Document Detail

Analysis of the impact of the Uruguay Round Agreements Act on pharmaceutical patents.
MedLine Citation:
PMID:  19998745     Owner:  HSR     Status:  MEDLINE    
The Uruguay Round Agreements Act (URAA) was enacted by the United States Congress in 1994. The URAA provided substantial modifications to the framework for U.S. patent law that came into effect January 1, 1953. Changes in patent regulation are especially important in the pharmaceutical sector because the patent system determines, in large part, the reward that an inventor can derive from discovery of a new drug. Most pharmaceutical patents are classified as utility patents. Pharmaceutical patents may include claims for the active ingredient per se, for the formulation of the active ingredient for use as a pharmaceutical, for therapeutic indications and uses, and for methods of manufacturing the drug. The U.S. has a First-to-Invent system to establishing the right of priority of an invention, but most countries have a First-to-File priority system. The First-to-Invent system allows for public disclosure of inventions prior to patent filing. In contrast, the First-to-File system encourages early filing of patent applications. In both systems, filing an application for a patent as soon as the drug is discovered allows inventors to obtain an earlier date of invention relative to potential competitors and establish the right of priority over the invention.
Enrique Seoane-Vazquez; Rosa Rodriguez-Monguio; Sheryl L Szeinbach; Andrew Beyer; Jay Visaria
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Food and drug law journal     Volume:  64     ISSN:  1064-590X     ISO Abbreviation:  Food Drug Law J     Publication Date:  2009  
Date Detail:
Created Date:  2009-12-10     Completed Date:  2009-12-22     Revised Date:  2010-01-13    
Medline Journal Info:
Nlm Unique ID:  9215384     Medline TA:  Food Drug Law J     Country:  United States    
Other Details:
Languages:  eng     Pagination:  171-81     Citation Subset:  T    
Ohio State University Colleges of Pharmacy and Public Health, Columbus, Ohio, USA.
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MeSH Terms
Drug Approval / legislation & jurisprudence*
Legislation, Drug*
Patents as Topic / legislation & jurisprudence*
Pharmaceutical Preparations
Time Factors
United States
Reg. No./Substance:
0/Pharmaceutical Preparations

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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