| Description |
1 online resource (260 pages) : illustrations |
| Contents |
1. Introduction to Intellectual Property -- Introduction -- The Meaning of "Intellectual Property" -- Types of Intellectual Property Protection -- Copyright -- Trademarks -- Trade Secrets -- Patents -- Requirements -- Underlying Theory of Intellectual Property -- Basis of Intellectual Property Law -- The U.S. Patent System -- United States Patent and Trademark Office -- Supreme Court -- Congress -- Summary -- References -- 2. Obtaining, Enforcing and Defending Patents -- Obtaining Patent Protection -- Patentable Subject Matter -- Utility -- Novelty -- Nonobviousness -- Written Description and Enablement -- Enforcement of Patents -- Types of Patent Infringement -- Determination of Infringement -- Remedies for Infringement -- Defenses -- Invalidity -- Inequitable Conduct -- Exhaustion -- Exhaustion and Self-Replicating Technologies -- Experimental Use -- Five Important Facts to Remember About Patents -- Summary -- References -- 3. Gene Patents -- History of Gene Patenting -- Chakrabarty and the Rise of Gene Patents -- Chakrabarty's Legacy -- The Harvard Oncomouse and the Patenting of Higher Level Life Forms -- The Current Controversy -- Public Health Implications -- Access to Medical Treatment -- Quality of Medical Treatment -- Innovation -- Summary -- References -- 4. Medical Procedure Patents -- History of Medical Procedure Patents -- The Patent Law Compromise -- Who is Protected -- The Loophole for Medical Devices -- The Unenforceable Patent Right -- Medical Procedure Patents as "Process" Under Section 101 -- A Possible Shift in the Trend: In re Bilski and the "Machine or Transformation" Test -- Aftermath of Bilski -- Immunizations: Classen Immunotherapies, Inc. v. Biogen -- In Vitro Diagnostics: Prometheus Laboratories, Inc. v. Mayo Collaborative Services -- Diagnostic Testing: Myriad Genetics v. Association for Molecular Pathology (AMP) -- Public Health Implications -- Ethical Issues |
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Academic Access -- Patient Privacy -- Access to Medical Treatment -- Impact on Innovation -- Infringement Liability -- Summary -- References -- 5. Rights and Roles of Universities and Inventors -- Researcher and Inventor -- Publish or Perish -- Determining Inventorship -- The Bayh-Dole Act: Stimulating Commercialization of University Research -- IP Policies and Assignment Provisions -- Stanford v. Roche -- Government's March-in Rights -- Effects of the Bayh-Dole Act -- Technology Transfer: Transferring University Technology to the Private Sector -- Summary -- References -- 6. Drug Development: Managing the Patent and FDA Processes -- Overview of Drug Development -- Reconciling Patent Protection with the Drug Development Process -- Extending the Life and Value of a Product -- Patent Exclusivities -- Patent Term Adjustments for Delays Due to USPTO Approval -- Patent Term Extensions for Delays Due to Regulatory Approval -- Nonpatent Exclusivities -- New Chemical Entity Exclusivity -- New Clinical Study Exclusivity -- Generic Drug Exclusivity -- Generic Biologic Exclusivity -- Orphan Drug Exclusivity -- Pediatric Exclusivity -- Implications for the Public's Health -- Misuse of Exclusivities -- Disproportional Incentives -- Minimal Health Benefits -- Summary -- References -- 7. Patent Battles Part I: The Hatch Waxman Act and Small-Molecule Drugs -- Generic Drugs -- Effect of Generic Drugs on the Market -- The Hatch-Waxman Act -- Restoring Patent Term and Providing Additional Market Exclusivity -- Safe Harbor -- Abbreviated New Drug Application (ANDA) -- Consequences of the Hatch-Waxman Act -- Evergreening -- Patenting of Obvious Inventions -- Authorized Generics -- Pay-for-Delay Settlement Agreements -- Multiple Orange Book Listings -- Continuation Application Practice -- Public Health Implications -- Availability of Generics Drugs -- Innovation of New Drugs -- Summary -- References |
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8. Patent Battles Part II: The Biosimilars Act and Biologics -- Overview of Biologics -- Regulation of Biologies in the United States -- Biologics Price Competition and Innovation Act (The "Biosimilars Act") -- Biosimilar Versus Interchangeable -- Brand-Name Exclusivities -- Generic Exclusivities -- Patent Dispute Resolution -- Public Health Implications -- Access to Biosimilars -- Achieving "Biosimilarity" or "Interchangeability" Status -- Uncertain Exclusivity Timelines -- Loop Holes for Brand-Name Biologics -- Promoting Innovation -- Summary -- References -- 9. International Patent Law, Trade Law, and Access to Drugs -- International Institutions Governing International Patent Law -- World Intellectual Property Organization -- World Trade Organization -- Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement) -- Exception to TRIPS: Compulsory Licensing -- Doha Declaration -- Amendment to TRIPS -- Compulsory Licensing Case Studies -- India's Patent Laws -- Evergreening Patents and the Battle over Glivec -- Compliance with TRIPS -- Constitutional Validity of Section 3(d) -- Patentability of Glivec -- Compulsory Licensing in India -- Why India is Important -- Drug Pricing and Access to Medicines -- Competition from Generics -- Price Differentiation -- Parallel Imports -- Corporate Donations -- Patents and Access to Drugs -- Stimulating New Drug Innovation -- Prize System: Health Impact Fund -- Patent Pools -- Open Source Model for Drug Discovery and Development -- Summary -- References |
| Summary |
Intellectual Property and Health Technologies Balancing Innovation and the Public's Health ¡ Joanna T. Brougher, Esq., MPH ¡ ¡ At first glance, ownership of intellectual property seems straightforward: the control over an invention or idea. But with the recent explosion of new scientific discoveries poised to transform public health and healthcare systems, costly and lengthy patent disputes threaten both to undermine the attempts to develop new medical technologies and to keep potentially life-saving treatments from patients who need them. ¡ Intellectual Property and Health Technologies grounds readers in patent law and explores how scientific research and enterprise are evolving in response. Geared specifically to the medical disciplines, it differentiates among different forms of legal protection for inventors such as patents, copyrights, trademarks and trade secrets, explains their limitations, and argues for balance between competing forces of exclusivity and availability. Chapters delve into the major legal controversies concerning medical and biotechnologies (deleted "in terms of pricing, markets, and especially the tension between innovation and access"), including: ¡ The patent-eligibility of genes The patent-eligibility of medical process patents The rights and roles of universities and inventors The balancing of access, innovation, and profit in drug development The tension between biologics, small-molecule drugs, and their generic counterparts International patent law and access to medicine in the developing world ¡ As these issues continue to shape and define the debate, Intellectual Property and Health Technologies enables professionals and graduate students in public health, health policy, healthcare administration, and medicine to understand patent law and how it affects the development of medical technology and the delivery of medicine |
| Analysis |
volksgezondheid |
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public health |
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geneeskunde |
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medicine |
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biomedische wetenschappen |
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biomedicine |
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recht |
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law |
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Medicine (General) |
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Geneeskunde (algemeen) |
| Bibliography |
Includes bibliographical references and index |
| Notes |
Print version record |
| Subject |
Medicine -- Patents -- Law and legislation
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Health services accessibility -- Law and legislation.
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Health Services Accessibility -- legislation & jurisprudence
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Patents as Topic -- legislation & jurisprudence
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LAW -- Administrative Law & Regulatory Practice.
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Médecine.
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Health services accessibility -- Law and legislation
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| Form |
Electronic book
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| ISBN |
9781461482024 |
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146148202X |
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