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Healthcare & Life Sciences Insights

Discover Latham’s latest insights into the commercial, regulatory, and legal developments shaping the global healthcare and life sciences landscape.

Latham’s cross-disciplinary team delivers insightful, practical guidance and sophisticated representation to a full spectrum of healthcare and life sciences companies across the globe, on every type of transaction or dispute a company may face.

Podcasts & Webcasts

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March 12, 2025

Episode 95 — Drug Pricing: FDA in the Age of Executive Orders and DOGE

The Department of Government Efficiency, Trump executive orders, and a recent Office of Management and Budget memorandum are making drastic changes at FDA. The Latham team discusses the potential impacts on FDA approval and enforcement activities, including with respect to novel tobacco and nicotine products.

Recognition

Relator

the private citizen or whistleblower who files suit under the False Claims Act on behalf of the government to assist in the prosecution of false or fraudulent conduct. After an investigatory period, the government then has the choice to either take over and prosecute the suit (typically called intervening) or to decline intervention in the case. Relators may receive a part of any recovery by the government, usually between 15-30%, plus attorney’s fees. If the government declines intervention, the relator can proceed alone as plaintiff on behalf of the government.

Word of the Day®

Licensed Patents

the Patents and patent applications that are licensed to a Licensee by the Licensor pursuant to a License.

Word of the Day®

Declaratory Judgment

a legal determination by a court resolving an issue affecting the rights of the parties to a dispute. Declaratory Judgments are common in Patent litigation because they allow alleged infringers to seek judicial determination of, for example, validity, non-infringement or enforceability of an Asserted Patent before the patent owner brings suit. A Declaratory Judgment action may allow the alleged infringer to determine the forum of the lawsuit.

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Inter Partes Review (IPR)

PTAB proceeding for challenging the validity of any issued Patent. IPR may be requested on the basis of Novelty and Obviousness, and only Patents and printed publications may be used as prior art. 37 C.F.R. § 42.104(b).
The PTAB will not institute a petition for IPR if the Petitioner previously filed a Declaratory Judgement action challenging the Patent’s validity. But a Declaratory Judgement action filed as a counterclaim to an infringement suit does not bar instituting an IPR. 37 C.F.R. § 42.101.
IPR may be requested at any time for first-to-invent Patents. But for first-to-file Patents, IPR may only be requested nine months after the issuance or later (the period when a Petition for post- grant review could be filed). 37 C.F.R. § 42.102. And if Petitioner has been served with a patent infringement complaint, then the Petition must be filed in the PTAB within one year after service. 35 U.S.C. § 315(b).

Word of the Day®

Obstetrics

the branch of medicine that deals with childbirth and the care of women before, during and after childbirth.

Word of the Day®