Prachi Mehta (University of Texas at Austin School of Law) has posted FDA Regulatory Evidence in Patent Litigation on SSRN. Here is the abstract:
Litigants routinely make representations to administrative agencies that later surface in court. These representations were made before litigation started, to an administrative agency, regarding a legal question different from the one before the court. This Article identifies agency-facing statements as a distinct and under-theorized category of evidence and gives them a name: regulatory evidence.
This Article investigates how Article III courts should treat such evidence in the FDA-patent law universe. When a pharmaceutical company submits an application to the FDA, the factual representations in that application may later migrate over into patent cases, where that same company is defending against allegations of patent infringement.
The Federal Circuit has landed on a suboptimal approach—it gives the regulatory evidence too much weight. Excessive weight is problematic because it can distort the infringement analysis, leading to increased risk of false positives and, in some cases, high prescription drug prices. Excessive weight can also corrupt regulatory incentives insofar as it penalizes candor during agency proceedings.
This Article proposes a rebuttable presumption framework under which the Federal Circuit would begin the patent infringement analysis with the regulatory evidence, while allowing the defendant the opportunity to rebut with additional evidence.
The Article concludes by setting a broader research agenda for studying regulatory evidence across the administrative state.
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