Greenberg v. Miami Children's Hospital Research Institute
264 F.Supp.2d 1064 (2003)
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Rule of Law:
A research participant's voluntary donation of biological materials for medical research does not create a property interest in the subsequent research or its commercial products, nor does it impose a duty on researchers to disclose their economic interests under the doctrine of informed consent. However, a claim for unjust enrichment may exist if a researcher profits from such donations in a manner that is inequitable under the circumstances of the collaboration.
Facts:
- Beginning in 1987, Daniel Greenberg and other parents of children with Canavan disease approached Dr. Reuben Matalon to help find the gene responsible for the fatal disorder.
- The plaintiffs, a group of individuals and non-profit organizations, provided Dr. Matalon with biological samples (blood, tissue), financial support, and access to a confidential 'Canavan registry' containing family information.
- Plaintiffs provided these contributions with the understanding that the research would remain in the public domain and any resulting genetic tests would be affordable and widely accessible, based on prior experience with Tay-Sachs disease research.
- In 1990, Dr. Matalon affiliated with Miami Children's Hospital (MCH) and continued to accept samples and support from the plaintiffs.
- Using the plaintiffs' contributions, Dr. Matalon and his research team successfully isolated the Canavan gene in 1993.
- Unbeknownst to the plaintiffs, Matalon and MCH filed a patent application for the gene sequence in September 1994, which was granted in October 1997.
- In November 1998, MCH began enforcing its patent rights by charging royalty fees and sending enforcement letters to medical centers offering Canavan testing, thereby restricting access and commercializing the research.
- Plaintiffs were never informed of the defendants' intent to patent the gene, commercialize the research, or restrict access to testing.
Procedural Posture:
- Plaintiffs filed a six-count complaint against Defendants in the U.S. District Court for the Northern District of Illinois on October 30, 2000.
- The case was transferred to the U.S. District Court for the Southern District of Florida on July 8, 2002.
- Defendants Matalon and Miami Children's Hospital filed separate motions to dismiss for failure to state a claim under Fed. R. Civ. P. 12(b)(6).
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Issue:
Does a research participant who voluntarily donates biological material for medical research retain a property interest in that material or the resulting patented scientific discoveries sufficient to support a claim for conversion if the researcher commercializes those discoveries?
Opinions:
Majority - Moreno, J.
No. A research participant who voluntarily donates biological material does not retain a property interest sufficient to support a claim for conversion. Following the precedent of Moore v. Regents of the University of California, the court held that plaintiffs had no cognizable property interest in body tissue and genetic matter once it was voluntarily donated for research. The court reasoned that the patented result of research is 'both factually and legally distinct' from the raw materials used and that recognizing such a property right would 'cripple medical research' by giving donors control over research outcomes. Similarly, the court declined to extend the doctrine of informed consent to require researchers to disclose their economic or commercialization interests, finding no legal support for such a duty and noting it would be unworkable. However, the court denied the motion to dismiss the unjust enrichment claim, finding that the plaintiffs had sufficiently alleged that they conferred a significant benefit on the defendants within a collaborative relationship, and it would be inequitable for the defendants to retain all the financial rewards without compensating the plaintiffs, whose contributions were essential to the discovery.
Analysis:
This decision reinforces the legal principle established in Moore v. Regents that individuals do not retain property rights in their cells or genetic material after they have been voluntarily donated for research. It clarifies that the doctrine of informed consent does not obligate researchers to disclose future commercialization plans, protecting scientific endeavors from certain types of donor claims. However, by allowing the unjust enrichment claim to proceed, the court created a potential equitable pathway for research participants to seek remedies when their contributions, made with an understanding of public benefit, are used for private commercial gain. This signals that while formal property rights do not exist, the context and mutual understandings of a research collaboration can still create legally cognizable equities.
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