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Analysis of the patent life of new m...

Seoane-Vazquez, Enrique Carlos.

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Analysis of the patent life of new molecular entities approved by the FDA between 1980 and 2001.

紀錄類型:	書目-電子資源 : Monograph/item
正題名/作者:	Analysis of the patent life of new molecular entities approved by the FDA between 1980 and 2001./
作者:	Seoane-Vazquez, Enrique Carlos.
面頁冊數:	310 p.
附註:	Source: Dissertation Abstracts International, Volume: 63-10, Section: B, page: 4620.
Contained By:	Dissertation Abstracts International63-10B.
標題:	Health Sciences, Pharmacy. -
電子資源:	http://pqdd.sinica.edu.tw/twdaoapp/servlet/advanced?query=3069208
ISBN:	0493888985

Analysis of the patent life of new molecular entities approved by the FDA between 1980 and 2001.
Seoane-Vazquez, Enrique Carlos.

Analysis of the patent life of new molecular entities approved by the FDA between 1980 and 2001. - 310 p.

Source: Dissertation Abstracts International, Volume: 63-10, Section: B, page: 4620.

Thesis (Ph.D.)--University of Minnesota, 2002.

The purpose of this study was to describe and analyze the factors affecting the market exclusivity life of the first and last patents listed in the FDA Orange Book for the first New Drug Application (NDA) of a New Molecular Entity (NME) approved in the U.S. between 1980 and 2001.

ISBN: 0493888985Subjects--Topical Terms:

1017737
Health Sciences, Pharmacy.

Analysis of the patent life of new molecular entities approved by the FDA between 1980 and 2001.
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245 1 0 $a Analysis of the patent life of new molecular entities approved by the FDA between 1980 and 2001.
300 $a 310 p.
500 $a Source: Dissertation Abstracts International, Volume: 63-10, Section: B, page: 4620.
500 $a Adviser: Stephen W. Schondelmeyer.
502 $a Thesis (Ph.D.)--University of Minnesota, 2002.
520 $a The purpose of this study was to describe and analyze the factors affecting the market exclusivity life of the first and last patents listed in the FDA Orange Book for the first New Drug Application (NDA) of a New Molecular Entity (NME) approved in the U.S. between 1980 and 2001.
520 $a A linear regression analysis model was used to determine the impact of drug characteristics, NDA sponsor characteristics, the size of the drug market, drug regulation and policy status, and the intellectual protection policy on NMEs' patent life. A total of 330 drugs approved between 1980 and 1999 were included in the regression analysis. NMEs approved during the period 2000--2001 were not included in the regression analysis due to lack of complete information on patent extensions requested and awarded. FDA and the U.S. Patent Office were the main sources of data for this study.
520 $a The results of the study demonstrate an increase in post-NDA patent and pediatric exclusivity time of the NMEs included in the study by almost 2 years from the period 1980--1989 to the period 1990--1999. The study also shows an increase in last patent post-NDA time and pediatric exclusivity by 1.5 years from the period 1980--1989 to the period 1990--1999. These results contradict the anecdotal reports often found in the literature which suggest a downward trend in post-NDA patent time in late 1980s and early 1990s.
520 $a Several factors explain the increase in patent protection time in the 1990s versus the patent protection time in the 1980s including: (1) a substantial reduction of the NDA review time, (2) increased pharmaceutical patent extension time, (3) increased pediatric exclusivity time, and (4) changes in statutory term for patents. The reduction in NDA review time is the main factor accounting for the increase in post-NDA statutory patent term time.
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