William Mitchell Law Review Celebrates 30 Years of the Hatch-Waxman Amendments

May 21, 2014By Kurt R. Karst

It’s been nearly 30 years since President Ronald Reagan, on September 24, 1984, held a ceremony in the Rose Garden to sign into law the Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585 (1984) – better known to most as the Hatch-Waxman Amendments.  To celebrate the upcoming anniversary, the William Mitchell Law Review of the William Mitchell College of Law has put out an issue – Volume 40, Issue 4: The 30th Anniversary of the Hatch-Waxman Act – with several articles dedicated to the anniversary.

A Foreword to the new volume by Senator Orrin Hatch provides some interesting insights into the triumphs and tribulations of the legislative process that led to the enactment of the Hatch-Waxman Amendments (and that aren’t in the legislative history).

Robert A. Armitage, in a piece titled “The Hatch-Waxman Act: A Path Forward for Making It More Modern,” offers some commentary on the economic and regulatory environment that led to the development of the Modernizing Our Drug & Diagnostics Evaluation and Regulatory Network Cures Act of 2013 (“MODDERN Cures Act of 2013”) (H.R. 3116).  According to Mr. Armitage:

What may be the best next-generation thinking on defining a common regime for copied versions of all new medicines to be able to come to market can be found in a bill that is now pending before Congress.  This latest congressional effort is the MODDERN Cures Act.  The MODDERN Cures Act, according to its proponents, has the potential to be a quantum improvement over both the Hatch-Waxman Act and the Biosimilars Act in terms of meeting the needs and expectations of patients for access to lowcost, high quality medicines—while spurring greater industry focus on the development of new medicines of the greatest potential benefits for patients (i.e., those addressing unmet medical needs).  Compared to the IP interface provisions of either the Hatch-Waxman Act or the Biosimilars Act, the MODDERN Cures Act is a virtual paragon of simplicity and directness.

This blogger (Kurt R. Karst), in an article titled “Letting the Devil Ride: Thirty Years of ANDA Suitability Petitions Under the Hatch-Waxman Act,” provides the first ever analysis of the FDA’s nearly 30-year track record of responding to ANDA suitability petitions submitted pursuant to FDC Act § 505(j)(2)(C).  The article traces the history of generic drug development and the petitioned ANDA from a regulation promulgated shortly before the enactment of the Hatch-Waxman Amendments to the current statute; analyzes almost 1,300 suitability petitions submitted to FDA since September 24, 1984 (and provides various data tables on suitability petitions submitted to and acted on by FDA each year from 1984 to 2013); suggests some reasons for the decline in the popularity of the petitioned ANDA as a vehicle for obtaining approval of a generic drug; and recommends that FDA implement procedures to meet the statutory 90-day deadline for approving or disapproving an ANDA suitability petition, or that Congress amend the FDC Act to provide FDA with a more practical deadline to rule on a suitability petition.

Shashank Upadhye’s article, titled “There’s a Hole in My Bucket Dear Liza, Dear Liza: The 30-Year Anniversary of the Hatch-Waxman Act: Resolved and Unresolved Gaps and Court-Driven Policy Gap Filling,” examines how implementation of the Hatch-Waxman Amendments (and amendments to that law) has caused significant problems in the marketplace and how court-driven policy has also been a culprit in the Act’s interpretations and executions.  Mr. Upadhye has been a busy writer of late.  In another article published in the Boston University Journal of Science and Technology Law, and titled “The FDA and Patent, Antitrust, and Property Takings Laws: Strange Bedfellows Useful To Unblock Access To Blocked Drugs,” he discusses the impact of REMS (Risk Evaluation & Mitigation Strategies) on generic drug development.

Lars P. Taavola, in a piece titled “Jumping into the Actavis Briar Patch—Insight into How Courts May Structure Reverse Payment Antitrust Proceedings and the Questions That Actavis Left Unanswered,” looks at how courts will have to decide some seminal questions in light of the U.S. Supreme Court’s decision in Federal Trade Commission v. Actavis, Inc., 133 S. Ct. 2223 (2013) (see here), concerning drug patent settlement agreements.

Brian P. Wallenfelt argues in his article, titled “Hatch-Waxman and Medical Devices,” that the similarities between medical devices and drugs outweigh the differences, and, accordingly, that there should be an abbreviated review process for medical devices.

In an essay titled “When Patents Aren’t Enough: Why Biologics Necessitate Data Exclusivity Protection” Kristina M. Lybecker, Associate Professor of Economics at Colorado College, says that the Trans-Pacific Partnership Trade Agreement currently being negotiated (see our previous post here) “should include the proposed twelve years of data exclusivity and provide innovative firms with the incentives needed to continue to invest in the breakthrough therapies that will extend and enhance life for years to come.”