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|   | *This staff working paper was discussed at the Council's July             2002 meeting. It was prepared by staff solely to aid discussion,             and does not represent the official views of the Council or of the             United States Government.*
             
 Staff Working Paper **Patenting Human Organisms**
 At the June meeting of the Council, we began to explore the potential               problem of the patenting of human organisms. Five guest-presenters               attempted to provide the Council with a sense of the issues at stake,               the history, the state of present law, the interests and needs of               the biotech industry, and the moral questions surrounding the matter.               This working paper, prepared by staff in light of those sessions,               is aimed at summarizing some of what was learned at the June meeting,               and at suggesting what a short and narrowly focused Council project               on the question of the patenting of human organisms might look like,               should the Council choose to pursue such a project.
**I. Present Law and the Question of Patenting             Humans**
The factual question is this: Are human organisms patentable subject               matter under the terms of the US Patent Code, as interpreted by               the courts? The ethical question is: should they be?

The picture that emerged from the two patenting sessions at the               June meeting of the Council seems roughly as follows. Under present               law, and in light of several important court decisions of the past               two decades, there is no explicit barrier to the patenting of a               human organism. This is a troubling circumstance, but any attempt               to address it must take careful note of the needs of the biotechnology               industry, and should not be a backdoor effort to address the moral               issues raised by embryo research, genetic manipulation and other               ethically charged developments in biomedical science and technology.             

Dr. Daniel Kevles presented us with a detailed history of the patenting               of life, showing the gradual expansion (especially through successive               court decisions) of the terms of the patent statutes to allow for               the patenting of living things. The patent laws as written, he suggested,               include no obvious obstacle to the further expansion of these terms               to include living human organisms. 

Ms. Karen Hauda of the US Patent and Trademark Office then informed               us that as a matter of policy the PTO does not grant patents on               human organisms, and that this policy is grounded in precedent and               in an interpretation of the 13th Amendment to the Constitution.               She noted, however, that this policy has never been tested in court,               and that it is not grounded in the text of the patent laws, and               therefore may not survive a legal challenge (as previous PTO policies               against the patenting of life have been rejected by judges in the               past.) She concluded: "Given the uncertain outcome of legal challenges               to the exclusion of humans from patent-eligible subject matter,               legislation may be required to ensure their exclusion."

Steven Holtzman, of Infinity Pharmaceuticals, reminded us that               the biotech industry depends on patent protections for its livelihood,               and would have great trouble attracting investors if these protections               were severely curtailed. He noted especially that the industry relies               on its ability to patent processes, including those that involve               or might result in human embryos. He explained the way in which               35 USC 271 (G) extends patent protections also to the products of               patented processes. Finally, he argued that the patenting issue               is not the proper way to approach the more general moral questions               surrounding biotechnology.

Andrew Kimbrell of the International Center for Technology Assessment               argued that current law allows the patenting of human organisms,               and in fact that one such patent (Patent 6,311,429 on a process               of cloning and a method of parthenogenesis) has already been granted.               He argued that the Supreme Court's 1980 Chakrabarty decision opened               the door to the possibility of patents on human beings, and that               the opening has since been enlarged. This subject, he concluded,               is part of the larger and important issue of the commodification               of life.

Finally, Professor Arti Rai offered an overview of the legal issues               involved. She argued that the question of patenting human life involves               many complicated questions about what a human organism is and what               the patent law says about products of a patented process. She argued               that concern about patents seems grounded in concern about the underlying               processes involved, and patenting is not the best way to get at               those. She also confirmed the tenuous nature of the PTO's policy               of rejecting patent applications on human organisms, suggesting               that 13th Amendment arguments about patents could potentially hold               with regard to live-born humans, but not to embryos and fetuses.               Those would have to be addressed by legislation.
**II. Issues to Consider**
These presentations all suggest the need to focus narrowly any               potential Council inquiry on the patenting question. The key claim               of several of the speakers was that patenting is not the right way               to get at the general moral questions surrounding embryo research               and other biotechnological matters of ethical concern. This of course               seems largely true, but it assumes that the Council's only interest               in taking up this question is to get at these other issues.

That assumption need not be true. Patenting may not be the best               route to the general ethical questions, but it is the only route               to the issue of the patenting of human life, itself a significant               ethical concern. In other words, there is some real importance to               this issue in itself-there is a moral aspect unique to the matter               of the patenting of human life.

Several ethical questions are raised by the prospect of the patenting               of human life, among them the following. Do we want to include human               organisms, at whatever stage of life-embryonic, fetal, child or               adult-among the subject matters that may be patentable? Why has               there been a reluctance to do so? To what does this reluctance point,               and what can it teach us? What would it mean to grant the quasi-property               right of patent protection over human organisms or their body parts?               These sorts of questions point us to the broader concern over the               commodification of human life, and force us to consider the meaning               of our embodied selves and their relation to human freedom and dignity.               Patenting is not a "back door" to these important questions; it               leads to them quite directly.

Given the speaker presentations and other documents made available               to staff and Members, it seems that under current law it is possible               for an individual or corporation to obtain a patent on a human organism.               We the people, through our government, might grant some individual               or group a partial property right over a human being. That may trouble               us, even enough to move us to suggest legislation that would preclude               it.

That said, the potential of doing harm to the biotech industry               must also be a real concern, and any effort to address the patent               question must take great care to avoid placing undue burdens on               this thriving and beneficial industry. The patent system exists               to assist and encourage commerce, industry, and the advancement               of knowledge, not to regulate it, and any attempt to close a loophole               in the current law must keep that fundamental purpose in mind.

These considerations point to the possibility of a brief and carefully               targeted Council project, resulting in a short report making concrete               recommendations for addressing concerns about the patenting of human               organisms and perhaps their parts. Such a project could be guided               by the following general ideas.
**A. The Purpose of the Patent System and             the Importance of the Bioetech Industry**
A reform of the patent system with regard to human organisms should not be a hidden attempt to bind the biotechnology industry, or to slip in through the backdoor restrictions not directly associated with the problem before us. The moral concerns raised by some work in the biotechnology industry should be dealt with directly, and the general questions surrounding embryo research and the like should be addressed on their own terms. The purpose of the patent system is to encourage invention and industry, not to hamper them, and any proposed alteration of the patent law must be carefully targeted to address only the moral problem of the potential patenting of human life itself, and not to unduly constrain the industry's capacity to profit from its work or even to engage in research that, for various other reasons, may trouble some of us.
**B. The Definition of a Human Organism**
Defining the human being is of course a notoriously difficult and controversial undertaking, and is very often a field of skirmish in the larger battle over defining what may be done with and to human embryos and fetuses. Nonetheless, the general term "human organism" might be defined in a reform of the patent law without reaching into questions of legal personhood or individual rights. Professor Rai, in her presentation, suggested a way toward a working definition:

*Organisms are already either full persons, like all of us standing around here or sitting around here, or are like embryos and fetuses capable of becoming full persons... I don't mean to include parts of humans. In other words, I don't mean to include organs, or, more relevantly for this discussion, genes.
A definition constrained in this way, to include human organisms but not genes or cells could prove useful in crafting a new law, and the question of whether to include organs could be taken up. The definition would be restricted only to this law, and would not provide some general federal government definition of a human being, human organism or person. It would thereby have a better chance of staying out of the larger battles surrounding human embryos and fetuses.
**C. The Reach of the Law**
A change in the patent law excluding human organisms from patentability would, therefore, need to be carefully crafted so as not to take in too much or too little and not to unduly burden the biotech industry. A perfect balance is likely impossible, but a working proposal might include the following two provisions:
- A prohibition on product patents for human organisms at any stage of development. An alteration of the language of section 271 G (which grants protection to the product of a patented process) indicating that if the product is a human organism at any stage of development, protection is not extended.

This would mean that processes that result in human organisms could still be patented and protected, but that the products of these processes would not themselves be protected under that patent. By drawing this distinction, a new law could allow the biotech industry to continue patenting processes surrounding work with human organisms, including embryos and fetuses, and to continue profiting from such work and drawing investments, while not obtaining patents on the living human organisms themselves. This is a somewhat narrower proposal than some of those that have been offered in Congress, but it may still work to prevent the patenting of human organisms while not restricting the biotech industry unduly. Such a proposal could offer a way to protect an important moral principle while still serving the important purpose of the patent system.
**III. Patenting as a Potential Council Project**This project, should the Council decide to pursue it, could be brief and narrowly focused, and may result in a short Council report. The report might provide a brief overview of the problem, and a proposal, or a set of proposals, which might help the President and the Congress decide whether and how to address it.
This issue and this project would not be a way into the larger questions of the ethics of embryo research. Instead, it would be guided by a concern about the narrow but serious problem of the potential patenting of human life, which might be addressed by legislation.
The Council may have a role to play in clarifying the issue-and particularly the moral questions it raises-and suggesting some possible solutions. This would be a small and short-term Council project, but a potentially quite useful and practical one.* |