PATENTABILITY OF HUMAN GENES
[LAST REVISED February 18, 2005. See Offsite Links]
A lot of the patentability of man-made organisms stemmed from the United States Supreme Court case of Diamond v. Chakrabarty, 447 U.S. 303, 100 S.Ct. 2204, 65 L.Ed.2d 144 (1980). This involved a bacterium that "ate" oil, and huge amounts of these bacteria are spread over oil spills, where hopefully the bacteria eat or neutralize the oil. The Court construed the federal Plant Act and held that a live, human-made microorganism is patentable subject matter under statute providing for issuance of patent to a person who invents or discovers "any" new or useful "manufacture" or "composition of matter." Our own United States Code, at 35 USC section 101, states that laws of nature, physical phenomena, and abstract ideas are not patentable.
While patents are now being issued in the U.S. for gene fragments and some genes, it certainly is not supported by the Chakrabarty case and really stretches the federal Patent Act. This is a sticking point between the U.S. and the European Union. I agree that some incentive should be there for companies to get a return on their investment, such as a patent on a test, and also that licenses, royalties be made available. I believe, however, that such costs should never get in the way of making a discovery, such as a medical procedure made possible via gene therapy, available to the public (case in Illinois just filed in year 2000 where a foundation was offering free tests to screen for Canavan disease, but then the hospital invoked its patent, requiring royalties for each test. The foundation had to stop offering the tests.).
I found an article that stated as follows: "Under current U.S. patent law, private companies, organizations, and individuals are allowed to patent, for 17-year terms, the rights to a specific human gene. This rule flows from a landmark case before the Supreme Court in 1980, Diamond vs. Chakrabarty. The court held that "anything under the sun that is made by the hand of man" (in that case, a genetically engineered bacterium) is patentable."
"Of course, genes are not made by the hand of man, but in the eyes of the court and the U.S. Patent and Trademark Office, the key aspect that allows for the patenting of genes is the sequencing process, according to Steve Kunin, associate commissioner for patent policy. In an interview with The Public i, Kunin said that the sequencing process "takes something out of nature, isolates it and purifies it." In that new "isolated" and "purified" state, he said, the gene is no longer a completely natural material, but a product of man and, therefore, patentable."[Note: that as of July 2000, there were 1,000 patents issued for human genes.]
But people, you know that the above quotes stretch the Diamond v. Chakrabarty holding of the U.S. Supreme Court. In that case a bacterium was involved under the federal Plant statute. It was not about the patentability of a human gene.
Let me crystallize things here a bit. We are speaking of 2 different things: the patenting of human genes, and the patenting of Expressed Sequence Tags (ESTs). I would bet you dimes to doughnuts that most of the 1,000 patented genes that were reported up to July 2000 are actually patents on ESTs or other gene fragments. What is an EST? It is a fragment of a gene obtained through sequencing. Generally very little is known about the EST at the time of its sequencing, other than its source. As of the end of 2000, under the federal Patent Act, Section 112 [35 U.S.C. 112], EST holders may not claim the entire gene from which the EST was sequenced. The sequencing of an EST simply does not provide enough information about the entire gene to be patentable.
Are ESTs patentable? To be patentable under the federal Patent Act, specifically, Sections 101, 102, and 103, an invention must be novel, nonobvious, and have utility. The specification in the patent application must "contain a written description of the invention ... in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains ... to make and use [the claimed invention]." In patent applications for ESTs, the brick wall is usually the utility requirement. If an applicant does not know the identity of the gene from which the EST came, then he or she will not know what the gene does.
Attorneys against the patenting of human genes will someday have to make the arguments above to the United States Supreme Court as well as that human genes were not involved in Chakrabarty, and the "anything under the sun" theory of the Court is pure dicta [means not part of the legal holding]. If there is ever a court challenge to the patenting of a human gene, the Court may strike the whole scheme down. It may not occur at the federal district court level, but either at the federal appellate level in circuit court or the United States Supreme Court. I believe that the Supremes would not wait for 2 federal circuits to be in disagreement, but would take the case because of the extreme importance of the issue. The challenges to the patentability of human genes cannot be that far away..........
Be sure to see the offsite links below, especially the USPTO view of the utility requirement and the one on the written description requirement. The utility link explains the USPTO's position on utility when dealing with patent applications for genes, gene sequences, EST's, etc. The written link talks about the written requirement in relation to all patent applications, including those for chemical compounds and genes.
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Medical Genetics and Genealogy: Genetic Diseases
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Free Patents Online
FTC Issues Report on U.S. Patent Policy (October 2003: 315 page pdf)
USPTO Patent Search Page
USPTO, Utility Examination Guidelines. Office review of patent applications for compliance with the utility requirement of 35 U.S.C. 101. [Federal Register: January 5, 2001 (Volume 66, Number 4)][Notices] [Page 1092-1099]
USPTO, Written Description Examination Guidelines. Office review of patent applications for compliance with the written description requirement of 35 U.S.C. 112, paragraph 1. [Federal Register: January 5, 2001 (Volume 66, Number 4)][Notices] [Page 1099-1111]
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