Originally Published IVD Technology April 2001
Industry News
PTO finalizes rules on gene patenting
With the final version of its examination guidelines
issued this January, the U.S. Patent and Trademark Office (PTO) has
raised the bar for companies seeking to obtain patents on genes and
gene fragments. The guidelines come at a time when PTO has already
issued more than 400 human gene patents and tens of thousands more
are awaiting approval.
According to the new guidelines, besides proving novelty and nonobviousness, the applicant must demonstrate a specific, substantial, and credible utility for the gene, such as a use in clinical testing or treatment of a specific disease. A patent could be denied if the utility is described simply as a tool for further research on similar gene sequences.
"Under the new guidelines, patents will be granted on the process of isolating the gene, the method of purifying it, or the use for it," says Michael Fein, chair of the intellectual property department at Cozen and O'Connor (Philadelphia).
In preparing the guidelines, PTO received comments from 35 individuals and 17 organizations—many disagreeing with the idea that genes should be patented at all.
One group of comments expressed the view that genes cannot be patented because they exist in nature, an opinion also put forward by the College of American Pathologists (CAP), in a July 2000 position paper on the subject of gene patents. "Information derived from mapping of the human genome represents a naturally occurring, fundamental level of knowledge which is not invented by man and should not be patented," CAP argued.
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Notable
Third Wave Technologies (Madison, WI) and the University of Minnesota (Minneapolis), working through the Fairview University Medical Center (also Minneapolis), have entered into a collaboration to validate the association between genetic mutations and the development of hemochromatosis, a commonly inherited genetic disorder. Sponsored by the National Institutes of Health (Bethesda, MD) and led by John H. Eckfeldt, MD, PhD, of the University of Minnesota, the study will genotype at least 100,000 patient samples using Third Wave's Invader operating system. The study will analyze a cross-section of Americans of varying backgrounds over a five-year period to determine risk profiles for hemochromatosis. |
The position paper went on to say that "The recent trend of issues and using patents on genes to monopolize gene-based testing violates the medical community's tradition of sharing information to bring the greatest benefit to patients."
In spite of such arguments, PTO's position on gene patenting has not changed significantly since its interim guidelines on the subject were issued, in 1999.
Responding to the comments, PTO argued that the office is legally permitted to grant patents on individual isolated genes provided they meet the necessary criteria. According to the guidelines, "Patent law provides no basis for treating DNA differently from other chemical compounds that are compositions of matter. If a patent application claims a composition of matter comprising DNA, and the claims meet all the statutory requirements of patentability, there is no legal basis for rejecting the application."
"The most important aspect of the guidelines is that these are 'final,' which introduces closure," says Richard Schifreen, business unit leader for molecular diagnostics at Promega Corp. (Madison, WI). "The only way for this issue to be reopened would be through Congress passing legislation—and that appears very unlikely."
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Notable
DNA Sciences (Fremont, CA) and Amersham Pharmacia-Biotech (Uppsala, Sweden), the life-sciences business unit of Nycomed Amersham plc (Amersham, UK), have announced that they will collaborate to develop microchannel chip technology for the automated high-throughput analysis of nucleic acids. The platform will be developed with chip technology from DNA Sciences and has the potential to improve DNA analysis through miniaturization, speed, and automation. The companies will combine their expertise and intellectual property in microfabrication, engineering, reagent and applications development, and production-scale sample processing to develop a high-throughput system that will be marketed exclusively to the life sciences and diagnostic industries. DNA Sciences will be paid licensing fees and collect royalties from future product sales. In other company news, DNA Sciences has acquired the rights from the University of Utah (Salt Lake City) and Yale University (New Haven, CT) to 152 variants in five separate genes associated with severe cardiac arrhythmias. The company has also entered into an agreement to acquire PPGx Inc. (San Diego), a pharmacogenomics products and services firm. |
Final or not, some organizations remain unconvinced that PTO's view makes for good policy. In a position statement on gene patents and accessibility of gene testing, the American College of Medical Genetics (ACMG) says that "The decision of the USPTO to permit the patenting of naturally occurring genes and disease-causing mutations has produced numerous difficulties." Instead, ACMG argues that gene-patenting policy should be guided by the following principles.
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Genes and their mutations are naturally occurring substances that should not be patented.
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Patents on genes with clinical implications must be very broadly licensed.
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Licensing agreements should not limit access through excessive royalties and other unreasonable terms.
Meanwhile, other organizations have applauded
PTO's decision. The Biotechnology Industry Organization affirmed its
support in a backgrounder, saying, "Patents are not granted on raw
fundamental gene, expressed sequence tag (EST), or single nucleotide
polymorphism (SNP) sequence data. A patent is granted only if the
research discerns the role of the gene, EST, or SNP in human health
or another
potential commercial application. No one can run a machine and generate
a patentable invention. Patents are granted for the value that is
added by the researcher, not on the raw sequence data."
"I don't think the IVD industry expected or even wanted major change in the PTO guidelines," says Schifreen. "The question is whether we will figure out how to structure win-win license agreements that will facilitate growth of the industry and benefit our customers."
—Susan Wallace
