Publications

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The Court of Justice of the European Union (CJEU)¹ has ruled in Brüstle v Greenpeace that processes involving the derivation of stem cells from a human embryo at the blastocyst stage, entailing the destruction of that embryo, cannot be patented. This article briefly sums up the CJEU decision of October 2011 and compares the different approaches to patentability of stem cells being taken in Europe and the US. We also consider the implications of these differences on the future of research involving human embryonic stem cells (hESC) in Europe and the US.

Stem cell patentability in the EU

Central to Brüstle was the interpretation given to Article 6(2)(c) of Directive 98/44/EC (the Biotechnology Directive),² which excludes the patentability of inventions involving “the use of human embryos for industrial or commercial purposes.” The CJEU 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 added 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 scientific research.However, the court did provide a carve-out from this exclusion, stating that use of a human embryo for therapeutic or diagnostic purposes which were applied to the human embryo and were useful to it are prima facie patentable. This exception is narrow – for example, when the purpose is to correct a malformation and to improve its chances of survival. In Brüstle, using human embryos for scientific research was indistinguishable from industrial and commercial use and was, thus, unpatentable.

Last, 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 which 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.

Stem cell patentability in the US

Efforts affecting stem cell research in the United States have focused largely on government funding rather than the legal scope of patentability. Since 1996, US federal appropriations bills have included the Dickey-Wicker Amendment, a rider explicitly prohibiting use of government funds to create human embryos or for research in which human embryos are 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.³ In 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.

Despite the events surrounding federal stem cell research funding, US patent law has long recognized the patentability of stem cells and stem cell research tools. In the recent Myriad decision,⁴ the Federal Circuit affirmed that biologically pure compositions that do not occur in nature are patentable. The USPTO’s official policy has been that stem cells and methods of making or using stem cells are patentable. Examples include US Patent No. 5,843,780 (issued 1998) directed to primate (including human) embryonic stem cells; US Patent No. 7,682,828 (issued 2010) directed to induced pluripotent stem cells; and US Patent No. 7,732,202 (issued 2010) directed to parthenogenetically derived stem cells.

The future of patentability

Under current law, hESCs and parthenogenetic stem cells and methods of making or using such cells are patentable in the US, 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 non-disclosure mechanisms of confidentiality and trade secrets. These institutions will need to carefully evaluate the suitability of seeking patent protection in the US, where the disclosure requirements of the patent system stand in conflict to the non-disclosure principles of trade secret and confidentiality.

In the US, institutions seeking patent protection for these same innovations 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.

Efforts currently under way in the US would redefine “embryo” under Dickey-Wicker so technologies such as parthenogenesis would fall outside of the definition. Similar efforts in Europe may allow stem cell technologies aside from embryonic stem cells to gain patent protection.

Currently, only a limited number of companies are true stem cell players in the global market. However, the EU is an important market. If the EU decision holds, and stem cell R&D for hESCs, SCNT and parthenogenesis does not enjoy legal protections under EU patent laws, then companies and investors may be less likely to proceed with their research. This would affect the future of regenerative medicine on a global basis for years to come.

For more information, please contact:

Aaron Fountain

Lisa A. Haile

Philippa Montgomerie

Grant Strachan

An earlier version of this article appeared in Genetic Engineering & Biotechnology News in December 2011.  See a video of Dr. Lisa Haile discussing the hESC patent decision here.

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^{1. Formerly the European Court of Justice, known as the ECJ.}

^{2. Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions.}

^{3. See Section 509 of the Omnibus Appropriations Act of 2009.}

^{4. Ass’n for Molecular Pathology v. U.S. Patent & Trademark Office, 653 F.3d 1329 (Fed. Cir. July 29, 2011).}