02 May Supreme Court ruling seen as blow to WARF stem cell patents
Madison, Wis. – Has the United States Supreme Court strengthened the case against stem cell patents held by the Wisconsin Alumni Research Foundation?
The answer is yes, according to the California consumer watchdog organization that is challenging the patents, but that’s not necessarily a consensus opinion.
The nation’s high court, in a strong rebuke to the U.S. Court of Appeals for the Federal Circuit, ruled in favor of KSR International Corp. in KSR International v. Teleflex, in effect saying the lower court has been too deferential to patent holders.
The case addressed a basic principle in patent law: how to determine whether a product is obvious based on prior art, and therefore unworthy of a patent.
The Supreme Court said the federal circuit court had applied too narrow an interpretation of the long-standing patentability standard for obviousness. To be patentable, an invention must not be “obvious” in light of what was publicly known at the time it was created by the inventor.
The stem cell patents held by WARF are based on discoveries made by University of Wisconsin-Madison professor Jamie Thomson, who developed a method for isolating and defining human embryonic stem cells.
In a patent challenge before the United States Patent and Trademark Office, the Foundation for Taxpayer and Consumer Rights claims that the stem cell patents granted to WARF are are based on discoveries that were obvious in light of previously art.
“The consensus generally was that the federal circuit court had swung too far in the direction of patent holders,” said John Simpson, stem cell project director for the FTCR. “The decision is part of a trend in the Supreme Court to swing back the other way. Obviousness will now be easier to prove.”
The FTCR, which has called on WARF managing director Carl Gulbrandsen to resign from the U.S. Patent Public Advisory Committee to avoid a conflict of interest, won an initial round in the dispute when patent examiners upheld its challenge to the WARF patents. WARF is in the process of responding to that ruling.
Andy Cohn, government and public relations manager for WARF, said the organization is confident that its stem cell patents will be upheld. He said the FTCR is desperate for publicity, and suggested that all parties let the review process run its course.
“The taxpayer and consumer rights group is desperately trying to get publicity for an issue that is in the process of being reviewed,” he said.
Supreme Court smack down
Two Wisconsin attorneys agreed the Supreme Court had sent a message to the federal circuit court, which oversees patent law. The dispute over WARF’s stem cell patents could eventually come before the court, which has used the “TSM” standard in patent cases. The standard requires a patent examiner, or any party trying to invalidate a patent, to find some teaching, suggestion, or motivation in known technology, or prior art, to sustain the rejection of a patent based on obviousness.
“The Supreme Court said, `we didn’t think the [TSM] test is wrong, but you have applied it in a wooden-headed manner,’” said Grady Frenchick, a patent attorney with Whyte Hirschboeck Dudek. “The Supreme Court is working to make the non-obviousness test a little more difficult to meet.”
Jeffrey Costakos, a partner in the Milwaukee office of Foley and Lardner, said the ruling is another in a line of cases in which the Supreme Court has criticized the federal circuit court for applying its own restrictive test.
“The Supreme Court is telling the federal circuit to look at Supreme Court precedents and not approve its own restrictive test,” Costakos said.
Costakos said he can’t speak to ruling’s impact on WARF’s stem cell patents, but he agreed that the ruling generally makes it more difficult to obtain a patent and easier to invalidate patents that have been issued. He also said it would be easier for an accused patent infringer to demonstrate obviousness.
Frenchick said the impact of he Supreme Court’s ruling may not be as profound on life-science patents.
He said the patent world has two classes of tests: a predictability test that pertains more to patents for mechanical inventions like the patent issued for adjustable gas pedals at issue in KSR vs. Teleflex, and a non-predictability test that pertains more to patents for life-science discoveries.
With life-science inventions, “we can extrapolate and guess, but until we conduct an experiment, we don’t know if it’s going to work,” Frenchick said. “That’s true in drug discovery and stem cell experiments.”
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