Who Owns Human Biological Specimens Collected for Research? Washington University v. Catalona

June 21, 2007

On June 20, 2007, the United States Court of Appeals for the Eighth Circuit issued a decision in Washington University vs. Catalona affirming the District Court for the Eastern District of Missouri’s holding that neither the medical researcher nor the contributing patients have any ownership or proprietary interest in biological tissue samples collected for research.  Rather, Washington University — the institution to whom patients consented to donate their tissue samples — retained ownership.

Pharmaceutical and biotech companies routinely use banked biological tissue specimens for product development and other purposes.  This court case involves a hotly-contested dispute among a leading medical research institution, Washington University, a well-established prostate cancer researcher and former employee of the University, Dr. William Catalona, and his patients.  At issue was who owns biological tissue specimens, such as prostate, blood, and DNA samples, collected by Dr. Catalona (and other medical researchers) from study subjects and patients for use in prostate cancer research.  The specimens at issue comprise a very large and valuable biorepository.  The repository includes more than 4,000 prostate tissue samples and more than 100,000 blood samples.  The Court of Appeals upheld the District Court’s holding in favor of the University – that research participants retained no ownership in the biological specimens they contributed to the University’s repository. 

The Court of Appeals narrowly framed the question presented, and limited its holding to the facts of this case.  The Court held that individuals who make a voluntary and informed decision to contribute their biological tissues to a particular institution for medical research do not retain an ownership interest that would allow them to direct or authorize that the specimens be transferred to a third party.

This holding is not new, and is consistent with what little legal precedent is available.  Still, this case appears to be the first to address the ownership of biological specimens themselves, as opposed to some improvement or attempt at commercialization (e.g., a cell line or patented gene).  The decision underscores the importance of having clear documentation of the intent of study subjects to contribute their tissues.  It remains to be seen whether Dr. Catalona and his patients will petition the Eighth Circuit for rehearing or petition the United States Supreme Court for certiorari.

By:  Anne Marie Murphy

Categories: Drug Development