107th Congress

Stem Cells-Ethical Issues and Intellectual Property Rights -- Hearing Before the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education -- August 1, 2001

Members Present

Senator Arlen Specter (R-PA), Ranking Minority Member

Witnesses

Panel One: Maria Freire, Ph.D., Director, Office of Technology Transfer, National Institutes of Health (NIH); Carl Gulbrandsen, Ph.D., Managing Director, Wisconsin Alumni Research Foundation (WARF).

Panel Two: Nigel M. de S. Cameron, Ph.D., Executive Chair, Centre for Bioethics and Public Policy, London, England; Arthur Caplan, Ph.D., Director, Center for Bioethics, University of Pennsylvania; Glenn McGee, Ph.D., Assistant Professor, University of Pennsylvania; Michael West, Ph.D., President and CEO, Advanced Cell Technology (ACT).

Summary

Purpose of Hearing: This was the ninth hearing convened on stem cell research by this Subcommittee. The purpose of the hearing was to explore how intellectual property rights held by certain entities might affect the ability of federally-funded researchers to both derive and use embryonic stem cells. The hearing was held to explore suggestions made at the stem cell hearing held on July 18, 2001, that intellectual property issues could affect research in this arena.

Opening Statements

Senator Specter opened the hearing by expressing again his excitement at the potential medical benefits that could be realized if Federal funding is available for embryonic stem cell research. He noted that the Subcommittee has taken the lead in working to double NIH's budget, and stated that those funds ought to be available for this research. In his view, "there is no issue before the Congress more important than embryonic stem cells." He indicated that he and Senator Tom Harkin (D-IA), Chairman, Senate Appropriations Subcommittee on Labor, HHS, Education, have introduced legislation to "free the prohibition against limiting Federal funding."

Statements of Witnesses

Panel 1:

Maria Freire provided an overview of the legal framework by which Federally-funded inventions are transferred to the private sector for commercialization. In addressing concerns raised by broad patents on biomedical technology, Dr. Freire stated that it is not usually the patent that raises concerns but rather the way in which the patent holder chooses to exercise its rights. She emphasized that NIH "has urged and will continue to urge patent owners and exclusive licensees to insure continuing availability of a technology under terms that do not limit basic research or encumber future products."

Carl Gulbrandsen is the holder of the patent on embryonic stem cells. In his testimony, Dr. Gulbrandsen emphasized that WARF has "never used its patents to block research and does not intend to do so with embryonic stem cell patents." He said that WARF has granted both research and commercial licenses under its patents, and added that research licensees are free to publish and patent their discoveries. He added, however, that if the researcher sought to commercialize a discovery made under the agreement, an "appropriate commercial license may be required." In supporting legislation introduced by Senators Specter and Harkin, Dr. Gulbrandsen noted that WARF would "welcome the opportunity to license centers for derivation of embryonic stem cells under WARF's patents."

Panel 2:

The second panel addressed general ethical issues related to stem cell research. Nigel Cameron testified in opposition to embryonic stem cell research, arguing that the promised benefit of the technology does not justify compromising the dignity of the early human embryo. Arthur Caplan testified in support of embryonic stem cell research. He suggested that because of the self-renewing properties of embryonic stem cells, it is possible that only a limited number of embryos would be needed. He closed by stating that "it seems to me the moral equation comes out in favor of those who are real, here and now with real needs and real disabilities and real problems."

Glenn McGee focused his remarks on the potential problems of the use of Ethics Advisory Boards (EAB) by the biotech industry as a means of self-regulation. Specifically, he testified that he resigned from the EAB of ACT because the company proceeded with some controversial cloning research without disclosing it to the EAB. He also expressed concern about private companies holding patents on embryonic stem cell research and suggested that perhaps "as much as 30 to 50 percent of Federal funding for stem cell research might flow directly or indirectly to small stem cell companies through the fees they are allowed to assess to any funded researcher."

Michael West testified in support of Federal funding for embryonic stem cell research. He specifically commended WARF for facilitating unencumbered access to the technology for deriving pluripotent stem cells from human embryos. He closed by commenting on House passage (after a scant 2 hours of debate) of legislation to criminalize cloning. He urged the Senate to consider this issue with "a great deal of caution and careful deliberation."

Questions for Panel 1

Senator Specter asked several questions of Dr. Gulbrandsen to explore the conditions under which WARF will exercise its intellectual property rights. Dr. Gulbrandsen responded that WARF is prepared to license the rights to derive human embryonic stem cells at a price that would be reasonable, but confidential. He reiterated that WARF would be interested in licensing centers to conduct derivation. Senator Specter suggested that perhaps Congress will need to craft legislation to place limits on patent claims in the case of a technology that has the potential for "such widespread application for humanity..."

Senator Specter asked Dr. Freire several questions about NIH's underlying rights to the use of technology to derive human embryonic stem cells in light of the fact that NIH provided funding to Dr. Thompson for his early work on non-human primates. Dr. Freire indicated that under the Bayh-Dole Act, NIH retains a non-exclusive royalty free license to the technology. She stated further that under the terms of the act, this would be limited to use by NIH intramural researchers and contractors, but would not extend to grantees.

Questions for Panel 2

Senator Specter began questions for this panel by probing both Dr. Cameron and Dr. Caplan on statements they made regarding the moral status of embryos. Dr. Caplan offered an analogy, comparing embryos to blueprints. He suggested that while a blueprint carries instructions for how to build a house, it is possible that in some circumstances it will not actually be turned into a house. AccORDingly, he suggested that because certain embryos, like blueprints, may never realize their full potential, they are not "members of the human species." Senator Specter then asked all of the panel members whether they were opposed to both reproductive cloning and therapeutic cloning. Reproductive cloning is generally defined as the use of cloning technology for the purpose of initiating a pregnancy, whereas therapeutic cloning is generally defined as the use of cloning technology for the purpose of conducting research. All panel members replied that they are opposed to reproductive cloning. In contrast, only Dr. Cameron indicated that he is also opposed to therapeutic cloning. Dr. West also indicated that he has a patent application pending on a technique called ooplasmic transfer, whereby a cell is returned to an embryonic state without creating an embryo.

Senator Specter also asked several questions of both Dr. McGee and Dr. West regarding the circumstances under which Dr. McGee resigned from the EAB of ACT.

Senator Specter concluded the hearing by returning to the issue of access to stem cell technology by federally-funded researchers. Senator Specter asked Dr. Caplan how patents on this technology should be regulated. In response, Dr. Caplan suggested that NIH should hold and control any new patents, and ensure that any new funding for the research is contingent on wide availability of the fruits of the research. In adjourning the hearing, Senator Specter expressed dismay that it took the House of Representatives less time to vote on a measure to outlaw cloning than it took to hold this particular stem cell hearing.

Prepared by Gemma Flamberg/OD/OLPA, September 20, 2001