Analysis of Legislative and Regulatory Chaos in the U.S.: Asexual Human Reproduction and Genetic Engineering


The new law on "Child Health Insurance Programs" could not apply to any asexually reproduced human embryos or fetuses, or to any in vitro IVF embryos sexually or asexually reproduced.

G. Weldon Amendment On Patenting Human "Organisms"

A recent controversy concerns whether or not the U.S. Patent Office's policy of prohibiting the patenting of "human beings" could withstand legal challenge. Note that the issue here is the patenting of products -- that is, genetically engineered products.

The legal conundrum that existed before the passage of the Weldon Amendment is best summed up in the following report:

Donald J. Quigg, Assistant Secretary of Commerce and Commissioner of Patents and Trademarks, issued a memo in 1987 stating that "a claim directed to or including within its scope a human being will not be considered to be patentable subject matter." Since then, the Patent Office has rejected all claims to human beings. 35 USC § 101 defines patentable subject matter as "any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement therefore." As support of the exclusion of humans from that definition, and as a foundation for rejecting claims to human beings, the Patent Office relies on the Thirteenth Amendment of the U.S. Constitution and its prohibition against any party owning property right in a human being.

The Patent Office believes that the substance of the Quigg memo should be put into law in order to strengthen the Office's position on rejections. The fear of the Patent Office is that the Supreme Court cannot judicially prevent the patenting of a human being in light of the holding in Diamond v. Chakrabarty, where the Court declared that virtually anything "made by the hand of man" is eligible for patenting. What does this statement mean? Some believe that cells and tissue structures, as they exist within a living pseudo-human organism, cannot be patented under current law because they have not been modified by the "hand of man." However, cells or tissues that are newly isolated or have novel structural or functional properties are potentially patentable.94 (emphases added)

Such is the long-reaching arm of stare decisis.

In response to this legal ambiguity, the Weldon Amendment was passed, and simply states:

Sec. 634. None of the funds appropriated or otherwise made available under this Act may be used to issue patents on claims directed to or encompassing a human organism.95 (emphases added)

Note that the Amendment has no formal definition of a "human organism" -- and that eerily calls to mind the current outrageous claim (see Part One supra) by California "stem cell" researcher Irving Weissman et al. that the immediate product of nuclear transplantation (cloning) is not an organism! It is, they claim, just a "cell". In fact, they claim, "therapeutic" cloning is not cloning -- if the purpose is just research.

The Amendment, attached to the Consolidated Appropriations Act 2004, was met with considerable confrontation as well as supportive commentary. But of more than passing interest is that in none of the comments -- nor in the Amendment itself -- was the original creating or killing of living human embryos and fetuses -- the "human organisms" required as "biological materials" to produce such bioengineered products -- even considered. Nor was the killing of the human organisms resulting from such bioengineering processes. They simply couldn't be patented.

That is, it is OK to reproduce a human organism and then kill it to get the required biological materials needed to make the products. One can even kill a human organism that is bioengineered as a "product". It just can't be patented. One can still patent the sexual and asexual reproductive methods and processes used to reproduce and genetically alter them; one can patent their "stem cells" and other bioengineered modifications; but one cannot patent human beings as products. Is that not an oxymoron? "Human organisms" -- i.e., living human beings -- are protected as "products", but not as "biological materials" required to get there! And they are "protected" as products only insofar as they can't be patented.

A similar amnesia was expressed in a Staff Working Paper prepared for a meeting of the President's Bioethics Council. In noting the apparently intractable problem of how to define a "human organism" (as if that were so difficult), it offered the following possible solution to the patent gap:

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.96

Note the gentle phrase, "processes surrounding work with human organisms, including embryos and fetuses" -- a nice way to sanitize what the biotech industry is really doing.

This amnesia was also expressed by the biotech industry itself, which understands fully their need to reproduce living human embryos and fetuses -- human organisms -- to use as "biological material" starting points for their eventual bio-genetically engineered "products". So they worried -- and rightly so -- about the lack of any formal definition of "human organism" in the Amendment. As succinctly articulated by the biotech industry itself:

This provision is objectionable for the following reasons: ... Since the language does not define "human organism" it could preclude patenting of many biotechnology inventions. ... The language is vague, overly broad and would jeopardize many human-derived biotechnology inventions. Among the biotech inventions that would be placed in jeopardy are stem cells and stem cell production methods, all cell and tissue therapy products and methods, including methods of making replacement tissue and organs, methods for therapeutic cloning, gene patents, transgenic animals capable of making human proteins, methods for inducing production of an exogenous protein by humans (such as gene therapy), and claims involving the in situ or in vivo formation of an active ingredient. These inventions often lead to important new products. ... The language "encompassing a human organism" creates uncertainty about the PTO's definition of a "human organism."97 (emphases added)

Any tinkering with their biological starting point -- human organisms -- would clearly be a disaster for their bio-engineered products. And note the long list of procedures, methods, processes and "products" now lumped together and euphemistically redefined by them collectively as just "biotech inventions". As noted in Part One, what a whopper of a "pre-embryo substitute" that one is!

But eventually their fears were assuaged. In response to concerns that the Amendment would effect "stem cell" research, Weldon explained that it "has no bearing on stem cell research or patenting genes, it only affects patenting human organisms, human embryos, human fetuses or human beings."98 (emphasis added)

Finally, the President's Bioethics Council briefly addressed the controversy in a recent report.99 It noted that the only constitutional provision suggested to have any bearing on this question is the Thirteenth Amendment, which prohibits slavery and involuntary servitude, "but it is possible this provision could be found by the courts to apply only to live-born humans, not human organisms at the embryonic or fetal stage." Meanwhile, they note, the Weldon Amendment has helped to temporarily fill in that gap:

[W]hile patents have been issued for living organisms (and even for certain processes for creating human organisms), it is not now possible to patent a human organism itself at any stage, in light of the Weldon Amendment and the policy of the PTO. ... . It will remain effective for the duration of the relevant appropriations period, namely, for the fiscal year ending September 30, 2004. To continue in affect, it would have to be included in subsequent appropriations bills or be enacted as a freestanding, permanent law.100

Presumably, as of this writing, the Weldon Amendment has expired.


1. Although the Amendment has no formal definition of "human organism", and despite the alleged "confusion" and "impossibility" of ever finding one, one would think that federal public policy would be based at least on accurate science. As noted in Part One (supra), all one would have to do is go to the library or the internet and look it up. Or will the erroneous and irresponsible false scientific definitions pushed by many in big biotech be allowed to be substituted for these long-established objective biological facts?

2. As noted, the Amendment applies only to "protecting" a human organism from being patented as a "product" of bioengineering. It does not address the sexually or asexually reproduced human beings destroyed to obtain the "biological materials needed for use in the bioengineering processes, nor those resulting from those processes.

3. As noted, Weldon assured the biotech industry that his Amendment would not affect "stem cell research". There are those who find no ethical problems with human embryonic "stem cell" research -- often because the "surplus" IVF-produced human embryos "are going to die anyway". But not all "stem cell research" is equal. What about human embryonic "stem cell" research that involves stem cells" derived from cloned or otherwise genetically engineered human embryos especially reproduced for research -- such as proposed in the contentious California Proposition 71? If no proper distinction is made between these two varieties of human embryonic "stem cells", then this Amendment would sanction the patenting of human embryonic stem cells derived from cloned or genetically engineered human embryos and fetuses.

4. As with this Amendment, several of the federal documents addressed here have been passed as amendments to laws requiring constant renewal. But the public is usually unaware of this, assuming wrongly that such amendments are permanent and the issue is settled. It is also often difficult to locate these amendments before or after passage when they are swallowed up in huge appropriations bills, or passed as amendments to bills with titles that seem to have no bearing on the issue addressed in the amendment. While such tactics might be taken advantage of from those on both sides of the aisle, it hardly makes for a genuine democratic process.

5. Note that if the Department of Commerce is involved, that government department falls under The Common Rule -- i.e., they voluntarily adhere to the current OHRP federal regulations, with those same scientifically erroneous definitions of "fetus" and "pregnancy" -- derived originally from the 1974 National Research Act which mandated the formal "birth" of bioethics.101 These OHRP federal regulations do not apply to any asexually reproduced human embryos or fetuses at any stage of development in vivo or in vitro, and do not apply to any human embryos reproduced sexually through 8 weeks of development in vivo or in vitro. The question is, then, could these OHRP federal regulations -- or any of the documents addressed in this analysis -- actually apply to any issues concerning any bio-engineered "starting materials" or "products -- including patents? Further, it is the Department of Commerce that recently co-sponsored (with the National Science Foundation) their nano/bio/info/cogno report102 which lays the very foundation for global genetic engineering on a "cosmic" scale. Is this not a conflict of interests on a cosmic scale?

CONCLUSION: While the Weldon Amendment temporarily filled in a glaring gap that still exists in our patent laws, it should not be taken for anything more than what it stated -- an amendment that temporarily protected living human organisms -- including embryos and fetuses -- from being patented as "products". It does not protect living human embryos and fetuses from being reproduced sexually or asexually and then killed for their "biological materials" to be used in bioengineering processes, nor does it protect human embryos or fetuses as bioengineered "products" from being killed -- and mined for their "biological materials". It unnecessarily leaves "open" one of the most critical definitions in these debates -- a "human organism" -- thereby setting the stage for the well-established objective and accurate scientific definition to be subtly replaced by the corrupt fairy tale "science" of biotechnology and genetic engineering.

H. Pending "Total Cloning Bans"

There are three "total human cloning bans" currently being considered in the U. S. Congress: the Weldon-Stupak and the Stearns bills in the House, and the Brownback-Landreau bill in the Senate. As all three "total bans" on human cloning have been analyzed in detail elsewhere, and because of the lack of space, readers are encouraged to review them elsewhere.103

However, it is worth noting -- and ending -- here that none of these bills will ban any human cloning -- especially because of the erroneous "science" and legal loopholes used. That situation is of deep concern alone, but for purposes of this article the concern broadens considerably with the realization that if the faulty "scientific" definitions used in these bills were to be used as the legal authority and standard for the attempted application of any of the federal documents discussed here, or especially for future legislation involving nano/bio/info/cogno that is looming around the corner, the resulting harm to individuals and to society would be immeasurable. We are looking at human genetic and social engineering on a global scale. Now. It is time for professional and legal responsibility and accountability; it is time to bring order to all of this legislative and regulatory chaos, while we still can.

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