ARTICLE
11 November 2025

The Regulatory Compliance Defense For "Improper" Orange Book Listings

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WilmerHale

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WilmerHale provides legal representation across a comprehensive range of practice areas critical to the success of its clients. With a staunch commitment to public service, the firm is a leader in pro bono representation. WilmerHale is 1,000 lawyers strong with 12 offices in the United States, Europe and Asia.
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.
United States Intellectual Property
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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 takeawaysabout the operation of the regulatory compliance defense in the context of Orange Bookantitrust cases in light of recent litigation.

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