Stem Cell Patents

By Dr. Ananya Mandal, MDReviewed by April Cashin-Garbutt, MA (Editor)

Stem cell patents in the United States and Canada

Three human embryonic stem cell patents are held by the Wisconsin Alumni Research Foundation (WARF) in the United States. These are based on University of Wisconsin scientist James Thomson’s pioneering research. The US Patent and Trademark Office (USPTO) had granted these patents in 1998 and 2001 (due to expire in 2015 and 2018).

The patents on human embryonic stem cells involve claims on human embryonic stem cells and the processes involved in making the stem cells. WARF in its turn has allowed two companies, Geron and Wicell, to license its patents to various users including the National Institutes of Health (NIH).

An agreement made to similar effect allows the NIH, Centers for Diseases Control (CDC) and the US Food and Drug Administration (FDA) to utilize the human embryonic stem cells in research. This agreement also allows the NIH to distribute embryonic stem cells to academic institutions for research.

These patents have managed to keep competitors out of the US market and this according to some may hinder research. Canada however has so far refused to grant patents on human embryonic stem cells.

Stem cell patents in Europe

The picture in Europe is different. In 1999, the European Patent Office (EPO) had issued the University of Edinburgh a patent for isolating and purifying human embryonic stem cells. This was met with a strong opposition forcing EPO to reverse its decision.

In the United Kingdom patents may be granted for pluripotent and multipotent human embryonic stem cells but not on totipotent embryonic stem cells. These totipotent stem cells have the potential to develop into human beings. Sweden allows patents on human embryonic stem cells.

On 18th of October 2011 the European Court of Justice announced a landmark decision that banned patenting of inventions based on embryonic stem cells. This decision is legally binding for all EU states.

The German Federal Patent Court had earlier referred the case to the European Court of Justice for interpretation of European biotechnology regulations. The court ruled that no patents can be granted for inventions based on embryonic stem cells even if the cell lines were established in the laboratory many years ago and the intervention does not involve obtaining embryonic cells.