NEWS

Genome Data Announcement Fuels Stock Plunge, Misunderstanding

Tom Reynolds

The Nasdaq stock index took its second steepest dive ever March 14, after President Clinton and British Prime Minister Tony Blair issued a joint statement affirming that human genome data should be freely available to all.

The biotech companies on the Nasdaq lost tens of billions of dollars in value when skittish investors interpreted the Anglo-American announcement as bad news for private-sector genome research, despite the two leaders’ assurance that intellectual property rights would be protected. The stock plunge highlighted the misunderstanding about gene patenting among the public—starting with federal officials and the national news media.

The Associated Press and Reuters wire services quoted White House press secretary Joe Lockhart, who said at a briefing that the U.S. Patent and Trademark Office has decided scientists cannot obtain patents for individual genes, but that "if you develop a vaccine or something off of the genetic data, that will continue to have intellectual property rights." And Dan Rather reported on CBS that the agreement "means no individual scientist or company could patent the recipe of life, though they could patent genetic medicines or products they invent." So it’s not surprising that readers and viewers came away with the impression that gene patents would be banned.

In fact, though, the Clinton–Blair statement signals no policy change, but simply reinforces existing policies that attempt to strike a balance between researchers’ need for access to genome data and the biotech/pharmaceutical industry’s need to protect its investments in gene research.

"The statement has no impact on current patent law or our examination of [gene] patents," said Richard Maulsby, director of public affairs at the PTO. The White House released a detailed question-and-answer document that set the facts straight, but the announcement was widely misrepresented by the media based on Lockhart’s statement. "It’s unfortunate the way it got reported," Maulsby added.

The two governments urged that all raw genome sequence data be made public as soon as it is available. This is already being done by the Human Genome Project, whose scientists are funded largely by the National Institutes of Health and the Wellcome Trust, a British medical charity. But several private companies, most notably Celera Genomics of Rockville, Md., have jumped into the sequencing race (see News, Jan. 19). With Celera making rapid progress, the Genome Project approached the company to discuss a potential collaboration. The talks broke down over the issue of publicizing sequence data. Celera declined to release its data immediately, although the company promises to make the entire sequence public after it is completed, probably this summer.

The raw DNA code churned out by the Genome Project’s and Celera’s sequencing machines is not patentable, and an estimated 97% of it is not even part of any gene. Moreover, the genome companies say their main business is not patenting genes, but organizing genetic information into comprehensive databases that will be useful (and, they hope, indispensable) for biomedical scientists and drug makers. Nevertheless, Celera’s stock plummeted 21% after the announcement, while Incyte Pharmaceuticals’ value fell 27% and Human Genome Sciences’ 19%.

In contrast to raw genome sequences, human genes are patentable in the United States. In fact, hundreds of genes are already patented, including the breast cancer genes BRCA1 and BRCA2 (see sidebar, p. 596). The March 27 U.S. News and World Report cites a joke current in biotech circles—that 800% of the human genome is already patented. The truth behind the jest is that the PTO will likely have to sort through many competing claims to gene rights.

The PTO in December released interim guidelines for patenting genetic material, taking public comment through March. On March 1, the office published a set of training materials for patent examiners with examples of DNA patent applications—including genes, gene fragments, expressed sequence tags (ESTs), and antisense compounds—that should be approved or rejected. These materials are on the PTO Web site, and will help clarify for both PTO employees and outsiders what is and isn’t patentable, said John Doll, the PTO’s director of biotechnology.

"What it does for the public is give them an idea of how we’re going to examine...a particular type of technology," Doll said. Essentially, by requiring specific and substantial utilities, it closes a loophole through which applicants were able to secure patents for genes whose function they could only guess. "We had people claiming [gene patents] when they didn’t know what the protein did," Doll said. "They would list pages and pages of assumed utilities, and at the very end would say, ‘by the way, it is useful as an animal food supplement,’ and that was the one utility that would carry the day." Applicants also claimed ESTs had utility as probes for unknown genes that could be expressed to discover the function of their proteins. Under the new guidelines, neither of these utilities would pass muster because they could apply to any expressed DNA sequence.

But even these stricter rules will not guarantee that those who make the most important discoveries about a gene’s function will win the rights to commercialize the findings. In February, nearly 5 years after filing the application, Human Genome Sciences was awarded patent rights to a gene making a protein they called HDGNR10. In its application, the company had speculated about the protein’s possible role in diseases from cancer to allergies to arthritis.

Soon after that, in 1996, several research groups reported findings on a receptor, CCR5, that gives HIV a foothold to enter cells. (Mutations in the CCR5 gene explain how some people can be exposed to the virus repeatedly without becoming infected.) It turns out that HDGNR10 and CCR5 are identical, and Human Genome Sciences controls the rights to commercialize CCR5 for AIDS therapies—even though the company had no part in the HIV research. The episode provided fodder for critics who claim the patent system is unfair.



             
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