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Cloning Patents: A Patent Office and Legislative Update

Given the ongoing debate in the political arena about stem cells research and human cloning, this article investigates the U.S. Patent and Trademark Office's (PTO) past and present practice with respect to patenting such technologies.

An Early Attempt

Interestingly enough, the cloning debate is no stranger to Missouri and Kansas. A couple of years ago, the University of Missouri obtained U.S. Patent No. 6,211,429. The patent was directed to a cloning technique used with "mammals," in which humans were not expressly excluded from the definition of "mammals." Arguing that MU had patented cloned human life, some critics of the MU patent characterized it as giving government approval to a new form of slavery. In response, Sen. Sam Brownback, R-Kan., was reportedly drafting legislation that would outlaw patents on humans. At the same time, other senators, such as Republican Sen. Jack Danforth and former Democrat Sen. Thomas Eagleton, both from Missouri, came out in favor of therapeutic cloning.

An Express Exclusion

In August 2004, the PTO went one step further and again made news, when it issued U.S. Patent No. 6,781,030 to Tufts University. While the claims were again directed to methods of cloning "mammals," this time "humans" were expressly included in the definition. The specification of the '030 Patent states that "[t]he present invention encompasses the cloning of a variety of animals. These animals include mammals (e.g., human, canines, felines), murine species (e.g., mice, rats), and ruminants (e.g., cows, sheep, goats, camels, pigs, oxen, horses, llamas)."

A Defense of Cloning Patents

Contrary to what opponents of both patents say, neither the MU nor Tufts patents cover cloned human beings themselves. The scope of a patent is defined by the claims read in light of the specification. With respect to MU's patent, among other things, the patent claims are directed to a method of activating a mammalian oocyte, transplanting a nucleus, producing a cloned mammalian embryo, producing a cloned mammal, and studying genetic imprinting in a mammal. Thus, the claims are for a particular cloning process – not for the product. As a result, most patent practitioners agree that the MU patent does not cover the mammalian organisms made by the patented process. The same is true for the Tufts patent.

Both the '429 Patent and the '030 Patent are consistent with the language of the Patent Act. According to the U.S. Constitution, the purpose of patent law is to promote the "useful" arts, and cloning technologies are certainly useful. For example, a cloned pig could be used for potential organ transplant into humans. Cloning could take other commercial forms, such as cows that produce milk with less fat or sheep that yield more wool. Pigs and other animals could be engineered to become bio-factories making specific proteins that are key ingredients in medical therapies. The biotechnology industry hopes to produce many new therapies from cloned cells, for instance, neurons for the treatment of Parkinson's disease and spinal cord injury, heart muscle cells for heart failure, cartilage for arthritis, pancreatic cells for diabetes, as well as many others. There is no question that cloning techniques are generally considered "useful."

The MU and Tufts patents are also consistent with the 2004 PTO appropriations legislation (H.R. 2673), which stated: "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." The sponsor of this language, Rep. David Weldon, R-Fla., stated:

Organism vs. Stem Cell

Some have questioned whether the term "organism" could include "stem cells." The answer is no. While stem cells can be found in human organism (at every stage of development), they are not themselves human organisms…. The amendment should not be construed to affect claims directed to or encompassing subject matter other than human organisms, including but not limited to claims directed to or encompassing the following: cells, tissues, organs, or other bodily components that are not themselves human organisms (including, but not limited to, stem cells, stem cell lines, genes, and living or synthetic organs); hormones, proteins or other substances produced by human organism, methods for creating, modifying or treating human organism, including but not limited to methods for creating human embryos through in vitro fertilization, somatic cell nuclear transfer, or parthenogenesis, drugs or devices (including prosthetic devices) which may be used in or on human organisms.

Some Clarification

The "Joint Explanatory Statement" of the Conference Committee endorsed Rep. Weldon's explanation of this provision given on July 22, 2003, when the appropriations bill was initially on the House floor. That explanation stated that the amendment simply mirrors the current PTO prohibition against patenting humans, and stated that it "has no bearing on stem cell research or patenting genes, it only affects patent human organisms, human embryos, human fetuses, or human beings." It says nothing about method claims for the cloned human organisms.

The MU and Tufts Patents are also consistent with PTO policy. For years, the Patent Office has issued several patents on improved reproductive methods that help couples conceive children (e.g. in vitro fertilization). See e.g., U.S. Patent Nos. 6,281,013; 5,882,928; and 5,532,155. Such patents have never been construed as covering the human organisms resulting from those processes. This was made clear by James Rogan, undersecretary to the PTO, who stated in a November 20, 2003 letter: "The USPTO's policy of rejecting patent application claims that encompass human lifeforms, which the Weldon Amendment elevates to an unequivocal congressional prohibition, applies regardless of the manner and mechanism used to bring a human organism into existence (e.g., somatic cell nuclear transfer, in vitro fertilization, parthenogenesis."). Thus, with both the MU and Tufts patents, the Patent Office's policy against issuing patents on human beings has not been violated.

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