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Legal Affairs : Dec 1, 2011 ( )
Stem Cell Research in the EU and U.S.
Recent Developments Highlight Differences Between the Two Regions!--h2>
On October 18, 2011, the Court of Justice of the European Union (CJEU) published its decision in Brüstle v. Greenpeace. The Court ruled that processes that involve the derivation of stem cells from a human embryo at the blastocyst stage, entailing the destruction of that embryo, could not be patented.
This article presents a brief synopsis of the CJEU decision and compares the current differences in the patentability of stem cells in Europe and the United States. The article further considers the implications of these differences on the future of research involving human embryonic stem cells (hESC) throughout Europe and the United States.
Central to this case was the interpretation given to Article 6(2)(c) of Directive 98/44/EC (the Biotechnology Directive), which excludes inter alia, the patentability of inventions involving “the use of human embryos for industrial or commercial purposes.”
The Court held that the concept of “human embryo” must be understood to encompass any ovum once fertilized, including whether created by transfer of a nucleus from another mature cell or stimulated to cell division by parthenogenesis.
The Court went on to state that the exclusion from patentability concerning the use of human embryos for industrial or commercial purposes set out in Article 6(2)(c) of the Biotechnology Directive also covered the use of human embryos for purposes of scientific research.
However, the Court did provide a carve out from this exclusion by stating that use of a human embryo for therapeutic or diagnostic purposes that were applied to the human embryo and were useful to it are prima facie patentable.
This exception is narrow and applies only where the invention is for the therapeutic or diagnostic purposes applied to and useful to that embryo, for example to correct a malformation and to improve its chances of survival. In this instant case, the use of human embryos for purposes of scientific research was indistinguishable from industrial and commercial use and was, thus, unpatentable.
Lastly, the Court found that where an invention does not itself “use” human embryos but relates to a product whose production necessitates the prior destruction of a human embryo or a process that requires a base material obtained from such destruction, that invention would not be patentable because it would constitute use within the meaning of Article 6(2)(c) of the Directive.
Unlike Article 6(2)(c) of the Biotechnology Directive, efforts affecting stem cell research in the United States have focused largely on government funding rather than the legal scope of patentability. Since 1996, United States appropriations bills have included the Dickey-Wicker Amendment as a rider that explicitly prohibits the use of government funds for the creation of human embryos or for research in which human embryos were destroyed or discarded.
Human embryos are broadly defined to include “any organism . . . derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploids.”
The National Institute of Health interpreted Dickey-Wicker as not applying to hESCs because hESCs are not organisms as defined in the Act. In July 2009, NIH issued new guidelines for funding hESC research that distinguished between the destruction of human embryos to derive hESCs and the use of hESCs in research not involving embryos or embryo destruction. This interpretation was recently upheld in Sherley v. Sebelius.
Despite the ongoing developments for government funding of stem cell research, U.S. patent law has long recognized the patentability of stem cells and stem cell research tools. In the recent, well publicized Myriad decision, the Federal Circuit affirmed the principle that biologically pure compositions that do not occur in nature are patentable.
The USPTO’s official policy under this principle has been that stem cells and methods of making or using stem cells are patentable subject matter. Examples include the following: U.S. Patent No. 5,843,780 (issued 1998) directed to primate (including human) embryonic stem cells; U.S. Patent No. 7,682,828 (issued 2010) directed to induced pluripotent stem cells; and U.S. Patent No. 7,732,202 (issued 2010) directed to parthenogenetically derived stem cells.
Under current law, hESCs and parthenogenetic stem cells and methods of making or using such cells are patentable in the U.S., but not in the EU. This difference may require research institutions and companies to re-examine their IP, regulatory, and commercial strategies on a jurisdictional basis.
In Europe, institutions may seek to protect hESC and parthenogenetic stem cell innovation through the nondisclosure mechanisms of confidentiality and trade secrets. These institutions will need to carefully evaluate the suitability of seeking patent protection in the U.S., where the disclosure requirements of the patent system stand in conflict to the nondisclosure principles of trade secrets and confidentiality.
In the U.S., institutions that seek patent protection for these same types of innovation will have to consider the absence of prohibition on others reproducing that work in Europe. Thus, these institutions will also need to consider the potential for global protection afforded by confidentiality and trade secrets.
It remains to be seen whether investors will favor the potentially broad geographic protections of confidentiality and trade secrets or the geographically localized protections afforded by the public disclosures of the patent system.
There are efforts currently under way in the U.S. by several groups to have the definition of “embryo” under the Dickey-Wicker Amendment revised so that technologies such as parthenogenesis would fall outside of the definition. Similar efforts may also be seen in Europe in the near future that may allow for stem cell technologies aside from embryonic stem cells to gain patent protection.
Currently, there are only a limited number of companies that are true stem cell players in the global market and these include companies using hESCs, iPS, somatic cell nuclear transfer (SCNT), and parthenogenesis.
However, if the EU decision holds and stem cell research and development for hESCs, SCNT, and parthenogenesis does not enjoy legal protections under the EU patent laws, companies and investors may be less likely to proceed with their research since the EU is such an important market, thereby affecting the future of regenerative medicine on a global basis for years to come.
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