A prescription for change How the Medicare Act revises Hatch-Waxman to speed market entry of generic drugs

A prescription for change How the Medicare Act revises Hatch-Waxman to speed market entry of generic drugs

A

prescription for change

How the Medicare Act revises Hatch-Waxman to speed market entry of generic drugs

Greene

Stephanie M.

Greene, Stephanie M.

Dept. of Business Law, Carroll School of Management

Author

Author

text

article

2005 2005 monographic

2005

2005

monographic

English eng

English

eng

electronic application/pdf digitized other analog

electronic

application/pdf

digitized other analog

The author reviews the pharmaceutical industry’s patenting process as it has been impacted by the Hatch-Waxman and Medicare legislation which expedite review and approval for generic follow-on drugs. The pharmaceutical industry’s business model of investment in research and development to create and patent innovations in drug therapies, has proven to be successful. Evidence suggests however, that the industry overreached in prolonging the life of its drug patents to the detriment of competitors and consumers. The legislative efforts which substantially increased the availability of generics caused pharmaceutical companies to reconsider their processes as well. This article considers ways to incent innovation while benefiting the public from these innovations. The complex regulatory scheme highlights the fact that unexpected problems occur which may necessitate further legislative amendments that will provide guidance for courts where there is need for further interpretation.

Version of record.

Electronic reproduction. Chestnut Hill, Mass. : University Libraries, Boston College, 2009.

The Journal of Corporation Law 0360-795X 30 2 309 355 pp. 309-355 Winter 2005

The Journal of Corporation Law

The

Journal of Corporation Law

0360-795X

30 2 309 355 pp. 309-355 Winter 2005

30

30

2

2

309 355 pp. 309-355

309

355

pp. 309-355

Winter 2005

Use of this resource is governed by the terms and conditions of the Creative Commons "Attribution-Noncommercial-No Derivative Works 3.0 United States" (http://creativecommons.org/licenses/by-nc-nd/3.0/us/)

Business Law JCL-v30-Greene-p309.pdf JCL-v30-Greene-permissions.pdf JCL-v30-cover-thumbnail.jpg

Business Law

JCL-v30-Greene-p309.pdf

JCL-v30-Greene-permissions.pdf

JCL-v30-cover-thumbnail.jpg

MChB English eng

MChB

English eng

English

eng