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Massive amounts of data flowing from the Human Genome Project and other genomics projects have stimulated an avalanche of applications to the U.S. Patent and Trademark Office (PTO) for patents on genes and gene fragments. Some 3 million ESTs (fragments that identify pieces of genes) and thousands of other partial and whole genes are included within pending patents. This situation has sparked controversy among scientists, many of whom have urged the PTO not to grant broad patents at this early stage to applicants who have neither characterized the genes nor determined their functions and specific uses.
Genes and other biological resources have been patentable since the landmark 1980 U.S. Supreme Court decision in Diamond v Chakrabarty that granted a patent for an oil-dissolving microbe. Patents give owners exclusive rights to their inventions or ideas for 20 years from the filing date. The rationale is to allow inventors time to recoup their investment costs in exchange for a public description of their knowledge, thereby revealing technical advances to competitors and the general public and avoiding duplicated efforts. Biological inventions are patentable if they meet the standard requirements for all patents: they must be novel, useful, not obvious, and described sufficiently for others to reproduce.
A single gene may be patented, in principle, by different scientists or companies. One concern is that such patent stacking may discourage product development because royalties are owed to all patent owners. Additionally, because applications remain secret, companies may work on developing a product, only to find that submarine patents already have been granted, leading to unexpected licensing costs and possible infringement penalties.
Some past controversies have centered around the utility requirement. Some fear the large-scale patenting of gene fragments by biotechnology companies who are unaware of their functions but would stake a claim to all future discoveries on those genes (sometimes called reach-through patents).
In December 1999, the PTO published revised interim guidelines clarifying the utility requirement for patent claims on genomic and other biotechnological inventions. The new rules call for specific and substantial utility that is credible, but some still feel the rules are not stringent enough. Public comments have been posted to the PTO Web site (www.uspto.gov; scroll to Notices of Public Comments).
In the comments, the National Advisory Council for Human Genome Research observes that a broad allowance of claims is unjustified and will strongly discourage the further research efforts necessary to translate gene discovery into medically important therapies.
Instead of patent protection for specific gene sequences, Bruce Alberts, President of the National Academy of Sciences, advocates patents for the new treatments and drugs that will result from the research and development efforts of many different individuals and companies working from the basic information in the human genome sequence.
Final revised guidelines are expected from the PTO (see also Witnesses Testify About Patenting Genes. [Denise Casey, HGMIS]
The electronic form of the newsletter may be cited in the following style:
Human Genome Program, U.S. Department of Energy, Human Genome News (v11n1-2).
The Human Genome Project (HGP) was an international 13-year effort, 1990 to 2003. Primary goals were to discover the complete set of human genes and make them accessible for further biological study, and determine the complete sequence of DNA bases in the human genome. See Timeline for more HGP history.