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Ha Kung Wong: The FDA's Role in Clarifying the BPCIA


Ha Kung Wong, JD, Partner at Fitzpatrick, Cella, Harper and Scinto, discusses whether the FDA might clarify its stance on the BPCIA.

Ha Kung Wong, JD, Partner at Fitzpatrick, Cella, Harper and Scinto


Justice Breyer seems to be indicating that the FDA’s interpretation of the [Biologics Price Competition and Innovation Act, BPCIA] would be eligible for Chevron deference. And that might make sense with respect to the timing of the notice of commercial marketing. So, for example, the FDA might have some incentive in the future to say that they interpret the BPCIA to require 180 days between formal FDA approval at the expiration of the biologic exclusivity and commercial marketing.

But with respect to the civil procedure requirements—the “patent dance” aspect of the Sandoz holding, it’s not really clear what the FDA’s incentive would be or how the FDA’s authority would extend to parties’ standing before the Article III courts. It’s uncertain if the FDA has any incentive to weigh in on the patent dance, and whether they would feel confident that their interpretation of the procedural aspects of patent litigation would be entitled to deference, you know, Justice Breyer’s concurrence notwithstanding.

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