The Solicitor General of the United States has filed an amicus brief in Sandoz Inc. v. Amgen Inc., asking the Supreme Court to grant certiorari and reverse the Federal Circuit’s interpretation of one of the “patent dance” provisions of the biosimilar statute. In particular, the Solicitor General does not agree that the pre-marketing notice required by 21 USC § 262(l)(8)(A) cannot be given until the biosimilar product has been approved by the FDA. While not dispositive, this filing increases the odds that the Court will weigh in on this issue, and may increase the odds that the Supreme Court also will side with Sandoz. 

The Neupogen® // Zarxio® Biosimilar Dispute

This case surrounds the first biosimilar product approved under the Biologics Price Competition and Innovation Act (BPCIA)–Sandoz’ Zarxio® (filgrastim-sndz) product, which was approved as a biosimilar of Amgen’s Neupogen® (filgrastim) product on March 6, 2015.

In the decision at issue, the Federal Circuit interpreted two of the “patent dance” provisions of the BPCIA:

• whether 42 USC § 262(l)(2)(A) required Sandoz to provide Amgen with a copy of its biosimilar application and other information describing how its product is made

  • The court held it did not, finding the information exchange provisions optional, while noting that the BPCIA imposes consequences for not providing the information.

    • The Solicitor General agrees with the Federal Circuit’s interpretation of § 262(l)(2)(A)

• whether § 262(l)(8)(A) required Sandoz to wait until its biosimilar application was approved before giving Amgen 180 days prior notice of commercial marketing.

  • The court held it did, finding that pre-marketing notice cannot be given until the FDA has approved the biosimilar product.

    • The Solicitor General disagrees with the Federal Circuit’s interpretation of § 262(l)(8)(A)

Sandoz petitioned the Supreme Court to review the Federal Circuit’s decision on the second issue. In response, Amgen filed a conditional cross-petition for review of the Federal Circuit’s decision on the first issue.

The Solicitor General Weighs In

The Solicitor General’s brief responds to the Supreme Court’s June 20, 2016, invitation “to file a brief in this case expressing the views of the United States.” Those views are aligned with Sandoz in this case.

The court of appeals erred in interpreting Subsection (l)(8)(A), but it correctly construed Subsection (l)(2)(A).

The Solicitor General urges the Court to take up the case for review, because:

The proper interpretation of those provisions has a significant impact on the operation of the BPCIA and the ability of aBLA applicants promptly to bring their biosimilars to the public. And because the provisions are integrally related, the Court should consider all of the questions presented together. Both the certiorari petition and conditional cross-petition therefore should be granted.

Pre-Marketing Notice May Be Given At Any Time

The Solicitor General reads § 262(l)(8)(A) as setting forth the latest date at which pre-marketing notice may be given, and disagrees with the Federal Circuit’s interpretation that notice cannot be given until the biosimilar product is approved.

According to the Solicitor General’s explanation of the patent dance framework, the pre-marketing notice serves two functions:

• Permitting the reference product sponsor (e.g., Amgen in this case) to bring suit on any “Round 2” patents and

• Permitting the reference product sponsor to seek a preliminary injunction until the court decides any “Round 2” patent issues.

With this limited purpose in mind, the Solicitor General criticizes the Federal Circuit’s interpretation:

[U]nder the Federal Circuit’s reading, the owner of a biosimilar with an effective license could be forced to wait 180 days after FDA has authorized it to commence marketing, even if the sponsor had no arguably valid infringement claim to warrant such delay.

(emphasis added).

Responding to the court’s rationale that requiring a licensed product would ensure that the Round 2 litigation would reflect a “fully crystallized controversy,” the Solicitor General argues that Congress already made “policy judgments” on this issue when it made the submission of an aBLA an act of infringement. The Solicitor General also emphasizes numerous ways in which the BPCIA gives the biosimilar applicant control over the “Round 1” patent litigation, and paints an overall picture of Congressional intent to permit all patent infringement issues to be resolved early.

The Remedy For Failing To Give Pre-Marketing Notice

Is A Patent Infringement Suit

The Solicitor General also takes issue with the remedy imposed by the Federal Circuit for Sandoz’ purportedly defective pre-marketing notice–the injunction  that kept Zarxio® off the market until 180 days after FDA approval.

Nothing in the BPCIA creates a cause of action to enforce Section 262(l)(8)(A)’s notice provision. …. The sponsor’s proper course if notice is not given under Section 262(l)(8)(A) is therefore the course contemplated by the BPCIA: an immediate patent-infringement action. See 35 U.S.C. 271(e)(2)(C); 42 U.S.C. 262(l)(9)(B).

The Realities Of Biosimilar Patent Litigation

The relevant provisions of the patent infringement statute (35 USC § 271(e)(2)) hold:

(2) It shall be an act of infringement to submit—

(C)(i) with respect to a patent that is identified in the list of patents described in [42 U.S.C. § 262(l)(3) including as provided under 42 U.S.C. § 262(l)(7)], an application seeking  approval of a biological product, or

(ii) if the applicant for the application fails to provide the application and information required under [42 U.S.C. § 262(l)(2)(A)], an application seeking approval of a biological product for a patent that could be identified pursuant to [42 U.S.C. § 262(l)(3)(A)(i)],

if the purpose of such submission is to obtain approval under such Act to engage in the commercial manufacture, use, or sale of a drug, veterinary biological product, or biological product

claimed in a patent or the use of which is claimed in a patent before the expiration of such patent.

However, § 262(l)(3)(A)(i) refers to “a list of patents for which the reference product sponsor believes a claim of patent infringement could reasonably be asserted … if a person … engaged in the making, using, offering to sell, selling, or importing into the United States of the biological product that is the subject of the subsection (k) application.” Thus, if the biosimilar Applicant does not provide the § 262(l)(2)(A) information, the reference product sponsor must decide whether to bring suit and which patents to assert based on whatever information is available to it about the biosimilar product.

While patent owners do bear the burden of policing the commercial marketplace for infringing products, requiring a reference product sponsor to conduct its own pre-litigation investigations of a confidential aBLA product imposes a much higher burden, and tips any balance thought to be embodied in the BCPIA far in favor of biosimilar applicants.

Supreme Court Denies Cert in Amgen v. Apotex

On December 12, 2016, the Supreme Court denied certiorari in Amgen v. Apotex, where the Federal Circuit applied its interpretation of the pre-marketing notice requirement in the dispute between Amgen and Apotex over Neupogen® (filgrastim) and Neulasta® (pegfilgrastim). Does this signal the Court’s view on this issue, or just the Court’s determination that it can fully address the issue in Amgen v. Sandoz?