Apotex Must Give Amgen 180 Days' Notice of Neulasta Biosimilar

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,...

By John T. Aquino

Dec. 10 — Apotex Inc. may not market its biosimilar of Amgen Inc.'s cancer treatment Neulasta for 180 days after it receives regulatory approval, a federal district court said in a Dec. 9 order.

The U.S. District Court for the Southern District of Florida thus answered a question that the U.S. Court of Appeals for the Federal Circuit had left unanswered in its interpretation of the biosimilar statute in Amgen v. Sandoz: Does the biosimilar applicant have to provide the 180 days' notice specified in the statute if it has engaged in the statute's patent and manufacturing information exchanges?

In Sandoz, the applicant hadn't exchanged the information with the biologic reference product sponsor (RPS) and the Federal Circuit ruled that the 180-day notice was mandatory. 

Apotex argued that to rule that Sandoz applies in all situations would unfairly delay the release of its biosimilar by six months. The Florida district court disagreed, although its order could be appealed to the Federal Circuit.

“The scenario proposed by Apotex would result in confusion and uncertainty, as well as inconsistent results,” Judge James I. Cohn wrote, saying that the 180-day notice gives the RPS time to determine whether it will sue the biosimilar applicant for patent infringement, thus leading to patent litigation that is “more crystallized.”

Less Disclosure Could Result

Nicholas K. Mitrokostas of Goodwin Procter LLP, Boston, told Bloomberg BNA in a Dec. 10 e-mail that the court's order could limit the exchange of information on biosimilars.

“As is apparent in the Apotexdecision, district courts are wrestling over how to give proper meaning to the interplay of various Biologics Price Competition and Innovation Act (BPCIA) provisions in light of the Federal Circuit’s recent decision in Amgen v. Sandoz. If the 180-day notice of commercial marketing is mandatory even when manufacturing and other disclosures have been provided by a biosimilars applicant under [45 U.S.C.] Section 262(l)(2), as the district court has now found in Apotex, then one consequence could be a reduced incentive on the part of future biosimilar applicants to engage in the disclosure of information.”

Mitrokostas added, “But, of course, we will have to wait and see how this issue continues to develop on appeal, which is likely to happen immediately in view of the injunction against Apotex.”

An Amgen spokeswoman told Bloomberg BNA Dec. 10 that the company was pleased with the court’s order. “The Court’s decision eliminates uncertainty and avoids inconsistent application of the notice obligation of the BPCIA,” she said.

Apotex didn’t immediately respond to Bloomberg BNA’s e-mail and phone requests for comment.

Under Shadow of Sandoz

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 the reference product.

The FDA has approved one biosimilar under the abbreviated pathway provided in the BPCIA—Sandoz's Zarxio, a biosimilar of Amgen's Neupogen, which was the subject of Sandoz.

In Sandoz, the Federal Circuit denied petitions by both Amgen and Sandoz for a rehearing by a different three-judge panel or for a full court (en banc) hearing, leaving both parties with a petition for Supreme Court review as their only option.

Amgen Claims BPCIA Violation, Infringement

Neulasta (pegfilgrastim) is used to treat neutropenia, a lack of certain white blood cells caused by cancer chemotherapy.

In its Aug. 6 complaint, Amgen said Apotex had provided it with a copy of its biologics license application (BLA) for a Neulasta biosimilar and exchanged information on Amgen patents that the biosimilar could infringe to conform with the BPCIA.

But Amgen also alleged that Apotex told it in a letter that because it had agreed to comply with the information exchanges concerning its Neulasta biosimilar under the BPCIA, it could opt out of providing the 180-day notice of commercial marketing. This communication prompted Amgen's lawsuit.

The complaint included counts that Apotex violated the BPCIA and that its Neulasta biosimilar would infringe Amgen's U.S. Patent Nos. 6,162,427 and 8,952,138.

Court Disagrees With Apotex

In its answer to Amgen's Aug. 6 complaint, Apotex denied the infringement and the BPCIA violation and made counterclaims of non-infringement, invalidity of one of the patents and unlawful monopolization in violation of the Sherman Act and the Clayton Act, 15 U.S.C. §2 and 15 U.S.C. §§§15 and 26, respectively. Apotex called Amgen's lawsuit a “sham” and its claims “baseless.”

Apotex's answer supported its interpretation of the BPCIA by quoting 42 U.S.C. §262(l)(9)(B), which describes what actions an RPS may take when a biosimilar applicant doesn't engage in the information exchanges.

Apotex said this section of the statute allows an applicant that provides the RPS with the required information to either provide a notice of commercial marketing or face an action for a declaration of patent infringement. Any other interpretation would make subsection (l)(9)(B) superfluous, Apotex wrote.

In his order, Cohn disagreed with Apotex's “superfluous” argument. “Subsection 262(9(9) gives the RPS the option to file a declaratory judgment action if the [biosimilar] applicant fails to comply with §262(l)(8)(A), but it is not an exclusive remedy. As the Sandoz court ruled, an injunction to compel compliance with the 180-days' notice provision of §262(l)(8)(A) is another remedy.”

Reflective of the court activity concerning biosimilars, a few days before Apotex's counterclaim filing over the Neulasta biosimilar, Amgen filed a similar but separate lawsuit in the same court against Apotex, alleging that its planned biosimilar of Neupogen infringes patents and violates the BPCIA. 

Amgen was represented by Hogan Lovells LLP, Miami, and Paul, Weiss, Rifkind, Wharton & Garrison, LLP, New York. Apotex was represented by Cozen O'Connor, Washington.

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

The decision is at http://www.bloomberglaw.com/public/document/Amgen_Inc_et_al_v_Apotex_Inc_et_al_Docket_No_015cv61631_SD_Fla_Au/2.