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By: Jeffrey Alan Hovden, Robins Kaplan LLP
This article discusses strategies that counsel for brand-name and generic drug companies may employ in pharmaceutical patent litigation under the Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act. It focuses on litigating infringement and validity of active pharmaceutical ingredient (API), formulation, and treatment patents using court decisions as a guide to what works and what doesn’t for each side in Hatch-Waxman litigation.
THE TERMS BRAND AND GENERIC ARE USED IN THIS ARTICLE as a shorthand to denote a brand-name drug company and a generic drug company respectively. But be aware that in Hatch-Waxman cases, a variety of terms may be used to refer to a generic drug company and a brand-name drug company. The generic drug company may be referred to as the ANDA applicant or the ANDA filer. ANDA is an acronym for Abbreviated New Drug Application, the drug approval application filed by generic drug companies.
A brand-name drug company may be referred to as the innovator, the pioneer, the patent owner, the NDA holder, or the RLD holder. NDA is an acronym for New Drug Application, a type of drug approval application filed by brand-name drug companies. A drug approved based on an NDA is called a reference listed drug or RLD. Also, note that while the patent owner and the NDA holder are often the same person, in some cases they are not. For example, they could be a parent corporation and its licensed subsidiary.
The Hatch-Waxman patent arsenal typically comprises three classes of patents: the API patent, the formulation patent, and the treatment (i.e., method of use) patent. These three classes of patents are those that can be listed in the FDA’s publication entitled Approved Drug Products with Therapeutic Equivalence Evaluations, known as the Orange Book.
A Paragraph IV certification that an Orange Book-listed patent is invalid, unenforceable, and/or will not be infringed by the proposed generic drug, is a trigger for patent litigation under the Hatch-Waxman Act. An application for FDA approval of a generic drug that contains a Paragraph IV certification qualifies as an act of patent infringement exposing the generic to an infringement suit by the patent owner and exposing the patent owner to a counterclaim for a declaration that the patent is invalid, unenforceable, and/or will not be infringed.1
To read the full practice note in Lexis Practice Advisor, follow this link.
Jeffrey Alan Hovden, a partner at Robins Kaplan LLP, practices in the area of patent litigation, with a focus on generic pharmaceutical patent cases under the Hatch-Waxman Act and within the biotechnology industry. He has litigated numerous patent infringement and invalidity actions, including many cases involving top-selling worldwide prescription drugs for both generic and namebrand clients.
For information on common patent law terminology and other foundational information, see
> PATENT LAW FUNDAMENTALS RESOURCE KIT
RESEARCH PATH: Intellectual Property & Technology > Patents > Patent Litigation > Practice Notes
For an explanation of the unique patent litigation scheme under the Hatch-Waxman Act, see
> HATCH-WAXMAN ACT FUNDAMENTALS
RESEARCH PATH: : Intellectual Property & Technology > Patents > Patent Litigation > Practice Notes
For a sample complaint that is applicable to Hatch-Waxman litigation, see
> PATENT INFRINGEMENT COMPLAINT (HATCH WAXMAN ACT)
RESEARCH PATH: Intellectual Property & Technology > Patents > Patent Litigation > Forms
For a form that is designed for use as a starting point in preparing interrogatories in litigation under the Hatch-Waxman Act, see
> PLAINTIFF’S INTERROGATORIES IN HATCHWAXMAN PATENT LITIGATION (INNOVATOR TO GENERIC CHALLENGER)
RESEARCH PATH: : Intellectual Property & Technology > Patents > Patent Litigation > Forms
For additional information on obviousness as a ground for patent invalidity, see
> OBVIOUSNESS IN PATENT LITIGATION
1. See 35 U.S.C. § 271(e)(2).