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New Stem Cell Patent Action Filed

THE SAN DIEGO UNION-TRIBUNE

A stem cell patent held by a Wisconsin university foundation should be invalidated, according to a legal filing made Tuesday by two consumer advocate groups.

Consumer Watchdog of Santa Monica and the New York-based Public Patent Foundation asked a federal appeals court to throw out the patent held by the Wisconsin Alumni Research Foundation on producing human embryonic stem cells. They said the patent is invalid because these cells are products of nature, and not patentable.

The group cited last month's Supreme Court ruling that the use of natural human gene sequences cannot be patented as applicable in this case. That case against Myriad Genetics invalidate that company's patents on the BRCA1 and BRCA2 genes, which can have mutations linked to breast, ovarian and other cancers. The Public Patent Foundation and the ACLU represented those challenging Myriad's patents.

The filing said WARF patent 7,029,913, referred to as the '913 patent, is also invalid because the invention is obvious to anyone skilled in the field.

The filing with the United States Court of Appeals for the Federal Circuit is the latest development in a dispute dating back to 2006. In that year, WARF's claim was first challenged by the two groups.

WARF later backed off of some claims and its 913 patent was upheld. The new challenge seeks to strike down the 913 patent.

Jeanne Loring, a San Diego stem cell researcher who took part in the initial challenge, said the underlying technology was invented three decades ago to produce embryonic stem cells in other animals. Applying it to humans was an obvious step, said Loring, of The Scripps Research Institute.

The president of California's stem cell agency, Dr. Alan Trounson did not directly say whether the California Institute for Regenerative Medicine supported or opposed the new filing.

"We don't want to do anything that gets in the way of finding treatments for some of the biggest killers today, so we feel that all patients with all kinds of diseases deserve to have access to these kinds of cells," Trounson said.

WARF had originally claimed three patents. In 2008, the U.S. Patent and Trade Office partially affirmed them, then in 2010 invalidated the key 913 patent.

The patent office later reversed its decision, which the filing said was made in error based on a flawed understanding of the facts.

In a 2007 article in Nature, Loring explained her position against the patenting of embryonic stem cells:

"Unlike a scientific publication, which encourages other scientists to reproduce a researcher's work, a patent has the force of law to exclude others from working with the patented invention or material," Loring wrote. "In this case, the patents are quite broad. Through a "composition of matter" claim, the patents would cover even human ES cells that were not derived through James Thomson's method, on whose work the patent is founded.

The '913 patent covers the isolation of human embryonic stem cells by researcher James Thomson of the University of Wisconsin - Madison in 1998.

Thomson's discovery was extremely significant, and deserved patent protection, WARF said in 2007.

"WARF has absolute confidence in the appropriateness and legitimacy of these patents," WARF Managing Director Carl E. Gulbrandsen said in a press release. "It is inconceivable to us that Dr. Thomson's discovery, which Science Magazine heralded as one of the greatest scientific discoveries in history, would be found to not be worthy of a patent. This discovery captured the imagination of people all over the globe from every discipline."

The filing says Thomson "was one of the lucky few stem cell researchers who managed to obtain both funding for hES (human embryonic stem cell) research and human embryos with which to work. At a time when the federal government was not funding ES cell research, Geron Corporation funded Thomson's laboratory."

Academic patent pioneer

WARF is a pioneer of commercializing university research discoveries. Fortifying milk with vitamin D by irradiation with ultraviolet light is its most famous claim. This discovery in 1923 led to the founding of WARF. That patent expired in 1945.

In 1941, a University of Wisconsin team discovered an anticoagulant called warfarin, that found dual uses, as a rat poison and a blood thinner trademarked Coumadin. One of the more interesting possible uses of warfarin was to kill Soviet dictator Joseph Stalin in 1953. Some medical evidence suggests this was the case, but conclusive proof is lacking.