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Finding an Intellectual Property Balance with Stem Cell Research
There are several challenges with protecting intellectual property (IP) in stem cell research. A balance must be struck between protecting the resources invested by companies and Universities with the need to share information and enable future research.
A recent article in Science titled, “Access to Stem Cells and Data: Persons, Property Rights and Scientific Progress,” outlines the difficulties in protecting IP in stem cell research. The crux of the dilemma is that scientists need data and material, i.e., stem cells, to conduct research and further therapeutic opportunities, but the resulting discoveries need to be protected so that individual entities conducting the research can be compensated for their investment. Where is the balance?
The authors of the article outline three topics that are key areas for debate. The first is the balance between “information and materials.” The issue is that information about the cells and the cells themselves are closely linked, making it difficult to separate the two in order to protect one and allow access to the other. In addition, live cells are evolving and the authors point out “what a cell is today isn’t necessarily what it will be tomorrow.” How does one patent a fluid and evolving process?
The next topic discussed is “persons versus artifacts.” Cells taken from living humans contain that human’s complete genome and a great deal of information is collected from donors. This information is sensitive, making privacy a big concern. The authors state that since the publication of “The Immortal Life of Henrietta Lacks” and discussion around the creation of the HeLa cell line, concerns have been raised regarding informed consent, commercial use of cell lines derived from a human donor, and the relationship between donated cells and their donors.
The last issue discussed was the debate on what is “public versus private” and how to determine what should be made available to the public, what can be privately owned, and whether the donors themselves have any claim to discoveries made with their cells. In addition, how can research continue and flourish if there is no sharing of data or materials?
In summary, the article describes a possible solution to these challenges in the form of an information and material hub for stem cell research, which could serve as a gatekeeper and manage the IP, ethical, and privacy concerns. The problem with this kind of hub would be maintaining the required security to protect the data, people to do the work, and significant funding.
It seems clear that for stem cell research to thrive there must be a way for information to be shared. This is a basic tenant of scientific research; to build on the earlier research of others and the promise of stem cells will be compromised if this is prevented. On the other hand, the industry of stem cell therapeutics will never thrive if IP cannot be protected. Companies and Universities who are investing significant resources in this research must be able to recoup monetary losses and make a profit from their investment. For stem cells to reach their full potential, a balance must be achieved between sharing of information and protection of intellectual investment.
To read the full article see www.ScienceMag.org – Volume 301, Feburary 11, 2011