and Jennifer Giordano-Coltart, Ph.D.
Sandoz Inc. (Sandoz) filed a Petition for Writ of Certiorari (Cert. Petition) on February 16, 2016, requesting U.S. Supreme Court (Supreme Court) review of the U.S. Court of Appeals for the Federal Circuit’s interpretation of the pre-commercialization notice provision of the Biologics Price Competition and Innovation Act of 2009 (BPCIA). The case relates to Sandoz’s abbreviated biologic license application for Zarxio®
(filgrastim-sndz), a biosimilar version of Amgen Inc.’s Neupogen®
(filgrastim). Sandoz provided notice of intent to commercialize its biosimilar to Amgen twice: first upon acceptance of its application by the Food and Drug Administration (FDA) and second, eight months later upon approval of the application. The notice was given pursuant to § 351(l
)(8)(A) of the Public Health Services Act (PHS Act), which states that a biosimilar applicant under subsection (k
) of the PHS Act “shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k
).” The Federal Circuit held that, “under paragraph (l
)(8)(A), a subsection (k
) applicant may only give effective notice of commercial marketing after the FDA has licensed its product.”
As a result, only Sandoz’s second notice to Amgen was considered effective for triggering the 180-day notice period. As a result, this interpretation of the pre-commercialization notice requirement provided Amgen with 6 months of additional market exclusivity (Neupogen®
was approved 23 years ago, and had since run out of any type of statutory exclusivity). However, Judge Lourie, writing the opinion for the Court
, noted that this additional period of market exclusivity would not likely be the case in the future as biosimilar applications will most likely be filed during the 12-year exclusivity period provided to new biologic products. Because the Federal Circuit denied review of its initial decision en banc
, the next course of action available to the parties was to seek Supreme Court review. As mentioned in our previous blog post,
Sandoz was granted an extension of time to file it petition for certiorari until February 16, 2016. Surprisingly, Amgen chose not to seek review. Sandoz’s Cert. Petition raises the following question: Whether notice of commercial marketing given before FDA approval can be effective and whether, in any event, treating Section 262(l
)(8)(A) as a standalone requirement and creating an injunctive remedy that delays all biosimilars by 180 days after approval is improper
. Sandoz’ Cert. Petition is available here
. Below we provide a short summary of Sandoz’s main arguments to the Supreme Court in support of its position: Sandoz’s main argument to the Supreme Court is that pre-commercialization notice can be given prior to FDA approval and that Section 262(l
)(8)(A) is not a standalone provision. To interpret the statute otherwise would be contrary to the text and purpose of the commercial marketing notice provision of the statute and conflicts with Supreme Court precedent. Specifically, Sandoz states that, as long as “notice is provided 180 days before the applicant brings its competing biosimilar to market, the plain language of this provision is satisfied. Nothing in the statutory text requires the applicant to wait until after FDA approval, then provide notice that it intends to market, and then wait six months more.” Cert. Petition at 23. Moreover, Sandoz notes that the Federal Circuit’s decision delays the launch of every biosimilar product by 6 months. Citing to 42 U.S.C. § 262(k
)(7)(A), which states that approval of a biosimilar application may not be effective until after the 12 year exclusivity period granted the reference product, Sandoz argues that “once the expressly granted exclusivity period has run, the FDA’s approval is ‘made effective,’ and the biosimilar applicant should be able to market immediately, absent the successful assertion by the sponsor of any valid patent claims.” Id
. at 28. Thus, the Federal Circuit’s decision “radically transformed this mere notice provision into an automatic six-month bar against the marketing of an already-approved biosimilar.” Id.
at 29. Sandoz also argues that the Federal Circuit’s interpretation not only “transform[s] the notice provision into a stand-alone requirement unconnected from the BPCIA’s patent resolution provisions . . .” but also disregard[s] the remedies provided by the BPCIA and instead creat[es] . . . [an] extra-textual remedy . . . [of] a private right of action for an automatic injunction.” Id
. at 31. Sandoz notes that this injunction “bars the marketing of the already approved biosimilar until 180 days after the post-approval notice—without regard to whether the sponsor could show any valid patent rights or any irreparable harm.” Id
. Moreover, the BPCIA already provides for patent-based remedies for enforcement of subsection (l
); specifically, “a possible pre-approval artificial infringement suit.” Id.
at 33. Pointing to Judge Chen’s dissent, Sandoz notes that the notice provision is not a standalone requirement and, “when there has been no initiation of the patent exchange process, ‘compliance with (l
)(8)(A) [is] unnecessary.’” Id.
at 35. Where the biosimilar applicant has failed to initiate the patent exchange process, “[t]he sponsor already ‘possesses the statutory right to seek a preliminary injunction for any of its patents.’” Id.
Interestingly, Sandoz draws the Court’s attention to Amgen’s ongoing suit with Apotex, Inc. in which a district court has held that the subsection (l
)(8) only applies to biosimilar applicants who have chosen to participate in the patent information exchange process. Id
. (citing Amgen Inc. v. Apotex Inc.
, No. 15-61631, slip op. at 2-8 (S.D. Fla. Dec. 9, 2015), appeal docket, No. 16-1308 (Fed. Cir. Dec. 11, 2015). Amgen has until the end of March to file a response to Sandoz’s Cert. Petition, unless an extension is granted. Amgen also has 30 days to file a conditional cross-petition under Supreme Court Rule 12.5, if it wishes to contest the Federal Circuit’s holding that the patent exchange provisions of the BPCIA are optional. Because Amgen did not file its own Cert. Petition, any cross-petition will be limited to this issue. It is difficult to state whether the Supreme Court is likely to grant Sandoz’s Cert. Petition in this case, particularly with the sudden death of Justice Scalia and the uncertainty of whether they will be a new Supreme Court Nominee before a new president is elected. Nevertheless, the expectation is that the Supreme Court will either grant or deny Sandoz’s Cert. Petition before the Court’s summer recess. Download PDF
 Amgen Inc. v. Sandoz Inc.
, 794 F.3d 1347, 1351 (Fed. Cir. 2015) (en banc
reh’g denied Oct. 16, 2015). The majority opinion was based on interpreting the phrase “licensed under subsection (k
)” to require that notice be given only after the product is licensed by the FDA. 
Of note, Judge Chen dissented from the Court’s conclusion. He considered paragraph (l
)(8) to be an integrated part of the patent litigation process set forth in paragraphs (l
)(7), not a “stand alone provision” that provides an 180-day injunction to the reference product sponsor (in this case, Amgen). As such, under the facts of the case, in which Sandoz did not comply with the initial step under paragraph (l
)(2), the remaining provisions of paragraphs (l
)(8) would not apply. He also disproved of the “extra-statutory exclusivity windfall” granted to the reference product sponsor under the majority’s decision. 
Our prior post on this issue is available here
Cert. Petition at ii.