Abstract

http://ssrn.com/abstract=1491299
 
 

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A Prescription for Change: How the Medicare Act Revises Hatch-Waxman to Speed Market Entry of Generic Drugs


Stephanie M. Greene


Boston College - Carroll School of Management

October 19, 2005

Journal of Corporation Law, Vol. 30, No. 2, pp. 309-355, Winter 2005

Abstract:     
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.

Number of Pages in PDF File: 48

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Date posted: October 20, 2009  

Suggested Citation

Greene, Stephanie M., A Prescription for Change: How the Medicare Act Revises Hatch-Waxman to Speed Market Entry of Generic Drugs (October 19, 2005). Journal of Corporation Law, Vol. 30, No. 2, pp. 309-355, Winter 2005. Available at SSRN: http://ssrn.com/abstract=1491299

Contact Information

Stephanie M. Greene (Contact Author)
Boston College - Carroll School of Management ( email )
140 Commonwealth Avenue
Chestnut Hill, MA 02467
United States
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