Patentability of Stem Cells

Resnik DB. The commercialization of human stem cells: ethical and policy issues. Health Care Analysis, 2002;10(2): 127-54.
The author argues that there has been a shift from a broader question of whether hESC research should be done at all to more specific concerns over who will own the products of stem cell research. The author then reviews different arguments for and against property rights before making several recommendations: (1) It should be legal to buy and sell ES cells and products;  (2) It should be legal to patent ES cells, products, and related technologies; (3) it should not be legal to buy, sell, or patent human embryos; (4) patents on ES cells, products, and related technologies should not be excessively broad; (5) they should be granted only when applicants state definite, plausible uses for their inventions; (6) there should be research exemptions for academic scientists in the field; (7) it may be appropriate to limit companies from using patents purely in efforts to block competition; (8) revisit these issues as the field progresses.

Rutz B, Yeats, S. Patents: patenting of stem cell related inventions in Europe. Biotechnology Journal. 2006 Apr;1(4): 384-7.
In this report, the authors focus on the legal situation under the European Patent Convention (EPC) that currently covers 31 countries, including all EU member states, except Malta. They also examine the issue of patentability and interpret some of the relevant patent law. They conclude that the patentability of hESC is subject to controversial debate and the legal situation differs considerably internationally.

Porter G, Denning C, Plomer A, Sinden J, Torremans P. The patentability of human embryonic stem cells in Europe. Nature – Biotechnology. 2006 Jun;24(6): 653-5.
An analysis of European human embryonic stem cell patents indicates that academia and industry face great challenges patenting hESC technologies in Europe.

Williams G. Patenting of stem cells. Regenerative Medicine. 2006 Sep;1(5): 697-703.
The author discusses the patentability of stem cells by comparing the legal issues affecting the issue in both the United States and in Europe. It views the type of patents that have been used in order to identify the trends in patenting for this controversial subject. The author argues that this is important in understanding the nuances of investment in stem cell research because of the desire to protect the results of the investment.

Salter B. Patenting, morality and human embryonic stem cell science: bioethics and cultural politics in Europe. Regenerative Medicine. 2007 May;2(3): 301-11.
The author examines the tension within the international market created by the difficulties of patenting stem cell science and technology. There are conflicts between patenting and morality at the national and international level, as demonstrated by the experiences of the European Patenting Office. Problems arise when trying to govern a scientific operation economically while still being sensitive to cultural values and policy.

Hansson MG, Helgesson G, Wessman R, Jaenisch R. Commentary: isolated stem cells–patentable as cultural artifacts? Stem Cells. 2007 Jun;25(6): 1507-10.
The author argues that an isolated embryonic stem cell basically represent a cultural artifact that is not equivalent to cells within a developing embryo and that it is likely that the isolation of adult stem cells has a similar consequence. Questions of morality, which may affect the patentability, should be viewed in light of the distinction between isolated result and body part. At the same time, it is essential that patent authorities do not accept broad patent claims that will be detrimental to research.

Resnik DB. Embryonic stem cell patents and human dignity. Health Care Analysis. 2007 Sep;15(3): 211-22.
The author examines whether hESC patents are immoral because they violate human dignity. He analyzes the concept of human dignity and its presence in the field of bioethics, and concludes that patents on human embryos or totipotent embryonic stem cells violate human dignity, but patents on pluripotent or multipotent do not. The main reason is the prior type can develop into an adult human, the latter can only be used to develop human tissue. Patents on processes for creating, culturing, preserving, or testing all types of cells is ethical since it does not treat an embryo as a property and does not violate their right to respectful treatment. Furthermore, even though patents on the latter type do not violate human dignity they are still troublesome because they might encourage people to treat embryos in general as property. Patent agencies should avoid this situation by making sure that patents on the latter type do not have any claims on human embryos or totipotent stem cells.

Vrtovec KT and Vrtovec B. Commentary: is totipotency of a human cell a sufficient reason to exclude its patentability under the European law? Stem Cells. 2007 Dec;25(12): 3026-8.
The authors write: “This article argues that totipotent character of human totipotent cells – defined as the capacity of a cell to differentiate into all somatic lineages (ectoderm, mesoderm, endoderm), the germ line and extra-embryonic tissues such as the placenta – is not a sufficient reason to exclude their patentability” on the basis of the EC Biopatent Directive. “Since human totipotent cells have both the potential to generate an entire new organism or to generate only different tissues or organs of an organism, they simultaneously fit the definition of the unpatentable human body at the earliest stage of its formation as well as of an element of the human body, which “may constitute a patentable invention.” The authors suggest that, when evaluating patentability of human totipotent cells, they should be further evaluated according to their location and their method of derivation (i.e., whether human totipotent cells are located in the human body, whether they are isolated from the human body, or whether they are produced otherwise by means of a technical process).”

*Plomer A, Taymor KS, Scott CT. Challenges to human embryonic stem cell patents. Cell Stem Cell. 2008 Jan 10;2(1): 13-7.
The authors consider the moral and legal challenges faced by the WARF patents in both Europe and the United States. WARF maintains a stronger patent position in the United States than in Europe due to the lack of any morality clause in patent policy for the former. Europe, on the other hand, presents in a confused state, with different states exercising a variety of approaches to patents based on variations in how the relevant moral principles play out across the nations. Even if alternative methods are developed that do not utilize the WARF patents, the authors believe WARF and Geron will continue to pursue control over stem cell technologies. The authors argue that this will result in an extremely complicated and unusual situation where patent law will be influenced by discrete national and jurisdictional dimensions, rather than a unified globalization of new scientific technologies.

Bonetta L. European stem cell patents: taking the moral high road? Cell. 2008 Feb 22;132(4): 514-6.
The author discusses the state of the WARF patents and the EPO morality clause that initially denied intellectual property rights. In the article, written before the EPO decision in 2008, Bonetta argues that other breakthroughs that sidestep the WARF patents may also be subject to similar morality clauses, and therefore not necessarily offer an easy solution to the problem. She mentions that experts hope that an EPO ruling will being homogeny within Europe by providing a broad standard for ethical issues in the area of science.

San Martin B. Embryonic stem cells: the moral dilemma of patentability and funding. Pharmaceutical Technology Europe. 2009: 21(9).
The author summarizes some of the key changes and debates surrounding the patentability of hES cells in the US, UK, and Europe. While all stem cells and their uses are patentable in the US and most Asia countries, its patentability in Europe is less clear. “According to the European Patent Convention (EPC), it is not possible to patent the human body at the various stages of its formation and development, or the simple discovery of one of its elements, including the sequence or partial sequence of a gene.” EPC has also excluded patents that are “contrary to public order or morality,” including processes that involve human cloning, modifying the germ line genetic identity of human beings, or use embryos for commercial purposes. The exclusion of the use of human embryos for commercial purposes raises questions about the patentability of hES cells and its applications. In a recent judgment, EPO said that inventions involving hES cells are not patentable if the only way to obtain the cells is by destroying human embryos. The UK IPO revised its guidelines to recognize the benefits of potential treatments for various diseases. The UK IPO no longer views commercialization of human pluripotent cells as “contrary to public policy or morality in the UK.” It is not clear whether EPO will follow UK IPO in revising its guidelines on hES cells. In the US, President Obama has lifted the ban on federal funding for hES cell research, but prohibits the use of funding for creating new hES cells or the destruction of embryos. NIH is tasked with writing the guidelines for implementing the Executive Order. Some worry that informed consent requirements can slow down research, especially when applied retrospectively.

Shyntum Y, Kalkreuter E. Stem cell patents–reexamination/litigation–the last 5 years. Tissue Engineering Part B Reviews. 2009 Mar;15(1): 87-90.
The authors discuss some of the key patent issues in three recent stem cell cases, including Consumer Watchdog’s challenge against three stem cell patents held by WARF regarding the standard of patentability used by the Patent Office; Neuralstem, Inc. and StemCells, Inc. both filed suits against each other over issues of patentability and infringement of a set of neural stem cell patents; and patent infringement suits filed by Pharmastem Therapeutics, Inc. against eight private cord blood banking companies. According to the authors, “current opinion is that it is more difficult to get a valid patent, and easier to challenge existing patents as obvious over the prior art in view of the recent Supreme Court decision in KSR Int’l Co. v. Teleflex

Fitt R. New guidance on the patentability of embryonic stem cell patents in Europe. Nature – Biotechnology. 2009 Apr;27(4): 338-9.
The author discusses various issues highlighted in the latest ruling by the European Patent Office regarding the WARF patents, including exceptions to patentability (commercialization of inventions contrary to the “ordre public” or morality), four questions considered by the Technical Board of Appeal in determining patent exceptions on moral grounds, and the impact of the ruling, which made it clear that patents involving the destruction of human embryos will not be granted by the EPO, while the use of existing hES cell lines is permitted. Following this ruling by the EPO, the UK IP Office has also issued a new practice notice consistent with the EPO policy of not granting patents for processes of obtaining hES cells involving the destruction of human embryos. However, the UK IP Office “decided that the commercial exploitation of inventions concerning human embryonic pluripotent stem cells would not be contrary to public policy or morality in the UK.”

Treichel P. Patenting of human embryonic stem cells in Europe. Biotechnology Journal. 2009 Apr;4(4): 462-4.
The author discusses the morality clause of the European Patent Convention and how that has impacted rulings by the European Patent Office, including the rejection of the patent application filed by WARF in 1995.

Chapman AR. The ethics of patenting human embryonic stem cells. Kennedy Institute Ethics Journal. 2009 Sep;19(3): 261-88.
The authors discuss the different approaches the USPTO and the European Patent Office took on the WARF patents and the ethical issues associated with these patents, “placing the discussion in the context of the deontological and consequentialist ethical issues related to human embryonic stem cell patenting.” The authors also recommend a patent system that “explicitly takes ethical factors into account and explores options for new types of intellectual property arrangements consistent with ethical concerns.”

*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

Plomer A.  Stem Cell Patents in a Global Economy: The Legal Challenges. Stanford 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.

*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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