This item is in: Biomedicine > Intellectual property, regulationPatently innovative: How pharmaceutical firms use emerging patent law to extend monopolies on blockbuster drugs
R A Bouchard, Intellectual Property Lawyer and Scholar, Canada
Woodhead Publishing Series in Biomedicine No. 7
- includes empirical research to relate innovation to drug law
- a multidisciplinary approach is taken, including the intersection of IP (intellectual property) law, drug law and innovation
- discusses the impact of government regulation on firm innovation
- brand vs. generic drug wars are also analyzed
- considers the balance of IP monopoly of private firms with public health mandate
- reviews the timeline for spread of linkage regulations worldwide and analyses the different linkage regimes in context of the policy goals predating the coming into force of legislation in each jurisdiction
The availability of generic and brand-name drugs worldwide is a function of a combination of traditional patent law incentives and emerging 'linkage regulations', which legally tie brand and generic drug approval to drug patents through mandatory litigation for generic firms. Together, these systems of intellectual property law operate to shape the marketplace for brand and generic pharmaceuticals, and thus determine the costs of public and private drug expenditures and access to essential medications in developed and developing nations.
The patent monopoly system has been in operation for about 500 years, with early patent laws in Italy and the United Kingdom. By contrast however, the linkage regime has only been in existence for 25 years following passage of the Hatch Waxman Act in the United States in 1984. By 2010, we were witnessing a global spread of the linkage regime stimulated in part by multilateral Free Trade Agreements with the United States and the European Union, which typically oblige participating nations to incorporate linkage provisions in exchange for preferential trade terms. Moreover, there appears to be movement afoot to broaden the concept of linkage outside the drug approval process to include that between patent rights and international trade regulation. Therefore, linkage regulations in respect of pharmaceuticals are emerging as a key driver of public health costs on the global stage.
Patently innovative provides a review of the importance of traditional patent law and emerging linkage regulations for pharmaceutical products on the global stage, with a focus on the linkage regime in Canada. The primary focus is on how innovation in the pharmaceutical sector can be strongly regulated and how government regulation can either stimulate or inhibit development of breakthrough products.
The work focuses on assessment of empirical data pertaining to: firstly, how linkage regulations, which legally tie drug patenting to drug approval for both brand-name and generic pharmaceutical firms can be used by sophisticated drug companies to substantially extend monopoly protection on blockbuster drugs; and, secondly, how incentives provided by government to stimulate pharmaceutical innovation can antecedently shape the rate and direction of innovation by firms in a manner opposite to that intended as a result of unintended consequences. Particular attention is given to data relating to trends in the development of 'new' and 'follow-on' drugs and the relation of these trends to the institution of reforms in drug law and patent law intended to stimulate innovation.
ISBN 1 907568 12 3
ISBN-13: 978 1 907568 12 1
296 pages 234 x 156mm hardback
£125.00 / US$210.00 / €150.00
Usually dispatched within 24 hours
About the author
Dr Ron A. Bouchard is an intellectual property lawyer and scholar, specializing in the innovation, regulation, and litigation of biomedical products. His career has focused on the science, law, policy, regulation, and commercialization of medical technologies. He began his career as a medical scientist, completing a PhD and Postdoctoral Fellowship in the field of ion channel biophysics and Ca2+ imaging. He shifted focus to obtain a law degree specializing in pharmaceutical and biotechnology law and has been involved in the prosecution, acquisition, financing, distribution, and litigation of intellectual property rights.
Dr Bouchard has appeared before the Federal Court of Canada and the Supreme Court of Canada. He has consulted with firms, universities, governments, and international organizations on legal, regulatory, and policy issues. He worked with the Government of Canada on its platforms for drug regulation and public private partnerships in technology commercialization. His research has been funded by federal and provincial funding agencies and private endowments. His scholarly expertise is focused on the intellectual property and regulatory aspects of therapeutic product development, including global aspects of technology commercialization, patenting, licensing, and regulatory approval, and empirical assessment of the impact of government stimulus packages and regulation on technology innovation. Dr Bouchard currently is involved with a new global consortium of scholars, physicians and economists studying the impact of emerging forms of patent law on the availability and costs of essential medications in developed and developing nations: the Consortium Study of Global Pharmaceutical Linkage.
Titles which may also be of interest:
The impact of regulation on drug development
Patent litigation in the pharmaceutical and biotechnology industries
Contract research and manufacturing services (CRAMS) in India
- The emergence of global pharmaceutical linkage
- Canadian pharmaceutical linkage regulations
Background: drug approval, drug patenting, pharmaceutical linkage, and public health policy
- Drug approval
- Linkage regulations
- IPR rights and innovation policy
Empirical analysis of drug approval
- Interpretation of data
- Study limitations
- Assessing the lifecycle approach: the long view
- Government as representative public agent
- Summary and conclusions
Empirical analysis of pharmaceutical innovation and drug approval-drug patenting linkage
Empirical analysis of drug patenting in multiple high-value cohorts
- Summary and conclusions
Implications of empirical data: are pharmaceutical linkage regulations a success?
- Debate preceding Bill C-91
- ‘Original policy intent’
- ‘Patent-specific’ analysis
- Statutory interpretation
- Revisiting the empirical data
- Summary and conclusions
Future directions: testable hypotheses and evolution toward global pharmaceutical linkage
- Hypotheses regarding cluster-based drug development
- Globalization of pharmaceutical linkage