United States: Controversial Weldon Amendment Has Negligible Impact on Issuance of Claims to Methods For Human Cloning

Last Updated: October 7 2004
Article by Judith Toffenetti and Thomas A Haag PhD

On January 23, 2004, President George W. Bush signed into law appropriations omnibus bill H.R. 2673 authorizing 2004 funding of the federal government including the United States Patent and Trademark Office (USPTO). The bill contained a hotly debated rider on human patenting introduced by Dave Weldon (R-Fla.). The Weldon amendment states that "[n]one of the funds appropriated or otherwise made available by this act may be used to issue patents on claims directed to or encompassing a human organism." It represents a strategy for restraining scientific research in an controversial field by prohibiting the issuance of patent claims to a particular technology.

In arguing for his amendment, Rep. Weldon, a physician, pointed to a recent report wherein researchers described co-culturing human male and female embryonic cells for six days, as an example of a study, "universally condemned as unethical and unnecessary." Weldon insisted there was a need to, "draw the line where some rogue scientists fail to exercise restraint," and that the investigators should not be allowed to financially exploit science of this type by being granted an "exclusive right to practice such ghoulish research."

Notwithstanding the Weldon law, the USPTO has a seventeen year-old ban on patent claims, if their "broadest reasonable interpretation as a whole" encompasses a "human being." Whereas the USPTO bans patent claims directed to "human beings," the Weldon law recited "human organisms." However, in the Congressional Record., Rep. Weldon strenuously asserted that the amendment exactly reflects the scope of the USPTO ban on the patentability of human beings, "at any stage of development." Accordingly, Weldon stated that his measure would not affect any existing patents on human stem cell lines or have any bearing on stem cell research.

An example of the type of patent claims that may be effected by the Weldon amendment exist in U.S. Patent No. 6,211,429. The patent has claims directed to methods of producing a cloned mammal by nuclear transfer into oocytes. As such, the claims includes methods of cloning humans. Weldon stated on the record, however, that such claims would be unaffected by the amendment.

Contrary to Weldon’s assertion, other supporters of the amendment argued that claims to methods of producing a cloned human being, also cover the human being itself. Their justification for this position relies on §271(g) which makes it an act of infringement to perform a process, e.g., a method of cloning a human, in another country that would infringe a process claim of a U.S. patent and then import the product, e.g., the cloned human organism, into the United States. The Court of Appeals for the Federal Circuit, in Bayer AG v. Housey Pharmaceuticals, Inc., (IP Update, Vol. 7, No. 8), recently narrowly construed §271(g) as applying only to importation of physical objects derived from manufacturing processes and specifically excluded the importation of information obtained through the execution of U.S.-patented methods abroad.

On August 24, 2004, the USPTO issued U.S. Pat. No. 6,781,030, (assigned to Tufts College in Massachusetts) claiming methods for generically cloning "mammals." Although some claims are directed to "non-human mammals," the specification 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)." The Weldon amendment impacts the validity of this patent because it issued during the current appropriations period.

The USPTO’s allowance of claims directed toward methods of cloning humans apparently indicates that it does not consider claims to methods of cloning humans to be "directed to or encompassing a human organism." Moreover, it does not appear that the USPTO is utilizing the amendment as a mechanism to block the issuance of claims to methods that may be used in controversial and allegedly "ghoulish" research. In fact, based on the issuance of the `030 patent is evidence that the USPTO is apparently narrowly interpreting the Weldon amendment.

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