Food, Drug & Cosmetic Law Section

12:00 p.m. – 12:10 p.m.

Welcome and Introduction

Speaker:

Larissa C. Bergin, Esq. Jones Day Washington, D.C.

12:10 p.m. – 1:00 p.m.

FDA and Patents? FDA’s Letter to the USPTO and Possible Next Steps

President Biden’s Executive Order 14036 (“Order”) aimed at “Promoting Competition in the American Economy” directed the Acting Commissioner (Janet Woodcock, M.D.) of the U.S. Food and Drug Administration (FDA) to take an unprecedented position on patents and related laws that may he been misused to inhibit or delay generic drugs and biosimilar products. In that letter, Dr. Woodcock addressed concerns of continuation patents creating patent thickets with no new inventive value and various evergreening or product hopping situations, where such continuation patents are granted post-approval to extent to follow-on products with little value except to delay generic and biosimilar approvals. The FDA asked the U.S. Patent and Trademark Office (USPTO) to provide feedback on whether post grant proceedings have helped to reduce such patent thickets. Finally, the FDA offered to work with the USPTO as the USPTO examined new patents to help the USPTO uncover relevant prior art and other regulatory considerations to patentability. This panel will look at the recommendations in the FDA’s letter to the USPTO and offer input whether one or more the FDA’s recommendations can be implemented and what the pros/cons would be for such actions to be taken.

Speakers:

Terry Rea, Esq. Crowell & Moring LLP; Former Acting Director of the USPTO Washington, D.C. Dr. Chris Holman Professor of Law, University of Missouri – Kansas City Kansas City, MO Ameet Sarpatwari, Ph.D., J.D. Assistant Professor of Medicine, Harvard Medical School; Assistant Director of the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital Boston, MA

Moderator:

Brian J. Malkin, Esq. McDermott Will & Emery LLP Washington, D.C.

1.0 Credit in Areas of Professional Practice

1:00 p.m. – 1:05 p.m.

Break

1:05 p.m. – 1:55 p.m.

Legal Considerations for Using CBD in Developing and Marketing Cosmetics

Joan McGillycuddy of Avon and Jennifer Adams of Amin Talati Wasserman will speak regarding the legal, regulatory, and enforcement considerations for using CBD in the development and marketing of cosmetics. Jennifer Adams, Esq. Partner, Amin Talati Wasserman Chicago, IL Thomas Cohn, Esq. Head of Regulatory & Product, Cronos Group; Cosmetics Committee Co-Chair New York, NY Jennifer L. Orendi, Esq. Cosmetics Law Counsel PLLC; Cosmetics Committee Co-Chair Washington, D.C. Joan M. McGillycuddy, Esq. Head of Legal, The Avon Company New York, NY

1.0 Credit in Areas of Professional Practice

1:55 p.m. – 2:00 p.m.

Break

2:00 p.m. – 2:50 p.m.

FDA, New Dietary Ingredients, and Intellectual Property: Recent Developments in a Difficult Area

The Dietary Supplement Industry has long struggled with issues surrounding its intellectual property rights, especially when it comes to protections for New Dietary Ingredients. Recent actions by FDA suggest that this will continue to a difficult area for the supplement industry to navigate. This panel will discuss efforts by industry stakeholders to move the needle at FDA, the US Patent and Trademark Office and on Capitol Hill.

Speakers:

Kevin M. Bell, Esq. Arnall Golden Gregory LLP Washington, D.C. Mark A. LeDoux Natural Alternatives International, Inc. Hollis, NH

Moderator:

Marc S. Ullman, Esq. Rivkin Radler LLP Uniondale, NY

1.0 Credit in Areas of Professional Practice

2:50 p.m. – 2:55 p.m.

Break

2:55 p.m. – 3:45 p.m.

What is the Current State of the Biologic Market? A Look at the Pipeline

• How is the transition affecting biologic reimbursement?
• Biologics and the payer formulary
• Discussion of the evolution of FDA Interchangeable policy
• Litigation Update

Speakers:

Harry Hayter GRAIL, Inc. Salt Lake City, UT Julie Hessick, RPh OneOme, LLC Hilliard, OH Ronald Lanton III, Esq. Lanton Law PLLC Washington, D.C. Jonathan Ogurchak, PharmD, C.S.P. Rhythm Group, LLC Pittsburgh, PA

1.0 Credit in Areas of Professional Practice

3:45 p.m. – 3:50 p.m.

Break

3:50 p.m. – 4:40 p.m.

Skinny Labels and Patent Infringement: Finding Generics, Insurers, PBMs and Pharmacies Liable for Induced Infringement After GSK v. Teva and Amarin v. Hikma & HealthNet

In GSK v Teva, the Federal Circuit held that Teva’s attempt to avoid infringing GSK’s patent with a “skinny label”, one excluding the patented indication, failed. The label was not skinny enough. The decision has been interpreted as broadening the universe of those liable for inducing patent infringement and limiting the efficacy of skinny labels. Following GSK v Teva, the Court in Amarin v Hikma and Health Net found HealthNet, but not Hikma, potentially liable for induced patent infringement; Health Net for reimbursing potentially infringing prescriptions. The panel will discuss avenues for insurers, PBMs and pharmacies, as well as generic companies, to avoid infringement.

Speakers:

Sheila H. Arquette, RPH President & CEO, National Association of Specialty Pharmacy Washington, D.C. Ronald Lanton III, Esq. Lanton Law PLLC Washington, D.C. Janet B. Linn, Esq. Tarter Krinsky & Drogin LLP New York, NY Kenneth E. White, J.D. Willis Towers Watson Fort Lauderdale, FL

1.0 Credit in Areas of Professional Practice

4:40 p.m. – 5:00 p.m.

Closing Remarks