Nathan A. Beaton

nathan.beaton@lw.com

+1.202.637.1062

Profile

Nate Beaton represents clients facing their most important and complex challenges before the US Food and Drug Administration (FDA), particularly high-stakes disputes with the agency.

He helps life sciences companies gain faster market access by navigating FDA premarket review and leveraging FDA expedited review and development programs. He also helps those companies maximize the value of their assets through sophisticated strategies to obtain non-patent exclusivity protections and other regulatory incentives.

Nate routinely advocates on behalf of his clients before the FDA. He guides clients through premarket regulatory meetings, formal and informal dispute resolution, administrative appeals, citizen petitions, and agency rulemaking.

Nate also has significant experience in Administrative Procedure Act (APA) litigation, challenging the legality of FDA decisions and programs or intervening to defend agency actions. His regulatory expertise has contributed to precedent setting decisions involving FDA drug approvals, orphan drug exclusivity, new chemical entity exclusivity, and FDA’s regulation of e-cigarettes.

Nate’s practice intersects FDA regulation and cutting-edge technology. He frequently advocates for the life sciences industry on the application of the FDA framework to emerging technologies, such as gene editing, artificial intelligence, synthetic biology, digital health tools, and novel alternatives to animal testing.

He also uses his legal and industry sector insights to help investors and lenders evaluate regulatory risks and opportunities in life sciences transactions.

Nate frequently speaks and writes on healthcare and life sciences topics. He formerly served on the Food and Drug Law Journal’s editorial advisory board.

Experience

Nate's representative experience includes representing:

Regulatory

Nate leverages his broad understanding of the regulatory landscape and sophisticated industry knowledge to serve as a trusted advisor for:

A biopharmaceutical company in a citizen petition concerning the scope of the Generating Antibiotics Incentives Now (GAIN) Act, in which FDA granted the petition and recognized exclusivity protection across multiple products under the FDA’s “umbrella policy”
A medical device manufacturer in a successful administrative appeal of an adverse determination on its marketing application, resulting in rescission of the adverse decision and FDA authorization
A pharmaceutical company in obtaining orphan drug designation based on a plausible hypothesis of clinical superiority
A medical products company in a request for designation, securing regulation as a medical device rather than a drug

Litigation and Investigations

Endo in obtaining a preliminary injunction in the US District Court for the District of Columbia (D.D.C.) staying FDA approval of a competitor’s drug product due to the agency’s likely arbitrary policy change
Fontem in litigation concerning a denial of its marketing application, in which the US Court of Appeals for the District of Columbia Circuit (D.C. Circuit) vacated the denial as unlawful under the Federal Food, Drug, and Cosmetic Act and arbitrary and capricious under the APA
Catalyst Pharmaceuticals in litigation concerning approval of a competitor’s drug due to Catalyst’s orphan drug exclusivity, in which the US Court of Appeals for the Eleventh Circuit reversed the district court and directed judgment in Catalyst’s favor
Eagle Pharmaceuticals in litigation, in which D.D.C. ordered the FDA to recognize orphan drug exclusivity for Eagle’s drug and in which the D.C. Circuit affirmed the lower court victory
Genus Lifesciences in litigation regarding an FDA patent certification, in which D.D.C. concluded that the FDA erred during its approval of a competitor’s product and granted partial summary judgment in favor of Genus
An international biopharmaceutical company in a review of whistleblower allegations regarding the company's public disclosures of clinical data and FDA interactions
A pharmaceutical company in an internal investigation of alleged misconduct by a principal investigator during a clinical trial

Transactional

Momenta Pharmaceuticals in its US$6.5 billion acquisition by Johnson & Johnson
The Carlyle Group and Ortho Clinical Diagnostics, a UK-organized, Nasdaq-listed global leader in in vitro diagnostics, in Ortho’s merger with Quidel, valuing Ortho at approximately US$6 billion
Nordic Capital in its investment in Equashield, an Israeli-based, leading global provider of closed-system transfer devices
Goldman Sachs in Lyell Immunopharma’s US$425 million initial public offering (IPO)
Sight Sciences in its US$240 million IPO
Revolution Medicines in its US$300 million and US$230 million public offerings