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

• Author: Aurélie Mahalatchimy,Alice Yuen‐Ting Wong
• Date: 01 November 2018
• DOI: http://doi.org/10.1111/jwip.12098
• Published date: 01 November 2018

DOI: 10.1111/jwip.12098

ORIGINAL ARTICLE

Human stem cells patents—Emerging issues

and challenges in Europe, United States, China,

and Japan

Alice Yuen-Ting Wong

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Aurélie Mahalatchimy

2,3

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Albert Wai-Kit Chan Intellectual Property

Limited, Hong Kong SAR, China

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Centre for Global Health Policy, School of

Global Studies, University of Sussex, Falmer

nr Brighton, United Kingdom

3

UMR 7318, DICE, CERIC, CNRS, Aix

Marseille Université, Université de Toulon,

Université Pau & Pays Adour,

Aix-en-Provence, France

Correspondence

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.

Email: alicewonginss@gmail.com;

wonga@kitchanip.com

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.

KEYWORDS

biotechnology, intellectual property rights, patentability

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INTRODUCTION

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

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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.

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EUROPE

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Background

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.

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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 package”will enter into force once ratified by any thirteen Member States

including France, Germany and the United Kingdom (UK).

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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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