Stem cell and biotechnological research is a flourishing industry around the globe. The growth of the industry can be attributed to its promise to lead to a cure for numerous human diseases that are currently considered unconquered. Within this industry, the patentability of researched innovations has been a hot topic in the past decade. Through the patenting process, the industry itself can be a source of economic opportunity for countries willing to extend patent protection for the inventions produced by stem cell and biotechnological research. Because it takes significant resources for research to produce a patentable invention, investors desire assurances that their time and money will head a result from which they can benefit, whether that be a financial benefit, a status benefit, or some other benefit. Despite the medical promises of stem cell and biotechnological research, there are concerns in some places around the world such as the European Union about potential policy implications that would stem from patenting innovations in this industry. These concerns are displayed in the two leading sources of law governing stem cell and biotechnological research: the European Union’s Directive 98/44/EC and the European Patent Convention. This Article discusses the patentability of stem cell and biotechnological inventions under both European Union law and the European Patent Convention. The Article continues by discussing several other topics that a practitioner must be familiar with when analyzing a patentability issue. A few of these topics include the morality debate, the promise of stem cell and biotechnological research, taxation of stem cell-related products, access to records, legal notice, research funding, and the free movement of goods. This Article also examines the key case law from both the European Court of Justice as well as the two judicial organs of the European Patent Office, the Board of Appeal and the Enlarged Board of Appeal, that provide insight into this area of law. Additionally, this Article identifies the discrepancies between the law governing stem cell research and biotechnological research within the European continent and provides recommendations for greater harmonization within these two areas of law.
Jacqueline Hill Tudor and Jarrod Tudor,
Stem Cell and Biotechnological Patentability and Research in the European Union: An Interdisciplinary Approach,
87 U. Cin. L. Rev.
Available at: https://scholarship.law.uc.edu/uclr/vol87/iss4/3