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Structural Genomics Leaders Eye Patent Pitfalls

WARRENTON, Va., April 6 - Data deposition policies in structural genomics must negotiate a minefield of inconsistent international laws on intellectual property, warned Joseph Straus of the Max Planck Institute of Foreign and International Patent, Copyright, and Competition Law in Munich.

Speaking Thursday at the National Institutes of Health’s Second International Genomics Meeting, Straus advised attendees to “be realistic” when it comes to establishing release policies that would prevent organizations from patenting work.

“Those who made and those who financed the invention would probably have a problem with this,” he said.

Like genomic and cDNA sequences, amino acids and proteins may be considered intellectual property if they are isolated or otherwise technically produced, even if the structure is exactly the same as that pre-existing in nature. Yet setting global standards for patenting such molecules in the US and abroad has already triggered a lively debate due in part to the differences between patent law in various countries.

In the US, the person who first develops an invention is entitled to the patent. Laboratory protocols, witnesses, and publications are all important for proof. By contrast, intellectual property laws in the rest of the world tend to discourage publication until a patent has been obtained. In almost all countries other than the US, the person who first files for a patent is entitled to obtain it. In Europe, anything that has already been released to the public is considered “prior art,” or not novel, and therefore no longer patentable. 

A key exception to this rule in the European patent law is that a product patent can be obtained on a previously published substance when the first medical use is discovered. Scientists who simply publish a structure without patenting it may soon find that someone else has deduced a medical application and patented not just that use, but the structure itself. All other uses would then be dependent upon that patent.

Within the international groups, the European and Japanese agencies are most concerned with patenting the results of their efforts in structural genomics, while groups funded by the National Institutes of Health are committed to a policy of early data release.

But patenting isn't the point of the publicly-funded structural genomics projects, said Marvin Cassman, director of the National Institute of General Medical Sciences at NIH. “This is a basic research function. That’s why the NIGMS is putting money into it,” he said. “We want to have a large array of proteins that one can evaluate as a group. It’s important to get as many structures into the public domain as soon as possible.”

“We need to proceed in a way that doesn't prevent commercial development, but that also does not compromise the essential goal of the program. If it's not high-throughput, it's not worth doing,” Cassman said.

Still, many scientists are wary of a situation in which commercial groups could scoop up the information they generate and use it to obtain patents that would make it more difficult for them to continue their research. With that in mind, Tom Terwilliger of Los Alamos National Laboratory suggested pursuing “protective disclosure,” annotating structures with possible medical uses, when they can be deduced, thus demonstrating priority under both the US and European patent systems. An adjustment to the US principle of immediate deposition might be warranted in such cases, he said.

“The best overall policy may require a different amount of time for different structures,” Terwilliger said.

British researchers are already planning a defensive strategy. While the UK’s Structural Genomics Consortium, a Wellcome Trust-sponsored group of 10 pharmaceutical companies, has agreed to pursue  basic “pre-competitive research” on a public domain basis, John Stewart, a lawyer for the Wellcome Trust, said the group would also consider filing patents should commercial exploitation of their work threaten their research activities.

Yet, the defensive strategy must be applied with caution, said Straus, warning against attaching generic “medical use” wording for deposited structures.

“You can indicate a use when depositing a structure, but if it’s rubbish, it probably will not stand,” he said.

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