Stay ahead of developments in federal and state health care law, regulation and transactions with timely, expert news and analysis.
Sandoz’s interpretation of the law would bring biosimilars to market sooner and resolve patent infringement litigation early, the company told the Supreme Court March 31 ( Sandoz, Inc. v. Amgen, Inc. and Amgen, Inc. v. Sandoz, Inc. , U.S., Nos. 15-1039 and 15-1195, reply brief 3/31/17 ).
The court is reviewing the July 21, 2015, decision of the U.S. Court of Appeals for the Federal Circuit in its first interpretation of the Biologics Price Competition and Innovation Act (BPCIA), which created a speedier pathway of approval for biosimilars—highly similar and less expensive versions of expensive biologic drugs. The dispute concerns Sandoz’s Zarxio, a biosimilar of Amgen’s Neupogen, which treats chemotherapy effects, and the companies’ differing interpretations of the BPCIA.
Amgen must submit its final brief by April 14, with oral arguments scheduled for April 26. The Supreme Court’s decision, expected by the end of June, will likely affect how quickly biosimilars are released to market in the U.S. and how long owners of the original biologic can remain the sole seller of the product.
The first words of Sandoz’s brief replying to Amgen’s went right to the jugular. “Sandoz agrees with Amgen that the Biosimilars Act should be applied ‘as written.’ But that means applying the statute as written in its entirety—not just the parts Amgen rips from context and reads in isolation.”
Biologics, which can cost tens of thousands of dollars a year, are generally regarded as prime drivers of cost increases in U.S. drug spending. Biosimilars are expected to cost consumers 15 percent to 30 percent less than the original biologic.
At issue before the court are two BPCIA provisions: One requires the applicant to give the biologic reference product sponsor (RPS) its biosimilar application and manufacturing information and to work with the sponsor on a list of the RPS patents that might be infringed; the other requires the applicant to give the RPS notice 180 days before it intends to start selling the biosimilar.
The Federal Circuit agreed with Sandoz and the district court that the exchange of information was optional but disagreed with its ruling on the 180-day notice, favoring Amgen’s interpretation that the statute means the applicant can’t give notice of commercial marketing until after the Food and Drug Administration has approved the biosimilar for market, thus delaying Zarxio’s release for six months.
The Federal Circuit basically awarded a split decision, with each party winning on one of the issues. Sandoz, a Novartis subsidiary, petitioned and Amgen cross-petitioned the Supreme Court for certiorari (review), with each party asking the court to reverse what was unfavorable to them. The court granted both petitions Jan. 13. Sandoz submitted its opening brief Feb. 10 11 LSLR, 2/17/17 and Amgen’s consolidated reply brief and opening brief of its cross petition were sent to the court March 10 11 LSLR, 3/17/17 .
Sandoz in its brief replying to Amgen’s said Congress laid out in the BPCIA different routes to resolving litigation and specified consequences depending on the parties’ actions or inactions. “In context, each step is not a freestanding command but a mandatory condition precedent to continuing the process,” Sandoz said.
Amgen’s BPCIA interpretation focuses exclusively on the procedural steps, disregarding the statute’s express consequences for not following them, Sandoz contended. One consequence is the RPS’s ability to immediately file litigation for declaratory judgment of patent infringement. “In place of those consequences, Amgen asks the Court to invent new ones—causes of action for injunctions mandating procedural compliance,” Sandoz wrote.
The statute “as written” precludes this approach for both the BPCIA’s exchange of information provision and the 180-day notice of commercial marketing, Sandoz wrote, adding that the latter provision includes only one timing element—notice “not later than 180 days before” marketing.
“Yet Amgen seeks to inject a second timing element—no notice until after FDA approval. Had Congress wanted a ‘before’ and an ‘after,’ it would have said so expressly (as in the very next provision),” Sandoz wrote.
According to Sandoz, Amgen’s interpretation of the BPCIA is also contrary to the statute’s purpose: patent litigation should be resolved early and shouldn’t delay biosimilar competition. “But under Amgen’s view, [litigation] could never even begin until after approval, making resolution impossible before a biosimilar product could be launched. And, perversely, a 180-day stay would apply even when no patents are left to litigate.”
Sandoz labeled as “fantasy” Amgen’s warning that Sandoz’s BPCIA interpretation would lead to chaos, with attorneys for the RPSs rushing into litigation before they knew what patents were being infringed and when the product was to be launched.
Sandoz wrote, “It is Amgen’s reading that promotes rushed litigation. Under Sandoz’s view, an applicant could withhold its application, triggering immediate litigation on all patents without waiting 250 days to complete the information exchange process. That increases the odds that litigation would finish before FDA approval. And by allowing notice before FDA approval, Sandoz continued, its reading of the BPCIA “would facilitate final judgment on any remaining patents before launch.”
Accordingly, Sandoz asked the Supreme Court to reverse the Federal Circuit’s judgment on the notice requirement and to affirm it on the information exchange.
The brief was filed by Morrison & Foerster LLP, Washington. Nine friends of the court brief were submitted in support of Sandoz’s argument, including one from the U.S. government 11 LSLR, 3/3/17 .
To contact the reporter on this story: John T. Aquino in Washington at firstname.lastname@example.org
To contact the editor responsible for this story: Randy Kubetin at RKubetin@bna.com
Sandoz's brief is at http://src.bna.com/nCq
Copyright © 2017 The Bureau of National Affairs, Inc. All Rights Reserved.
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to email@example.com.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to firstname.lastname@example.org.
Put me on standing order
Notify me when new releases are available (no standing order will be created)