On Friday, March 10, Amgen filed its consolidated opening and responsive brief to the Supreme Court in Sandoz v. Amgen. As we covered in a previous post, Sandoz filed its opening brief in the case last month, addressing the question of whether an effective notice of commercial marketing can be given before FDA licensure of a biosimilar, and whether courts can order applicants to provide post-licensure notices of commercial marketing.
Amgen’s consolidated brief responds to that question and addresses a second question raised in Amgen’s cross-petition for Supreme Court review: “Is an applicant required to provide the sponsor with a copy of its biologics license application and related manufacturing information, and may a court issue an order enforcing that duty?”
I. The Notice Question
A. Amgen Argues: “Applicants Must Provide 180-Day Marketing Notice After Licensure”
Amgen argues that the text, structure, and purpose of the BPCIA notice provision (§262(l)(8)(A)) support the Federal Circuit’s holding that applicants are required to provide post-licensure notice at least 180 days before marketing.
Text: Amgen emphasizes that the text of the notice provision states that the 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 subsection (k).” (Br. at 28.) Whereas other provisions in the BPCIA refer to “the biological product that is the subject of” a biosimilar application, Amgen argues that (l)(8)(A)’s reference to “the biological product licensed under subsection (k)” is “a strong textual indication that §262(l)(8)(A), unlike the other provisions, refers to a product that has already been ‘licensed’ by the FDA.” (Br. at 28.) Amgen also notes that other provisions using the term “biological product licensed” refer to products that have already received FDA approval.
Structure: Amgen argues that the “structure of the BPCIA further supports reading §262(l)(8)(A) to require post-licensure notice” because “§262(l) divides patent litigation into two distinct phases–an immediate infringement action on patents the parties deem appropriate for early resolution, and a subsequent action involving other patents.” (Br. at 23-24.) “Allowing notice before licensure,” Amgen argues, “enables the applicant to collapse or even invert the two phases” by triggering the second phase simultaneously with, or before, the first-phase litigation. (Br. at 24.) “It makes no sense,” Amgen argues, that Congress would go through “the trouble of distinguishing two phases of litigation” with “detailed rules about which party can institute litigation and at what time” if it meant “to allow applicants to collapse or invert that distinction and thus render meaningless the statutory framework…that produces the distinction.” (Br. at 31-32.)
Amgen also argues that post-licensure notice is required because the notice is meant to authorize the sponsor to begin preliminary injunction proceedings, which “by definition occur in exigent circumstances,” (Br. at 33), such as when a biosimilar product receives FDA approval and presents a “concrete risk of harm” to the reference product sponsor. (Br. at 24.)
Amgen argues that its position is further supported by the fact that the BPCIA’s provision for exclusivity of an “interchangeable” biosimilar product marks the end of the exclusivity period by the first of five events, one of which is “1 year after the first commercial marketing” of the interchangeable product, and another of which is “18 months after approval” of the interchangeable product. The six-month gap between those time-points, Amgen argues, shows that “Congress expected a gap of roughly 180 days between licensure and marketing of a biosimilar product.” (Br. at 34.)
Sandoz’s position, Amgen argues, would “disorder” the litigation of later-acquired patents: “[I]f the applicant could provide an early marketing notice….[t]here could, for example, be a proliferation of patent suits filed as new patents issue or are licensed by the sponsor.” (Br. at 34.)
Purpose: Amgen argues that requiring post-licensure notice of commercial marketing “also advances Congress’s purpose of providing an orderly process for the resolution of patent disputes” by providing a “180-day window” that is “critical to both litigants and courts.” (Br. at 35-36.) According to Amgen, the 180-day window provided by (l)(8)(A) is critical to litigants because without that window, a sponsor will not know if or when it can seek a preliminary injunction from the courts. Amgen argues that sponsors need to be able to assess their patent rights “once the scope of the applicant’s permitted conduct is clearly defined by the biosimilar license”— before that point, Amgen explains, sponsors cannot adequately assess their rights because the biosimilar application may continue to change in ways that implicate or avoid certain patent claims. (Br. at 24.) Amgen also argues that the briefs from Sandoz and the government fail to answer “the key question: Without a post-licensure marketing notice, how will the sponsor know when is ‘an appropriate time’ to seek a preliminary injunction?” (Br. at 39.)
The 180-day window is also critical to the courts, Amgen argues, because biologics patents are highly technical and complex, and require more time than Sandoz’s view would allow for courts to consider and adjudicate the issues in an effective exercise of their “remedial powers.” (Br. at 41.)
B. Amgen Argues: “Courts May Order Applicants To Comply With The Notice Requirement”
Amgen argues that the Court “need not decide” whether federal law authorizes an injunction to enforce §262(l)(8)(A) because Amgen sought an injunction under state–not federal–law, and Sandoz has not argued that federal law preempts Amgen’s state law claims. (Br. at 26.) If the Court does address the question, Amgen argues that it should conclude that federal law does authorize injunctive relief to enforce the notice provision: Amgen argues that the BPCIA “expressly authorizes sponsors to sue in federal court, and does not limit the courts’ inherent power to grant equitable relief for statutory violations in a properly filed suit.” (Br. at 25.)
Contrary to what Sandoz and the government assert, Amgen argues that §262(l)(9)(B) and (C) do not provide an exclusive remedy for violations of the notice provision–they only “preserv[e] the sponsor’s background right to file a declaratory-judgment action in all circumstances except one–where the applicant is fully complying with its obligations under §262(l)(8)(A).” (Br. at 47.) That “preservation of existing rights,” Amgen argues, “does not provide a remedy for a marketing-notice violation.” (Br. at 47.)
Amgen also argues that “there is no conflict between the 180-day notice period” and the reference-product exclusivity provision stating that FDA approval of a biosimilar application “may not be made effective…until the date that is 12 years after the date on which the reference product was first licensed.” (Br. at 52.) Amgen argues that the post-licensure notice requirement still permits FDA approval to be made effective after 12 years, but that effective approval “is only a necessary condition, not a sufficient one, for the applicant to being marketing its biosimilar. A 180-day post-licensure notice period is a distinct prerequisite.” (Br. at 52.) Amgen also analogizes its reading of the notice requirement to the Hatch-Waxman regime, which provides a 30-month period for patent dispute resolution for small molecule drugs, arguing “there is nothing unusual about delaying the market entry of a drug to facilitate orderly patent litigation.” (Br. at 52.)
II. The (2)(A) Information Disclosure Question
A. Amgen Argues: “Applicants Must Provide Sponsors With Their Applications And Manufacturing Information”
Amgen argues that the text and purpose of the BPCIA compel a reading of the statute that requires applicants to comply with the information disclosure provisions of (l)(2)(A).
Text: Amgen argues that the word “shall” in (l)(2)(A) (the applicant “shall provide to the reference product sponsor a copy of [its] application” and manufacturing information) means that the provision is mandatory. Amgen argues that “[n]othing in the statute justifies departing from the ordinary, mandatory construction of the word ‘shall.’” (Br. at 25.) Other provisions that “contemplate” non-compliance by allowing the reference product sponsor to take certain actions in response to non-compliance “simply ensure that the sponsor is not denied access to the courts by the provisions of the BPCIA in the event of an applicant’s non-compliance.” (Br. at 60.)
Purpose: Amgen argues that construing (l)(2)(A) as mandatory serves the statute’s purpose of “enabl[ing] the sponsor to identify and narrow the list of patents implicated by the application.” (Br. at 60.) Amgen rejects the argument that sponsors can acquire such information by filing a suit and obtaining information about the biosimilar through discovery. That argument fails, Amgen writes, because “the statute entitles the sponsor to this information, without delay or the burden of discovery disputes,” and ongoing litigation in Amgen v. Hospira (see coverage here) suggests that a sponsor may need to “sue on every conceivably relevant patent” in order to preserve its ability to obtain discovery through litigation. (Br. at 61-62.)
B. Amgen Argues: “Courts May Order Applicants To Comply With The Disclosure Requirement”
As with the notice requirement, Amgen argues that the Court need not decide whether federal law authorizes courts to issue injunctions requiring compliance with the disclosure provisions of (l)(2)(A), but that in any case federal courts have the inherent power to grant such equitable relief in a properly filed suit brought under the BPCIA.
III. Considering the Questions Together
Amgen argues in closing that “the combined effect of Sandoz’s positions” on the two questions presented “illustrates why those positions are incorrect.” (Br. at 67.) Under Sandoz’s view, Amgen argues, a sponsor might not even be aware of the biosimilar application until the FDA approves it, or until it is too late to begin orderly proceedings to assert patent rights in litigation. Even if a sponsor monitors public databases to determine if a biosimilar application or approval is on the horizon (and Amgen argues that sponsors should not bear that burden under the statute), those public sources will not provide sufficient information for a sponsor to adequately assess its patent rights and the timing of a possible preliminary injunction proceeding. The result, Amgen argues, would be “chaos”—sponsors would be forced into hurried, emergency proceedings to try to prevent the launch of an approved biosimilar, or would be effectively forced to file a “needlessly broad action asserting dozens or hundreds of patents.” (Br. at 70.)
Amicus briefs in support of Amgen are due this Friday, March 17.
Sandoz’s reply brief is due on March 31. Amgen’s reply is then due April 14. Oral argument is set for April 26.
Stay tuned for further developments from the Big Molecule Watch.