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Intellectual Property Rights and the Evergreening of Pharmaceuticals
A Service of Leibniz-Informationszentrum econstor Wirtschaft Leibniz Information Centre Make Your Publications Visible. zbw for Economics Boscheck, Ralf Article — Published Version Intellectual property rights and the evergreening of pharmaceuticals Intereconomics Suggested Citation: Boscheck, Ralf (2015) : Intellectual property rights and the evergreening of pharmaceuticals, Intereconomics, ISSN 1613-964X, Springer, Heidelberg, Vol. 50, Iss. 4, pp. 221-226, http://dx.doi.org/10.1007/s10272-015-0546-y This Version is available at: http://hdl.handle.net/10419/172664 Standard-Nutzungsbedingungen: Terms of use: Die Dokumente auf EconStor dürfen zu eigenen wissenschaftlichen Documents in EconStor may be saved and copied for your Zwecken und zum Privatgebrauch gespeichert und kopiert werden. personal and scholarly purposes. Sie dürfen die Dokumente nicht für öffentliche oder kommerzielle You are not to copy documents for public or commercial Zwecke vervielfältigen, öffentlich ausstellen, öffentlich zugänglich purposes, to exhibit the documents publicly, to make them machen, vertreiben oder anderweitig nutzen. publicly available on the internet, or to distribute or otherwise use the documents in public. Sofern die Verfasser die Dokumente unter Open-Content-Lizenzen (insbesondere CC-Lizenzen) zur Verfügung gestellt haben sollten, If the documents have been made available under an Open gelten abweichend von diesen Nutzungsbedingungen die in der dort Content Licence (especially Creative Commons Licences), you genannten Lizenz gewährten Nutzungsrechte. may exercise further usage rights as specified in the indicated licence. www.econstor.eu DOI: 10.1007/s10272-015-0546-y Intellectual Property Ralf Boscheck Intellectual Property Rights and the Evergreening of Pharmaceuticals Escalating healthcare expenditures and the need to ensure access to affordable medicine in both emerging and emerged economies are fuelling calls to contain the so-called evergreening practices of drug producers around the world. -
Overcoming Intellectual Property Monopolies in the COVID-19 Pandemic
MSF Briefing Document July 2020 Overcoming intellectual property monopolies in the COVID-19 pandemic Médecins Sans Frontières (MSF) is responding to the global COVID-19 pandemic, providing treatment and care for people with COVID-19, protecting people living in vulnerable conditions, and ensuring uninterrupted essential health services for people suffering from other diseases.1 Having universal access to existing and future tools for treatment, diagnosis and prevention is critical. MSF has repeatedly witnessed how exclusive rights and monopolies granted to pharmaceutical corporations, resulting in high prices and blocking generic competition, have had a negative impact on our medical actions in different countries.2 For example, in the past, high prices for patented medicines have undermined the capacity of countries to provide access to treatment for HIV/AIDS, tuberculosis (TB), hepatitis C and cancer to all patients who need them. However, the impact of intellectual property (IP) monopolies is not limited to drugs. The availability of more affordable pneumococcal conjugate vaccine and human papillomavirus vaccine in low- and middle-income countries has been delayed due to unmerited patents on key technologies blocking follow-on producers.3 Intellectual property monopolies in the COVID-19 pandemic While several of the drugs being trialled as COVID-19 treatments are now off patent, patented drugs and experimental drugs are also being trialled, and some of which are under patent protection in many developing countries.4 With control over the market as a result of patents or other exclusive rights, pharmaceutical companies could determine how global production and supply chain are organised, who ultimately has access, who can produce medicines and where they can be supplied. -
Evergreening" Metaphor in Intellectual Property Scholarship
University of Missouri School of Law Scholarship Repository Faculty Publications Faculty Scholarship 2019 The "Evergreening" Metaphor in Intellectual Property Scholarship Erika Lietzan University of Missouri School of Law, [email protected] Follow this and additional works at: https://scholarship.law.missouri.edu/facpubs Part of the Food and Drug Law Commons, Intellectual Property Law Commons, and the Science and Technology Law Commons Recommended Citation Erika Lietzan, The "Evergreening" Metaphor in Intellectual Property Scholarship, 53 Akron Law Review 805 (2019). Available at: https://scholarship.law.missouri.edu/facpubs/984 This Article is brought to you for free and open access by the Faculty Scholarship at University of Missouri School of Law Scholarship Repository. It has been accepted for inclusion in Faculty Publications by an authorized administrator of University of Missouri School of Law Scholarship Repository. For more information, please contact [email protected]. DATE DOWNLOADED: Wed Jan 20 13:42:00 2021 SOURCE: Content Downloaded from HeinOnline Citations: Bluebook 21st ed. Erika Lietzan, The "Evergreening" Metaphor in Intellectual Property Scholarship, 53 AKRON L. REV. 805 (2019). ALWD 6th ed. Lietzan, E. ., The "evergreening" metaphor in intellectual property scholarship, 53(4) Akron L. Rev. 805 (2019). APA 7th ed. Lietzan, E. (2019). The "evergreening" metaphor in intellectual property scholarship. Akron Law Review, 53(4), 805-872. Chicago 7th ed. Erika Lietzan, "The "Evergreening" Metaphor in Intellectual Property Scholarship," Akron Law Review 53, no. 4 (2019): 805-872 McGill Guide 9th ed. Erika Lietzan, "The "Evergreening" Metaphor in Intellectual Property Scholarship" (2019) 53:4 Akron L Rev 805. AGLC 4th ed. Erika Lietzan, 'The "Evergreening" Metaphor in Intellectual Property Scholarship' (2019) 53(4) Akron Law Review 805. -
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DRUGS-2017/05/02 1 THE BROOKINGS INSTITUTION REINING IN PRESCRIPTION DRUG PRICES Washington, D.C. Tuesday, May 2, 2017 Introduction: LOUISE SHEINER Senior Fellow, Economic Studies Policy Director, Hutchins Center on Fiscal and Monetary Policy The Brookings Institution Paper: Framework for Negotiation in Part D of Medicare MODERATOR: PAUL B. GINSBURG Senior Fellow, Economic Studies Leonard D. Schaeffer Chair in Health Policy Studies Director, Center for Health Policy The Brookings Institution Presenters: RICHARD G. FRANK Margaret T. Morris Professor of Health Economics Department of Health Care Policy Harvard Medical School RICHARD J. ZECKHAUSER Frank P. Ramsey Professor of Political Economy Harvard Kennedy School of Government Paper: Can Importation Address High Generic Drug Prices? MODERATOR: PAUL B. GINSBURG Senior Fellow, Economic Studies Leonard D. Schaeffer Chair in Health Policy Studies Director, Center for Health Policy The Brookings Institution Presenters: THOMAS BOLLYKY Senior Fellow for Global Health, Economics and Development Council on Foreign Relations AARON KESSELHEIM Associate Professor of Medicine ANDERSON COURT REPORTING 706 Duke Street, Suite 100 Alexandria, VA 22314 Phone (703) 519-7180 Fax (703) 519-7190 DRUGS-2017/05/02 2 Brigham and Women’s Hospital and Harvard Medical School Paper: Removing Barriers to Competition in Pharmaceutical Markets MODERATOR: PAUL B. GINSBURG Senior Fellow, Economic Studies Leonard D. Schaeffer Chair in Health Policy Studies Director, Center for Health Policy The Brookings Institution Presenters: -
Canada's Continuing Support of US Linkage Regulations For
Marquette Intellectual Property Law Review Volume 15 | Issue 1 Article 1 I'm Still Your Baby: Canada's Continuing Support of U.S. Linkage Regulations for Pharmaceuticals Ron A. Bouchard University of Manitoba, Canada Follow this and additional works at: http://scholarship.law.marquette.edu/iplr Part of the Intellectual Property Commons Repository Citation Ron A. Bouchard, I'm Still Your Baby: Canada's Continuing Support of U.S. Linkage Regulations for Pharmaceuticals, 15 Intellectual Property L. Rev. 71 (2011). Available at: http://scholarship.law.marquette.edu/iplr/vol15/iss1/1 This Article is brought to you for free and open access by the Journals at Marquette Law Scholarly Commons. It has been accepted for inclusion in Marquette Intellectual Property Law Review by an authorized administrator of Marquette Law Scholarly Commons. For more information, please contact [email protected]. I’M STILL YOUR BABY: CANADA’S CONTINUING SUPPORT OF U.S. LINKAGE REGULATIONS FOR PHARMACEUTICALS RON A. BOUCHARD∗ ABSTRACT ...................................................................................................... 72 INTRODUCTION ............................................................................................. 73 I. REVIEW OF EMPIRICAL STUDIES............................................................ 77 A. Study 1 ........................................................................................... 77 B. Study 2 ............................................................................................ 83 C. Study -
In Re: Glaxosmithkline Plc Securities Litigation 05-CV-3751
UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF NEW YORK __________________________________________ ) In re: GlaxoSmithKline plc Securities ) Civil Action No. 05 CIV. 3751 (LAP) Litigation ) ) DEMAND FOR JURY TRIAL __________________________________________) CONSOLIDATED SECOND AMENDED COMPLAINT JURISDICTION AND VENUE 1. The claims asserted herein arise under §§ 10(b) and 20(a) of the Securities Exchange Act of 1934 (“1934 Act”) and Rule 10b-5. Jurisdiction is conferred by § 27 of the 1934 Act, and 28 U.S.C. §1331. Venue is proper here pursuant to § 27 of the 1934 Act. GlaxoSmithKline plc and SmithKline Beecham Corporation doing business as GlaxoSmithKline plc (collectively “GSK”) is headquartered in London, England, but conducts business in this District. GSK’s ADRs trade on the New York Stock Exchange headquartered in this District. THE PARTIES 2. Lead Plaintiff Joseph J. Masters (“Plaintiff”) acquired publicly traded securities of GSK during the Class Period and was damaged thereby. 3. Defendant GlaxoSmithKline plc is a public company. GlaxoSmithKline plc’s ADRs trade in an efficient market on the NYSE under the symbol “GSK.” GlaxoSmithKline plc’s ordinary shares trade in an efficient market on the London Stock Exchange. Defendant SmithKline Beecham Corporation is a Delaware corporation, which is a wholly-owned subsidiary of GlaxoSmithKline plc. GlaxoSmithKline plc was created in December 2000 when Glaxo Wellcome merged with SmithKline Beecham. Both GlaxoSmithKline plc and SmithKline Beecham, as well as all of their predecessors, subsidiaries and successors, are referred to herein collectively as “GSK.” 4. Defendant Jean-Pierre Garnier (“Garnier”) was CEO and Chairman of GSK throughout the Class Period. By reason of his position, Garnier had access to material inside information about GSK and was able to control directly or indirectly the acts of GSK and the contents of the representations disseminated during the Class Period by or in the name of GSK. -
Evergreening and Patent Cliff Hangers CRISPR/Cas9 System and Gene
Evergreening and patent cliff CRISPR/Cas9 system and gene Being equitable about hangers editing tools equivalents Ove Granstrand Thomas Hedner and Jean Lyckel John Hornby Page 4 Page 12 Page 24 Second medical use claims Do rules experience culture The patentability of Dosage and scope of protection shock? Regimes Clara Berrisch Lisa West Åkerblom Ester-Maria Elze Page 38 Page 48 Page 60 Safeguarding public health In pursuit of Robinson Crusoe The CJEU clarifies the effects in the wake of hegemonic Kristina Björnerstedt of skinny labelling intellectual property rights and Gunnel Nilsson Sofia Bergenstråhle Katarina Foss-Solbrekk Page 94 and Valter Gran Page 76 Page 98 Editorial Preface “Some industries are different but some are more different than others. The discusses how developing countries’ access to medicines is EDITOR-IN-CHIEF pharmaceutical industry fits the latter category” (Scherer 1996:336). There is impeded by the patent system as well as how flexibilities in really no other industry where the nature of the products, the economics of the international and national legal framework contribute Silvia A. Carretta research and development as well as the market structure and the societal to this end. The article shows that while exceptions to implications of the industry’s strategic decisions are as unique as in the patent rights might not be as effective, they have however pharmaceutical industry. Furthermore, there is no other industry that tests triggered a very interesting development of voluntary the boundaries and effects of intellectual property (IP) rights on a national and licensing, a company-centered initiative providing access international level as the pharmaceutical industry. -
Creditor Rights and Allocative Distortions – Evidence from India
Creditor Rights and Allocative Distortions { Evidence from India Nirupama Kulkarni CAFRAL (Reserve Bank of India) April 5, 2018 Creditor rights and Allocative Distortions I Large literature on creditor rights and impact on credit access I +: Due to higher payoffs (La Porta et. al (1998)). I −: Due to liquidation bias ((Hart and Moore (1994), Vig (2012)). I −: Heterogeneous impact (Lilienfeld-Toal, Mookherjee and Visaria (2012)). I This paper: focuses on the general equilibrium effects of creditor rights. I Delays in creditors' ability to seize defaulters' assets prevents reallocation of resources to their best use. I # creative destruction =) spurious allocation of resources. I \Evergreening" and \zombie" distortions (Caballero et al. (2008)). Do improvements in creditor rights lead to a better allocation of debt (and other resources)? This paper . My setting: Exploit a collateral reform in 2002 in India that made it easier for creditors to seize secured assets. I Step 1: Examine reallocation of debt away from low quality borrowers to high quality borrowers (Partial Equilibrium). I Step 2: Examine whether this is partly driven by the reduction in zombie firms. I Step 3: Examine spillovers on non-zombies due to reduction in zombie distortions (General Equilibrium). I Step 4: Examine productive efficiency at the industry level. Preview of Findings 1. Reallocate secured debt away from \low quality" borrowers: # INR 39 million (75 %). I No similar impact on unsecured borrowing, " in interest rates by 72 bps =) NOT driven by liquidation bias. 2. 59% reduction in secured borrowing due to reduction in zombie lending (\evergreening"). 3. Spillover effects on non-zombies due to reduction in zombie distortions. -
Drug Pricing and Pharmaceutical Patenting Practices
Drug Pricing and Pharmaceutical Patenting Practices February 11, 2020 Congressional Research Service https://crsreports.congress.gov R46221 SUMMARY R46221 Drug Pricing and Pharmaceutical Patenting February 11, 2020 Practices Kevin T. Richards, Intellectual property (IP) rights in pharmaceuticals are typically justified as necessary to allow Coordinator manufacturers to recoup their substantial investments in research, development, and regulatory Legislative Attorney approval. IP law provides exclusive rights in a particular invention or product for a certain time period, potentially enabling the rights holder (e.g., a brand-name drug manufacturer) to charge Kevin J. Hickey higher-than-competitive prices. If rights holders are able to charge such prices, they have an Legislative Attorney incentive to lengthen the period of exclusive rights as much as possible. Indeed, some commentators allege that pharmaceutical manufacturers have engaged in patenting practices that unduly extend the period of exclusivity. These critics argue that these patenting practices are used Erin H. Ward to keep drug prices high, without any benefit for consumers or innovation. Criticisms center on Legislative Attorney four such practices: “Evergreening”: So-called patent “evergreening” is the practice of filing for new patents on secondary features of a particular product as earlier patents expire, thereby extending patent exclusivity past the original twenty-year term. Later-filed patents may delay or prevent entry by competitors, thereby allowing the brand-name -
Explaining and Comparing
ACES EU CENTERS OF EXCELLENCE AY2011GRANT- 12DELIVERABLE GWU Explaining and Comparing AY 2011-12 To Promote the Progress: Why Do States Create New Intellectual Property Rights? Gabriel J. Michael 1 To Promote the Progress: Why Do States Create New Intellectual Property Rights? Gabriel J. Michael1 August 15, 2012 Table of Contents Introduction 3 Dependent Variable 7 Theories 10 Existing Literature 10 Preferred Theory 14 Hypotheses 21 Scope Conditions 23 Alternative Theories 24 Collective Action Theory 24 Varieties of Capitalism 25 Methodology 26 Unit of Analysis 26 Case Selection 26 Geographical Indications 27 1 Doctoral Candidate, Department of Political Science, The George Washington University. This project is supported by a grant from the American Consortium on European Union Studies. The author can be reached at [email protected] 2 Fashion Designs 29 Data Exclusivity 30 Software 32 Research Design 36 Conclusion 38 Introduction Why do states create new intellectual property rights? While the main forms of intellectual property (IP)—patents, copyrights, trademarks, and trade secrets—have a long and storied history, during the 20th century a number of actors sought out legal protection for a variety of goods whose principal value was intangible. In some cases their efforts were successful, and states around the world created new bodies of law to protect the items in question, even going so far as to pressure other states to adopt similar legislation. In other cases these efforts failed, and states refused to create new IP rights. In still other cases, states pigeonholed or subsumed what could have been a new form of IP into an existing body of law. -
Stimulating Innovation in the Biologics Industry: a Balanced Approach to Marketing Exclusivity
Stimulating Innovation in the Biologics Industry: A Balanced Approach to Marketing Exclusivity by Laurence J. Kotlikoff Professor of Economics Boston University September 2008 Stimulating Innovation in the Biologics Industry: A Balanced Approach to Marketing Exclusivity1 Executive Summary Bestowing lengthy monopolies by statute on brand biologic com- panies not only greatly delays entry by competitors with low-cost New and improved medications are critical to Americans’ health alternatives, but also excludes other innovators from building — in and welfare. Today, the most significant, but also most expensive, a timely manner — on the stock of prior knowledge — much of advances in medications come in biologics. Biologics are protein- which was accumulated at public expense. THE BIOLOGICS INDUSTRY IN INNOVATION STIMULATING based, rather than chemical-based, medicines. The new drugs can be of tremendous help in alleviating, if not curing, a wide New medications that alleviate or cure terrible disease are such range of heartbreaking diseases. At the same time, their prices are remarkable gifts that we all want to do everything possible to con- remarkably high, leaving millions of uninsured and underinsured tinue their discovery. But the new drugs of today are not those of Americans unable to access their use. tomorrow. The reason is clear. Today’s inventors have strong incentives to protect their discoveries, not to make new ones whose As policymakers in Congress debate legislation to create an approval arrival on the market would undermine their existing profits. pathway for affordable biologic medicines, a strong case has been made regarding the potential savings and increased access that Numerous papers in the economics literature on invention and will result. -
Evergreening in the Euro Area: Facts and Explanation
A Service of Leibniz-Informationszentrum econstor Wirtschaft Leibniz Information Centre Make Your Publications Visible. zbw for Economics Steinkamp, Sven; Tornell, Aaron; Westermann, Frank Working Paper Evergreening in the Euro Area: Facts and explanation Working Paper, No. 113 Provided in Cooperation with: Institute of Empirical Economic Research, University of Osnabrueck Suggested Citation: Steinkamp, Sven; Tornell, Aaron; Westermann, Frank (2018) : Evergreening in the Euro Area: Facts and explanation, Working Paper, No. 113, Osnabrück University, Institute of Empirical Economic Research, Osnabrück This Version is available at: http://hdl.handle.net/10419/184713 Standard-Nutzungsbedingungen: Terms of use: Die Dokumente auf EconStor dürfen zu eigenen wissenschaftlichen Documents in EconStor may be saved and copied for your Zwecken und zum Privatgebrauch gespeichert und kopiert werden. personal and scholarly purposes. Sie dürfen die Dokumente nicht für öffentliche oder kommerzielle You are not to copy documents for public or commercial Zwecke vervielfältigen, öffentlich ausstellen, öffentlich zugänglich purposes, to exhibit the documents publicly, to make them machen, vertreiben oder anderweitig nutzen. publicly available on the internet, or to distribute or otherwise use the documents in public. Sofern die Verfasser die Dokumente unter Open-Content-Lizenzen (insbesondere CC-Lizenzen) zur Verfügung gestellt haben sollten, If the documents have been made available under an Open gelten abweichend von diesen Nutzungsbedingungen die in der dort Content Licence (especially Creative Commons Licences), you genannten Lizenz gewährten Nutzungsrechte. may exercise further usage rights as specified in the indicated licence. www.econstor.eu Note: This working paper is a substantially revised version of an older working paper published under the reference: Steinkamp, Sven, Aaron Tornell and Frank Westermann, "The Euro Area’s Common Pool Problem Revisited: Has the Single Supervisory Mechanism Ameliorated Forbearance and Evergreening?" IEW Working Paper No.