Update on the Patent Dance Case – Zarxio® Enjoined Pending Appeal

In an earlier post, I discussed a recent district court decision holding that the “patent dance” provisions of the Biologics Price Competition and Innovation Act are not mandatory. Yesterday, there was a new development in this case. The Court of Appeals for the Federal Circuit entered an injunction pending appeal preventing Sandoz “from marketing, selling, offering for sale, or importing into the United States its FDA approved ZARXIO® biosimilar product.” The oral argument in Amgen v. Sandoz on appeal is scheduled to be held on June 3.

Table of Contents

Spring ’16
Issue 94/Vol. 50/No. 2

From the Dean

Cover Story

Law of Democracy
In this feature, Stanford Law faculty weigh in on important legal questions raised in this election year, such as redistricting, the Voting Rights Act, the disenfranchisement of disabled Americans, campaign communications post-Citizens United, and how to improve the actual voting experience.

Rabia Belt Explores the History of Voter Disenfranchisement that Continues Today

Big Money, Campaigns, and Communication

Legal Matters

Voting in America
Benjamin Ginsberg and Robert Bauer co-chaired the bipartisan Presidential Commission on Election Administration, an investigation into voting in the United States. In this Q&A, the commission’s senior research director, Professor Nathaniel Persily, JD ’98, discusses with them this year’s election and the key findings of the commission’s report.

In Brief

Alumni and School News

Smart Prosecution

SVLO Hosts Veterans Treatment Courts Conference

J. Paul Lomio Memorial Fellowship Established

First OUTLAW Conference at SLS

SLS Launches Foreign Corrupt Practices Act Clearinghouse

JSD Candidate Doron Dorfman Receives Colin B. Picker Prize, First Honorable Mention for a Paper by a Graduate Student

In Focus

Justice Cuéllar: At the California Supreme Court
Former Stanford Law Professor Mariano-Florentino Cuéllar (MA ’96, PhD ’01) addresses the importance of diversity in legal institutions and his role as the only Latino justice on the California Supreme Court.

Applying Design Thinking to Law
Stanford Law students in this practicum apply “design thinking” to develop solutions to privacy concerns with online consumer contracts.

Ailsa Chang: Reporting from Washington
Award-winning journalist Ailsa Chang, JD ’01, discusses her career as a political reporter for NPR.

Jonathan Schwartz: From DOJ to Napster to Univision
Univision’s Chief Legal and Corporate Affairs Officer Jonathan Schwartz, JD ’86, on his career in criminal justice and media

Bridging the Law Firm Gender Gap
Women make up close to 50 percent of law graduates in the U.S., yet only 18 percent are law firm equity partners. In this practicum, Stanford Law students explore ways to bridge the gender gap in law firms.

Hilary Tompkins: Representing America’s Lands, Waters, and Wildlife
Hilary Tompkins, JD ’96, GC at the U.S. Department of the Interior, reflects on her career choices and the role her Native American heritage has played in her life’s work.

Point of View

Adultery: Infidelity and the Law
An excerpt from Professor Deborah L. Rhode’s new book


The End of Sex?
A report on Professor Hank Greely’s (BA ’74) new scholarship on reproduction technologies and the accompanying legal and ethical complexities of those advances

Clinic News

Organizations and Transactions Clinic
A report on the Organizations and Transactions Clinic and its work demystifying corporate practice

5 Responses to Update on the Patent Dance Case – Zarxio® Enjoined Pending Appeal
  1. Dmitry,

    Is it unusual for the CAFC to issue an injunction pending appeal? I guess they couldn’t just stay the lower court decision because that wouldn’t necessarily stop Sandoz. Also, June 3 seems like an awfully fast hearing date – is that unusual? That gives practically no time for a briefing schedule – seems odd, especially with the injunction to hold the status quo in place.

    I am assuming this all looks like it presages a quick and perhaps harsh reversal?

  2. Hank,

    Injunctions pending appeal are somewhat common in Hatch-Waxman cases. I think a part of the reason for this is that the harm to the brand company may be truly irreparable if a generic manufacturer launches its product and then the district court’s decision allowing the launch turns out to be in error on the merits. In contrast, the harm to the generic may be compensable by a bond. My sense is that the considerations in biosimilars cases should be pretty much the same. Indeed, and a part of the order issuing the injunction pending appeal in this case asks the parties to brief what the amount of the bond should be.

    An injunction pending appeal against a generic – or here, a biosimilar – can certainly be a sign that the decision on the merits will go against the follow-on manufacturer. But not always. For example, in a recent Hatch-Waxman case, the Federal Circuit entered an injunction pending appeal but ultimately held for the generic and dissolved the injunction. See below:


    In a case like this, where there could be a huge mess if the biosimilar launched but then later had to take its product “off the shelf,” I think the injunction pending appeal is the prudent course unless the case in favor of the generic is slam-dunk.

    As for the date of the argument, the parties requested expedited briefing and hearing, and the case (which the district court decided back in March) has already been fully briefed on appeal. The merits briefing in this case proceeded pretty much in parallel to the temporary injunction briefing. So I think the parties and the judges will be fully ready.

    We do know one thing for sure. Sandoz has talked about launching its biosimilar product on Monday May 11. Now, in view of the injunction, it cannot.


  3. Hi Dmitry – great posts here; thanks for the work.

    Any takeaways from today’s oral arguments? Given the expedited briefing, can we expect a decision fairly soon?



  4. Hi Alan,

    Thank you for your interest! I attended the argument and it looked like a close case all the way, though maybe the appellant, Amgen, looked a little stronger based on the panel’s questions. One clue – Sandoz’s counsel asked the court to dissolve the injunction pending appeal immediately if the panel reached a decision favorable to Sandoz, and according to PACER as of 5PM east coast time today, the injunction has not been dissolved. Speaking of which, it is interesting that Amgen’s claim is under California unfair competition law and California common law, but the injunction pending appeal against Sandoz appears to be nationwide. And the court has not yet determined the amount of bond.


  5. By the way, I plan to post a summary of the oral argument fairly soon.

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