Cellpat.txt part 2 of 2

Bryan Ness bryan.ness at bbs.puc.edu
Thu Feb 10 22:42:00 EST 1994

The university first applied for a patent in 1981 and was awarded one in
1984 for a cell line extracted from the spleen cells.  Golde negotiated
contracts to investigate and develop the cell line with two companies,
Genetics Institute, Inc., and Sandoz Pharmaceuticals Corp.  Court records
state that Genetics Institute paid Golde and the university $330,000 and
gave Golde 75,000 shares of stock at a nominal price.  Sandoz paid another

Moore alleged, however, that at no time did the university, Golde, and
Quan ever tell him that his tissues might have any research purpose
beyond his own treatment or that they had any commercial value.  He
claimed in his conplaint that had he been informed, he would not have
allowed his tissues to be used in this manner.  Only on one occasion, in
September 1983, did Moore give the university the right to conduct research
on his tissues.  At that time, he formally declined to relinquish rights to
any cell lines or products that might be produced.

The Superior Court of California, acting on the defendants' motion,
dismissed the case in 1986.  It ruled that the complaint was technically
defective and did not demonstrate that a taking of property had occurred.
As a result the case did not go to trial and 12 other counts in Moore's
complaint were not addressed, including allegations that he was not told
about the research and the commercial potential of his spleen cells and
that the university engaged in deceit and fraud.

The appeals court in its 21 July Decision sent the entire case back to the
Superior Court.  The appeals court found that there had been an adequate
showing of a property right and it concluded that a probability that an
unwarranted use of Moore's tissues had taken place.  "To our knowledge, no
public policy has ever been articulated, nor is there any statutory
authority against a property interest in one's own body," said the court
in affirming Moore's property right, which the Superior Court had rejected.

Unless the appeals court decision is successfully appealed to the state
supreme court, the lower court must examine the facts of the case for the
first time in a trial and it will be obliged to heed the appeals court's
finding that Moore had a right to determine how his body tissues were to
be used.  UCLA had argued that California's health and safety code
stipulates that body parts obtained during surgery may be retained for
scientifice use.  The court rejected this argument stating that "simple
consent to surgery does not imply a consent to medical research on a
patient's tissues unrelated to treatment nor to commercial exploitation
of the patient's tissues."

The full effect of this decision may not become clear for years. Allen B.
Wagner, a University of California attorney, says the decision could be
appealed to the state supreme court.  The university's decision will be
based at least partly on an analysis of the dissenting opinion written by
appeals court Judge Ronald M. George.

George contended that his colleagues on the panel have interpreted the
state's property law statute too broadly.  "A patient who consents to
surgical removal of his bodily substances," he said, "has no reasonable
expectation as to their subsequent use other than an understanding that
licensed medical personnel will comply with applicable medical standards
and legal restraints."  George asserted that the issue of human tissues
property rights should be addressed by the state legislature instead of
the court.  Said George, "... that body has shown itself willing, able
and best suited to regulate areas involving comparable competing

While the ultimate outcome of this legal tangle will not be decided for
some time, John Fletcher, former chief of the bioethics program at the
National Institutes of Health, predicts the appeals court ruling will
have some near-term impact.  "The immediate effect will be to make
investigators think three or four times about the potential use of their
research materials," he says.

Indeed, attorneys for Genentech, Inc., say they and other firms began
changing their disclosure forms and sought to explicitly define property
rights on cell lines, tissues, and related materials after Moore brought
suit in 1984.  The Office of Technology Assessment estimates that
one-third of the country's biotechnology companies make use of human
tissues and cells.

While expanding the property rights of patients who provide tissues to
researchers has been portrayed by University of California lawyers as
creating an administrative burden for researchers, the impact is
overstated, Genentech officials say.  It should not have a chilling
effect on biomedical research, says Stuart Weisbroad, a biotechnology
analyst with Prudential-Bache Securities.

Michael H. Shapiro, a law professor at the University of Southern
California who studies biomedical questions, agrees.  Only a small
fraction of the tissues and cells of research patients are likely to
yield breakthroughs of commercial value, he says.  The notion of
compensating tissue donors in unique cases is not unreasonable, Shapiro
says.  but resolving what donors are entitled to, he adds, is likely to
be sticky.

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