In This Issue:

Legal Implications and Business Considerations for Technologies Involving Human Embryonic Stem Cells in Europe and U.S.; The Expedited Request for Continued Examination – Choosing the Right Strategy for Fast-Tracked Prosecution; and Patent Term Extensions and Regulatory Exclusivities for Pharmaceuticals in Asia and South America.

Excerpt from Legal Implications and Business Considerations for Technologies Involving Human Embryonic Stem Cells in Europe and U.S.

The future may be getting brighter for stem cell researchers in the United States as restrictions for funding of stem cell research have been loosened, but efforts to commercialize stem cell technologies have faced a new hurdle with a recent decision by a European court regarding the patentability of human embryonic stem cells. In October 2011, the Court of Justice of the European Union (CJEU) issued a decision ruling that inventions related to human embryonic stem cells are unpatentable in the European Union. An aspect of the court’s decision that is particularly troublesome to stem cell practitioners is the court’s ruling that even if claims in a patent application do not require destruction of a human embryo per se, if the claim is construed to use cells that had to have been obtained by the destruction of a human embryo, then the claim is not patentable. The court ruling does not prohibit stem cell research in Europe but limits patent protection for human embryonic stem cells, methods that use human embryonic stem cells, and cells that are derived from human embryonic stem cells. This European court decision will have major implications for stem cell companies when formulating a global patent protection strategy and should be considered as part of the business plan.