Supreme Court Grabs Chance to Clarify Biosimilar Law

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By John T. Aquino

Life sciences companies will get some clarity about how the U.S. must approve cheaper copies of biologic drugs after the Supreme Court Jan. 13 agreed to review an appeals court decision ( Sandoz, Inc. v. Amgen, Inc., U.S., No. 15-1039, 1/13/17 ).

The acting U.S. solicitor general had advised the court that the decision by the U.S. Court of Appeals for the Federal Circuit concerning Sandoz’s Zarxio (filgrastim-sndz), a biosimilar of Amgen’s chemotherapy-related biologic Neupogen (filgrastim), incorrectly provided a six-month delay before biosimilars can come to market ( 11 LSLR 01, 1/6/17 ). The acting solicitor general recommended the high court grant review. The court agreed in an order with no comment.

“The Supreme Court’s grant of both Sandoz’s petition and Amgen’s conditional cross-petition will perpetuate, at least for several more months, the uncertainty as to how future biosimilar litigations will proceed,” Sanya Sukduang of Finnegan, Henderson, Farabow, Garrett & Dunner LLP told Bloomberg BNA in a Dec. 13 e-mail,

“Given the Acting Solicitor General position, however, biosimilar applicants have hope that the Supreme Court will overturn the decision and allow them to provide notice of commercial marketing well in advance of receiving final regulatory approval,” he said.

The high court will hear arguments in April and could issue a decision by the end of June.

Petition, Cross-Petition

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 Biologics Price Competition and Innovation Act (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 BPCIA provides that the biosimilar applicant will give the RP sponsor its abbreviated biologics license application (aBLA) 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 a 180-day notice of the date that it intends to commercially market the biosimilar.

In its Amgen decision, the Federal Circuit held that the patent dance wasn’t mandatory, as Sandoz argued, and that the 180-day notice couldn’t be issued until the FDA approved the biosimilar, as Amgen argued ( 09 LSLR, 7/24/15 ).

Sandoz, which is part of Novartis, petitioned for certiorari, and Amgen cross-petitioned.

Clarification Welcome

Attorneys contacted by Bloomberg BNA offered different perspectives on the impact of the court’s action on life sciences law and industry.

“While the Supreme Court’s ultimate decision on these issues will result in regulatory and litigation war-gaming by biosimilar applicants and reference product sponsors, the court’s decision will necessarily rest on fundamental basics of statutory interpretation,” Sukduang wrote.

“Both Sandoz and Amgen have pointed out the Federal Circuit’s seemingly contradictory interpretation of the term ‘shall’ in the aBLA disclosure provisions of §262( l)(2)(A) and 180-day notice of commercial marketing provision of §262( l)(8)(A), and it will be interesting to see whether the court will apply the same, or different meaning, to the same term contained in the same piece of legislation,” he said.

Nicholas K. Mitrokostas, a partner in Goodwin Procter LLP’s intellectual property litigation group, Boston, told Bloomberg BNA in a Dec. 13 e-mail that the court’s decision to grant review isn’t surprising given the acting attorney general’s recommendation. “The grant today gives the court time to consider the issues and hand down a decision by the end of its current term in June.”

“However the case comes out, everyone on both sides of the issue will welcome getting a definitive answer to these important questions relatively early in the history of the BPCIA,” he said.”

To contact the reporter on this story: John T. Aquino in Washington at

To contact the editor responsible for this story: Randy Kubetin at

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