George A. O'Brien

George has deep experience providing regulatory advice to pharmaceutical and biotech companies on lifecycle management issues, including regulatory exclusivities and FDA-facing patent issues. He is a leading expert on orphan drug matters, including orphan designation and exclusivity, and has successfully advocated on behalf of clients to FDA on matters related to prevalence, orphan subsets, and clinical superiority. George also regularly advises pharmaceutical and biotechnology companies on pediatric study and pediatric exclusivity issues arising under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. George also regularly assists clients to take advantage of FDA’s expedited programs, including Fast Track and Breakthrough Therapy designation, as well as FDA’s priority review voucher programs.

George has an active hand in drafting citizen petitions, and has obtained key victories for his clients on several issues, including bioequivalence and approval requirements for generic drug products, the operation of 180-day exclusivity, and therapeutic equivalence issues, as well as a groundbreaking petition that persuaded FDA to expand its application of new chemical entity exclusivity to fixed-dose combination drug products.

George regularly works with life sciences clients on FDA-facing patent issues. As part of this work, he routinely assists clients on the submission of patent information to FDA’s Orange Book and Purple Book. George also works closely with his IP colleagues during the entire Hatch-Waxman litigation process to ensure that intellectual property protections and regulatory strategies are aligned throughout a product’s lifecycle.

George also works closely with colleagues across the Mergers & Acquisitions, Private Credit and Lending practices to provide FDA regulatory expertise on transactions for public and private companies, both domestic and global, including acquisitions, divestitures, mergers, spin-offs, and IPOs, as well as post-transaction services agreements. George’s transactional work spans the breadth of FDA-regulated industries, including pharma and biotech manufacturers, food and beverage companies, and infant formula manufacturers, among others.

George is currently a member of the Food and Drug Law Institute’s Medical Products Committee. He regularly speaks and writes on FDA life sciences issues at FDLI’s annual conference and elsewhere.

• Counseled a Japanese pharmaceutical company regarding orphan drug regulation in the US, EU, UK, Japan and China, including showing of “significant benefit” in the EU.
• Drafted a landmark citizen petition persuading FDA to grant 5-year “new chemical entity” exclusivity for fixed-dose combination products containing novel active moieties.*
• Advised clients on patent term extension for drugs, biologics, and medical devices, including successfully resolving PTO objections regarding multiple marketing applications submitted on the same day.
• Submitted multiple citizen petitions on behalf of innovator pharmaceutical companies regarding labeling carve outs/“skinny labeling,” including petition that ensured generic competitors could not obtain approval with carved-out labeling.*
• Advised a global biotech company regarding alignment of IP and regulatory strategy to prevent approval of biosimilars with labeling carve outs/“skinny labeling.”
• Represented a global biotechnology company in assessing opportunity for 12-year reference product exclusivity for biologic-biologic combination product, an issue of first impression at FDA.
• Represented a clinical-stage pharmaceutical company in clinical trial development and expedited approval pathways, including Breakthrough and Fast Track Designation.
• Represented a global specialty pharmaceutical company in evaluating 5-year NCE exclusivity for oligonucleotide products.
• Represented a commercial-stage pharma company in negotiating Pediatric Written Request with FDA.

FDA REGULATORY – FOOD AND BEVERAGE, DIETARY SUPPLEMENTS, AND COSMETICS

• Counseled a Chinese client on resolving import alert regarding bulk dietary supplement shipments, with labeling remediation and justification for food additives.
• With colleagues in the US and Germany, represented a Dutch infant formula manufacturer in addressing misbranding and illicit drop-shipping, as well as related contract disputes and potential litigation.

TRANSACTIONAL – PHARMACEUTICAL AND BIOTECHNOLOGY

• Represented a Korean company in the acquisition of clinical-stage pharma company in the US.
• Represented a UK-based manufacturer of cannabis-derived pharmaceutical products in their acquisition of US-based pharmaceutical and botanical product manufacturer.
• Represented Société des Produits Nestlé S.A in the acquisition of Seres Therapeutics, Inc.'s VOWST microbiome therapeutic business.
• Represented a mid-size pharma manufacturer in the acquisition of drug-device combination product, including assessment of potential generic entry based on Orange Book patents, bioequivalence concerns, and pending citizen petition.
• Advised a client on the potential $150 million sale of a rare pediatric disease priority review voucher.

TRANSACTIONAL – FOOD, DIETARY SUPPLEMENTS, AND COSMETICS

• Advised Unilever Plc in the acquisition of Dr. Squatch personal care brand.
• Represented Marubeni Corporation in the acquisition of US-based Bubbies Homemade Ice Cream & Desserts Inc.
• Advised US Foods in multiple transactions involving food manufacturers and wholesale suppliers.

*Matters handled prior to working at Mayer Brown.