Pharmaceutical Patent Two-Step: The Adverse Advent of Amarin v. Hikma Type Litigation

42 Pages Posted: 6 Sep 2022 Last revised: 21 Nov 2022

See all articles by S. Sean Tu

S. Sean Tu

West Virginia University College of Law; Program On Regulation, Therapeutics, And Law (PORTAL), Brigham and Women's Hospital; Georgetown University - The O'Neill Institute for National and Global Health Law

Date Written: September 5, 2022

Abstract

Pharmaceutical companies have long sought to protect their exclusive rights to market drugs in a myriad of ways including creating patent thickets and evergreening. This article describes a two-step strategy by which pharmaceutical companies attempt to keep market exclusivity and delay generic entry. This new strategy can work in tandem with ANDA litigation and FDA labeling requirements to reclaim exclusive rights that might have been lost via patent protection.

The “first wave” of litigation involves a typical ANDA litigation, where brand manufacturers sue for patent infringement to prevent generics from entering the market. The “second wave” of litigation involves suing the generic for induced infringement based on the “skinny label” on the generic drug. Interestingly, this second wave of litigation can act regardless of if the brand firm wins or loses the first wave of litigation.

In this article we use Amarin v. Hikma as a case study of this strategy. We show that after the generic firm Hikma won the ANDA litigation invalidating a set of patents, they were subjected to a second wave of litigation based on a new set of patents. In this article we examine this new strategy and take a deep dive into the patent portfolios to determine how Amarin was able to create large method of use-based patent thickets to set up this second wave of litigation.

Although Hikma was able to win both the first and second waves of litigation, these court cases raise transaction costs and may deter or delay generic entry. These delays can amount to billions of added dollars to drug costs. This second wave strategy is especially important after the landmark GSK v. Teva case, which could breathe new life into this type of litigation strategy.

Keywords: patent, patent litigation, generic, drug, drugs, brand, manufacturer, pharmaceutical, skinny label, health

JEL Classification: K31, O31, O34

Suggested Citation

Tu, Shine (Sean), Pharmaceutical Patent Two-Step: The Adverse Advent of Amarin v. Hikma Type Litigation (September 5, 2022). NYU Journal of Intellectual Property & Entertainment Law, 12 (Forthcoming), WVU College of Law Research Paper No. 2022-017, Available at SSRN: https://ssrn.com/abstract=4210624

Shine (Sean) Tu (Contact Author)

West Virginia University College of Law ( email )

101 Law School Drive
Morgantown, WV West Virginia 26506
United States

HOME PAGE: http://https://www.law.wvu.edu/faculty-staff/faculty/s-sean-tu

Program On Regulation, Therapeutics, And Law (PORTAL), Brigham and Women's Hospital ( email )

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Suite 3012
Boston, MA 02120
United States

HOME PAGE: http://https://www.portalresearch.org/sean-tu.html

Georgetown University - The O'Neill Institute for National and Global Health Law ( email )

600 New Jersey Avenue, NW
Washington, DC 20001
United States

HOME PAGE: http://https://oneill.law.georgetown.edu/experts/s-sean-tu/

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