All Eyes on Sandoz Biosimilar Case After High Court Denies Apotex Review

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By John T. Aquino

Dec. 12 — The Supreme Court’s Dec. 12 denial of review of a biosimilar decision makes its potential review of another biosimilar case “the only game in town” in interpreting the biosimilar statute ( Apotex, Inc. v. Amgen, Inc., U.S., No. 16-332, 12/12/16 ).

The court denied without an opinion Apotex’s petition for review of the U.S. Court of Appeals for the Federal Circuit’s ruling in Apotex, Inc. v. Amgen,Inc. concerning Apotex’s biosimilar of Amgen’s Neulasta, a chemotherapy-related biologic drug ( 10 LSLR, 7/8/16 ). In Apotex, the Federal Circuit reaffirmed its decision in Sandoz, Inc. v. Amgen, Inc. on the issues of if and when a biosimilar applicant must give notice of commercial marketing to the owner of a biologic patent.

“This does indeed turn all attention to Sandoz,” a life sciences patent attorney told Bloomberg BNA in a Dec. 12 e-mail, asking not to be identified and suggesting that the court might have felt no need to review Apotex if it takes on Sandoz.

Sandoz petitioned and Amgen cross-petitioned the high court for review of Sandoz. The acting solicitor general advised the court on Dec. 7 to review the decision and suggested that the Federal Circuit’s interpretation of the 180-day notice requirement of the Biologics Price Competition and Innovation Act (BPCIA) was incorrect ().

Several attorneys contacted by Bloomberg BNA used the phrase “only game in town” in referring to Sandoz now that the Apotex petition has been denied. Nicholas K. Mitrokostas, a partner at Goodwin Procter’s IP litigation group, Boston, said that if the court accepts the petitions in Sandoz and adopts the acting solicitor general’s interpretation of the BPCIA, it will essentially mean a six-month earlier entry date for biosimilars, which are expected to be less expensive than the original biologics.

Sandoz Ruling Becomes Focus

Biologics are used to treat diseases such 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 that for RPs.

In exchange for using 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 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 Sandoz decision, the Federal Circuit held that the patent dance wasn’t mandatory, as Sandoz had argued, and that the 180-day notice couldn’t be issued until the FDA approved the biosimilar, as Amgen had argued.

No Distinction Between Apotex, Sandoz

Apotex’s primary contention in its argument was that the 180-day notice requirement only applied when the biosimilar applicant didn’t participate in the BPCIA’s patent dance, which Apotex did and Sandoz didn’t.

After a detailed examination of the relevant sections of the BPCIA, the Federal Circuit said that there was no “legally material distinction” as to the law in Apotex and Sandoz. Apotex petitioned the Supreme Court for review, and Amgen filed an opposition to the petition.

An Amgen spokeswoman in a Dec. 12 e-mail told Bloomberg BNA about the denial of review in Apotex, “All we can say at this time is that ‘we can confirm that the Supreme Court denied Apotex’s petition for cert, which Amgen opposed.’”

An Apotex spokesman didn’t immediately respond to Bloomberg BNA’s e-mail request for comment.

David C. Frederick of Kellogg, Huber, Hansen, Todd, Evans & Figel PLLC filed Apotex’s petition. Nicholas Groombridge of Paul, Weiss, Rifkind, Wharton & Garrison LLP was Amgen’s counsel of record.

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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