U.S. Stem Cell Patents and Considerations for Reform

U.S. Stem Cell Patents and Considerations for Reform

On March 9, 2009, President Obama signed an executive order removing restrictions on federal funding for research involving embryonic stem cells.  Prior to the signing, he noted that the Federal government plans to vigorously support scientists who pursue stem cell research.  Stem cells are found in almost all multi-cellular organisms and are characterized by their ability to differentiate into a wide range of specialized cell types.  There are two broad categories of stem cells: embryonic and adult stem cells.  Embryonic stem cells can differentiate into all types of adult cells, while adult stem cells can only differentiate into the cell types of their tissue of origin.  Many researchers believe that stem cell therapies have the potential to drastically improve the treatment of human disease.  As a result of the removal of the ban on funding, there is likely to be increased interest in stem cell research.  This post will examine the current state of U.S. stem cell patents, and will outline considerations that could be assessed in reform discussions.

In February 2008, the United States Patent and Trademark Office (“USPTO”) upheld the claims of an embryonic stem cell patent held by the Wisconsin Alumni Research Foundation (“WARF”).  One month later, the USPTO upheld two other WARF patents for human embryonic stem cells.  Together, the patents broadly cover a method of isolating human embryonic stem cells and five unmodified stem cell lines. 

In praise of the decision, some have argued that such intellectual property protections are critical to stimulating private-sector investment in stem cell technology and commercializing new treatments.  However, the challengers to the patents and their supporters disagreed with the decision, arguing that WARF’s stem cell patents are overbroad.  In addition, they are concerned that granting such broad patents will lead to a situation where stem cell research will be monopolized by the few institutions that hold the key patents, which will have a chilling effect on useful research.  At the same time, others view the decision as a victory for the challengers, since the USPTO narrowed the claims of the three patents and WARF has eased its previously burdensome licensing requirements.

In response to the challengers’ concerns that overbroad patents will slow research, a number of considerations have been raised.  First, the scope of patent protection could be limited by using more restrictive tests when interpreting existing patent criteria such as novelty, utility, and non-obviousness.  Second, the National Institutes of Health could support exemptions that give third parties access to stem cell research.  Third, compulsory licensing could enable third parties to obtain access to stem cell research without authorization from the patent owners.  Fourth, competition law could intervene in cases where market power is misused.  While some considerations are more intrusive than others, it is clear that despite WARF’s currently held stem cell patents and the USPTO’s decision, other avenues for access to stem cell research exist.

In order to achieve President Obama’s goal of increased stem cell research, it seems that a balance must be struck between providing incentives for private sector investment in stem cell technology and allowing third party researchers access to it.