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Subject: BPCIA Update: The 180-day Notice of Commercial Marketing in the Courts
Date/Time: Thursday, April 28
1:00 pm – 2:00 pm EST, 12:00 pm – 1:00 pm CST, 10:00 am – 11:00 am PST
Mark I. Bowditch Mark Bowditch
Vice President, Intellectual Property and Litigation
Coherus BioSciences, Inc.
(Redwood Shores, CA)
Donald R. Ware Bio photo for Donald Ware
Partner and Chair, Intellectual Property Department
Foley Hoag LLP
Last year, in Amgen v. Sandoz, a divided Federal Circuit panel held that a biosimilar applicant who “opted out” of the BPCIA patent dance cannot give the reference product sponsor the required 180-day notice of the applicant’s intent to commence commercial marketing until after the FDA formally approves the biosimilar. The effect of the ruling is to give the reference product sponsor an additional six months of data exclusivity beyond the 12-year period specified in the statute. After the Federal Circuit denied en banc review, Sandoz filed a cert petition in the Supreme Court, which is currently pending. Based on this decision, in litigation against another biosimilar applicant, Apotex, Amgen obtained a preliminary injunction against the commercial launch of Apotex’s biosimilar until 180 days after post- approval notice of commercial marketing is given. Apotex appealed based on the argument that the Sandoz decision does not apply where the applicant complied with the information exchange provisions of the BPCIA. The Federal Circuit heard argument on April 4.
This 60-minute webinar will analyze the reasoning of these cases, their current status, and the various scenarios that could result from further decisions in the Federal Circuit or the Supreme Court.
- What was the purpose of the 180-notice requirement?
- Should FDA approval be a prerequisite to giving notice?
- Could the FDA give tentative approval to a biosimilar during the 12-year data exclusivity period and thereby allow the applicant to avoid the additional six-months of exclusivity?
- What kind of notice will satisfy the statute?
- How will future decisions on this issue affect the desirability of opting out of the patent dance?