Everything you need to know about ranked-choice voting in one spot. Click to learn more!

Amgen v. Sandoz

From Ballotpedia
Jump to: navigation, search



Supreme Court of the United States
Amgen v. Sandoz
Reference: 15-1195
Issue: Patent law
Term: 2016
Important Dates
Argued: April 26, 2017
Decided: June 12, 2017
Outcome
Federal Circuit Court of Appeals vacated in part, reversed in part and remanded
Vote
9-0 to vacate in part, reverse in part, and remand
Majority
Chief Justice John G. Roberts • Anthony Kennedy • Clarence Thomas • Ruth Bader Ginsburg • Stephen Breyer • Samuel Alito • Sonia Sotomayor • Elena Kagan • Neil Gorsuch
Concurring
Breyer


Amgen v. Sandoz is a case argued during the October 2016 term of the U.S. Supreme Court. Argument in the case was held on April 26, 2017. The case came on a writ of certiorari to the United States Court of Appeals for the Federal Circuit. The Supreme Court consolidated arguments in the case with arguments in Sandoz v. Amgen. On June 12, 2017, in an opinion by Justice Clarence Thomas, the court vacated in part, reversed in part, and remanded the judgment of the Federal Circuit. Justice Stephen Breyer authored a concurring opinion.

In the consolidated cases, the court held that an applicant to manufacture a biosimilar drug may notify the original manufacturer before the applicant receives a license by the Food and Drug Administration (FDA) to produce the biosimilar product. The court also held, however, that federal courts cannot, through the use of an injunction, enforce the requirement that an applicant seeking FDA approval of a biosimilar product must provide its application and manufacturing information to the manufacturer. Though the court held that Amgen was not entitled to relief via an injunction by a court under federal law, the court remanded the case to the Federal Circuit to determine if injunctive relief was available under state law.

HIGHLIGHTS
  • The case: A federal law, the Biologics Price Competition and Innovation Act (BPCIA), states that a manufacturer of a biosimilar product shall provide a copy of the manufacturer's abbreviated biologics license application (aBLA) to the original manufacturer. The failure to provide an aBLA under the BPCIA, however, requires the original manufacturer to either bring a separate patent infringement claim or to seek a declaratory judgment, which defines the relationship between parties and their rights in a matter before the court but does not provide for any enforcement.
  • The issue: Is a biosimilar product manufacturer required to provide an aBLA under the BPCIA and, if so, are the only remedies available to the original manufacturer for the failure to provide an aBLA either to pursue a separate patent infringement claim or to seek declaratory judgment?
  • The outcome: On June 12, 2017, the court vacated the judgment of the Federal Circuit in this case, but remanded the case to the Federal Circuit to determine if Amgen was entitled to relief through an injunction under state law.


    • In brief: A federal law, the Biologics Price Competition and Innovation Act (BPCIA), states that a manufacturer of a biosimilar product shall provide a copy of the manufacturer's abbreviated biologics license application (aBLA) to the original manufacturer. Sandoz sought to manufacture a filgastrim drug named Zarxio and submitted an aBLA to the FDA for approval. Amgen, the original manufacturer of a filgastrim drug called Neupogen, was to receive Sandoz's aBLA, but Sandoz notified Amgen that it would not provide the aBLA. A federal district court held that the BPCIA did not require Sandoz to provide the aBLA. A three-judge panel of the United States Court of Appeals for the Federal Circuit affirmed, holding that Amgen could seek relief for the failure to provide an aBLA either through a separate patent infringement action or through a declaratory judgment, which defines the relationship between parties and their rights in a matter before the court but does not provide for any enforcement. Argument was held on April 26, 2017.

    You can review the Federal Circuit's opinion here.[1]

    Here is our page on the consolidated case: Sandoz v. Amgen.

    Click on the tabs below to learn more about this Supreme Court case.

    Case

    Background

    In 2010, pursuant to the passage of the [Obamacare_overview|Patient Protection and Affordable Care Act]], Congress enacted the Biologics Price Competition and Innovation Act (BPCIA). The Act[2]

    “

    established an abbreviated pathway for regulatory approval of follow-on biological products that are 'highly similar' to a previously approved product ... under the abbreviated pathway created by the BPCIA, codified at 42 U.S.C. §262(k), an applicant filing an abbreviated biologics license application ('aBLA' or 'subsection (k) application') ... submits information to demonstrate that its product is 'biosimilar' to or 'interchangeable' with a previously approved reference product, together with publicly-available information regarding the [FDA]’s previous determination that the reference product is safe, pure, and potent.' ... The BPCIA thus permits a biosimilar applicant to rely in part on the approved license of a reference product.[3]

    		”

    The law provides that the sponsor of an approved reference product, known as the reference product sponsor (RFS), receives up to 12 years of patent protection against follow-on biological products. The Act further states that the seller of the follow-on biosimilar product shall provide the RFS with the details of its aBLA within 20 days of receiving notice of FDA review as well as 180-days advance notice of the seller's intended first commercial marketing of the biosimilar product.[2]

    Since 1991, Amgen has marketed a drug, filgastrim, under the brand name Neupogen. Filgastrim is a bone marrow stimulant. In May of 2014, Sandoz filed an aBLA seeking FDA approval of its biosimilar filgastrim product, Zarxio, which is biosimilar to Neupogen. On July 7, 2014, Sandoz was notified by the FDA that its application for Zarxio was under review.[2]

    The next day, Sandoz notified Amgen that it had a biosimilar product to Neupogen, that the aBLA had been placed under FDA review, and that Sandoz intended to commercially launch the product upon FDA approval. Sandoz, however, informed Amgen that Sandoz was opting not to share details of its aBLA as required under the BPCIA and that Amgen was entitled to sue Sandoz. Sandoz did not disclose either its aBLA or its manufacturing information. On March 6, 2015, the FDA approved Sandoz's aBLA. Sandoz claimed that Amgen was given an operative notice of commercial marketing via Sandoz's July 8, 2014, communication to Amgen. However, on March 6, 2015, the day the FDA approved the product, Sandoz notified Amgen of its intent to go to market having secured FDA approval of Sandoz's aBLA. Still, Sandoz sought to begin commercial marketing immediately based on its July 8, 2014, notice to Amgen rather than wait the required 180 days from FDA approval.[2]

    In October of 2014, Amgen filed suit against Sandoz in federal district court claiming that Sandoz failed both to provide the required information about its aBLA for Zarxio and that Sandoz did not provide proper notice of its intent to go to commercial marketing before the FDA's approval of Sandoz's biosimilar product. The district court held that Sandoz's failure to disclose its aBLA to Amgen did not authorize Amgen to either receive damages from Sandoz or prevent the sale of Zarxio. The court also held that an applicant could give notice of commercial marketing prior to FDA approval.[4]

    Amgen appealed to the United States Court of Appeals for the Federal Circuit. A three-judge panel of that court vacated that portion of the district court’s ruling that permitted Sandoz's effective commercial notice prior to FDA approval. The circuit panel held that effective notice could only be given after the FDA has approved the aBLA. Therefore, Sandoz’s notice was effective on March 6, 2015, rather than on July 8, 2014, as Sandoz alleged. Therefore, Sandoz was preempted from selling Zarxio until September 2, 2015. The panel further held that, because the BPCIA only permits remedies based on patent infringement claims, Sandoz’s failure to disclose its aBLA to Amgen did not violate the Act.

    The panel affirmed the lower court's dismissal of Amgen's allegations that Sandoz engaged in unfair competition and conversion. To show conversion, a party must demonstrate its ownership or right to possession of a property, conversion of those property rights to another through a wrongful act or disposition, and that damages were suffered. The panel held that Amgen's unfair competition claim was moot based on the panel's order preempting sales of Zarxio until September 2015. Regarding conversion, the panel held that Amgen's 12-year exclusivity under the Act had expired, so its exclusivity of ownership or right to possession had also expired. The panel remanded the case back to the lower court to assess outstanding patent infringement claims made by both parties. Amgen and Sandoz both appealed to the Supreme Court of the United States.[2][4]

    Petitioner's challenge

    Amgen Inc., the petitioner, challenged the holding of the United States Court of Appeals for the Federal Circuit that Sandoz's failure to disclose its abbreviated biologics license application (aBLA) did not violate the Biologics Price Competition and Innovation Act (BPCIA) and that Amgen's only recourses to challenge this failure are either to bring a separate patent infringement action or to seek declaratory judgment.

    Certiorari granted

    On March 21, 2016, Amgen Inc., the petitioner, initiated proceedings in the Supreme Court of the United States in filing a petition for a writ of certiorari to the United States Court of Appeals for the Federal Circuit. The U.S. Supreme Court granted Amgen's certiorari request on January 13, 2017. The court consolidated the case with arguments in Sandoz v. Amgen. Argument in the case was held on April 26, 2017.[5]

    Arguments


    Question presented

    Question presented:

    "Is an Applicant required by 42 U.S.C. § 262(l)(2)(A) to provide the Sponsor with a copy of its biologics license application and related manufacturing information, which the statute says the Applicant 'shall provide,' and, where an Applicant fails to provide that required information, is the Sponsor's sole recourse to commence a declaratory-judgment action under 42 U.S.C. § 262(l)(9)(C) and/or a patent-infringement action under 35 U.S.C. § 271 (e)(2)(C)(ii)?"[5]


    Audio

    • Audio of oral argument:[6]



    Transcript

    • Transcript of oral argument:[7]

    Outcome

    Decision

    On June 12, 2017, in an opinion by Justice Clarence Thomas, the court vacated in part, reversed in part, and remanded the judgment of the Federal Circuit. Justice Stephen Breyer authored a concurring opinion.

    In this case, the court held that an applicant to manufacture a biosimilar drug may notify the original manufacturer before the applicant receives a license by the Food and Drug Administration (FDA) to produce the biosimilar product. The court also held, however, that federal courts cannot, through the use of an injunction, enforce the requirement that an applicant seeking FDA approval of a biosimilar product must provide its application and manufacturing information to the manufacturer. The court remanded the case to the Federal Circuit to determine if injunctive relief was available under state law.[8]

    Opinion

    This case, Amgen v. Sandoz, presented the first of two separate questions that the court addressed in its opinion for the consolidated cases: "whether §262(l)(2)(A)’s requirement that an applicant provide the sponsor with its application and manufacturing information is enforceable by an injunction under either federal or state law."[8] In his opinion for the court, Justice Thomas held that the Federal Circuit held correctly, but for reasons which the Supreme Court did not adopt. Justice Thomas said,[8]

    “

    In concluding that the remedies specified in the BPCIA are exclusive, the Federal Circuit relied primarily on §271(e)(4), which states that it provides 'the only remedies which may be granted by a court for an act of [artificial] infringement.' ... The flaw in the Federal Circuit’s reasoning is that Sandoz’s failure to disclose its application and manufacturing information was not an act of artificial infringement, and thus was not remediable under §271(e)(4). Submitting an application constitutes an act of artificial infringement. ... Failing to disclose the application and manufacturing information under §262(l)(2)(A) does not. ...

    A separate provision of §262, however, does provide a remedy for an applicant’s failure to turn over its application and manufacturing information. When an applicant fails to comply with §262(l)(2)(A), §262(l)(9)(C) authorizes the sponsor, but not the applicant, to bring an immediate declaratory-judgment action for artificial infringement as defined in §271(e)(2)(C)(ii). Section 262(l)(9)(C) thus vests in the sponsor the control that the applicant would otherwise have exercised over the scope and timing of the patent litigation. It also deprives the applicant of the certainty that it could have obtained by bringing a declaratory-judgment action prior to marketing its product. The remedy provided by §262(l)(9)(C) excludes all other federal remedies, including injunctive relief. Where, as here, 'a statute expressly provides a remedy, courts must be especially reluctant to provide additional remedies.' ... The BPCIA’s 'carefully crafted and detailed enforcement scheme provides strong evidence that Congress did not intend to authorize other remedies that it simply forgot to incorporate expressly.' ... The presence of §262(l)(9)(C), coupled with the absence of any other textually specified remedies, indicates that Congress did not intend sponsors to have access to injunctive relief, at least as a matter of federal law, to enforce the disclosure requirement.[3]

    		”

    In vacating this portion of the Federal Circuit's opinion, the court noted that a question of whether Sandoz's actions for marketing its biosimilar product Zarxio could be considered for injunctive relief under California state law remained unanswered. As this was a question of state and not federal law, the Supreme Court remanded this question to the Federal Circuit for additional proceedings.

    Concurring opinions

    Justice Stephen Breyer authored the following concurrence in this case. He wrote,[8]

    “

    The Court’s interpretation of the statutory terms before us is a reasonable interpretation, and I join its opinion. In my view, Congress implicitly delegated to the Food and Drug Administration authority to interpret those same terms. That being so, if that agency, after greater experience administering this statute, determines that a different interpretation would better serve the statute’s objectives, it may well have authority to depart from, or to modify, today’s interpretation ... though we need not now decide any such matter.[3]

    		”

    Dissenting opinions

    There were no dissenting opinions filed in this case.

    The opinion


    Filings

    The U.S. Supreme Court granted Amgen's certiorari request on January 13, 2017. The court consolidated the case with arguments in Sandoz v. Amgen.

    Merits filings

    Parties' briefs

    Amicus curiae briefs

    The following groups filed amicus curiae briefs in support of Amgen Inc. in the consolidated cases:

    • Brief of America's Health Insurance Plans (AHIP)
    • Brief of Apotex Inc. and Apotex Corp.
    • Brief of the Biosimilars Council
    • Brief of Coherus Biosciences Inc.
    • Brief of the United States of America

    The following groups filed amicus curiae briefs in support of Sandoz Inc. in the consolidated cases.

    • Brief of the Biotechnology Innovation Organization
    • Brief of Janssen Biotech Inc.
    • Brief of various professors

    Certiorari filings

    Parties' filings

    • Amgen Inc. filed a petition for certiorari on March 21, 2016.

    Amicus curiae filings

    The United States of America filed an amicus curiae brief in support of granting certiorari:

    • Brief of the United States of America


    See also

    Footnotes

    1. ↑ United States Court of Appeals for the Federal Circuit, Amgen Inc., Amgen Manufacturing Limited v. Sandoz Inc., decided July 21, 2015
    2. ↑ 2.0 2.1 2.2 2.3 2.4 Cite error: Invalid <ref> tag; no text was provided for refs named Federal
    3. ↑ 3.0 3.1 3.2 Note: This text is quoted verbatim from the original source. Any inconsistencies are attributable to the original source.
    4. ↑ 4.0 4.1 Oyez.org, "Sandoz Inc. v. Amgen Inc.," accessed April 20, 2017
    5. ↑ 5.0 5.1 Supreme Court of the United States, Amgen Inc. v. Sandoz Inc., January 13, 2017
    6. ↑ Supreme Court of the United States, Sandoz Inc. v. Amgen Inc., argued April 26, 2017
    7. ↑ Supreme Court of the United States, Sandoz Inc. v. Amgen Inc., argued April 26, 2017
    8. ↑ 8.0 8.1 8.2 8.3 Supreme Court of the United States, Sandoz Inc. v. AmGen Inc. et al., June 12, 2017
    Retrieved from "https://ballotpedia.org/wiki/index.php?title=Amgen_v._Sandoz&oldid=8890131"