Hatch-Waxman 2003 - Patented V. Generic Drugs: Regulatory, Legislative and Judicial Developments

By Smith, Richard J. | Santa Clara Computer & High Technology Law Journal, March 2004 | Go to article overview
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Hatch-Waxman 2003 - Patented V. Generic Drugs: Regulatory, Legislative and Judicial Developments


Smith, Richard J., Santa Clara Computer & High Technology Law Journal


TABLE OF CONTENTS  I.   INTRODUCTION   A.   Overview of Hatch-Waxman     1. Pre-Hatch-Waxman     2. Hatch-Waxman Amendments     3. Summary of FDA Approval Process   B.   FTC Recommendations II.  REGULATORY DEVELOPMENTS   A.   FDA Regulations     1. One 30-Month Stay Per ANDA     2. Patent Listing Regulations       a. Polymorphs       b. Method-of-Use Patents   B.   FTC Enforcement     1. Bristol-Myers Squibb     2. Schering-Plough III. LEGISLATIVE DEVELOPMENTS   A.   Limits to 30-Month Stay   B.   Agreements By Generic Applicants   C.   Declaratory Judgment Actions   D.   Orange Book Listing Remedies IV.  JUDICIAL DEVELOPMENTS   A.   [section] 271(e)(l) Safe Harbor   B.   [section] 271(e)(2) and Method-of-Use Patents   C.   Battle of the Generics--TorPharm and Purepac   D.   Antitrust Issues--In re Cardizem and Valley Drug V.   CONCLUSION 

I. INTRODUCTION

Enacted twenty years ago, the Hatch-Waxman Amendments (1) sought to balance the two competing policy interests of (1) inducing pioneering research and development of new drugs, and (2) enabling competitors to bring low-cost generic copies of those drugs to market. (2) The increasing costs of drug development and public concerns over consumer drug prices have resulted in a renewed focus on the desired balance between these competing policy objectives.

A. Overview of Hatch-Waxman

1. Pre-Hatch-Waxman

The regulatory framework of the drug approval process before the Hatch-Waxman Amendments created a number of obstacles, both for brand-name and generic pharmaceuticals. Notwithstanding the substantial time and expense of drug discovery and development, brand-name pharmaceutical companies often had the effective terms of their patents shortened due to issuance of the patents before FDA approval of the corresponding drugs and the time required for the FDA to ensure the safety and efficacy of the brand-name drug. (3) Generic pharmaceutical companies also faced hurdles, such as the requirement to perform their own safety and efficacy studies. (4) In addition, a generic company could not begin the required FDA approval process until after patents on the relevant brand-name product had expired, since to begin earlier would typically have infringed the patents of the brand-name company. (5) As a result, by 1984 there were approximately 150 brand-name drugs whose patents had expired but for which there was no generic equivalent. (6)

2. Hatch-Waxman Amendments

The Hatch-Waxman Amendments provided brand-name pharmaceutical companies with the opportunity to extend the term of a patent in certain circumstances, thereby restoring patent protection as compensation for the time used to obtain FDA approval. (7) Generic drug companies were also provided substantial relief from the approval time delays in two ways. First, generic companies were allowed to rely on the innovators' safety and efficacy data and merely demonstrate that their generic drug was "bioequivalent" to the relevant brand-name product. (8) Second, the patent statute was amended to clarify that it was not an act of infringement to make, use, or sell a patented invention "solely for uses reasonably related to the development and submission of information" to the FDA. (9)

3. Summary of FDA Approval Process (10)

A pharmaceutical company seeking to manufacture a new drug must file a New Drug Application ("NDA") for consideration by the FDA. (11) Preparing an NDA is a time-intensive and costly process since it must contain, among other things, detailed clinical studies of the drug's safety and efficacy, as well as a list of patents that claim the drug. (12) If the FDA approves the NDA, it publishes a listing of the drug and patents on the drug's approved aspects in Approved Drug Products with Therapeutic Equivalence Evaluations, referred to as the "Orange Book." (13)

A company seeking approval of a generic drug may file an Abbreviated New Drug Application ("ANDA").

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