Last week, the Solicitor General submitted its brief in Amgen v. Sandoz, arguing that the Supreme Court should review and decide in Sandoz’s favor both questions presented by the parties’ cross-petitions for certiorari. Two days later, however, the Supreme Court denied cert in Amgen v. Apotex, which raised similar issues.
Amgen v. Sandoz was the Federal Circuit’s first decision interpreting the BPCIA. The court first addressed the patent dance, the series of back-and-forth pre-suit information exchanges between the biosimilar applicant and the reference product sponsor that the BPCIA says the parties “shall” engage in. Sandoz, which sought to market (and has since launched) Zarxio, a biosimilar version of Amgen’s Neupogen (filgrastim), did not provide Amgen with the information required to commence the patent dance. Amgen sued, arguing that Sandoz had violated the BPCIA by refusing to provide the statutory information, and also by providing a notice of commercial marketing before its product had been approved. On appeal, the Federal Circuit held that Sandoz’s decision to opt out of the patent dance did not violate the BPCIA. However, the Federal Circuit held that Sandoz’s pre-approval notice of commercial marketing was ineffective because the notice must come after FDA licensure of the biosimilar product. The Federal Circuit enjoined Sandoz from marketing its product during the 180-day post-approval notice period. Subsequently, in Amgen v. Apotex, the Federal Circuit clarified that the 180-day post-approval period was mandatory and enforceable by an injunction whether or not the biosimilar applicant chose to participate in the patent dance.
Earlier this year, Sandoz filed a petition for cert on the notice of commercial marketing issue. Amgen opposed Sandoz’s petition and filed a conditional cross-petition on the patent dance issue. In June, the Supreme Court deferred a decision on cert, instead asking the Solicitor General to weigh in and express the views of the United States. In September, Apotex filed its own petition for certiorari raising similar questions concerning the BPCIA’s notice of commercial marketing provision as Sandoz raised in its petition.
In its brief of last week, the Solicitor General argues that the Supreme Court should accept review of the petition and cross-petitions in Amgen v. Sandoz and rule for Sandoz on all questions. First, the SG argues that the notice of commercial marketing can come before the approval of the biosimilar product, as long as it is given at least 180 days before the biological product goes on sale. In Amgen v. Sandoz, the Federal Circuit reasoned that the notice must come after licensure because the BPCIA refers to a notice for a “licensed” biosimilar product. The SG disagrees with this reading, arguing that “licensed” merely refers to the status of the biosimilar at the time commercial marketing begins, not at the time the notice is provided. The SG argues that even though its interpretation means that there may be no time in between approval and marketing to litigate a preliminary injunction, the BPCIA is designed to promote early litigation and affords the parties the opportunity to litigate before marketing. According to the SG, once notice of commercial marketing is given, “the sponsor can initiate whatever infringement litigation it wants to well before that commercial marketing, and it can do so even if the notice is given at the beginning stages of the regulatory process rather than at the end.” The SG also argues that the Federal Circuit’s interpretation improperly gives innovators an extra six months of exclusivity on top of the 12 years provided for by the BPCIA.
Second, the SG briefly addresses the availability of an injunction to enforce the BPCIA’s notice of commercial marketing provision. In Amgen v. Sandoz, the Federal Circuit imposed an injunction to prevent Sandoz from entering the market prior to 180 days after FDA licensure of its biosimilar. In its subsequent Amgen v. Apotex decision, the Federal Circuit reaffirmed that an injunction was “proper to enforce” the notice of commercial marketing provision. The Solicitor SG disagrees, arguing that the BPCIA provides no express or implied private right of action to enforce its provisions. According to the SG, the reference product sponsor’s only recourse if the notice of commercial marketing is not provided is to bring an immediate patent infringement action.
Finally, the SG addresses Amgen’s cross-petition and argues that the Federal Circuit’s holding on the patent dance should be upheld. The SG agrees with the appellate court’s reasoning that although the BPCIA uses the word “shall,” it specifies a consequence for failure to participate in the pre-suite dispute resolution procedures: forfeiture of the applicant’s right to bring a declaratory judgment action and the ability of the reference product sponsor to immediately commence patent litigation. The SG takes the position that even if “shall” is read to be mandatory, the sole consequences are those specified in the BPCIA. The biosimilar applicant may choose not to participate in the patent dance so long as it is willing to accept those consequences.
Coincidentally or not, the SG filed its brief supporting cert in Amgen v. Sandoz two days before the Supreme Court considered Apotex’s related petition in Amgen v. Apotex. On December 12, the Supreme Court denied Apotex’s petition. The cross-petitions in Amgen v. Sandoz are still pending.