As we covered in a previous post, following the Federal Circuit’s decision in Amgen v. Sandoz, Sandoz filed a petition for a writ of certiorari asking the Supreme Court to review the Federal Circuit’s interpretation of the BPCIA’s “notice of commercial marketing” provision. Sandoz’s petition also asks the Court to consider whether the Federal Circuit erred in creating a private right of action to force a biosimilar applicant to provide timely notice of commercial marketing, and in granting an “extra-statutory” injunction to enforce that right.
Amgen responded to Sandoz’s petition in late March, and concurrently filed a conditional cross-petition for a writ of certiorari, challenging the Federal Circuit’s ruling that the BPCIA disclosure provision (l)(2)(A) is not mandatory, and that the BPCIA provides its own statutorily defined remedies for non-compliance with the patent dance. The cross-petition was conditional in that Amgen asked the Supreme Court to take up this question only if it decides to grant Sandoz’s petition for certiorari.
Last week, Sandoz filed its opposition to Amgen’s conditional cross-petition. Sandoz’s opposition presents the question raised by Amgen’s conditional petition as:
When a biosimilar applicant does not provide its application to the reference product sponsor under 42 U.S.C. § 262(l)(2)(A), can the sponsor obtain an injunction under California law requiring the applicant to do so?
In the preceding litigation, Amgen had sought to enjoin Sandoz from launching its biosimilar product under California’s Unfair Competition Law and common law conversion claims. Sandoz emphasizes in its opposition brief that “Amgen did not invoke any cause of action under the BPCIA itself or claim any right to an injunction under that federal statute,” (Opp. at 2) and argues that Amgen’s cross-petition should be denied for two reasons:
(1) the Federal Circuit correctly held that the BPCIA “expressly contemplates that an applicant may choose to withhold its application,” and choosing an option permitted by the statute is therefore not “unlawful” under California state law; and
(2) the Federal Circuit correctly interpreted California state law and the common law of conversion to deny Amgen’s claims, and “the necessity of resolving state law questions to reverse that portion of the judgment makes [Amgen’s] conditional cross-petition a poor vehicle for review.” (Opp. at 14.)
On the first point, Sandoz argues that the Federal Circuit correctly held that the word “shall” does not make the information disclosure provision of BPCIA (l)(2)(A) mandatory, and rather “simply means that there is a statutorily defined consequence for ‘failure’ to take a particular action.” (Opp. at 21.) Sandoz also disputes Amgen’s policy-based arguments: Amgen argued (a) that (l)(2)(A) must be mandatory because otherwise the reference product sponsor (“RPS”) would not know which of its manufacturing patents would be infringed, and (b) that the “regulatory balance” will be upended if an applicant does not initiate the patent dance and thereby precludes an injunction authorized by 35 U.S.C. § 271(e)(4). According to Sandoz, these arguments fail because (a) the RPS can obtain manufacturing information without the patent dance, through pre-suit letters and ordinary vehicles of discovery, and (b) far from providing a “mandatory permanent injunction,” 35 U.S.C. § 271(e)(4) provides for an injunction only in narrowly defined circumstances not applicable, (“when there is patent litigation that proceeds to a final decision in the Federal Circuit before the reference product’s statutory period of exclusivity expires”) (Opp. at 22), while 35 U.S.C. § 271(e)(4) provides for the RPS’s ability to obtain an injunction without a condition precedent related to the patent dance.
On the second point, Sandoz argues that the independent California state law grounds on which Amgen sought enforcement of the BPCIA “make Amgen’s conditional cross-petition a poor vehicle for review of the proper interpretation of the BPCIA’s disclosure provisions.” Amgen’s cross-petition, Sandoz argues, “could support at most an advisory opinion on the meaning of the BPCIA’s disclosure provisions,” unless the Supreme Court “were to take the unusual step of reaching questions of state law.” (Opp. at 1.) Sandoz distinguishes its own petition, arguing that unlike Amgen’s conditional cross-petition, Sandoz’s petition warrants Supreme Court review because it “challenge[s] the Federal Circuit’s creation of a federal injunctive remedy under the BPCIA to enforce its notice of commercial marketing provision.” (Opp. at 1.) In anticipation of Amgen’s possible reply that “the declaratory judgment entered in favor of Sandoz on Sandoz’s counterclaims seeking an interpretation of the BPCIA… presents federal questions that provide a vehicle for this Court’s review,” Sandoz argues that its declaratory judgment counterclaims were relevant only to the extent that interpretation of the BPCIA would resolve Amgen’s state law and conversion claims, and “cannot be reviewed in isolation because they do not rest on any federal cause of action.” (Opp. at 32-33.)
The case will be distributed to the Court on May 31, and both sides may file replies in support of their respective petitions by then. The Court would most likely consider the petitions at its June 16 conference. A decision on the petitions could be released as soon as June 20.
Stay tuned to the Big Molecule Watch for further developments.