Friday, April 13, 2007

Patenting Genes [International]

The practice of patenting genes, which had largely faded from the headlines, has suddenly attracted a swarm of critics. The blitz includes an op-ed article in The New York Times by best-selling-novelist-turned-patent-gadfly Michael Crichton, a torrent of posts and comments on patent law blogs, and a disturbingly sweeping piece of intellectual property legislation.

The first salvo, introduced in the House of Representatives in early February, was bill H.R. 977, the "Genomic Research and Accessibility Act." The bill would insert a change in the U.S. patent code which reads, in its entirety: "Notwithstanding any other provision of law, no patent may be obtained for a nucleotide sequence, or its functions or correlations, or the naturally occurring products it specifies."

Though it has attracted some media coverage, experts expect the bill to sink without a trace. "I just don't see how the heavy hitters in the biotechnology and pharmaceutical industries are ever going to let that get by," says David Clough, head of the worldwide life sciences practice at Howrey. Besides massive industry resistance, "there are all sorts of constitutional arguments against it," says Clough. "You can be assured that it would be in the courts a long time.
"What's more, patient groups would likely be in an uproar once they realized that such legislation could put a crimp, to say the least, on much genetic research on new cures. The legislation would likely preclude patents on many highly respected categories of intellectual property, including current biotechnology drugs, animal strains and genetically modified crops. Coincidentally or not, the bill was introdued by Crichton's congressman, Xavier Becerra, just four days before the New York Times ran Crichton's op-ed piece on the same topic. The op-ed opens with the dramatic claim that "you, or someone you love, may die because of a gene patent that should never have been granted in the first place."

The editorial and the legislation also happened to coincide with the launch of Crichton's new book, "Next," which is itself a screed against gene patenting. The novel's cast of characters includes a researcher trying to hide a human-chimpanzee hybrid baby, a greedy venture capitalist who patents human genes, and an evangelical Christian administrator at the National Institutes of Health who steals research data.

Crichton's editorial foray into patent law prompted a vigorous response from patent law bloggers, including a detailed critique by Kevin Noonan, of McDonnell Boehnen Hulbert & Berghoff, on his Patent Docs blog. Putting the new campaign in the context of Crichton's earlier work, Noonan concludes that "while space viruses, inhuman cyborgs, and thunder lizards are entertaining as fiction, they shouldn't inform national policy."

Ironically, gene patents are already losing their glow as a biotech IP panacea. An analysis in the February issue of Nature Biotechnology shows that new gene patent applications are declining in the United States, Europe and Japan. Observers cite several reasons for the slide, including the realization that a gene sequence is a long way from a commercial product and tightening standards at the PTO. "As a general rule, the patent office will [now] allow you to have only one DNA sequence in your claims," says Clough. Genomics companies that could previously file a single application covering thousands of genes would now have to file -- and pay fees on -- thousands of separate applications.

Besides applying for fewer gene patents, some companies are actively preventing them. For example, Switzerland-based Novartis recently announced the free release of a massive database of gene mutations that might be involved in diabetes. Dumping this data into the public domain precludes competitors from patenting the sequences, while making it easier for researchers to study them. Unfortunately, that wouldn't make a very exciting screenplay.

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