How will patents impact the commercialization of stem cell therapeutics?

It is often assumed that patents, especially broad patents, will impede the commercialization of stem cell therapeutics. That assumption, however, merits close consideration. While a number of stem cell patents have issued and legions of applications are pending, it is far from certain that a blanket of patents will stifle the commercialization of stem cell therapeutics. A number of legal factors are lessening the impact of stem cell patents. Moreover, developments in the stem cell field are tracking historical trends for biotechnology, a field that not only survived several patent gold rushes but also is thriving because of them. In actuality, greater immediate threats to the commercialization of stem cell therapeutics are impaired public funding within the United States and a private equity market that seems unconvinced that viable stem cell business models exist.

The Current Picture for Patenting Embryonic Stem Cells

Much of the angst over stem cell patents concerns broad claims to embryonic stem cells. Various jurisdictions around the world are split, however, as to whether that particular subject matter is even eligible for patent protection. A prime example of that split exists within Europe. The European Union Biotechnology Directive excludes from patentability "human embryos," "parts of the human body," and subject matter that is contrary to "ordre public" or morality. The European Patent Office applies that exclusion to human embryonic stem cells and uses of human embryonic stem cells. The national patent office of the United Kingdom, however, considers claims to human embryonic stem cells as being outside the directive and has issued a number of patents for stem cell lines.

In the United States, regulations preclude any patent "claim ... including within its scope a human being," but the US Patent and Trademark Office (USPTO) has not deemed embryonic stem cells to be the equivalent of a human being. Thus, the USPTO has applied the standard substantive legal requirements to stem cell-related inventions, namely practical utility, written description, enablement, novelty, and non-obviousness.

Existing US Stem Cell Patents

Applying those substantive legal requirements, the USPTO has issued more than 1,000 patents directed to stem cell technologies. Some of the patents could dominate various aspects of stem cell research and development. For example, issued patents claim embryonic stem cells and methods for their use. Issued patents also claim tissue-specific stem cells, including stem cells derived from adipose, blood, breast epithelial, endothelial, liver, mesenchymal, myeloid, neural, central nervous system, pancreatic, renal, retinal, and skeletal tissues. The law presumes all of these patents to be valid, although mechanisms do exist for challenging that presumption in litigation and administrative proceedings.

Issued stem cell patents vary widely in scope and content. Exemplary stem cell patents include ones owned by the Wisconsin Alumni Research Foundation (WARF). Those patents concern research done by Dr. James Thomson, et al., at the University of Wisconsin in which isolated …