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# Early BPCIA Decisions Set Future Course
- URL: https://www.fdaweb.com/early-bpcia-decisions-set-future-course/
- Published: 2016-07-27T12:00:00.000Z
- Updated: 2026-09-14T21:18:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136298

Attorney **Chittam Thakore** (Womble Carlyle) says that since biosimilar litigation is poised to gain momentum, early court decisions on rudimentary although fundamental questions about the Biologics Price Competition and Innovation Act (BPCIA) will be guiding lawyers and companies as they decide “whether to dance.” Writing in an online blog [post](http://www.lexology.com/library/detail.aspx?g=189e7866-bdf9-463b-b11b-a45305f114e7&ref=fdaweb.com), Thakore reviews the issues that have come up and the decisions thus far.

She notes that only a small handful of aBLAs have been filed and only two have been approved by FDA — Sandoz’ Zarxio (biosimilar to Amgen’s Neupogen) and Celltrion’s Inflectra (biosimilar to Janssen’s Remicade). Litigation continues over both of these drugs, she says, and many of the issues brought to the forefront in those and other cases are of first impression and highlight the questions and uncertainties surrounding the biosimilar licensing process envisioned by the BPCIA.

Thakore describes the “patent dance” dispute resolution process in the BPCIA in which an aBLA filer provides a copy of the application and the biosimilar’s manufacturing information to the reference-product sponsor. The parties then exchange a list of patents that each contends “could reasonably be asserted in an infringement action” by the sponsor. The two sides try to agree on specific patents to be included in an infringement action or, if agreement is not reached, proceed to sue on each patent listed by either party.

“Although time consuming in itself, taking the better part of a year or more to complete,” she writes, “the dispute resolution mechanism of the BPCIA promotes information exchange to streamline subsequent patent litigation. But there are obvious drawbacks, with the aBLA filer required to provide confidential and sensitive information upfront and the parties obligated to provide detailed statements of their litigation provisions before suit is filed and to engage in often futile negotiations. Thus, it is unsurprising that aBLA filers may balk at the constraints of the BPCIA’s dispute resolution framework, and so questions arise as to whether and to what extent a party must engage in the patent dance.”

The post describes several suits involving Sandoz and others raising questions about the patent dance and notice of commercial marketing provisions of the BPCIA. Thakore says the Federal Circuit Court of Appeals has ruled that an aBLA filer’s participation in the patent dance is not mandatory under the BPCIA. The court also concluded that an aBLA filer who did not engage in the patent dance is required to provide a notice of commercial marketing and that such notice could be effectively given only after FDA had approved the aBLA. That ruling left open the question of whether an aBLA filer who participated in the patent dance was required to provide a notice of commercial manufacturing. The decision is on appeal to the Supreme Court, which has not decided whether to hear the case. Meanwhile, the Federal Circuit in another case has ruled that the commercial marketing notice provision is mandatory even for those aBLA filers who engage in the patent dance. But that court also said it saw no reason that FDA could not issue a license to a biosimilar early and deem it to take effect on the 12-year patent exclusivity date, so that the period of exclusivity does not exceed 12 years. “This suggestion is ripe for attention in later-filed actions and may well spin off suits against FDA,” the post concludes.