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US Supreme Court Decision Boosts Stem Cell Patent Challenge, Consumer Groups Say

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A US Supreme Court decision in favor of KSR International Corp. on Monday strengthens challenges against overreaching human embryonic stem cell patents held by an affiliate of the University of Wisconsin, the Foundation for Taxpayer and Consumer Rights (FTCR) and the Public Patent Foundation (PUBPAT) said.

The patents, held by the Wisconsin Alumni Research Foundation (WARF), were challenged by FTCR and PUBPAT on the grounds that they were obvious in light of previous scientific work. In March the Patent Office agreed with the challengers and rejected all of the patents' claims. WARF has two months to respond.

In Monday's unanimous decision the justices ruled that the US Court of Appeals for the Federal circuit, which oversees patent law, had been too generous to patent holders. It said it had allowed patent holders to claim patents for incremental advances that were in fact obvious.

The justices ruled that the circuit court was too narrow in its definition of "obvious." Justice Anthony Kennedy wrote, "Granting patent protection to advances that would occur in the ordinary course without real innovation retards progress."

"We believed that what James Thomson did to develop stem cell lines was obvious in the light of prior scientific work when we first filed our complaint," said John M. Simpson, FTCR Stem Cell Project Director. "Now, the Supreme Court decision only strengthens our position."

"The decision eliminates some of the formal requirements imposed by the lower courts for proving patents are obvious," said Dan Ravicher, PUBPAT executive director. "It says that combining previously known things will generally be obvious and thus no patent is deserved."

The WARF stem cell patents do nothing but combine previously isolated stem cells and known techniques to cultivate animal cells, Ravicher noted, and thus the Supreme Court decision will have direct applicability to the FTCR and PUBPAT patent challenges.

Thomson's work was an important contribution to science, Simpson said, just not patentable. Simpson said the best thing for WARF would be to accept the PTO's initial findings and move on. "It would save them some money and gain them respect in the scientific community," he said.

The patent challenges were filed last July by FTCR and PUBPAT because the three WARF patents were impeding scientific progress and driving vital stem cell research overseas.

FTCR and PUBPAT argued that the work done by University of Wisconsin researcher Thomson to isolate stem cell lines was obvious in the light of previous scientific research, making his work unpatentable.

Dr. Jeanne Loring of the Burnham Institute for Medical Research filed a statement supporting the challenge. To receive a patent, something must be new, useful and non-obvious. The PTO agreed with the groups.

In the face of the challenges by FTCR and PUBPAT, WARF announced in January that it would ease its licensing requirements on human embryonic stem cells. The groups said the patents' dubious validity is underscored by the fact that no other country in the world honors them.