FDLI Publications: Food and Drug Law Journal 54-2

Volume 54 Issue 2

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> Striking the Right Balance Between Innovation and Drug Price Competition:
Putting the Hatch-Waxman Act Into Perspective
> Overview of the Hatch-Waxman Act and Its Impact on the Drug Development Process
> FDA's Role in Making Exclusivity Determinations
> The Role of the Patent and Trademark Office Under 35 U.S.C. Section 156
> FDA's Role in Administering the Hatch-Waxman Act
> Patent Issues That Both Regulatory Affairs Personnel and Patent Attorneys Should Understand
> Striking the Right Balance Between Innovation and Drug Price Competition:
Understanding the Hatch Waxman Act-An Introduction of Speakers
> Originator Drug Development
> The Hatch-Waxman Act During Patent Prosecution and Beyond
> Biotechnology and Patent Term Extension Issues
> The Biotechnology Industry Organization's View on Hatch-Waxman Reform
> Market Exclusivity After a Prescription to Nonprescription Drug Switch:
Striking the Right Balance Between Innovation and Competition
> Patenting Drug Products: Anticipating Hatch-Waxman Issues During the Claims Drafting Process

Striking the Right Balance Between Innovation and Drug Price Competition:
Putting the Hatch-Waxman Act Into Perspective
Author: Jill B. Deal
Issue: 54 Food and Drug Law Journal 185-186 (1999).

Waiting until just before patents expired can be disastrous to both research-based companies and generic companies planning to copy a pioneer drug. Appropriate planning for Hatch-Waxman purposes start as early as the claims drafting process and should be an important part of the licensing process. Although this conference is focused on domestic issues, Hatch-Waxman issues are global. Common international issues, such as patent extensions, non-patent exclusivity, and experimental use exemptions demonstrate that a cross-border strategy is preferable to achieve maximum exclusivity for a product or to break exclusivity worldwide.

Overview of the Hatch-Waxman Act and Its Impact on the Drug Development Process
Author: Gerald J. Mossinghoff
Issue: 54 Food and Drug Law Journal 187-194 (1999).

The Hatch-Waxman Act, enacted in 1984, has had a profound impact on the U.S. pharmaceutical industry. The robust generic drug industry owes its existence to the Act, and the patent term extensions or restorations mandated by the Act are extremely important to the research-based pharmaceutical industry. Professionals involved in the pharmaceutical industry - particularly patent counsel and regulatory affairs executives - need to fully understand the Hatch-Waxman Act in order to benefit from its very complex provisions. It operates at the intersection of two very detailed and specialized laws: the U.S. patent law, and the laws and regulations regarding the discover, development, and approval for new drugs. Many of the assumptions that were made fifteen years ago when the Act was passed - that provided the bases for the arbitrary time limits established in the Act - have proven to be invalid. Thus, it is time to revisit the Hatch-Waxman Act with a view to increasing the patent incentives for the creation of new life-saving medicines.

FDA's Role in Making Exclusivity Determinations
Author: Elizabeth H. Dickinson
Issue: 54 Food and Drug Law Journal 195-204 (1999)

The Food and Drug Administration (FDA) implements the exclusivity provisions enacted under the Hatch-Waxman Act, a piece of economic legislation with a public health goal. This article examines exclusivity determinations that FDA makes under the Hatch-Waxman Act, and other exclusivity provisions enacted by Congress, and how these determinations generally affect the drug approval process as well as the timing of market entry of generic drug products. This article also examines the four types of patent certifications and some of their procedural requirements, focusing on the "paragraph four" certification. The article concludes by detailing the two exclusivities for innovator drugs, the five-year new chemical entity exclusivity and the three-year new clinical study exclusivity, as well as the seven-year orphan drug exclusivity and the six-month pediatric exclusivity.

The Role of the Patent and Trademark Office Under 35 U.S.C. Section 156
Author: Karin L. Tyson
Issue: 54 Food and Drug Law Journal 205-210 (1999).

This article reviews key points of the method the U.S. Patent and Trademark Office (PTO) employs to process patent term extension (PTE) applications, including details of what applicants need to know, pitfalls that applicants have encountered, and helpful hints on filing PTE applications. The article provides a step-by-step look at the interaction between the PTO and the Food and Drug Administration (FDA) during the PTE approval process, including FDA's determination of the regulatory review period, and the PTO's PTE calculation. It also discusses who can file PTE applications and what patent claims that applicants should make. Common mistakes in a PTE application are discussed including prior approval of the active ingredient, an insufficient explanation of how the patent claims the approved product, the medical device claimed in the patent was approved under section 510(k) of the Federal Food, Drug, and Cosmetic Act, not under section 515. Helpful hints are addressed as well, including the broad definition of "active ingredient," tips on mailing the application to the PTO, and an explanation of how to calculate a PTE.

FDA's Role in Administering the Hatch-Waxman Act
Author: Brian J. Malkin
Issue: 54 Food and Drug Law Journal 211-214 (1999).

The Food and Drug Administration (FDA) works with the U.S. Patent and Trademark Office (PTO) to administer the patent term restoration portions of the Hatch-Waxman Act. FDA first provides the PTO with information as to whether the product has been approved and the patent extension application was submitted within sixty days of approval, the product has undergone a regulatory review period as defined under the Act, and the product represents the first permitted commercial marketing or use of the product. If the PTO determines that the product is then eligible for extension, FDA determines the regulatory review period and publishes the information in the Federal Register, resolves any comments or petitions, and notifies the PTO. The PTO then determines the patent extension period and the PTO Commissioner signs the certificate of extension. The patent applicant then may notify FDA of the extension for publication, if appropriate.

Patent Issues That Both Regulatory Affairs Personnel and Patent Attorneys Should Understand
Author: Edward V. Filardi
Issue: 54 Food and Drug Law Journal 215-222 (1999).

Sections 271(e)(1) and (e)(2) of title 35 of the United States Code raise a number of complicated patent issues. Understanding the polices behind the provisions and how the provisions interact can aid both regulatory affairs professionals and patent attorneys. In addition, Abtox, Inc. v. Exitron Corp., dealing with devices, is discussed because device issues are becoming prevalent in law practices across the board. Exemptions and how courts determine what is exempt under section 271(e)(1) is another topic. Some recent cases on that point also are discussed, as well as the declaratory judgment and whether it is available, for example, to a patent holder who applies to enjoin the safe harbor activity, and an "unsafe harbor activity" declaratory judgment against future infringement should the exemption be put into place.

Striking the Right Balance Between Innovation and Drug Price Competition: Understanding the Hatch Waxman Act-An Introduction of Speakers
Author: Teresa Stanek Rea
Issue: 54 Food and Drug Law Journal 223-226 (1999).

This article provides an overview of the Hatch-Waxman Act as well as introductions for each panel speaker. This article also serves as a roadmap to the seminar's discussion, outlining the events of the day. The conference began with an interactive workshop highlighting concepts useful in developing an optimal strategy for both new drug applications and abbreviated new drug applications. The conference continued with the afternoon panel discussing the extent to which the Hatch-Waxman Act has achieved the optimal balance in the United States to produce appropriate incentives to encourage manufacturers to develop pioneering products while ensuring that sufficient generic competition exists to keep drug prices at a reasonable level.

Originator Drug Development
Author: Richard J. Findlay
Issue: 54 Food and Drug Law Journal 227-232 (1999).

This article covers issues in originator drug development. First, this article discusses the stages and tests performed during the drug development process. Second, the article provides a basic discussion of how variations in the originator and generic drug development processes can occur, and how these variations can affect drug development time frames. The article concludes with a discussion of commercial practices since 1984, and how the balance sought by the Hatch-Waxman Act has been achieved by originators, branded pharmaceutical companies, and generic companies.

The Hatch-Waxman Act During Patent Prosecution and Beyond
Author: Terry G. Mahn
Issue: 54 Food and Drug Law Journal 233-236 (1999).

Decisions made early in the patent drafting and prosecuting stage influence many later opportunities, including Food and Drug Administration (FDA) approval, yet the regulatory and patent departments of most drug manufacturers are not in communication. This article briefly discusses practical ways to protect companies against unintended consequences of early decisions, including factors to consider during patent prosecution, method of use and field of use extensions, and the impact on companies if certain requirements of the Hatch-Waxman Act are not addressed in the patent prosecution stage.

Biotechnology and Patent Term Extension Issues
Author: Lisa Raines
Issue: 54 Food and Drug Law Journal 237-240 (1999).

Biotechnology products are a large and diverse class of products that differ from traditional pharmaceutical molecules and preparations. This article discusses issues unique to the biotechnology industry that are raised by patent term extension under the Hatch-Waxman Act. Although the industry, the Food and Drug Administration, and the U.S. Patent and Trademark Office have made significant progress in certain areas of patent approval, the article points out that novel and complex issues continue to arise that delay the process. The article also points out key areas of improvement in the regulations governing the biotechnology product approval process.

The Biotechnology Industry Organization's View on Hatch-Waxman Reform
Author: David Schmickel
Issue: 54 Food and Drug Law Journal 241-242 (1999).

The biotechnology industry does not believe that the Hatch-Waxman Act is producing the optimum amount of incentives for innovation, or that Congress got the balance right. Moreover, there is uncertainty as to whether or not this perceived unfairness and lack of incentives should be addressed by the 106th Congress. This article examines the potential gain to the biotechnology industry from opening the Act to amendment.

Market Exclusivity After a Prescription to Nonprescription Drug Switch:
Striking the Right Balance Between Innovation and Competition
Author: Kevin Kraushaar
Issue: 54 Food and Drug Law Journal 243-244 (1999).

Nonprescription, over-the-counter drugs have been shown to reduce healthcare costs and help to provide greater patient access to medicines. This article briefly addresses the incentives and process provided by the Hatch-Waxman Act for switching a product from prescription to nonprescription status. It also calls for the modernization of the Act to authorize the Food and Drug Administration to take into account research requirements other than "clinical" studies when the agency makes its decision whether to grant exclusivity when making a switch.

Patenting Drug Products: Anticipating Hatch-Waxman Issues During the Claims Drafting Process
Author: Terry G. Mahn
Issue: 54 Food and Drug Law Journal 245-255 (1999).

This article examines the potential benefits to drug manufacturers who implement a forward-looking Hatch-Waxman strategy during the drafting and prosecution of their drug patents. In addition, this article discusses the purpose behind the Hatch-Waxman Act in the context of drug patents and explains how a keen understanding of the law often can be used to provide drug manufacturers an added advantage in their battles with generic competitors. The patent term extension provisions of the Hatch-Waxman Act are examined in detail and strategies are offered for maximizing the term of a drug company's most valuable patent claims. This article also discusses the Food and Drug Administration's Orange Book for drug patent listings, offering insights on how pioneer drug companies use the Orange Book as a strategic weapon against emerging generic competition.