On January 13, 2017, the U.S. Supreme Court consolidated a petition and a cross-petition between pharmaceutical companies Sandoz and Amgen, and granted certiorari to resolve questions of statutory interpretation surrounding specific provisions of the Biologics Price Competition and Innovation Act of 2009 (BPCIA).1 The litigation centers around Sandoz’s biosimilar, Zarxio® (filgrastim-sndz)—the first biosimilar approved by the United States Food and Drug Administration (FDA).2 Filgrastim-sdnz is a biosimilar of Amgen’s Neupogen® (filgrastim),3 which is a granulocyte colony-stimulating factor (CSF) agent that stimulates bone marrow to produce white blood cells. With oral arguments scheduled for April 26, 2017, the Supreme Court will weigh in on the language in two sections of the BPCIA—one discussing the requirement for disclosure, the other regarding the timing of notice.
The first issue addresses whether a biosimilar applicant, such as Sandoz, is required by Section (l)(2)(A)4 of the BPCIA to provide a reference product sponsor (RPS), such as Amgen, with a copy of its biologics license application and related manufacturing information—which triggers a “patent dance” of information exchange between applicant and RPS. As a corollary, where the biosimilar applicant fails to provide the required information, the question arises whether the reference product sponsor’s sole recourse is to commence a declaratory judgment action5 and/or a patent infringement action.6 The second issue focuses on whether a “notice of commercial marketing” given before FDA approval is considered effective under Section (l)(8)(A) of the BPCIA.7 In answering this, the Court must decide whether it is improper to treat this section as a stand-alone requirement that creates an injunctive remedy by delaying biosimilars from launching by 180 days after approval.
In May 2014, Sandoz filed an abbreviated Biologics License Application (aBLA) under the BPCIA,8 which allows a biosimilar applicant to submit information to demonstrate that its product, i.e., Zarxio® (filgrastim-sndz), is “biosimilar” or “interchangeable” with a previously approved reference product, i.e., Amgen’s Neupogen® (filgrastim).9 On July 8, 2014, Sandoz notified Amgen that it filed an aBLA10 and planned to launch its biosimilar product immediately upon FDA approval.11 However, Sandoz “opted” not to provide Amgen with its biosimilar application or manufacturing information within 20 days of the FDA’s notice of acceptance according to BPCIA Section (l)(2)(A).12 In July 2014, Sandoz allegedly provided Amgen with operative notice of commercial marketing—before it received official FDA approval for filgrastim-sndz. In October 2014, Amgen commenced suit in the Northern District of California, alleging, among other offenses, that Sandoz violated the BPCIA by failing to disclose the required information under Section (l)(2)(A) and by giving premature and ineffective notice of commercial marketing under Section (l)(8)(A).
District Court Decision
At trial, the district court approached statutory interpretation beginning with an assessment of the plain meaning of the words, but couched in context and with regard to the overall statutory framework, looking to legislative history where appropriate.13 With regards to the disclosure and negotiation procedures of Section (l)(2)(A), the district court found Sandoz’s interpretation more persuasive, indicating that compliance with the patent dance allowed a biosimilar applicant to enjoy a “temporary safe harbor from litigation.”14 However, an applicant could trade in such a safe harbor by skipping the patent dance, at its own risk and discretion, for the expediency of an immediate law suit with the RPS.15 In terms of the 180-day notice requirement before commercial marketing under Section (l)(8)(A), the district court also found in favor of Sandoz. It reasoned that since FDA approval must precede market entry of a biosimilar, accepting notice as “effective” only if it comes after FDA approval would give the RPS an additional extra six months of market exclusivity, on top of the 12 years already granted by statute.16 Thus, the district court did not find Sandoz’s notice to Amgen—prior to FDA approval—wrongful. Amgen appealed both interpretations.
Federal Circuit Holding
On appeal from the district court, the Federal Circuit examined the two main sections of the BPCIA in detail:
- Section (l)(2)(A) states that a biosimilar applicant “shall provide to the reference product sponsor a copy of the [biosimilar] application . . . and such other information that describes the process or processes used to manufacture the biological product . . . .”
- Section (l)(8)(A) indicates a biosimilar applicant “shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under [the BPCIA].”
The Federal Circuit concluded that while, read in isolation, the word “shall” would seem to require a biosimilar applicant disclose its aBLA and manufacturing information to the reference product sponsor (RPS), Section (l)(2)(A) must be read together with other provisions of the BPCIA.17 Because the statute expressly sets forth remedies under patent infringement if a biosimilar applicant fails to disclose such “required” information,18 and did not offer any “non-patent-based remedies” for failing to comply with Section (l)(2)(A), then the BPCIA “expressly contemplated” such inaction by a biosimilar applicant.19 The Federal Circuit reasoned that once the RPS brings an infringement suit, it can access the required information through discovery. Thus, Sandoz did not violate the BPCIA, and its refusal to engage in a patent dance did not prevent Amgen from ultimately obtaining such information.20 In the context of Section (l)(2)(A), the Federal Circuit concluded that “shall” does not mean “mandatory,” in favor of Sandoz.
As an added wrinkle, the Federal Circuit further stated that “shall” in Section (l)(8)(A) is, in fact, mandatory because no other provision in the BPCIA contemplates or specifies the consequence for noncompliance.21 Therefore, Section (l)(8)(A) is a “stand-alone notice provision,” requiring notice of commercial marketing to be given “to allow the RPS a period of time to assess and act upon its patent rights.”22 As such, in its review of Section (l)(8)(A), the Federal Circuit not only examined the meaning of “shall,” but also “licensed,” and found that a biosimilar applicant can only give effective notice of commercial marketing after the FDA has licensed its product. Thus, notice, if it is to be effective under the BPCIA, must be given only after the product is licensed, i.e., officially approved, by the FDA.23 Therefore, Sandoz could not market its biosimilar until 180 days after the date it provided RPS with effective notice, i.e., at the earliest, 180 days after its FDA approval date of March 6, 2015.
Judge Newman filed a separate opinion, dissenting from the Court’s holding that Sandoz complied with the statutory requirements of the BPCIA under Section (l)(2)(A).24 Nevertheless, taking the literal meaning of “shall” to be a “command,” she concurred that notice of future commercialization is mandatory, and that an FDA license is necessary to commence the 180-day stay under Section (l)(8)(A).
Judge Chen came to the opposite conclusion.25 While agreeing that Sandoz’s failure to supply a copy of its aBLA to Amgen did not violate the BPCIA, he dissented from the conclusion that “shall” in Section (l)(8)(A) mandates compliance, because the statute provides for alternative measures. The BPCIA did not require prior FDA approval to commence the 180-day notification period preceding commercialization.
Ongoing Arguments and Impact of Supreme Court Decision
In its petition, Sandoz attacked the Federal Circuit’s finding that the 180-day notice per Section (l)(8)(A) can only be given after a biosimilar is licensed by the FDA.26 Such a finding, as reasoned at the district court, could essentially give the biologic maker an additional 180 days of exclusivity, on top of the 12-year exclusivity provided under the BPCIA; this can compound to millions (or billions) of dollars.27 The Supreme Court’s decision with respect to when notice can commence—before or after FDA approval—will determine how quickly lower-cost biosimilars may enter the market to compete with the “brand name” biologic.
In its cross-petition, Amgen argued that Sandoz’s interpretation of the BPCIA would create chaos, and pushed for a traditional understanding of the word “shall” to mean “mandatory.”28 Amgen stated that biosimilar makers must divulge its aBLA to RPSs pursuant to Section (l)(2)(A) and wait for product approval before giving the required notice of sales per Section (l)(8)(A).29 Otherwise, if biosimilar applicants could keep their applications secret and give notice long before FDA approval, biologic makers would be forced to speculate about which patents are potentially infringed.30
If the Supreme Court overruled the Federal Circuit’s reading of “shall” as “optional” in Section (l)(2)(A), it would require a biosimilar maker and a RPS to engage in a mandatory patent dance, which may streamline and focus litigation. Conversely, if the Supreme Court overruled the Federal Circuit’s reading of “shall” as “mandatory” and “licensed” to mean “approved by the FDA” in Section (l)(8)(A), it would remove the notice provision as a stand-alone, suggesting RPSs may not have recourse through this provision and should look to other sections of the BPCIA to assert its patent rights, but also prevent an artificial six-month extension to an RPS’s 12-year exclusivity period. Further, should the Supreme Court determine that the word “shall” must have consistent meanings within two different sections of the BPCIA, it could downplay the importance of interpreting a statute in the context of an Act’s overall spirit and legislative history. In any event, the outcome of this case will impact biologic makers and biosimilar applicants alike.
1 Amgen Inc. v. Sandoz Inc., 794 F.3d 1347 (Fed. Cir. 2015), cert. granted, 137 S. Ct. 808 (2017).
2 Zarxio (filgrastim-sndz) was approved by the FDA on March 6, 2015. See http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125553Orig1s000TOC.cfm.
3 Neupogen® (filgrastim) was originally approved by the FDA in 1991. See, e.g., Lisa A. Raedler, “Zarxio (Filgrastim-sndz): First Biosimilar Approved in the United States,” 9 AM. HEALTH & DRUG BENEFITS 150 (Mar. 2016), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5013845/pdf/ahdb-09-150.pdf.
4 42 U.S.C. § 262(l)(2)(A) (A biosimilar applicant “shall provide to the reference product sponsor a copy of the application submitted to the Secretary under subsection (k), and such other information that describes the process or processes used to manufacture the biological product that is the subject of such application . . . .”).
5 See Section 262(l)(9)(C) of the BPCIA, i.e., 42 U.S.C. § 262(l)(9)(C) (A reference product sponsor “may bring an action under section 2201 of title 28 for a declaration of infringement, validity, or enforceability of any patent that claims the biological product or a use of the biological product.”).
6 See 35 U.S.C. § 271(e)(2)(C)(ii). The BPCIA essentially creates an artificial act of infringement to allow suits based on a biosimilar application prior to FDA approval and prior to marketing of the biological product.
7 42 U.S.C. § 262(l)(8)(A) (“[A]pplicant shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k).”).
8 See 42 U.S.C. § 262(k), discussing licensure of biological products as biosimilar or interchangeable.
9 Such an abbreviated pathway is aimed to encourage competition in the field of biologics. Traditionally, the Food and Drug Administration (FDA) approves a biological product for commercial marketing by granting a Biologics License Application (BLA). Under a BLA, the biosimilar applicant has to provide clinical data to demonstrate safety and efficacy of its product.
10 Sandoz twice offered to share a copy of its aBLA under the protection of a proposed Offer of Conditional Access, which apparently Amgen declined. See Amgen Inc. v. Sandoz Inc., No. 14-CV-04741-RS, 2015 WL 1264756, at *3 (N.D. Cal. Mar. 19, 2015), aff'd in part, vacated in part, remanded, 794 F.3d 1347 (Fed. Cir. 2015), cert. granted, 137 S. Ct. 808 (2017).
11 The FDA approved Sandoz’s aBLA on March 6, 2015.
12 Instead, Sandoz asserted that the BPCIA entitled it to opt out of subsection (l)’s procedures, and that Amgen could instead obtain such information via an infringement action. See Amgen Inc. v. Sandoz Inc., No. 14-CV-04741-RS, 2015 WL 1264756, at *3.
13 Id. at *5.
14 Id. at *6.
15 Id. at *7.
16 Id. at *8 (“Because the FDA cannot license a biosimilar until twelve years after approval of a reference product, Amgen's reading would tack an unconditional extra six months of market exclusivity onto the twelve years reference product sponsors already enjoy under 42 U.S.C. § 262(k)(7)(A). Had Congress intended to make the exclusivity period twelve and one-half years, it could not have chosen a more convoluted method of doing so.”).
17 Amgen Inc. v. Sandoz Inc., 794 F.3d 1347, 1355–56 (Fed. Cir. 2015), cert. granted, 137 S. Ct. 808 (2017). Specifically, Section (l)(2)(A) should be interpreted in relation to Sections (l)(9)(A) and (C), as well as 35 U.S.C. § 271(e)(2)(C)(ii) regarding patent infringement.
18 E.g., Section (l)(9)(C) provides that if a biosimilar applicant “fails to provide the application and information required under paragraph (2)(A), the reference product sponsor. . . may bring an action . . . for a declaration of infringement, validity, or enforceability of any patent that claims the biological product or a use of the biological product.
19 Amgen Inc. v. Sandoz Inc., 794 F.3d 1347, 1356 (Fed. Cir. 2015).
20 Id. at 1356–57.
21 Id. at 1359.
22 Id. at 1359–60. See also Scott Pierce, “Dance Marches on for Biosimilars in Amgen v. Sandoz,” LAW360 (Jan. 13, 2017), https://www.law360.com/articles/878398/dance-marches-on-for-biosimilars-in-amgen-v-sandoz.
23 Amgen Inc. v. Sandoz Inc., 794 F.3d at 1357.
24 Id. at 1362–66 (Newman, J., concurring in part, dissenting in part).
25 Id. at 1366–71 (Chen, J., dissenting in part).
26 See generally Petition for Writ of Certiorari at 23–37, Sandoz Inc. v. Amgen Inc., No. 15-1039 (Feb. 16, 2016).
27 See Jeff Overley, “Sandoz Kicks Off Supreme Court Biosimilar Battle,” LAW360 (Feb. 10, 2017), https://www.law360.com/articles/891070/sandoz-kicks-off-supreme-court-biosimilar-battle.
28 See generally Cross-Petition for Writ of Certiorari at 22–40, Amgen Inc. v. Sandoz Inc., No. 15-1195 (Mar. 21, 2016).
29 Id. at 3–9.
30 See Jeff Overley, “Amgen Warns Of ‘Chaos’ In High Court Biosimilar Clash,” LAW360 (Mar. 10, 2017), https://www.law360.com/lifesciences/articles/900738/amgen-warns-of-chaos-in-high-court-biosimilar-clash.
*Yan-Xin Li, a Baker Botts law clerk, assisted in the preparation of this article.
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