Today’s Science Magazine reports on the implications of patent law on embryonic stem cell research. (Sorry, subscription only, excerpts below.)
Somehow, there has not been much notice that the Wisconsin Alumni Research Foundation (WARF) was awarded the patent to human embryonic stem cells in 2001.
“On 9 August 2001, U.S. President George W. Bush directed that federal funding could be used for human embryonic stem (HES) cell research, but only for the small number of ES cell lines then in existence (listed on the National Institutes of Health Stem Cell Registry) (1). In reaction to the limitations, individual states and private foundations are designating funds to support research on the much larger number of HES lines that were derived after the President’s deadline. Although these funding sources sidestep the strictures of the President’s order, they do not remove what may ultimately prove a more daunting barrier to progress in this field: the intellectual property rights for HES cells. This commentary describes two fundamental patents that cover HES cells in the United States and highlights their implications for HES cell research.
“What are the patents on HES cells?
Three years before the presidential directive, the U.S. Patent and Trademark Off ice (PTO) issued a broad patent claiming primate (including human) ES cells, entitled “Primate Embryonic Stem Cells” (Patent 5,843,780). On 13 March 2001, a second patent (6,200,806), with the same title but focused on HES cells, issued from a “divisional application” (2).
“These two patents have considerable consequence for HES cell research in the United States, because they have claims to ES cells themselves, not just a method of deriving them. The claims give the patent owner, the Wisconsin Alumni Research Foundation (WARF) the legal right to exclude everyone else in the United States from making, using, selling, offering for sale, or importing any HES cells covered by the claims until 2015. The right of exclusivity is rooted in the U.S. Constitution (3) and was intended to benefit society by encouraging innovation while discouraging secrecy on the part of inventors.”
. . .
“How do fundamental HES cell patents affect scientific research?
Although many patent holders choose to license others to practice the patented invention in exchange for royalties, in the United States, licensing is not compulsory; patent holders can choose to license on their own terms or not to license at all. Because
WARF controls the rights to HES cells, researchers
who wish to use these cells must be aware of their obligations to the patent owners under U.S. law. The NIH took steps to engage WARF’s cooperation shortly after the presidential announcement, signing a memorandum of understanding (MOU) with WARF. The NIH retains rights to the 1998 (-780) patent, because
the work was supported by federal grants (12).
This MOU gave researchers employed by the
NIH, the Food and Drug Administration, and
the Centers for Disease Control and Prevention
a license to use HES cells for research. Also,
WARF agreed that it would not impose more
restrictive terms for any other not-for-profit
institutions. In early 2002, the NIH made similar
MOU agreements with other groups that had
made lines that were eligible for funding,
including the University of California at
San Francisco, Mizmedi (Korea), BresaGen
(Australia), Technion (Israel), Cellartis (Sweden),
and ES Cell International (Singapore). These
institutions received Infrastructure grants from
the NIH of about $200,000 to $500,000 a year
(13) to facilitate the distribution of their own
HES cell lines under a license from WARF, and
were limited by the MOU to charge no more
than $5000 (or $6000 for foreign shipping to the
United States) per cell line.
“Currently, WARF requires a license agreement
for distribution of any HES cell lines in
the United States, whether or not they are on
the NIH registry. The Harvard HES cell material
transfer agreement (MTA) (14), for example,
requires that the recipient of their cell
lines acknowledges WARF’s patent rights.
Only the institutions that have MOUs with the
NIH have price regulations; other suppliers of
HES cells can charge as much or as little as
they wish for the cells. Harvard charges nothing
for its lines. However, because the WARF
patents are only valid in the United States,
non–U.S.-based HES researchers do not need
a license unless they import the cells into the
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