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Dec. 8 — The Supreme Court is more likely to clarify biosimilar law as a result of a Dec. 7 brief by the acting solicitor general encouraging it to review a lower court decision ( Sandoz, Inc. v. Amgen, Inc. , U.S., No. 15-1039, brief filed 12/7/16 ).
The acting solicitor general 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), was incorrect in providing a six-month delay before biosimilars can come to market.
“This is a really significant development because it means the Supreme Court is likely to grant certiorari [review] and provide clarity about key provisions of the [biosimilar statute] that will impact nearly every biosimilars patent case,” Nicholas K. Mitrokostas, a partner in Goodwin Procter LLP’s intellectual property litigation group, told Bloomberg BNA in a Dec. 7 e-mail.
The justices will consider the review petition in a private conference on Jan. 6. If the court decides to review the Federal Circuit decision, it would hear arguments in April and could issue a decision by the end of June.
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 Biologic 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 was not mandatory, as Sandoz argued, and that the 180-day notice couldn’t be issued until the FDA approved the biosimilar, as Amgen argued ( 9 LSLR, 7/24/15 ).
Sandoz, which is part of Novartis, petitioned for certiorari, and Amgen cross-petitioned.
The acting solicitor general’s brief indicates that the text of Section 262(l)(8)(A) of the BPCIA directly addresses the requisite timing of the 180-day notice of commercial marketing when it states that notice must be given “not later than 180 days before the date of the first commercial marketing.” According to the acting solicitor general, “That restriction places the only limit on the appropriate timing. Nothing in Section 262(l)(8)(A) additionally restricts how soon the applicant may provide notice after the applicant submits its aBLA to FDA.”
The Federal Circuit inferred a temporal restriction from the phrase “the date of the first commercial marketing of the biological product licensed under Section 262(k), because, it concluded, the word “licensed” indicates that the notice “must be given only after the product is licensed,” the brief said.
“But ‘licensed’ there is most naturally read as describing the biological product at ‘the date of [its] first commercial marketing.’ And Section 262(l)(8)(A) simply requires notice be given ‘not later than 180 days before th[at] date,’ a time at which the product may not yet be licensed,” the acting solicitor general wrote.
Under the Federal Circuit’s reading, the owner of a biosimilar with an effective license could be forced to wait 180 days after FDA has authorized it to commence marketing, even if the sponsor had no arguably valid infringement claim to warrant such delay, the brief said.
“The timing of biosimilars’ entry onto the market was a significant issue addressed by the BPCIA, which prohibits FDA from making its approval of an aBLA effective before 12 years after the reference product’s first licensure. Given the expressly granted exclusivity periods, it is particularly unlikely that Congress would have further delayed biosimilars’ marketing in such an indirect manner.”
The acting solicitor general also indicated that the Federal Circuit had correctly interpreted the other aspects of the BPCIA that it considered.
The acting solicitor general urged the court to review the Federal Circuit’s decision, explaining the issues presented are sufficiently important to merit the court’s review because biologic medicines are among the most important and expensive drugs available today.
“Although petitioner is no longer enjoined from marketing Zarxio for allegedly violating Section 262(l)(8)(A), petitioner explains that this case is not moot because the dispute is capable of repetition, yet evading review,” the brief said.
The brief was signed by Ian Heath Gershengorn, acting solicitor general; Benjamin C. Mizer, principal deputy assistant attorney general; Edwin S. Kneedler, deputy solicitor general; Anthony A. Yang, assistant to the solicitor general; and Scott R. McIntosh and Lowell V. Sturgill Jr., attorneys.
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The brief is at http://src.bna.com/kBT.
Copyright © 2016 The Bureau of National Affairs, Inc. All Rights Reserved.
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