Human ES Cell Intellectual Property

Current HESC Patents

The process of derivation of human ES cells and any hESC lines created are currently under patent in the United States.  James Thomson of the University of Wisconsin and the  Wisconsin Alumni Research Foundation (WARF) own three patents on primate and human ES cells.  These patents are not enforceable outside of the U.S. 

WARF Key HESC Patents Fact Sheet 

The claims of patent # 6,200,806 cover:

      1. An isolated culture of human ES cells.

      2. The human ES cell isolation method.

      3. The cell lines derived using such a method.

These claims are sufficiently broad–based that any use of human embryonic stem cells in the United States for any purpose may fall under the WARF patents. 

In July of 2006, formal challenges to these patents were filed with the USPTO by two groups, the Foundation for Taxpayer and Consumer Rights (Consumer Watchdog) and the Public Patent Foundationon the basis that the discovery was not unique.

Current Status: In two separate 2008 rulings, the USPTO upheld patent 7,029,913 and patents 5,843,780 and 6,200,806.  The ruling on patent 913 can be appealed, but the decisions on patents 806 and 780 are final.

Licensing for use of human ES cells

Currently, WiCell Research Institute Inc. (a subsidiary of WARF) requires a licensing agreement, or Memorandum of Understanding (MOU) acknowledging WARF’s patent rights, for the distribution of any human ES cell lines in the US regardless of their source or NIH approval status. In addition, any University receiving human ES cells for research are expected to sign a MOU with WiCell. These licenses are free of charge to academic researchers, but commercial enterprises must pay a fee for licensing.  (Example: NIH-WiCell MOU)

Resources:

Human Embryonic Stem Cells: A Review of the Intellectual Property Landscape. (PDF) An excellent review of the patent issues surrounding human ES cells, written by Irene Abrams, Executive Director of the Office of Technology Licensing at Brandeis University in Waltham, Massachusetts. Published in the AUTM Journal (2006).

 Intellectual Property and Human Embryonic Stem Cell Research.  A 2006 article written by Jeanne Loring (Scripps Institute, La Jolla, CA) and Cathryn Campbell (McDermott Will & Emery, LLP, Washington, DC) covers the history of hESC patents, WARF licensing, and their effects on human ES cell research in the US (Science 24 March 2006: Vol. 311. no. 5768, pp. 1716 - 1717).

The patentability of human embryonic stem cells in Europe.  This 2006 paper, authored by Gerard Porter,and Paul Torremans (University of Nottingham, School of Law, Nottingham, UK), Chris Denning (University of Nottingham, Institute of Genetics, School of Biology, Queen's Medical Centre, Nottingham, UK), Aurora Plomer (Sheffield Institute of Biotechnological Law and Ethics, University of Sheffield, Sheffield, UK), and John Sinden (ReNeuron Group plc, Surrey, UK), examines Rule 23d(c) of the European Patent Convention (which prohibits patents of the "human embryo" on moral grounds) and its impact on human ES cell patents in Europe (Nat Biotech. 24:653-655).

Challenges to Human Embryonic Stem Cell Patents.  This 2008 article, written by Aurora Plomer (Sheffield Institute of Biotechnological Law and Ethics, University of Sheffield, Sheffield, UK), Kenneth S. Taymor (Berkeley Center for Law, Business and the Economy, University of California, Berkeley, Berkeley, CA) and Christopher Thomas Scott (Stanford Center for Biomedical Ethics, Stanford University, Palo Alto, CA) describe the legal and moral challenges to the US hESC patents as well as the conflicts between European Union policy on hESC patents and the policies of its member nations. (Cell Stem Cell, Vol. 2, Issue 1, 10 January 2008, Pages 13-17).

Fourth UK National Stem Cell Network (UKNSCN) Patents Digest covers the period of May 1 to June 30, 2009. This report contains 42 pages of information about 152 published and granted patents in the areas of adult stem cells, embryonic stem cells and iPS/de-differentiation. The UKNSCN produced this report in partnership with the UK's Intellectual Property Office.