Amgen Sues Apotex Alleging Violations of Biosimilar Statute

Life Sciences Law & Industry Report connects the dots among the many disciplines that make up the burgeoning life sciences industry, with biweekly updates on current regulatory, legislative,...

Oct. 6 — Apotex Inc. violated the biosimilar statute by refusing to meet the law's marketing notice provision even though it provided other information as required, Amgen Inc. alleged in litigation filed Oct. 2 in federal district court. 

This appears to be the first biosimilar lawsuit in which the defendant engaged in the patent and other information exchange as required under the Biologics Price Competition and Innovation Act (BPCIA).

According to Amgen's complaint in the U.S. District Court for the Southern District of Florida, Apotex told Amgen in March 2015 that it had filed a biologic license application (BLA) for a biosimilar of Amgen's cancer treatment Neupogen (filgrastim). Apotex provided Amgen with a copy of the BLA and its manufacturing information for the biosimilar. In addition, Apotex engaged in the “patent dance” with Amgen, an exchange of patent information that resulted in the selection of two Amgen patents that the parties agreed should be the subject of any patent infringement suit brought pursuant.

But Apotex declined to provide Amgen with a date when it expected to market its biosimilar of Neupogen, saying that providing notice of commercial marketing wasn't mandatory because it had given Amgen the BLA and manufacturing and patent information, Amgen said.

Amgen wrote that this violates the BPCIA as interpreted by the U.S. Court of Appeals for the Federal Circuit in Amgen v. Sandoz (9 LSLR 828, 7/24/15).

In his intellectual property blog, Chris Holman, professor of law at the University of Missouri-Kansas City, wrote on Oct. 5 that to his knowledge this is the first biosimilar lawsuit in which the defendant had actually complied with the “patent dance” requirements. He added that he didn't understand the basis for Apotex's justification of not satisfying the notice requirement but was eager to see how it plays out.

A biosimilar is a biologic product that is approved for market by the Food and Drug Administration based on a showing that it is highly similar to an already-approved biologic product known as a reference product.

Gap in Sandoz Ruling

In its complaint, Thousand Oaks, Calif.-based Amgen also asserted counts of infringement against the two patents selected by the parties, U.S. Patent Nos. 8,952,138 and 6,162,427. One of the purposes of the BPCIA's provision requiring exchange of patent information is to allow the biologic reference product sponsor (RPS) and the biosimilar applicant to deal with the possibility of an infringement action sooner rather than later to avoid unnecessarily putting the applicant's launch of the biosimilar at risk.

 

In Amgen v. Sandoz, Sandoz had refused to share its BLA and manufacturing and patent information with Amgen for Zarxio, its biosimilar of Amgen's Neupogen. Zarxio was the first biosimilar approved by the FDA under the abbreviated approval pathway of the BPCIA.  

A panel of the U.S. Court of Appeals for the Federal Circuit agreed with Sandoz that the sharing of the BLA and the manufacturing and patent information exchanges are optional, not mandatory. An applicant's refusal to share the necessary information with the RPS allows the RPS to immediately sue for infringement and for a preliminary injunction delaying release of the biosimilar, it said.

The court disagreed with Sandoz's contention that he BPCIA's 180 days' notice of its plan to commercially market Zarxio could start on the day of the FDA's approval of its application. The notice period can only begin after the FDA has approved the biosimilar for market, the court held. This part of the decision caused Sandoz to delay the release of Zarxio from March until September.  

Both Amgen and Sandoz have petitioned for an en banc (full) Federal Circuit hearing of their litigation. The Federal Circuit panel focused on the issue of a company declining to provide the information to an RPS and not what happens if an applicant complies with the information exchange requirements.

Notice Must Wait for FDA Approval

In its complaint, Amgen said that, on April 17, Apotex sent Amgen a letter purporting to be Apotex's notice of commercial marketing pursuant to 42 U.S.C. §262(l)(8)(A). The notice failed to specify a date on or after which Apotex intended to commence commercial marketing of its biosimilar. In response, Amgen wrote asking for Apotex to confirm that it intended to provide an effective notice of commercial marketing after the biosimilar was licensed by the FDA.

On Aug. 24, the complaint said, Apotex sent Amgen a letter responding that “because Apotex followed the pathway and provided Amgen with its application and manufacturing information, providing a notice of commercial marketing is not mandatory.

Under Sandoz, Amgen said, Apotex can't provide commercial notice of its intent to market its Neupogen biosimilar because the FDA hasn't yet approved the biosimilar.

Amgen wrote that it is bringing the action “to lift the cloud created by the imminent threat of Apotex's refusal to provide a legally effective Notice of Commercial Marketing pursuant to 42 U.S.C. §262(l)(8)(A).” Without the court providing declaratory judgment that Apotex's notice violates the BPCIA, Amgen wrote, it can't exercise its rights under the statute.

Amgen also asked the court for judgments and declaratory judgments of infringement, injunctions preventing Apotex from infringing the patents, an injunction preventing Apotex from launching its Neupogen biosimilar until a date that is at least 180 days after Apotex provides effective notice to Amgen, damages adequate to compensate Apotex for infringement and attorneys' fees and costs.

Apotex, which is based on Toronto, didn't immediately respond to Bloomberg BNA's e-mail and phone requests for comment. The complaint was filed by Hogan Lovells US LLP, Miami, with Paul, Weiss, Rifkind, Wharton & Garrison, New York, and attorneys from Amgen, of counsel.

To contact the reporter on this story: John T. Aquino in Washington at jaquino@bna.com

To contact the editor responsible for this story: Randy Kubetin at rkubetin@bna.com