Thank you for sharing!

Your article was successfully shared with the contacts you provided.

A recent decision blocking the patenting of inventions which involve the destruction of human embryos is causing heated debate in the life sciences fraternity. Martin Hyden and Rosemarie Lee report

The patentability of human embryonic stem cells (hESCs) is a subject that has been taxing patent authorities and practitioners around the world for some time, raising difficult legal and ethical questions. While the issue has arisen in a number of cases in the past, the recent application for patent protection of inventions involving hESCs by the Wisconsin Alumni Research Foundation (WARF) has provided a focus for discussion, highlighting the different views on the subject, both within Europe and elsewhere.

What are stem cells?

To understand why this is such a vexed question, it is necessary to understand what makes stem cells in general, and hESCs in particular, so interesting. Stem cells are animal cells that remain undifferentiated (i.e. not developed into a cell of a particular organ or structure in the body), even after many cell-division cycles. They only differentiate into mature cells of a particular type after exposure to appropriate conditions. There are two broad types of human stem cells: hESCs, found in blastocysts (formed just before the embryonic stage) or embryos; and human adult stem cells (hASCs), found in adult tissue. hESCs can be ‘totipotent’, with the potential to develop into all cell types of a human being, including placental cells; or ‘pluripotent’, which means they can develop into a number of cell types, but not placental cells.

Controversial medical advances

The potential for hESC-derived treatments to provide advances in the medical world has been widely reported. It is this potential that brings stem cell technology and patenting into the limelight. There are two main aspects of hESCs that cause the related technologies to be placed under scrutiny. The first is that the conventional technique to obtain hESCs involves destruction of an early-stage embryo, raising the question of destruction of life. The second is the potential for hESCs to develop into all human cell types, raising the question of artificially creating life or cloning.

Patents in the European Union

Because of these (and other) concerns, the European Commission (EC) issued a directive in 1998 regarding patenting in the field of biotechnology (Directive 98/44/EC), which sets out classes of biotechnology invention that can and cannot be patented. This directive is binding on member states of the European Union (EU), each of which is empowered to grant patents in its own territory. The directive does not specify hESCs as a class of inventions to be excluded, but includes broader definitions that can be interpreted to include hESCs in certain cases.

Somewhat confusingly, patents can also be obtained in individual member states through the European Patent Convention (EPC). Patents granted under the EPC are done so by the European Patent Office (EPO). The EPO is an organ of the European Patent Organisation, whose members include not only member states of the EU, but also of other, non-EU, European countries. The EPO is not subject to the directives of the EC, but it has modified its rules to be essentially consistent with the 98/44/EC directive, thus avoiding potential conflict between the two systems.

The two main restrictions of the European Patent Convention relating to the patenting of hECSCs are:

This premium content is reserved for
Legal Week Subscribers.
Subscribe today and get 10% off.


  • Trusted insight, news and analysis from the UK and across the globe
  • Connections to senior business lawyers within the leading law firms and legal departments
  • Unique access to ALM's unrivalled, market-leading reporting in the US and Asia and cutting-edge research, including Legal Week's UK Top 50 and Global 100 rankings
  • The Legal Week Daily News Alert, Editor's Highlights, and Breaking News digital newsletters and more, plus a choice of over 70 ALM newsletters
  • Optimized access on all of your devices: desktop, tablet and mobile
  • Complete access to the site's full archive of more than 56,000 articles

Already have an account?

For enterprise-wide or corporate enquiries, please contact Paul Reeves on Preeves@alm.com or call on +44 (0) 203 875 0651


Legal Week Newsletters & Alerts

Sign Up Today and Never Miss Another Story.

As part of your subscription, you can sign up for an unlimited number of a wide range of complimentary newsletters and alerts. Get the timely legal news and critical analysis you cannot afford to miss. Tailored just for you. In your inbox. Every day.

Copyright © 2019 American Lawyer Media International, LLC. All Rights Reserved.