Congressional Research Service Reports - 73 Matching Results

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Follow-On Biologics: Intellectual Property and Innovation Issues

Description: Biologics, which are sometimes termed biopharmaceuticals or biotechnology drugs, have begun to play an increasingly important role in U.S. health care. Not only are sales of biologics growing rapidly, some experts estimate that in coming years half of all newly approved drugs will result from biotechnology. This report contains information on marketing approval issues, intellectual property issues, and innovation issues as related to biologics.
Date: March 20, 2009
Creator: Schacht, Wendy H. & Thomas, John R.
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Partner: UNT Libraries Government Documents Department
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Follow-On Biologics: Intellectual Property and Innovation Issues

Description: Biologics, which are sometimes termed biopharmaceuticals or biotechnology drugs, have begun to play an increasingly important role in U.S. health care. Not only are sales of biologics growing rapidly, some experts estimate that in coming years half of all newly approved drugs will result from biotechnology. This report contains information on marketing approval issues, intellectual property issues, and innovation issues as related to biologics.
Date: June 4, 2007
Creator: Schacht, Wendy H. & Thomas, John R.
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
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Follow-On Biologics: Intellectual Property and Innovation Issues

Description: This report reviews doctrinal and policy issues pertaining to follow-on biologics. The report first introduces the application of federal food and drug legislation to follow-on biologics. It next turns to the patent implications of marketing follow-on biologics. Following this review of substantive law, the remainder of the report introduces innovation policy issues pertaining to follow-on biologics.
Date: October 31, 2008
Creator: Schacht, Wendy H. & Thomas, John R.
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
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Follow-On Biologics: Intellectual Property and Innovation Issues

Description: Biologics, which are sometimes termed biopharmaceuticals or biotechnology drugs, have begun to play an increasingly important role in U.S. health care. Not only are sales of biologics growing rapidly, some experts estimate that in coming years half of all newly approved drugs will result from biotechnology. This report contains information on marketing approval issues, intellectual property issues, and innovation issues as related to biologics.
Date: March 5, 2007
Creator: Schacht, Wendy H. & Thomas, John R.
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
open access

Follow-On Biologics: Intellectual Property and Innovation Issues

Description: This report reviews doctrinal and policy issues pertaining to follow-on biologics. The report first introduces the application of federal food and drug legislation to follow-on biologics. It next turns to the patent implications of marketing follow-on biologics. Following this review of substantive law, the remainder of the report introduces innovation policy issues pertaining to follow-on biologics.
Date: August 3, 2009
Creator: Schacht, Wendy H. & Thomas, John R.
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
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Patent Reform in the 111th Congress: Innovation Issues

Description: This study provides an overview of current patent reform issues. It begins by offering a summary of the structure of the current patent system and the role of patents in innovation policy. The report then reviews some of the broader issues and concerns, including patent quality, the high costs of patent litigation, international harmonization, and speculation in patents, that have motivated these diverse legislative reform proposals.
Date: April 9, 2009
Creator: Schacht, Wendy H. & Thomas, John R.
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
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Genetically Engineered Soybeans: Acceptance and Intellectual Property Rights Issues in South America

Description: This report discusses issues regarding genetically engineered soybeans in South America. U.S. soybean growers and trade officials charge that Argentina and Brazil–the United States’ two major export competitors in international soybean markets–gain an unfair trade advantage by routinely saving genetically-engineered (GE), Roundup Ready (RR) soybean seeds from the previous harvest (a practice prohibited in the United States) for planting in subsequent years.
Date: October 17, 2003
Creator: Schnepf, Randy
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Partner: UNT Libraries Government Documents Department
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American Inventors Protection Act of 1999

Description: After several years of consideration, on Friday, November 19, 1999, Congress gave final approval to a bill which makes major changes to the patent laws. On this day the Senate passed the American Inventors Protection Act of 1999 as part of the Intellectual Property and Communications Omnibus Reform Act of 1999, attached by reference to the Consolidated Appropriations Act for Fiscal Year 2000. This report summarizes major provisions of the patent reform bill.
Date: February 28, 2000
Creator: Seitzinger, Michael V.
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Partner: UNT Libraries Government Documents Department
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An Examination of the Issues Surrounding Biotechnology Patenting and Its Effect Upon Entrepreneurial Companies

Description: The biotechnology industry is notable both for its heavy concentration of small businesses and its weighty research and development (R&D) expenditures. Given the small size and heavy expenses of many biotechnology firms, their ability to raise venture capital may be of some consequence. The patent law has been identified as a facilitator of these R&D financing efforts. Congress may choose to exercise oversight on these issues. Such consideration would likely include examination of U.S. commitme… more
Date: August 31, 2000
Creator: Thomas, John R.
Item Type: Refine your search to only Report
Partner: UNT Libraries Government Documents Department
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Intellectual Property and the Free Trade Agreements: Innovation Policy Issues

Description: This report offers a broad overview of the intellectual property components of the FTAs. It begins by offering a brief introduction to the global intellectual property system. Next, this report considers the subject matter of the different free trade agreements themselves. It then reviews perceived concerns with respect to the free trade agreements and closes with concluding observations.
Date: January 17, 2007
Creator: Thomas, John R.
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Partner: UNT Libraries Government Documents Department
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Intellectual Property in Industrial Designs: Issues in Innovation and Competition

Description: This report identifies several current issues relating to intellectual property in industrial designs. It begins by describing the different sorts of intellectual property protection that apply to industrial designs. The report then identifies current issues at the interface between intellectual property and industrial designs. The report closes by reviewing the impact that sui generis rights regimes may have upon innovation and competition in the United States.
Date: July 1, 2008
Creator: Thomas, John R.
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Partner: UNT Libraries Government Documents Department
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Patents and Drug Importation

Description: This report explores the intellectual property laws and policies concerning the parallel importation of patented pharmaceuticals into the United States.
Date: June 1, 2007
Creator: Thomas, John R.
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Partner: UNT Libraries Government Documents Department
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Patents and Drug Importation

Description: This report explores the intellectual property laws and policies concerning the parallel importation of patented pharmaceuticals into the United States.
Date: May 25, 2004
Creator: Thomas, John R.
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Partner: UNT Libraries Government Documents Department
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Patents and Drug Importation

Description: This report explores the intellectual property laws and policies concerning the parallel importation of patented pharmaceuticals into the United States.
Date: January 17, 2007
Creator: Thomas, John R.
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Partner: UNT Libraries Government Documents Department
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Pharmaceutical Patent Litigation Settlements: Implications for Competition and Innovation

Description: This report introduces and analyzes innovation policy issues concerning pharmaceutical patent litigation settlements, including pharmaceutical patent litigation procedures under the Hatch-Waxman Act, the concept of reverse payment settlements, the status of reverse payment settlements under the antitrust laws, and congressional issues and alternatives.
Date: November 4, 2008
Creator: Thomas, John R.
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Partner: UNT Libraries Government Documents Department
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Plants, Patents, and Seed Innovation in the Agricultural Industry

Description: This report offers an overview of the availability of intellectual property rights for plants, focusing upon the seed industry. It initially offers an introduction to seed innovation. The report then reviews the three intellectual property regimes applicable to plant innovation: utility patents, plant patents and plant variety protection certificates. It then details a 2001 decision of the U.S. Supreme Court, J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred International, Inc., which held that sexuall… more
Date: September 13, 2002
Creator: Thomas, John R.
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Partner: UNT Libraries Government Documents Department
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