U.S. Realizing Biosimilars’ Promise But Court Disputes Remain

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By John T. Aquino

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.

Three Patent Dance Scenarios

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.).

Dance Optional

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.

180-Day Notice Mandatory

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.

Backing Out Question Open

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 jaquino@bna.com

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

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