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- 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.
- 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.
- 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.
- The Bayh-Dole Act: Selected Issues in Patent Policy and the Commercialization of Technology
- Congressional interest in facilitating U.S. technological innovation led to the passage of P.L. 96-517, Amendments to the Patent and Trademark Act, commonly referred to as the "Bayh-Dole Act" after its two main sponsors former Senators Robert Dole and Birch Bayh. Under this 1980 law, as amended, title to inventions made with government support is provided to the contractor if that contractor is a small business, a university, or other non-profit institution. This report discusses the rationale behind the passage of P.L. 96-517, its provisions, and implementation of the law.
- An Overview of Recent U.S. Supreme Court Jurisprudence in Patent Law
- This report provides a brief summary of the Supreme Court's patent law jurisprudence in the following nine cases that have been decided since 2005: Merck KGaA v. Integra Lifesciences I, Unitherm Food Systems v. Swift-Eckrich, Illinois Tool Works v. Independent Ink, eBay v. MercExchange, Laboratory Corporation of America Holdings v. Metabolite Labs., MedImmune v. Genentech, KSR International Co. v. Teleflex Inc., Microsoft v. AT&T, Quanta Computer, Inc. v. LG Electronics, Inc., and Bilski v. Kappos.
- 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.
- The Bayh-Dole Act: Selected Issues in Patent Policy and the Commercialization of Technology
- Report that discusses the rationale behind the passage of P.L. 96-517, its provisions, and implementation of the law.
- Intellectual Property Law: A Brief Introduction
- This report provides a brief overview of each form of federal intellectual property (IP) protection, including patent law, copyright law, and trademarks.
- 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.
- 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-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.
- Patent Reform: Overview and Comparison of S. 507 and H.R. 400
- H.R. 400 and S. 507 are similar but different omnibus patent reform proposals. Both bills generally transform the Patent and Trademark Office into a government corporation; require publication of patent applications 18 months after filing, subject to certain exceptions that differ in these bills; and extend the patent term for certain delays in patent issuance. S. 507 also contains provisions on patent reexamination reform. This report summarizes and compares the bills and reviews arguments for and against the proposals.
- 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.
- 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.
- Remedies for Patent Infringement
- This report discusses the current legal system rules for patent infringement cases and current bills introduced in Congress related to patents.
- Patentable Subject Matter Reform
- This report reviews the current law governing patentable subject matter and recent proposals for legislative reform. It begins by providing a basic overview of the patent system and introducing the principles of patentable subject matter. It then considers the leading Supreme Court decisions construing section 101 of the Patent Act. The report then considers the implications of these decisions within the information technology and life sciences industries. The report closes with a review of legislative reform options.
- Where Can Corporations Be Sued for Patent Infringement? Part 1
- This report is part one of two and discusses patent venue jurisprudence, including the "TC Heartland" opinion, and the impact of the decision on the patent litigation system generally.
- Where Can Corporations Be Sued for Patent Infringement? Part 2
- This report is part two of two and discusses other implications of the "TC Heartland" decision, including two notable recent decisions in the Federal Circuit interpreting the decision, "In re Cray" and "In re Micron Technology, Inc.," as well as other potential issues raised by TC Heartland and options for Congress.
- Update of "All Eyes on Allergan: Drug Company's Unprecedented Move Raises Questions for Patent and Drug Law (Part 1)"
- This report is an update of a previous report discussing the case of "Allergan Inc. v. Teva Pharmaceuticals USA Inc." which deals with patent law and the rights of brand-name pharmaceutical companies and generic pharmaceutical companies as well as Native American tribes sovereign rights because the St. Regis Mohawk Tribe is a co-plaintiff in the case. The case is currently in the appeals process.
- 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.
- An Overview of the "Patent Trolls" Debate
- This report reviews the current debate and controversy surrounding "patent assertion entities" (PAEs) and their effect on innovation, examines the reasons for the rise in PAE litigation, and explores the legislative options available to Congress if it decides that these are issues that should be addressed.
- 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.
- 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).
- Patent Law: A Primer and Overview of Emerging Issues
- This report begins with an overview of patent law. It then discusses the Supreme Court's role in the development of patent law generally before examining the Court's recent decisions in detail. Finally, the report closes with a preview of developments in patent law that are on the horizon, such as the continued viability of certain administrative proceedings related to the validity of patents, which is the subject of two cases scheduled to be heard during the Court's upcoming term, as well as patent reform activity in the legislative and executive arenas.
- Patent Boxes: A Primer
- This report looks at several aspects of patent boxes, including their general purpose. In addition, the report looks at the key considerations in designing a patent box, identifies the countries that currently have a patent box, describes the main elements of those boxes, and sheds light on the U.S. industries that would be likely to benefit the most from such a tax subsidy if the United States were to adopt one. The final two sections discuss what is known about the effectiveness of patent boxes and several other policy issues raised by patent boxes. The report is intended to complement a 2016 CRS report on the "expected effectiveness" of patent boxes.
- 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.
- U.S. Patent and Trademark Office Appropriations Process: A Brief Explanation
- This report examines The United States Patent and Trademark Office (USPTO) which is funded by fees collected from customers. However, appropriation measures limit USPTO use of all fees accumulated within a fiscal year. Critics of this approach argue that because agency operations are supported by payments for services, all fees are necessary to fund these services in the year they are provided.
- 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.
- 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.
- 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).
- The Bayh-Dole Act: Selected Issues in Patent Policy and the Commercialization of Technology
- This report discusses the rationale behind the passage of P.L. 96-517 (Amendments to the Patent and Trademark Act, or the "Bayh-Dole Act") as well as its provisions and information regarding the implementation of the law. Under this 1980 law, as amended, title to inventions made with government support is provided to the contractor if that contractor is a small business, a university, or other non-profit institution.
- An Overview of the "Patent Trolls" Debate
- This report reviews the current debate and controversy surrounding "patent assertion entities" (PAEs) and their effect on innovation, examines the reasons for the rise in PAE litigation, and explores the legislative options available to Congress if it decides that these are issues that should be addressed.
- Patent Ownership and Federal Research and Development (R and D): A Discussion on the Bayh-Dole Act and the Stevenson-Wydler Act
- Two major laws govern the dispensation of patents associated with federal research and development (R&D) activities. Both P.L. 96-418, the Stevenson-Wydler Technology Innovation Act, as amended, and P.L. 96-517, Amendments to the Patent and Trademark Act (commonly referred to as "Bayh-Dole" after its two main sponsors, former Senators Birch Bayh and Robert Dole), are the foundation for efforts to utilize patent ownership to encourage the commercialization of technologies and techniques that have their roots in the federal R&D enterprise
- Qui Tam: An Abbreviated Look at the False Claims Act and Related Federal Statutes
- This is a brief discussion of the constitutional questions raised by qui tam provisions; of the history of such provisions; and of the three existing, active federal qui tam statutes--the False Claims Act, 31 U.S.C. 3729-3733; the false marking patent statute, 35 U.S.C. 292; and the Indian protection provisions of 25 U.S.C. 201.
- 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.
- 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.
- 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.
- Patent Reform: Overview and Comparison of S. 507 and H.R. 400
- The pending omnibus patent reform bills (S. 507 and H.R. 400) would reorganize the Patent and Trademark Office (PTO) as a government corporation and enact several other patent law reforms including early publication (with exceptions) and patent term restoration. S. 507 consists of six titles; H.R. 400 contains five titles.
- 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.
- 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.
- Patent Reform: Issues in the Biomedical and Software Industries
- No Description Available.