Human stem cells patents—Emerging issues and challenges in Europe, United States, China, and Japan

Date01 November 2018
Published date01 November 2018
DOI: 10.1111/jwip.12098
Human stem cells patentsEmerging issues
and challenges in Europe, United States, China,
and Japan
Alice Yuen-Ting Wong
Aurélie Mahalatchimy
Albert Wai-Kit Chan Intellectual Property
Limited, Hong Kong SAR, China
Centre for Global Health Policy, School of
Global Studies, University of Sussex, Falmer
nr Brighton, United Kingdom
Marseille Université, Université de Toulon,
Université Pau & Pays Adour,
Aix-en-Provence, France
Alice Yuen-Ting Wong, Albert Wai-Kit Chan
Intellectual Property Limited, Flat D, 10/F,
Wing Cheong Commercial Building, 23
Jervois Street, Sheung Wan, Hong Kong.
Funding information
REGenableMED, Grant number: UK ESRC
Project ES/L002779/1
Stem cell technology is undergoing a rapid development for
its high potential in versatile therapeutic applications. Patent
protection is a vital factor affecting the development and
commercial success of life sciences inventions; yet human
stem cells-based inventions have been encountering signifi-
cant restrictions particularly in the perspective of patentable
subject matters. This article looks into the patentability limits
and unique challenges for human stem cells-based patents in
four regions: Europe, the United States, China, and Japan.
We will also provide suggestions for addressing the
emerging issues in each region.
biotechnology, intellectual property rights, patentability
Stem cell technology is an eye-catching and fast-growing research area with huge therapeutic potential. Human stem
cells in particular are the focus of much interest in research, and much hope and hype surrounds their clinical therapy
potential. However, ethical considerations and regulatory restrictions over human stem cells have framed the
development of regenerative medicine and drug discovery. While the legal protection of life sciences inventions via
patents has been recognized for years, it continuously raises challenges worldwide. It is especially true regarding
patents based on human stem cells, particularly human Embryonic Stem Cells (hESCs). For instance, the recent Courts
decisions regarding the restriction of patents based on hESCs in Europe and the exclusion of natural products in the
United States have undoubtedly hampered the patent protection for many human stem cells products. On the other
© 2018 The Authors. The Journal of World Intellectual Property © 2018 John Wiley & Sons Ltd
| J World Intellect Prop. 2018;21:326355.
hand, methods for the treatment or diagnosis of diseases practiced on human are generally not patentable in most
major jurisdictions. While it is difficult to have a clear idea of how the patentability limits are affecting the human stem
cells markets, it is obvious that developers of stem cells-based products or processes, whether they be academics or
companies, have to adapt their research and commercial strategies to the scopes of patentability. Looking into the
context of in-force patent laws, rules, regulations, and relevant court decisions, this paper looks into the emerging
issues in the patentability of inventions based on human stem cells in four regions: Europe, the United States (U.S.),
China, and Japan which have the majority of patents applications (World Intellectual Property Organization, 2015, p.
23). However, this article does not cover the patentability of human stem cells under the Trade-Related Aspects of
Intellectual Property Rights (TRIPS) agreement (World Trade Organization, 1994), even though the U.S., China, Japan,
all Member States of the European Union (EU) as well as the EU itself are contracting parties to the TRIPS agreement.
It should be noted that, despite each region has its unique patent system imposing various patentability requirements,
most countries build their patentability framework around five limbs of patentability; namely patentable subject
matter, novelty, inventiveness, written description and enablement. This article does not only discuss these
requirements and their standard in each of the four jurisdictions as far as stem cells are concerned. More importantly,
the authors aim to provide an overview of the patent framework and exclusions of patentability in the four
jurisdictions, and highlight the unique challenges for human stem cells-based patents in each region. We will also
provide suggestions for overcoming these obstacles and adapting the changing landscape. Last but not least, specific
aspects of the four patent systems are compared to provide a glimpse of global protection for stem cell inventions.
In Europe, patent law is relatively uniform although in addition to each State, two different organizations are
regulating the field: the European Patent Organization (EPO) and the European Union (EU).
The European Patent Organization covers 28 Member States of the EU and 10 non-EU countries.
It is based on
the European Patent Convention (EPC), a multilateral Treaty signed in Munich on October 5, 1973 (European Patent
Organisation, 1973). The EPO is mainly in charge of granting European patents. Its organizational structure notably
includes 28 independent Technical Boards of Appeal that can refer to the Enlarged Board of Appeal to ensure a
uniform application of the law. A European patent confers protection in all the contracting States that have been
designated by the applicant as long as it has been validated by their national patent offices.
The European Union regulates stem cells patents on the basis of the Directive on the legal protection of
biotechnological inventions of July 6, 1998 (European Parliament and Council, 1998). The Directive harmonizes
national patent laws: it has been transposed in every EU Member States and it is applied by their national patent
offices. Contrary to the EPO that has been established to regulate patents only, the EU competency goes beyond
patentability. Thus, it has not had a specific court for patents disputes and these matters have fallen under the remit of
the general Court of Justice of the European Union. However, in 2012, the Member States of the EU (except Spain,
Poland and Croatia) decided to establish an enhanced cooperation and to adopt the so-called patent package.It
includes a regulation creating a European patent with unitary effect (hereafter the unitary patent) (European
Parliament and Council, 2012), a regulation on the language regime applicable to the unitary patent (European
Council, 2012) as well as an agreement between the EU countries to set up a specialized Unified Patent Court
(European Council, 2013). This patent packagewill enter into force once ratified by any thirteen Member States
including France, Germany and the United Kingdom (UK).
However, following the UK's vote to exit the EU, a minima
new delay could be expected for such entry into force (Grubb, Thomsen, Wright, & Hoxie, 2016; Jaeger, 2017).
Besides already existing national patents (regulated by national laws that have been harmonized by the European
Directive 98/44/EC) and the classical European patents (regulated by the EPC), the unitary patent will be a third

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