A patent controlling use of human embryonic stem cells should be struck down, two consumer groups said in a legal appeal filed Tuesday.
Promising therapies developed with these cells will be delayed from reaching patients if the patent remains intact, say researchers, including Jeanne Loring of The Scripps Research Institute and Gene Yeo of UC San Diego.
The appeal was filed by Consumer Watchdog, based in Santa Monica, and the New York-based Public Patent Foundation, with the U.S. Court of Appeals. The groups said the U.S. Patent and Trade Office incorrectly upheld a patent awarded to the Wisconsin Alumni Research Foundation.
The foundation’s use of patent 7,029,913, called the ’913 patent, “has put a severe burden on taxpayer-funded research in the State of California,” the appeal stated. The California Institute for Regenerative Medicine funds embryonic and nonembryonic stem cell research with $3 billion from state bonds.
Yeo said the foundation permits basic research with embryonic stem cells, but warns scientists that any products resulting from that research requires a license. This warning scares away potential corporate partners.
Last month’s U.S. Supreme Court decision invalidating gene patents held by Myriad Genetics makes the case especially timely, the groups said in their brief. Human embryonic stem cells are a product of nature like genes, and so cannot be patented, they say.
In addition, isolating those cells is an obvious extension of their discovery in other animals.
The case began in 2006, when stem cell scientists joined the two groups in challenging the Wisconsin Alumni Research Foundation patent and two others. The other two have been dropped from the litigation. Loring took part in the original challenge and continues to advise the groups. The ’913 patent is the most troublesome, because of its broad scope, Loring said.
The foundation said it was properly protecting breakthrough research from the University of Wisconsin at Madison by James Thomson.
In 1998, Thomson was the first to isolate and culture human embryonic stem cells, which had previously been found in other animals. Loring said Thomson’s work is not patentable, because he didn’t do anything other embryonic stem cell scientists couldn’t have done, if they had his resources.
“The difference between Jamie Thomson and the rest of us working on ES cells at the time is that he had both funding, from Geron, and embryos,” Loring said. “But he used methods that had been published long ago.”
The foundation’s managing director, Carl Gulbrandsen, said he had not read the appeal and so couldn’t comment on it.
But biotech attorney Lisa Haile said the challenge threatens patents for many other life science products outside of stem cells. Haile practices in the San Diego office of DLA Piper.
The challenge was surprising, she said, because the foundation had earlier narrowed the scope of its patent claims to embryonic cells so that research with other types of stem cells was not affected. That compromise appeared satisfactory, she said.
“The Myriad case, taken on its face, does not extend beyond DNA,” Haile said. “It doesn’t extend to proteins, doesn’t extend to antibodies, doesn’t extend to just about anything.”
A successful use of the Myriad case as a precedent for throwing out the foundation’s patent would open the door to similar challenges in just about any biotech product using material derived from life, Haile said.
