At least 18.5% of human genes are covered by U.S. patents, say researchers who have produced the first comprehensive map of the patent landscape for the genome.
The researchers called the figure "surprisingly high" and their findings, published in Friday's issue of the journal Science, are likely to add fuel to an already heated debate over ownership and the right to exploit human gene sequences commercially.
U.S. and European patent law preclude anyone from patenting a gene as it exists in the human body. But for several decades, inventors and institutions have been filing for patents by claiming a proprietary way of isolating the genes or developing a specific therapeutic use for them that is claimed to be unique.
They have also been making similar claims over the specific proteins that each gene instructs cells to produce. A well-known example is erythropoietin, a blood protein manufactured as the blockbuster drug Epogen to stimulate the production of red blood cells and whose patent rights are owned by Amgen Corp.
But gene patents can still be subject to dispute. BRCA1, a gene involved in breast cancer, is one of the most often-patented genes, with 14 patents issuing claims to it, according to the study by researchers at the Massachusetts Institute of Technology.
The BRCA1 has been the subject of legal battles in Europe, where several countries challenged Utah-based Myriad Genetics' patent claims on the use of the gene's sequence for diagnostic purposes. The European Patent Office invalidated one of the company's key patents for the gene and its diagnostic use last year.
The opposition in Europe stemmed from researchers' sentiment that one company shouldn't monopolize the use of the gene and the test, according to Arti Rai, a law professor at Duke University who specializes in biotechnology intellectual property.
As the number of gene patents increased in the late 1990s, mainly due to the explosion of genomics-based companies, concern grew that too many parties were claiming a stake on gene sequences, says Ms. Rai. Some companies were patenting sequences on a mass scale, without a clear knowledge of what those genes did, she says.
Based on looking at a handful of genes, some groups had offered estimates on the extent of gene patenting, but nobody really knew for sure how widespread the practice was. "The real novelty of the work is that it's a whole-genome approach," says Kyle Jensen, an MIT graduate student and co-author of the study.
In the report, Mr. Jensen and Fiona Murray, a professor at MIT's Sloan School of Management, compared all the gene sequences claimed in U.S. patents from 1990 until today with the sequences stored in the government's public database of human genes.
The team found that of the 23,688 genes in the U.S. government's public database, 4,382, or 18.5%, were claimed as intellectual property. This is probably an underestimate because the analysis didn't look at patents claiming rights to proteins and which might have omitted the gene sequence -- the string of DNA code letters that define it -- for the corresponding gene from the text, says Dr. Murray. The actual number "could be up to double" the 4,382, she says.
The patents were owned by 1,156 institutions or inventors. About 63% were assigned to private companies, with Incyte Pharmaceuticals and its parent, Incyte Corp., in Delaware, being the one with the highest number of genes -- over 2,000 -- covered by patents.
The University of California, SmithKline Beecham, Genentech and Human Genome Sciences Inc. also are among the top holders of genome patents.
Scott Stern, a professor at Northwestern University's Kellogg School of Management who studies how scientific ideas get to the marketplace, said the MIT work "illustrates in a very dramatic fashion the degree to which intellectual-property rights over the human genome are inextricably linked with those areas of high medical and scientific interest."
Mr. Stern, who has worked with Dr. Murray in the past but wasn't involved in her current research, says the debate over the patenting of human genes "is going to be with us for a long time" and that the MIT work lays the groundwork needed to make informed policy decisions. The National Academy of Sciences, which advises the U.S. government on science issues, is currently looking at the issue of gene ownership and its effects on research.
With the new map of the human genome's patent landscape, a series of longstanding questions -- until now untested -- will be easier to answer, says Dr. Murray. The map "is a good beginning" for finding out in a more empirical manner to what extent genes are patented and what the effects of the patenting truly are, says Ms. Rai.
Some scientists have argued that having too many patents on a single gene stifles innovation because researchers or companies hoping to work with that gene will think the risk of infringement is too high, or that licensing rights to the gene will be an uphill battle. Now that the map provides information on which human genes are patented the most, the idea can be tested, says Dr. Murray.
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