Partner Mark Ford and Associate Kristen Parnigoni have authored a chapter in the American Bar Association's September/October 2025 issue of Landslide Magazine about how shifting the burden of proving good faith to pharmaceutical patent holders in antitrust cases may require waiver of the attorney-client privilege. They discuss the precedent set by other cases in this realm and key takeaways about the operation of the regulatory compliance defense in the context of Orange Book antitrust cases in light of recent litigation.
Excerpt: "The U.S. Food and Drug Administration (FDA) publication known as the “Orange Book” lies at the center of the complex statutory and regulatory scheme that governs approval of generic drugs in the United States. The Hatch-Waxman Act requires that every sponsor of a new, “branded” drug submit for listing in the Orange Book certain patents that either “claim[] the drug” or “a method of using [the] drug.” The listing is intended to provide notice of those patent rights to would-be generic applicants, but the Hatch-Waxman Act also allows branded drug companies to seek to enforce those Orange Book–listed patents before the generic drug hits the market. In fact, when Orange Book–listed patents are asserted against generic challengers under the procedures created by the Hatch-Waxman Act, FDA approval of the generic drug is automatically stayed for up to 30 months as the patent infringement case is litigated."