"The effort to decipher the human genome...will be the scientific breakthrough of the century - perhaps of all time. We have a profound responsibility to ensure that the life-saving benefits of any cutting-edge research are available to all human beings."
President Bill Clinton, Wednesday, March 14, 2000

" Any company that wants to be in the business of using genes, proteins, or antibodies as drugs has a very high probability of running afoul of our patents. From a commercial point of view, they are severely constrained - and far more than they realize."(1)
Dr. William A. Haseltine, Chairman and CEO, Human Genome Sciences

Summary:

President Clinton's announcement pledging to ensure that the human genome remains in the public domain brought attention to the fundamental importance of preventing the privatization of human genetic material. However, the effect of the statement did nothing more than lull the public into believing that something has actually been done to change that trend. The commercialization and privatization of the human genome was not slowed by the announcement. In fact for the most part, the patenting and privatizing of the genetic information contained in the human genome has already taken place.

Wrestling for control of the human genome:

The Human Genome Project, launched in 1990, is a 15-year, $3 billion project supported primarily by the U.S. government and British partners to map the entire human genome, the 80,000-100,000 genes that exist within our DNA. Late in 1999, the Human Genome Project's leadership predicted that they would complete the identification and sorting of the estimated 3.5 billion genetic "letters" in human DNA by the end of 2000 - perhaps three years ahead of schedule. In 1998, a powerful private enterprise known as Celera announced its ambitious goal of sequencing the human genome more quickly and cheaply than the publicly funded Human Genome Project. The stage was set for the race to see who would dominate the human genome - the publicly funded HGP or the privately backed companies like Celera.(2)

Celera and the Human Genome Project had recently embarked on negotiations to merge their efforts to ensure that the sequencing of the human genome was done more accurately and efficiently. Talks between the two broke down last week after they were unable to come to an agreement over the length of time that Celera would be awarded exclusive monopoly rights to the entire database.(3)

It was in the wake of this controversy that U.S. President Bill Clinton announced that he and UK Prime Minister Tony Blair were advocating that the genetic material of the human genome should be freely available to the world's scientists. They argued that only "unencumbered access" to the data would benefit humanity, and that proprietary information of biotech companies would thwart drug discovery and health improvements. Too little, too late: While bringing to public attention the importance of preventing the privatization of genetic material, Clinton's announcement did nothing more than lull the public into believing that something had actually been done to change that trend. Shortly after the announcement, the USPTO issued a press release assuring investors that nothing had changed. Todd Dickinson, the Commissioner of Patents and Trademarks, made a mockery of the President's announcement when he maintained that "genes and genomic inventions that were patentable last week continue to be patentable this week under the same set of rules." The commercialization and privatization of the human genome was not slowed by the announcement. In fact for the most part, the patenting and privatizing of the genetic information contained in the human genome has already taken place.

Patent Mania:

The number of patents issued or being applied for by genomics companies is mind-boggling. Over 2,000 patents on full-length genes have already been granted by the U.S. Patent and Trademark Office (USPTO). But the number of patent applications runs into the millions.(4) The USPTO confesses that they have no idea how many patents applications are pending on expressed sequence tags (EST's) - which are "signatures" or parts specific to each gene - since they "quit tracking them" about four years ago, at which time they had about half a million.(5) In the past 200 years, the USPTO has processed six million patent applications. Based on company disclosures, there are currently over three million patent applications on ESTs alone. Since the date of application determines who owns a patent, the race to get in these applications has been intense. Though only a small proportion of the patents have actually issued, the patent "gene grab" is almost over.

Rebuilding the house of cards:

After the announcement, investor panic was swift. Genomics companies who are in the business of sequencing, mapping, and patenting human DNA saw their stock prices plunge. The huge sell-off in stocks ended weeks of biotech buying in which those same stocks soared to unprecedented highs. By the next day, however, the genomic company spin doctors began to recover ground in a brilliant move which turned the Clinton announcement into a public relations coup.

All major genomics companies issued press releases applauding President Clinton's announcement. The real news they argued, was that "for the first time a President strongly affirmed the importance of gene based patents." William Haseltine of Human Genome Sciences, one of the biggest losers in the biotech stock fall, positively gushed as he happily pointed out that he "could begin his next annual report with the [President's] monumental statement, and quote today as a monumental day."(6)

The companies were also quick to point out that their companies (and their patents) were "completely consistent with the goals of assuring that the world's researchers have access to this important information."(7) In particular, genomics companies promised investors that they were "not in the business of speculating on genes." But of course, that is precisely their business.

In the majority of cases, the companies have little or no idea about the gene or gene fragment's function. For its part, Celera, which describes itself as 'the world's largest DNA data factory'(8) "is using a 'shotgun' approach, sequencing bits of genes willy-nilly in the belief they will all fit together when they are done."(9) Celera and its rivals are not waiting for the pieces to fit together before filing for patents.

And that approach is apparently reaping the rewards of exclusive monopoly patents. Human Genome Sciences was issued a patent on a gene that could be used in the commercial development of a new class of HIV drugs. However, the company knew nothing of the gene's potential role in the disease when they filed for the patent in 1995.(10) Academic scientists and many legal scholars argue that the patent system has gone awry when companies can file patents without understanding the function of the gene before seeking the patent. This patent speculation, they argue, effectively prevents others from doing research and slows drug discovery. For example, when Hyseq received a patent on a gene thought to control weight the company announced that "the broad scope of the patent presents significant impediments for competitors seeking to exploit (the gene) for the discovery of drugs..." It is no secret that companies are using patents to protect market share and maximize future profits, not to better humankind.

Patents on human genetic material are increasing medical costs and restricting access to gene-based products. Instead of promoting innovation, gene patents threaten to stifle biomedical research and hinder competition in an industry that is already dominated by a handful of giant, multinational firms. The Clinton/Blair announcement did nothing to slow or stop the privatization and exclusive monopoly control of human genetic material.

Please see chart on PDF version on RAFI's website: www.rafi.org

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1. Fisher, Lawrence. "The Race to Cash in on the Genetic Code," NYT, August 29, 1999.
2. The Economist. 1999. "Genomic Pronouncements." 4 December 1999, p.77
3. Gillis, Justin, "Gene-Mapping Controversy Escalates." Washington Post, Tuesday, March 7, 2000, p. E01.
4. Garber, K., "Homestead 2000: The Genome" Signals Magazine, 03/03/2000, pg. 2.
5. Ibid, pg. 3.
6. Cited in Fisher, Jeff, "Today's Real News: Government Supports Gene Patents: How investors are misunderstanding biotech." www.fool.com, March 14, 2000.
7. Celera Press Release, March 15.
8. Celera Press Release. "Celera compiles DNA Sequence Covering 90% of the Human 7. Genome." Celera Genomics, Rockville. January 10, 2000
9. Ibid
10. Paul Jacobs and Peter G. Gosselin, "Experts Fret Over Effect of Gene Patents on Research." Los Angeles Times, 2/28/2000, http://www.latimes.com/news/nation/updates/latgenes000228.htm.