Intellectual Property

Knowles SM, Adams SD. Who owns my DNA?: the national and international intellectual property law on human embryonic tissue and cloning. Cumberland Law Review. 2001-2002;32(3): 475-86.
The authors discuss the problems surrounding federal regulation of cloning and use of embryonic stem cells. The authority given to the FDA to regulate experimentation has been highly disputed because of the difficulty in categorizing gene therapy as a “drug.” Further, the authors describe the discussions that have led to U.S. patent laws that create legal distinctions between patenting techniques for reproductive cloning and therapeutic cloning of humans, and between patenting techniques for human and non-human subjects. Considering the multifaceted and nuanced moral arguments on either side, it is obvious that the subject is far from reaching national, let alone international, legal agreement.

Caulfield TA. From human genes to stem cells: new challenges for patent law? Trends in Biotechnology. 2003 Mar;21(3): 101-3.
The author argues that stem cell research will face increasing ethical challenges in relation to intellectual property concerns. Caulfield recommends using lessons learned in gene patenting to serve as guide for developing coherent new policy that is transparent and internationally relevant.

Then SN. Stem cell technologies: regulation, patents and problems. Journal of Law Medicine and Ethics. 2004 Nov;12(2): 188-204.
A key feature of the development of stem cell research is that it falls under the jurisdiction of different governments, some of which have opposing views on its moral status. The author examines the basis of the lack of universal approach to regulate stem cell research by comparing the policies of the United States, the United Kingdom, and Australia, and identifies problems with the attempts to patent the technologies, as well as the implications for future research.

Wadman M. Licensing fees slow advance of stem cells. Nature, 2005 May;435(7040): 272-273.
The author discusses varying views on the broad human embryonic stem cell patents held by the Wisconsin Alumni Research Foundation (WARF) and their impact on R&D at universities and companies. According to one scientist, “The greatest roadblock to the development of human embryonic stem-cell research in the United States is WARF’s fundamental patent.” Scientists and companies complain that the fees and aggressive patenting and licensing strategies of WARF are slowing down research. WARF argues that such policies are important because it allows WARF to honor promises made to the donors of the embryos used to generate the cell lines.

Loring JF, Campbell C. Science and law. Intellectual property and human embryonic stem cell research. Science. 2006 Mar 24;311(5768): 1716-7.
In this commentary, the authors describe the WARF patents that cover HES cells in the US and their implications for hESC research. They explore the patents themselves, what these patents protect, how they became patented in the first place, how these patents affect science research, and whether they are ultimately enforceable.

*Kiatpongsan S. Intellectual property and patent in stem cell research era. Journal of the Medical Association of Thailand. 2006 Nov;89(11): 1984-6.
The author argues that intellectual property and patents will inevitably be of vital interest to stem cell researchers. To allow for the development of affordable stem cell therapies and innovative treatments for patients international patent barriers must be overcome. Kiatpongsan argues that the owner of the original research material must be allowed to receive proper acknowledgement for findings in order to build his or her career and gain financially. Overcoming the barriers that exist in international patent law will be crucial to progress in the field.

Martin-Rendon E, Blake DJ. Patenting human genes and stem cells. Recent Patents on DNA and Gene Sequences. 2007;1(1): 25-34.

The authors provide a landscape of recent patents on pluripotency, gene transfer into stem cells and genetic reprogramming and review hematopoietic and embryonic stem cells as model systems. They note that future directions for patenting human genes and stem cells are following a new and tighter guidelines established by the patent offices such as the USPTO, and that the ethical debate continues to lag behind the fast developing science of stem cell research. They conclude however, that the science of stem cells will advance because of the great therapeutic upside of possible treatments, even without the support of the private sector.

*Bergman K, GD Graff. The global stem cell patent landscape: implications for efficient technology transfer and commercial development. Nature – Biotechnology, 2007 April. 25(4): 419-424.
The authors provides an overview of the key issues and trends in stem cell patents, including the rate of stem cell patent applications and grants, stem cell patenting activities by country, distribution and concentration of stem cell patent ownership by sector and assignee, technical areas in stem cell patenting, and the most dominant stem cell patents. The authors also propose a solution to the existing patent thicket by means of a “intellectual property clearinghouse mechanism.” The main functions of such a clearinghouse would be to provide a database on available patents for licensing thereby promoting openness and access, as well as a more established set of “best practices” in order to promote ethical and efficient transfer of information. Where there are multiple competing technologies, a clearinghouse will allow transparent competition for the best available product.

see also:
Bergman K, Graff GD. Collaborative IP Management for Stem Cell R&D. Center for Intellectual Property, Göteborg, Sweden, and Public Intellectual Property Resource for Agriculture, Davis, California, USA, published online.

*Caulfield T et al. Patents, commercialization and the Canadian stem cell research community. Regenerative Medicine, 2008. 3(4): 483-496.
The authors present a survey of Canadian stem cell researchers to determine their attitudes toward commercialization and patent issues in research. About half had a negative attitude toward patents. Concerns about patents included information withholding and decreased accessibility to research materials. “Results indicate that although many researchers believe that patents may have adverse effects on research, very few have encountered any such effects in practice. The researchers admitted to withholding data to protect patenting opportunities, while also maintaining that patents did not contribute to publication delays. The pressure to commercialize their research was largely held to be reasonable by researchers.”

*Martin P, Hawksley R, Turner A. The Commercial Development of Cell Therapy—Lessons for the Future? Survey of the Cell Therapy Industry and the Main Products in Use and Development. Institute for Science and Society, University of Nottingham. 2009 April.
The authors summarize the findings of an international survey of the cell therapy industry, completed in January 2009, to assess the current state of private sector activity, the prospects for the future of the industry and the main challenges it currently faces. It also attempted to map the commercial development of cell based therapies within regenerative medicine and tissue-engineering, describe the main products on the market or in development, and chart the changing pattern of the industrial collaborations in this area. Using this summary, the authors provide recommendations in the following areas: addressing the risk of market failure; supporting SMEs; bridging the development funding gap; building manufacturing capabilities; reducing regulatory uncertainty; creating realistic expectations.

*Plomer, A., Torremans, P. Embryonic Stem Cell Patents: European Law and Ethics. Oxford: Oxford UP, 2009.
Comprehensive multidisciplinary treatment of the application of European patent law in the field of human embryonic stem cells and the role of ethics and morality in patent law, especially in stem cell related applications

Offers practical solutions to dealing with problems in this controversy, such as how the regime of the Biotech Directive can be made to work and unblocking the current stalemate surrounding the patentability of human embryonic stem cell related applications

Centres around and contributes to a controversial and newsworthy current debate in science, dealing with many of the legal and ethical questions raised

CONTENTS
PART I: BACKGROUND
1: The Drafting History of the European Biotechnology Directive
PART II: MORALITY, RESEARCH AND ETHICS
2: Towards Commonality? Policy Approaches to Human Embryonic Stem Cell Research in Europe
3: Human Embryonic Stem Cell Research in Central and Eastern Europe: A Comparative Analysis of Regulatory and Policy Approaches
4: Morality Provisions in Law Concerning the Commercialisation of Human Embryos and Stem Cell
PART III: EUROPEAN PATENT LAW
5: A Comparative Analysis of the National Implementation of the Directive’s Morality Clause
6: The Construction of the Directive’s Moral Exclusions under the EPC
7: Towards Systemic Legal Conflict: Article 6(2)(c) of the Biotech Directive
8: Human Dignity, Human Rights and Article 6(1) of the Biotech Directive
9: Jurisdictional and Institutional Aspects of Stem Cell Patenting in Europe (EC and EPO): Institutional and Jurisdictional Tensions of Stem Cells Patenting in Europe
10: A Transnational Institution Confronted with a Single Jurisdiction Model: Guidance for the EPO’s Implementation of the Directive from a Private International Law Perspective
PART IV: WIDER ISSUES
11: An Ethics Committee for Patent Offices
12: The Research Exemption in Patent Law and its Application to hES Cell Research
13: Human Embryos, Patents and Global Trade: Assessing the Scope and Contents of the TRIPS Morality Exception
14: Stem Cells Patenting and Competition Law

Contributors
Prof. Dr Antonina Bakardjieva Engelbrek
Professor of European Law in the Department of Law, Stockholm University
Asa Hellstadius
Lecturer, Stockholm University
Dr Rosario Isasi
Postdoctoral Researcher, Centre de Recherche en Droit Public (CRDP), University of Montreal
Professor Bartha Knoppers O.C., PhD
Canada Research Chair in Law and Medicine, Professor at the Faculte de Droit, University of Montreal; Senior Researcher at the Centre for Public Law (CRDP) and Officer of the Order of Canada and Fellow of the AAAS
Dr Josef Kure
Assistant professor in the Faculty of Medicine at Masaryk University in Brno,Head of the Department of Medical Ethics and the University Centre for Bioethics
Elodie Petit
Research ethics consultant and a lecturer at the Bioethics Programs, Department of Social and Preventive Medicine, University of Montreal
Dr Aurora Plomer
Chair in Law and Bioethics and Director of SIBLE, School of Law, University of Sheffield
Gerard Porter Lecturer in Medical Law and Ethics, School of Law, University of Edinburgh
Professor Paul Torremans
Professor of Intellectual Property Law at the School of Law, University of Nottingham
Adrian Viens
Doctoral Candidate in Philosophy, Queen Mary, University of London

Konski AF, Spielthenner DJ. Stem cell patents: a landscape analysis. Nature – Biotechnology. 2009 Aug;27(8): 722-6.
The authors used a network or cluster method to analyze stem cell patents, enumerating the dominant patents in several areas: hematopoietic stem cells; culturing hematopoietic stem cells; embryonic-like stem cells; neural stem cells; non-human stem cell research; embryonic stem cells.  They use this method to identify the most significant patents in these areas.

Plomer A.  Stem Cell Patents in a Global Economy: The Legal ChallengesStanford Journal of Law, Science and Policy, 2010
This paper reviews recent developments in the international legal landscape on stem cell patents and compares the fate of one of the early patent applications on stem cells derived from hESCs at leading patent offices around the world.  Parts II and III set out the international and European legal contexts for the case study in Part IV, which reveals considerable international variance in the application of patentability criteria and examining standards. Part V argues that the difficulties attending the drawing of patent boundaries in this emerging field of science suggest that international initiatives to harmonize standards may be premature.  On the other hand, there is an urgent need for major investment in the global infrastructure of patent information systems to adequately support the dissemination of patent data, not only to realize the intended function of the patent system to facilitate disclosure, but also in order to facilitate monitoring and comparative analysis of international patenting trends and their impact on innovation.

Mills AE, Tereskerz, PM (2010). Empirical analysis of major stem cell patent cases: the role of universities. Nature Biotechnology. 28, 312-328.
The authors studied stem cell patents to determine the rate of litigation of such patents, and to describe that litigation for two reasons: (1) the area of stem cell research and technology is once again at the forefront of the US’ research agenda and has the potential to yield new treatments and cures, and (2) concerns about emerging anti-commons are particularly acute in stem cell research. Building on the work of Bergman and Graff (2007) the authors create two tables exploring patent litigation before January 2006 and between that date and Feburary 9, 2010. The results of their study indicate that although the rate of litigation is fairly small, the patents that do get litigated often are litigated more than once, meaning that relatively few stem cell patents account for a large portion of the litigation. Furthermore, contrary to the idea that industry is responsible for almost all patent litigation, it appears that for stem cell litigation, universities have already assumed the role of plaintiff.

Georgieva, B., & Love, J. (2010). Human induced pluripotent stem cells: a review of the US patent landscape. Regenerative medicine , 5 (4), 581-91.
The advent of iPS cells has created an additional level of complexity to the already complicated stem cell patent landscape. In this paper, the author ares that since iPS cells are not derived from human embryos, they are a less complicated source of human pluripotent cells and are considered valuable research tools and potentially useful in therapeutic applications in regenerative medicine.  Since there are only three worldwide issued patents related to iPS cells, the patent landscape in this area is fairly undefined. The auuthors provide an overiew of the issued patents as well as the pending published patent applications in the field. They conclude that the patentability of claims to iPS cells, methods for making iPS cells and treatment methods using iPS cells will likely depend on the evidence obtained via continued research and development. The value of claims to iPS cell technology will depend on the type of claims allowed by the US PTO, the overall patent landscape of iPS cells, and the speed in which vivo cell demonstrations can be achieved.

Malakoff, D. (2011). Intellectual property. Patent reform shuffles who is first in line. Science. 333 (6049), 1559-60.
Malakoff reports on the resent passage of The American Invents Act (H.R. 1249). This new law, some argue, will enable U.S. investors to compete more effectively in the global marketplace. Others, however, doubt its impact and fear that it will favor large companies and could dampen scientific collaboration and increase secrecy. The major change that this bill introduces is changing the unque US system of “first to invent” to align with the more international standard of “first to file” in regards to securing patent protection for discoveries. Reform advocates argue that shifting to the first to file system will reduce uncertainty, accelerate patent reviews, and reduce waste litigation. Other claim that the law’s true impact won’t be clear for many years.

Caulfield T. & Ogbogu (2012). Stem cell research, scientific freedom and the commodification concern. EMBO reports. 13, 12-16.
Traditionally, regulations and ethics in research were based on preserving human health and safety. However the policies governing stem cell research are highly contested as “undermining human dignity” and are, the authors argue, unrelated to protecting health and safety. Further, the authors continue, even the precise “meaning, scope and demands of the principle of human dignity” is unclear within the academic and policy communities. In addition to “human dignity,” “commodification” (“treating something untainted by commerce as a commodity”) is another term bandied around in stem cell debates that the authors consider to be “vague.” Like “human dignity,” “commodification” is rarely defined in the literature or commentaries even by high-profile sources, and similarly, the authors speculate that it is used as justification to restrict stem cell research. In this paper, the authors give examples how the term “commodification” is utilized in stem cell ethics and policy debates in order to highlight the imprecision in the term and question its use as a research-halting rationale by stem cell-naysayers. The authors believe, based on their analysis, that while this term will remain a core part of the bioethics debate surrounding stem cell research, it is unlikely that this term “can ever legitimately guide ethical analysis” due to its vagueness in use. 

*Note: entries are presented in chronological order within each category. Entries marked with an asterisk are those that we found to be particularly helpful as we developed materials for this project.

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