As we reported in a previous post, the parties in Janssen v. Celltrion–a BPCIA-related case pending in the District of Massachusetts—are currently litigating whether Celltrion’s pre-FDA-licensure notice of commercial marketing was legally effective under the BPCIA. The parties have filed cross-motions for partial summary judgment on this issue, and these motions were pending when the Federal Circuit issued its decision in Amgen v. Sandoz.
The parties have now both submitted briefs regarding their cross-motions for summary judgment and the plaintiffs’ motion for a preliminary injunction. The plaintiffs’ brief is covered in our post here. Celltrion and Hospira (“Celltrion”) filed their opposition brief yesterday.
Celltrion argues that in order for Janssen to obtain the effective 180-day bondless injunction it seeks based on the BPCIA’s (l)(8) notice provision, it must win three legal points:
- A biosimilar applicant’s notice of commercial marketing may not be given until FDA approves/licenses the applicant’s biosimilar product;
- Such notice of commercial marketing is mandatory even if the biosimilar applicant produces its biosimilar application within the statutory 20-day period provided for in the BPCIA patent dance; and
- The BPCIA grants reference product sponsors like Janssen “a private right of action for an automatic 180-day injunction, without satisfying the traditional four-factor test for injunctive relief.” (5).
On the first issue, Celltrion concedes that the Federal Circuit’s decision in Amgen v. Sandoz “alleviated Janssen’s first burden by holding that, where notice is required, a biosimilar ‘applicant may only give effective notice of commercial marketing after the FDA has licensed its product.’” (5-6).
According to Celltrion, however, Janssen reads too far into this first victory because although notice of commercial marketing, if required, may be given only after FDA approval, the notice itself is not always required. Celltrion argues that the Federal Circuit in Amgen “held that the notice of commercial marketing provision is mandatory only where the biosimilar applicant ‘completely fails’ to participate in the statutory information-exchange process.” (6). It is the Court’s “completely fails” language that distinguishes Celltrion from Sandoz, according to Celltrion, because unlike Sandoz, Celltrion did timely provide its biosimilar application (including “detailed manufacturing information” satisfying the disclosure requirement for “other information that describes the process or processes used to manufacture” the proposed biosimilar product). Celltrion also raises an interesting argument that even if it is found not to have provided the necessary manufacturing information (as Janssen claims), it still prevails under Amgen v. Sandoz because Amgen held that the notice provision “is mandatory only where the applicant ‘completely fails’ to provide both ‘its aBLA and the required manufacturing information to the RPS by the statutory deadline.’” (17)
Celltrion cites for support Judge Chen’s opinion in Amgen v. Sandoz, in which he stated that “nothing in the majority opinion suggests that this automatic [180-day] injunction remedy would be available in cases where the applicant complied with [the initial disclosure provision] by providing its [application] to the RPS, but later failed to provide notice under (l)(8)(A).” (7). The Federal Circuit, Celltrion argues, “has apparently read the BPCIA to prevent a situation where the applicant does not disclose its application and launches upon FDA approval without any prior notice to the sponsor,” (11) a situation that is preempted if the biosimilar applicant engages in the patent dance and thereby puts the RPS on notice of its biosimilar application and intent to market. Moreover, Celltrion argues, the Federal Circuit made it clear that the notice provision serves “a limited purpose” to “kick-start any second litigation phase over patents whose relevance the parties dispute.” (17). Since Celltrion has accepted Janssen’s list of “relevant” patents, “there are no ‘phase-two’ patents to litigate,” (19)–the 180-day window of (l)(8) would not serve its limited purpose, and the (l)(8) notice provision therefore does not apply.
On the third issue listed above, Celltrion argues that even if the court were to find that the BPCIA notice provision is mandatory in this case, Janssen would still have to meet the traditional four-factor eBay test to warrant a preliminary injunction. According to Celltrion, the Federal Circuit in Amgen v. Sandoz did not grant an automatic injunction as a result of its ruling on the 180-day notice provision; rather, in extending the injunction against Sandoz’s launch, the Court had implicitly relied upon the four-factor test it applied in its earlier decision granting Amgen’s motion for injunction pending appeal.
Further briefing on this issue is expected–check back here on the Big Molecule Watch for coverage of future developments.