Stay ahead of developments in federal and state health care law, regulation and transactions with timely, expert news and analysis.
Nov. 15 — The promise of biosimilars to provide less costly biologic drugs in the U.S. is increasingly becoming reality, but ongoing court disputes leave the path forward unclear, panelists told a Nov. 15 conference session.
Howard W. Levine, a partner at Finnegan, Henderson, Farabow, Garrett & Dunner LLP, said two years ago biosimilars were still hypothetical. “But as of today, the FDA has approved four biosimilars and litigation in federal courts has made important steps in interpreting the Biologics Price Competition and Innovation Act (BPCIA),”
Work still needs to be done before all issues are dealt with and all questions about biosimilars are answered, said Finnegan attorney Jonathan R. Davies. “Almost every part of the BPCIA is currently being challenged in court,” he said.
The session was part of the BIO IP Counsels Committee Conference in Savannah, Ga.
Biologics are used to treat such diseases as cancer and hepatitis C. A biosimilar is a biologic drug product that is highly similar to a Food and Drug Administration-approved biologic. The BPCIA provides an abbreviated approval pathway for biosimilars that partly relies on data submitted for FDA approval of the original biologic, also known as a reference product (RP).
The abbreviated pathway allows lower development costs for the biosimilar than for the RP. The cost to consumers for most biosimilars is expected to be at least 15 percent less than the RP.
In exchange for the ability to use the RP’s data, the biosimilar applicant must give the RP sponsor its abbreviated biologic license application for the biosimilar and jointly develop with the RP sponsor a list of the sponsor’s patents that the biosimilar might infringe. This exchange has been called “the patent dance.”
The BPCIA also provides for the biosimilar applicant to give the RP sponsor 180-days’ notice of the date that it intends to commercially market the biosimilar.
Davies separated the BPCIA-related litigation into three light-hearted categories: “I Never Received My Invitation to the Dance”— Amgen v. Sandoz (Fed. Cir.); “I Went to the Dance”— Amgen v. Apotex (Fed. Cir.); and “I Went to the Dance but My Date Left Early”— Amgen v. Sandoz (D.N.J.).
In Amgen v. Sandoz, Amgen argued that Sandoz, which is part of Novartis, hadn’t complied with the BPCIA in developing its biosimilar of Amgen’s Neupogen (filgrastim), a chemotherapy-related biologic that, as Zarxio, became the first FDA-approved biosimilar.
The U.S. Court of Appeals for the Federal Circuit agreed with Sandoz that the patent dance is optional and with Amgen that the 180-days’ notice is mandatory and can’t be given until the FDA has approved the biosimilar.
Sandoz petitioned the Supreme Court for review. Amgen cross-petitioned. Sandoz raised the issues in its petition of whether treating the section at issue in the BPCIA as a standalone is improper because it gives the RP sponsor 12.5 years of exclusivity rather than 12 years, and whether notice before licensure is improper.
“The best argument in Amgen’s cross-petition is that interpreting ‘shall’ as non-mandatory violates the explicit benefits and obligations of the BPCIA,” Davies said.
The Supreme Court on June 20 asked the U.S. Solicitor General for its opinion before the court decides on whether or not it will review the decision. “And so we don’t yet know whether the Federal Circuit’s Sandoz decision is really it,” Davies said.
In Amgen v. Apotex, which dealt with Apotex’s biosimilar of Amgen’s chemotherapy-related Neulasta (pegfilgrastim), Apotex argued that the 180-day notice didn’t apply because Apotex had engaged in the patent dance.
The Federal Circuit affirmed the district court’s ruling that the 180-day notice is required regardless of whether the applicant has engaged in the patent dance and that “shall” means “shall.”
Davies noted that the decision was made by a different panel of the Federal Circuit than the one that decided Sandoz. Apotex has petitioned the Supreme Court for review.
Davies asked: What happens when parties agree to comply with the BPCIA but then one changes its mind?
In Amgen v. Sandoz, Sandoz engaged in the patent dance with Amgen concerning its Neulasta biosimilar, changed its mind and then insisted that Amgen immediately file an infringement suit or face penalty for untimely suit. Amgen filed a protective suit in the U.S. District Court for the District of New Jersey, alleging Sandoz violated the BPCIA, but it didn’t file an infringement claim.
“Amgen noted that this was the third time applicants have attempted to shortcircuit the BPCIA,” Davies said.
After the suit was filed, the parties negotiated, Sandoz agreed to comply with the BPCIA and Amgen filed an infringement suit against Sandoz in the U.S. District Court for the Northern District of California.
“The suit was dismissed in the District of New Jersey on July 22,” Davies said. “So it is still an open question whether you can leave the dance early.”
To contact the reporter on this story: John T. Aquino in Washington at email@example.com
To contact the editor responsible for this story: Randy Kubetin at firstname.lastname@example.org
Copyright © 2016 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)