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R&D Partnerships and Intellectual Property: Implications for U.S. Policy
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Patent Reform in the 111th Congress: Innovation Issues
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.
Bioterrorism Countermeasure Development: Issues in Patents and Homeland Security
In the 109th Congress, several bills have been introduced, including S. 3, the Protecting America in the War on Terror Act, and S. 975, the Project Bioshield II Act, that would generate additional incentives for the creation of new technologies to counteract potential biological threats. These bills propose reforms to current policies and practices associated with intellectual property, particularly patents, and the marketing of pharmaceuticals and related products. This report includes patents and innovation, the role of patents in pharmaceutical/biomedical R&D, legislative developments and proposals for change.
Bioterrorism Countermeasure Development: Issues in Patents and Homeland Security
Congressional interest in the development of bioterrorism countermeasures remains strong, even after passage of legislation establishing Project BioShield. In the 109th Congress, several bills have been introduced, including S. 3, the Protecting America in the War on Terror Act, S. 975, the Project Bioshield II Act, and S. 1873, the Biodefense and Pandemic Vaccine and Drug Development Act, that would generate additional incentives for the creation of new technologies to counteract potential biological threats. These bills propose reforms to current policies and practices associated with intellectual property, particularly patents, and the marketing of pharmaceuticals and related products.
Follow-On Biologics: Intellectual Property and Innovation Issues
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.
Follow-On Biologics: Intellectual Property and Innovation Issues
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.
What's on Television? The Intersection of Communications and Copyright Policies
This report discusses how the Federal Communications Commission (FCC), Congress, and the courts have overseen the rise of the internet by applying a combination of communications and copyright laws to regulate the distribution of television programming.
Genetically Engineered Soybeans: Acceptance and Intellectual Property Rights Issues in South America
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.
Intellectual Property Provisions of the GATT 1994: "The TRIPS Agreement"
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Patent Reform: Overview and Comparison of S. 507 and H.R. 400
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Intellectual Property Protection for Noncreative Databases
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American Inventors Protection Act of 1999
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.
Patenting Life
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An Examination of the Issues Surrounding Biotechnology Patenting and Its Effect Upon Entrepreneurial Companies
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. commitments in international agreements along with other factors.
Intellectual Property and the Free Trade Agreements: Innovation Policy Issues
This report discusses Free Trade Agreements (FTA) with Australia, Chile, Singapore, and other trading partners in respect to copyrights, data protection, patents, trademarks, and other forms of intellectual property.
Intellectual Property, Computer Software and the Open Source Movement
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Scientific Research and the Experimental Use Privilege in Patent Law
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Deferred Examination of Patent Applications: Implications for Innovation Policy
This report provides an overview of deferred patent examination. It begins by offering a brief review of patent acquisition proceedings as well as challenges faced by the U.S. Patent and Trademark Office (USPTO). The report then introduces the concept of deferred examination. The potential positive and negative consequences of deferred examination upon the environment for innovation within the United States are then explored. The report closes by identifying salient design parameters for deferred examination systems and reviewing congressional options.
Follow-On Biologics: The Law and Intellectual Property Issues
This report reviews the Biologics Price Competition and Innovation Act of 2009 (BPCIA), within the context of intellectual property and innovation issues. It provides an introduction to the biologics industry, introduces the regulatory and intellectual property provisions of the BPCIA, considers the potential market for biosimilars and possible industry responses that may arise in the wake of this legislation, and closes with concluding observations.
Innovation and Intellectual Property Issues in Homeland Security
This report examines concerns that patents, trade secrets or other intellectual rights may impede the prompt, widespread and cost-effective distribution of innovations that promote homeland security.
Innovation and Intellectual Property Issues in Homeland Security
This report examines concerns that patents, trade secrets or other intellectual rights may impede the prompt, widespread and cost-effective distribution of innovations that promote homeland security.
Intellectual Property in Industrial Designs: Issues in Innovation and Competition
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.
Intellectual Property in Industrial Designs: Issues in Innovation and Competition
Report that identifies several current issues relating to intellectual property in industrial designs. It describes the different sorts of intellectual property protection that apply to industrial designs, and identifies current issues at the interface between intellectual property and industrial designs.
Mayo v. Prometheus: Implications for Patents, Biotechnology, and Personalized Medicine
Report that reviews the Supreme Court's 2012 Mayo Collaborative Services v. Prometheus Laboratories decision (wherein the court held that a patent claiming a method of optimizing therapies for autoimmune disease was invalid) and briefly consider its implications for innovation and public health.
Patent Reform: Judicial Developments in Areas of Legislative Interest
This report reviews the relationship between Congress and the courts in patent reform. It begins by offering a summary of the patent system. The report then discusses a number of topics that have been the subject of both judicial and legislative consideration. The current state of the law is then contrasted with legislative reform proposals before previous Congresses. The report closes with observations concerning the subtle interaction between legislative, administrative, and judicial actors within the patent system and their impact upon the U.S. innovation environment.
Patents and Drug Importation
This report explores the intellectual property laws and policies concerning the parallel importation of patented pharmaceuticals into the United States.
Patents and Drug Importation
This report explores the intellectual property laws and policies concerning the parallel importation of patented pharmaceuticals into the United States.
Patents and Drug Importation
This report explores the intellectual property laws and policies concerning the parallel importation of patented pharmaceuticals into the United States.
Pharmaceutical Patent-Antitrust: Reverse Payment Settlements and Product Hopping
This report introduces and analyzes innovation and competition policy issues associated with the pharmaceutical industry. It begins with a review of the Hatch-Waxman Act and its implications upon the availability of generic substitutes for brand-name medications. The report then turns to a basic review of the antitrust law. It then addresses judicial developments with respect to reverse payment settlements and product hopping. The report closes with a summary of congressional issues and possible alternatives.
Pharmaceutical Patent Litigation Settlements: Implications for Competition and Innovation
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.
Pharmaceutical Patent Litigation Settlements: Implications for Competition and Innovation
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.
Plants, Patents, and Seed Innovation in the Agricultural Industry
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 sexually reproducing plants may be subject to utility patents.
Copyright Law: Legalizing Home Taping of Audio and Video Recordings
Various Members of Congress have proposed amendments to the Copyright Act that would provide a blanket exemption for noncommercial home audio and video off-air recording. The major thrust of the copyright owners' opposing position is if you cannot protect what you own, or at least receive some compensation for its use, you own nothing. This is countered by those who feel the purpose of the copyright law is to promote broad public availability of artistic products and when the copyright owners decide to use the distribution mechanism of the public airwaves, they have to accept the premises of the public airwaves.
The Copyright Doctrine of Fair Use and the Internet: Caselaw
This report examines the evolving copyright doctrine of fair use within the context of copyrighted works published or placed on the Internet. American courts have been examining the various property rights of copyright owners concurrently with the unauthorized use of these copyrighted materials by Web site operators, Internet consumers, access providers, and other interested parties. This report analyzes the early fair use copyright cases concerning Internet use, as well as the most recent judicial interpretations.
Copyright Protection of Digital Television: The "Broadcast Flag"
This report addresses the adoption of a “broadcast flag” system by the Federal Communications Commission (FCC) to protect digital television (DTV) broadcasts from unauthorized redistribution. The report also addresses the recent decision of the United States Court of Appeals for the District of Columbia Circuit reversing and vacating the FCC’s broadcast flag report and order.
The GATT and the WTO: An Overview
The Uruguay Round Agreement reduced tariffs, brought services, intellectual property, and agriculture under the discipline of the General Agreement on Tariffs and Trade, and established the World Trade Organization. Multilateral trade issues for the future include continuing services negotiations, the relationship of the environment and labor standards to trade, and investment and competition policy.
Availability of Injunctive Relief for Standard-Essential Patent Holders
This report provides an overview of the current debate over whether a holder of a patent essential to an industry standard, who has promised to license such patented technology on fair, reasonable, and non-discriminatory (FRAND) terms, may nevertheless obtain an injunction from a federal court or an exclusion order from the International Trade Commission against infringing products that implement the industry standard. The report first summarizes several fundamental principles of patent law, then discusses the relationship between standard-setting organizations and FRAND licensing.
Copyright Protection for Fashion Design: A Legal Analysis of the Design Piracy Prohibition Act (H.R. 2196)
Fashion design does not currently receive explicit protection under U.S. copyright law. This report analyzes the amendments that the Design Piracy Prohibition Act would make to the Copyright Act to provide for fashion design protection. It also summarizes arguments both in favor of and against extending such protection.
The Copyright Registration Requirement and Federal Court Jurisdiction: A Legal Analysis of Reed Elsevier, Inc. v. Muchnick
In New York Times Co. v. Tasini, six freelance authors who had contributed articles to several publications, including The New York Times, Newsday, and Time, sued when the publishers licensed rights to copy and sell the articles to electronic databases such as Lexis/Nexis. Shortly after the Court decided Tasini, three preexisting class action infringement suits, which had been suspended pending the decision, were activated and consolidated in the U.S. District Court for the Southern District of New York. A fourth, nearly identical action was coordinated with that consolidated action. Together, these claims comprise the litigation discussed in this report.
Exporting Software and the Extraterritorial Reach of U.S. Patent Law: Microsoft Corp. v. AT&T Corp.
Generally speaking, United States patent law does not have extraterritorial effect. The exception, however, is § 271(f) of the Patent Act, which makes it an act of patent infringement to manufacture within the United States the components of a patented invention and then export those disassembled parts for combination abroad into an end product. This report discusses Microsoft Corp. v. AT&T Corp. (550 U.S. ___ , No. 05-1056, decided April 30, 2007), in which the U.S. Supreme Court held that software companies are not liable for patent infringement under § 271(f) when they export software that has been embodied in machine-readable, physical form (a CD-ROM, for example), with the intent that such software be copied abroad for installation onto foreign-manufactured computers.
False Patent Marking: Litigation and Legislation
This report will describe and analyze the Federal Circuit's 2009 decision that requires a per-article penalty for false marking, as well as two subsequent Federal Circuit decisions in 2010 that answer several questions that have arisen during the recent false patent marking litigation. It also identifies and discusses legislation in the 111th Congress that would amend § 292 in order to retroactively end qui tam false marking suits and with the intent of reducing the number of false marking suits filed in the future.
False Patent Marking: Litigation and Legislation
This report will describe and analyze the Federal Circuit's 2009 decision that requires a per-article penalty for false marking, as well as two subsequent Federal Circuit decisions in 2010 that answer several questions that have arisen during the recent false patent marking litigation. It also identifies and discusses legislation in the 111th Congress that would amend § 292 in order to retroactively end qui tam false marking suits and with the intent of reducing the number of false marking suits filed in the future.
Illegal Internet Streaming of Copyrighted Content: Legislation in the 112th Congress
This report describes streaming technology, explains the disparity in criminal penalties for different forms of infringement committed by electronic means, analyzes legislation in the 112th Congress that would harmonize penalties for illegal streaming with those available for other forms of online copyright infringement, and summarizes arguments for and against such a legislative change.
Influenza Antiviral Drugs and Patent Law Issues
This report identifies and analyzes the patent law aspects of the current avian influenza drug situation. First, the report explains the role that patent rights have played in affecting the availability of Tamiflu. Second, the report examines options for increasing the drug’s production, including the possibility of governments abrogating Roche’s patent rights by issuing compulsory licenses to other drug companies to manufacture generic versions of Tamiflu without Roche’s consent.
Influenza Antiviral Drugs and Patent Law Issues
This report examines the role that intellectual property rights play in affecting the availability of a patented drug such as Tamiflu during public health crises. The report also explains one legal mechanism for increasing a patented drug’s production without the patent holder’s consent: governments may abrogate a pharmaceutical company’s patent rights by issuing compulsory licenses to other drug companies to manufacture generic versions of the drug.
Intellectual Property Rights Violations: Federal Civil Remedies and Criminal Penalties Related to Copyrights, Trademarks, and Patents
This report provides information describing the federal civil remedies and criminal penalties that may be available as a consequence of violations of the federal intellectual property laws: the Copyright Act of 1976, the Patent Act of 1952, and the Trademark Act of 1946 (conventionally known as the Lanham Act).
Intellectual Property Rights Violations: Federal Civil Remedies and Criminal Penalties Related to Copyrights, Trademarks, and Patents
This report provides information describing the federal civil remedies and criminal penalties that may be available as a consequence of violations of the federal intellectual property laws: the Copyright Act of 1976, the Patent Act of 1952, and the Trademark Act of 1946 (conventionally known as the Lanham Act).
Intellectual Property Rights Violations: Federal Civil Remedies and Criminal Penalties Related to Copyrights, Trademarks, Patents, and Trade Secrets
This report provides background information and issues for Congress on multiyear procurement (MYP) and block buy contracting (BBC), which are special contracting mechanisms that Congress permits the Department of Defense (DOD) to use for a limited number of defense acquisition programs.
The Jurisprudence of Justice John Paul Stevens: Selected Opinions on Intellectual Property Law
This report briefly surveys decisions of retiring Justice John Paul Stevens in intellectual property cases. An examination of Justice Stevens' written opinions relating to intellectual property law reveals a strong desire to ensure that the rights of intellectual property creators are balanced with the rights of the public to access creative and innovative works.
Online Copyright Infringement and Counterfeiting: Legislation in the 112th Congress
The global nature of the Internet offers expanded commercial opportunities for intellectual property (IP) rights holders but also increases the potential for copyright and trademark infringement. This report discusses the following recent draconian legislation in regard to this topic: the Preventing Real Online Threats to Economic Creativity and Theft of Intellectual Property Act (PROTECT IP Act); the Stop Online Piracy Act (SOPA); and the Online Protection and Enforcement of Digital Trade Act (OPEN Act).