On April 26, 2017, the Supreme Court heard oral argument in Sandoz Inc. v. Amgen Inc. on two questions regarding the Biologics Price Competition and Innovation Act ("BPCIA"): (1) whether a biosimilar applicant's 180 days' notice of commercial marketing is properly given only after its biosimilar product has been approved by the FDA, and (2) whether a biosimilar applicant is obligated to provide its abbreviated biologics license application ("aBLA") and manufacturing information to the reference product sponsor within 20 days after the FDA accepts the aBLA for filing, thereby triggering early patent litigation.
Background
Congress passed the BPCIA in 2010 to promote competition by allowing faster market entry of biosimilars while also fostering innovation by providing a period of market exclusivity for innovator biologics. The BPCIA allows a biosimilar applicant to rely on the safety and efficacy data of an approved reference product, but provides 12 years of marketing exclusivity for the reference product before a biosimilar application may be approved by the FDA.
To facilitate early resolution of patent disputes between a reference product sponsor ("sponsor") and a biosimilar applicant ("applicant"), the BPCIA sought to create a process for the parties to exchange information and litigate patent infringement claims in an orderly fashion. Two parts of that process are at issue in this case.
The BPCIA at 42 U.S.C. § 262(l)(2)(A) states that the applicant "shall provide" the sponsor a copy of the applicant's aBLA and information describing the manufacturing processes used to make the proposed biosimilar. This exchange triggers a series of information exchanges between the applicant and the sponsor commonly referred to as the "patent dance," which results in early litigation of key patent disputes. The BPCIA at 42 U.S.C. § 262(l)(8)(A) also states that the applicant "shall provide notice" of commercial marketing of the biosimilar to the sponsor "not later than 180 days before the date of the first commercial marketing of the biologic product licensed under subsection (k) [the subsection concerning abbreviated biosimilar approval]." After receiving this notice, the sponsor is entitled to bring a declaratory judgment action based on any remaining patents not yet litigated.
In this case, Sandoz filed an aBLA for a biosimilar to Amgen's Neupogen® (filgrastim) product. The aBLA for Sandoz's product—now sold as Zarxio® (filgrastim-sndz)—was accepted for review by the FDA on July 7, 2014. The following day, Sandoz notified Amgen of its application and its intent to market Zarxio® upon FDA approval, which Sandoz expected in the first half of 2015, but did not provide Amgen with a copy of the Sandoz aBLA or any manufacturing information.
The Decision Below
The Federal Circuit affirmed the district court's decision that providing a copy of the aBLA and manufacturing information pursuant to section (l)(2)(A) is optional, and held that when an applicant opts not to provide that information, the sponsor's sole remedy is to bring a declaratory judgment action; injunctive relief is not available to compel the applicant to comply. But the Federal Circuit vacated the district court's decision regarding the 180-day notice provision, holding that, under § (l)(8)(A), the applicant may give effective notice of commercial marketing only after the FDA has approved the biosimilar product because the statute expressly refers—in the past tense—to "the biologic product licensed under subsection (k)." To remedy Sandoz's failure to comply with the 180-day notice provision, the Federal Circuit enjoined Sandoz from marketing Zarxio® for 180 days after FDA approval. Both parties' petitions for rehearing en banc were denied.
Cert Petitions, Briefing, and Oral Argument
Sandoz
Sandoz petitioned for certiorari on the § (l)(8)(A)/180 days' notice issue, and Amgen filed a conditional cross-petition arguing that the Supreme Court should not review the Federal Circuit's decision, but if it did, it should also review the Federal Circuit's decision that information exchange under section (l)(2)(A) is optional. The United States joined as amicus curiae in support of Sandoz's positions.
In its petition and briefs, Sandoz argued that § (l)(8)(A) does not require that notice be given only after the applicant's aBLA is approved, in part because according to Sandoz, giving 180 days' notice only after licensure amounts to "a grant of 180 days of additional exclusivity for all biological products beyond the [12 year] exclusivity period." Sandoz also argued that by granting a 180-day injunction to prevent Sandoz from launching its product, the Federal Circuit created a judicial remedy not contemplated by the statute.
As expected, at oral argument Sandoz argued that Congress had no concern that the 180 days' notice could be too early, and that early notice of commercial marketing "lifts the gate" to allow the sponsor to litigate any remaining patent rights via a declaratory judgment action. Sandoz argued that the word "licensed" is just a description of the biosimilar for which a license is sought, and that Congress did not use the word "licensed" to impose a timing limitation, requiring that the biosimilar actually be licensed before notice can be given. According to Sandoz, Congress would not have extended the 12-year exclusivity period in "such a bizarre way."
Early on Justice Kennedy expressed skepticism that a 180-day notice period would make sense without a trigger for providing that notice (namely approval of the biosimilar application by the FDA). Justice Breyer similarly questioned how notice of the launch of a "licensed" product could be given if no product had been licensed, which could not occur until after the sponsor's 12-year exclusivity had run. Justice Breyer also observed that Sandoz's position had the potential to "gut" the patent dance process because, under Sandoz's interpretation of the law, "everyone will be free . . . to start bringing declaratory judgment actions" following early notice of commercial marketing.
The Court, through Justices Sotomayor and Kagan, and Chief Justice Roberts, also expressed some concern about whether a sponsor not in possession of the applicant's aBLA and manufacturing information would have a good-faith basis for bringing a declaratory judgment action. Sandoz argued that sponsors have a good-faith basis to bring suit because the BPCIA creates an artificial act of infringement, and also because a biosimilar product must be "highly similar" to the reference product, and thus would be expected to be covered by the sponsor's patents covering its own product.
The Court also questioned why the FDA had not promulgated rules to aid in implementing the statute. In response to a question by Justice Ginsburg, Sandoz responded that Sandoz did not believe the FDA had authority to interpret these statutory provisions through rulemaking and that "the [statutory] text answers the questions I'm being asked."
As to the § (l)(2)(A) question regarding an applicant's obligation to provide its aBLA and manufacturing information to the sponsor early on, Sandoz argued in its petition and briefs that Amgen misinterpreted the statute, that the information exchange process is merely "one route to pre-approval litigation," and that the BPCIA "expressly contemplates that an applicant might not" take that route. At oral argument, Sandoz reiterated that position, and added in response to a question from Justice Sotomayor that the information in question could easily be obtained via the discovery process in a declaratory judgment action. In support of Sandoz, counsel for the United States argued that the courts should not police whether or not the parties engage in the patent dance.
Amgen
In its conditional cross-petition and briefs, Amgen argued that the statutory text and legislative history of the BPCIA make clear that the "shall provide" language of § (l)(2)(A) require the applicant to provide its aBLA and manufacturing information to the sponsor, and that federal law authorizes courts to compel the applicant to comply. Without receiving that information, Amgen argued, a sponsor might have insufficient information to determine which patents could properly be included in a declaratory judgment suit, primarily because the sponsor would lack information about the applicant's manufacturing process and about the therapeutic indications for which the applicant was seeking approval. As to the § (l)(8)(A) question, Amgen argued that the statutory text (i.e., "biosimilar licensed under subsection (k)") and legislative history require that an applicant's 180 days' notice of commercial marketing may only be effective after the FDA has licensed its aBLA, and that allowing applicants to provide effective notice before the aBLA is approved would cause chaos, including because the sponsor would not know when launch in fact will occur, decreasing the likelihood of success in seeking a preliminary injunction to prevent launch of the biosimilar.
At oral argument Amgen built on those core messages, stating that "Congress did not create detailed procedures for resolving biosimilar disputes and repeatedly use the word 'shall' merely to have applicants who choose to take advantage of the statute's benefits and use the sponsor's information, then disregard those mandates." Amgen also emphasized that until a biosimilar has been licensed, the reference product sponsor has no notice of what the marketed biosimilar product or the approved therapeutic uses of that product will be. While stopping short of suggesting that the FDA could give Hatch-Waxman style "tentative approval" to a biosimilar application in order to speed up the timing of declaratory judgment actions, Amgen's counsel noted that the statute only says that approval may not be "made effective" within 12 years.
As expected, Amgen's counsel also argued that premature notice of commercial marketing could thwart a sponsor's efforts to get a preliminary injunction because it would be difficult to show that harm was imminent.
The Court pressed Amgen on the idea that, even if "shall means shall," and applicants are mandated to provide their applications and manufacturing information to the sponsor under the BPCIA, the statute still provides a remedy—in the form of a declaratory judgment action—when the applicant fails to abide by the mandates of the statute. Amgen disputed that declaratory judgment actions were included in the statute as a remedy for the reference product sponsor, arguing that those provisions were intended instead to foreclose the applicant itself from bringing a declaratory judgment action after it violated the statute.
Conclusion
Although it is difficult to predict how the Court will rule, the justices seemed reluctant to adopt Sandoz's view that 180-days' notice may be provided before FDA licensure of the biosimilar in question. Affirmance of the Federal Circuit's opposite view on that issue would provide sponsors with at least some degree of predictability as to when they should bring declaratory judgment actions and what patents to include in those actions. The Court focused comparatively little on whether it is optional for a party to provide its aBLA and manufacturing information during the "patent dance," with some justices seeming to treat the supposedly optional nature of the exchange as a foregone conclusion. If the Court affirms Sandoz's position on that issue, sponsors will need to carefully consider how to prepare for and undertake declaratory judgment actions, perhaps within a compressed time frame and with little knowledge at the outset of the proposed biosimilar or its manufacturing process.