United States: Apotex—Biosimilars Must Provide 180-Day Marketing Notice After FDA Approval

Last Updated: July 12 2016
Article by Jennifer Dienes and Christopher Betti

According to the Federal Circuit, post-licensure notice 180 days before commercial marketing is mandatory for biosimilars.

On July 5, the US Court of Appeals for the Federal Circuit affirmed the district court's preliminary injunction against Apotex Inc. and Apotex Corp. (collectively, "Apotex"). The preliminary injunction prevents Apotex from entering the market with its biosimilar to Amgen Inc.'s and Amgen Manufacturing Limited's (collectively, "Amgen's") Neulasta®1 (pegfilgrastim) unless it has given Amgen notice after being licensed by the US Food and Drug Administration (FDA) and waiting a mandatory period of 180 days.2


In Apotex's appeal to the Federal Circuit regarding the district court's order, it requested reconsideration of

  • whether the district court erred in holding that Apotex must provide Amgen with a notice of commercial marketing under 42 U.S.C. § 262(l)(8)(A);
  • whether the district court's holding that the 180-day notice of commercial marketing is mandatory is contrary to Congress's intent to provide a brand holder a market exclusivity of 12 years, not 12.5 years; and
  • whether the district court erred in holding that the penalty provision of 42 U.S.C. § 262(l)(9)(B) is not Amgen's exclusive statutory remedy if Apotex declines to provide a notice of commercial marketing.3

Apotex argued that the commercial marketing notice is not mandatory and cannot be enforced by injunction where the biosimilar applicant engaged in the statutory process for exchanging patent information (known as the "patent dance").4

Notice of Commercial Marketing is Mandatory

The Federal Circuit held that the 42 U.S.C. § 262(l)(8)(A) post-licensure notice 180 days before commercial marketing is mandatory and enforceable by injunction regardless of whether a (2)(A) notice to launch the "patent dance" was given.5 The Federal Circuit reasoned that paragraph (8)(A) states that the applicant shall provide, and "shall" generally indicates that the directive is mandatory.6 Further, there are no words in the paragraph that make its applicability turn on whether the applicant provided notice under (2)(A).7 Instead, (8)(A) is "a standalone notice provision" that is not dependent on the patent dance that begins with notice under (2)(A).8 There is no other statutory language that compels a contrary interpretation of "shall."9

Providing a Brand Holder with 12.5 Years of Exclusivity is Not Contrary to the Intent of Congress

With respect to the effective extension of the exclusivity period, the Federal Circuit observed that § 262(k)(7) only establishes the 12-year date as the earliest date on which a biosimilar license can take effect, not the latest date.10 Thus, delaying entry under (8)(A)—by 12 years plus 180 days after the brand holder's licensure—is consistent with § 262(k)(7). Additionally, the Federal Circuit noted that it is implicit in the Biologics Price Competition and Innovation Act (BPCIA) that any delay beyond 12 years will occur less often over time.11 More brand holder products will be newer, and an applicant will be able to seek licensure long before (four years after licensure of the branded product) the 12-year exclusivity period has elapsed.12 There is no reason why the FDA would not issue a license before the 11.5 year mark and deem it to take effect at the 12-year mark.13 The Federal Circuit held that the 180-day notice of commercial marketing may be sent as soon as the biosimilar is licensed—even if that license is not yet effective—because at that time the product, its uses, and manufacturing process are fixed.14

Additionally, the Federal Circuit stated that the "evident purpose of (8)(A) covers applicants that file (2)(A) notices as well as those that do not" because its purpose is to ensure that "the necessary decision-making regarding further patent litigation is not conducted under time pressure that will impair its fairness and accuracy."15 The brand holder needs time to make a decision regarding seeking relief on patents not yet in litigation, and a district court needs time for litigants to prepare their cases.16 Congress "clearly made a categorical fixed-period judgment in (8)(A)."17

The Penalty Provision of (9)(B) is Not the Exclusive Remedy for Failing to Provide a Notice of Commercial Marketing

Finally, the Federal Circuit rejected Apotex's argument that a declaratory judgment action is the exclusive remedy for violations of (8)(A).18 In doing so, the Federal Circuit cited US Supreme Court precedent that equitable jurisdiction should not be denied or limited in the absence of a clear legislative command to do so.19 Paragraph (9) does not "declare the exclusivity of the declaratory-judgment actions to which it refers—either in (9)(B) as it applies to an (8)(A) violation or more generally."20 No language excludes other remedies for failing to provide commercial marketing notice.21


1 Neulasta® is used in patients undergoing chemotherapy to stimulate the production of neutrophils (a type of white blood cell), which reduces the likelihood of infection. (Order at 4.)

2 Order at 3.

3 Apotex's Opening Brief at 2.

4 Order at 3-4.

5 Id. at 15.

6 Id.

7 Id.

8 Id. (internal quotations omitted).

9 Id.

10 Id. at 16.

11 Id. at 17.

12 Id.

13 Id.

14 Id.

15 Id. at 17.

16 Id. at 17-18.

17 Id. at 18.

18 Id. at 21.

19 Id. (citing Porter v. Warner Holding Co., 328 U.S. 395, 398 (1946)).

20 Id. at 21-22.

21 Id. at 22.

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