Therapeutic applications of stem cells are central to the
promise of regenerative medicine. An increasing number of stem cell
therapies are being approved for clinical use and by some estimates
the global market is expected to grow to ~5 billion dollars by
2024. However, commercializing any therapeutic application is
difficult. Careful consideration of patent strategy at the outset
of R&D is critical for establishing a competitive
advantage.
Different jurisdictions have different restrictions on what may
be patented. In most cases, claims directed to isolated stem cells
as well as therapeutic uses of those cells are permissible in
Canada and Europe as long as the claims meet the remaining criteria
for patentability such as novelty and inventiveness. In the United
States, isolated products of nature are no longer considered
patentable subject matter. This may limit the availability of
patent protection for cells that are not “significantly
different” from those found
