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Eleventh Circuit decision could significantly expand scope of orphan exclusivity
01 February 2022
PartnerWashington, D.C.
Email [email protected]hoganlovells.com
Phone +1 202 637 5600
Fax +1 202 637 5910
Practice groupLitigation, Arbitration, and Employment
"The IP practice at Hogan Lovells benefits from the keen abilities of Susan Cook."
Managing Intellectual Property
Susan Cook co-heads the firm's Administrative Procedure Act (APA) group. Susan also handles complex commercial litigation involving the life sciences, health care, pharmaceutical, medical device, and consumer industries.
Susan has robust experience litigating APA cases against federal and state agencies in courts around the country, as well as handling administrative appeals at the agency level. Susan also brings legal challenges to state regulatory laws on state APA, preemption, dormant commerce clause, and other constitutional grounds. Susan regularly represents clients in APA challenges involving the Department of Health and Human Services (HHS), the Food and Drug Administration (FDA), the Centers for Medicare & Medicaid Services (CMS), the Health Resources and Services Administration (HRSA), the Federal Communications Commission (FCC), the Department of Education (ED), and other federal and state agencies. In all of these matters, Susan works seamlessly with the firm's regulatory and appellate lawyers to bring the whole of the firm to the client. She also advises clients on rulemaking procedures, comment letters, FOIA issues, and reverse-FOIA disputes.
In addition to her APA practice, Susan also handles competitor and contract disputes in heavily regulated industries, including claims under the Lanham Act and state laws governing false advertising, unfair competition, and corporate defamation. Susan successfully navigates the complex interplay of such laws with regulatory requirements, helping each client to craft a unique litigation strategy targeted to its own specific goals.
Susan’s legal practice spans more than 20 years at the firm.
Healthcare: Life Sciences, Recommended
Legal 500 US
IP Star, (Managing Intellectual Property)
Top 250 Women in IP (Managing Intellectual Property)
Education
J.D., Harvard Law School, cum laude, 1998
B.A., Yale University, cum laude, 1995
Memberships
Administrative Law and Agency Practice Steering Committee for the District of Columbia Bar, 2016
Member, American Bar Association
Member, American Intellectual Property Law Association
Member, District of Columbia Bar Association
Member, Intellectual Property Owners Association
Member, ITC Trial Lawyers Association
Member, Maryland State Bar Association
Bar admissions and qualifications
District of Columbia
Maryland
Court admissions
District of Columbia Court of Appeals
Maryland Court of Appeals
U.S. Court of Appeals, Federal Circuit
U.S. Court of Appeals, District of Columbia Circuit
U.S. Court of Appeals, Fourth Circuit
U.S. District Court, District of Columbia
U.S. District Court, Eastern District of Texas
Represented numerous pharmaceutical companies in APA challenges against FDA, CMS, and HHS.
Successfully represented a pharmaceutical company in a constitutional challenge to a state's regulations governing the prescribing and dispensing of its drug product.
Successfully represented clients seeking to challenge state laws and regulations on federal preemption grounds.
Represented numerous pharmaceutical and food and beverage clients in Lanham Act and state law false advertising and unfair competition disputes.
Represented clients in false advertising claims brought by non-profit organizations under state consumer protection statutes.
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