The district court rejected Apotex's argument, concluding that the "defined statutory window exists for all biosimilar products that obtain FDA licenses, regardless of whether the subsection(k) applicant complies with § 262(l)(2)." This appeal followed.
On appeal, Apotex again argued that the 180-day notice contemplated in subsection (8)(A) not be provided until after licensure should not apply to applicants who have followed the requirements of section 262(l)(2). Agreeing with the district court, the Federal Circuit rejected Apotex's argument.
In doing so, the Federal Circuit reaffirmed that the 180-day notice requirement of subsection (8)(A) is mandatory — a conclusion the court reached in Amgen, Inc. v. Sandoz, Inc., 794 F.3d 1347 (Fed. Cir. 2015). In Sandoz, the Federal Circuit found that it is "counterintuitive to provide that notice of commercial marketing be given at a time before one knows when, or if, the product will be approved or licensed," even if this means that the reference product sponsor will have an additional 180 days of exclusivity beyond the 12-year exclusivity period provided for in the BPCIA. In affirming Sandoz, the Court noted that language of paragraph (8)(A) stating that an applicant "shall provide notice to the reference product sponsor" "contains no words that make the applicability of its notice rule turn on whether the applicant took the earlier step of giving the (2)(A) notice that begins the § 262(l) information-exchange process." Thus, the provision is mandatory regardless of the circumstances.
Taken together, these two opinions demonstrate the Federal Circuit's intent to take a hard line with regard to enforcement of the BPCIA's notice provisions, creating an uphill battle for any biosimilar applicant who attempts to argue around the 180-day provision moving forward.
Finally, with regard to Apotex's argument that the Court's holding would extend the exclusivity period beyond 12 years, the Federal Circuit explained that the 12-year exclusivity period is not meant to provide the latest date by which a reference product sponsor may maintain exclusivity. Rather, it is the earliest date by which exclusivity may end, and to allow exclusivity to remain 180 days after this is in no way inconsistent with the remaining provisions of the Act. The court also noted that as time goes on, the frequency of exclusivity periods longer than 12 years will decline, as newer reference products will enter the market, allowing biosimilar applicants to file applications a mere four years after licensure of the new product, as allowed by the BPCIA.