Buoyed by the Supreme Court’s ruling last month invalidating gene patents, two advocacy groups on Tuesday asked a federal appeals court to similarly forbid a patent on human embryonic stem cells held by the University of Wisconsin’s research marketing arm.
The lawsuit, against the Wisconsin Alumni Research Foundation, was filed by Consumer Watchdog and the Public Patent Foundation. It was made possible only after the plaintiffs finished slogging through years of appeals at the U.S. Patent and Trademark Office, the advocacy groups said.
In their complaint, filed with the U.S. Court of Appeals for the Federal Circuit, the groups argue that the foundation’s patent covers in vitro cultures of human embryonic stem (hES) cells “that are not markedly different from naturally occurring hES cells.”
As with the Supreme Court’s action against gene patents that originated at the University of Utah, a court ruling on embryonic stem cells could come with relatively little time left on the original patent. But the Supreme Court’s decision on gene patents raises hopes for victory in a case that still would have important implications for stem-cell researchers, the plaintiffs said.
The potential to help all stem-cell researchers realize financial rewards from their work is important, but it’s not the main objective of the lawsuit, said Jeanne F. Loring, a professor of developmental neurobiology at the Scripps Research Institute who has advised the advocacy groups bringing the case.
More important, Ms. Loring said, a court victory involving human embryonic stem cells would make clear the breadth of the Supreme Court’s decision in the gene-patent case that no forms of nature can be patented.
“There is an argument to be made for letting the world know that this kind of thing is not allowed,” she said.
Carl E. Gulbrandsen, managing director of the Wisconsin Alumni Research Foundation, said he hadn’t previously heard of the lawsuit and could not comment on it. “Until we have a chance to study what has been filed, anything I say will be totally speculative,” he said.
Clinical Trial Abandoned
The Supreme Court, in a unanimous decision announced on June 13, ruled that Myriad Genetics Inc. did not have a right to claim ownership of the BRCA1 and BRCA2 genes, which it discovered along with partners that include the University of Utah.
The court found that the genes are naturally occurring and thus ineligible for patent protection, contradicting years of decisions by the U.S. patent office. With those patent rights, which are due to expire next year, Myriad had for years been charging women some $3,000 for tests to check their hereditary risk of breast and ovarian cancer.
The Wisconsin Alumni Research Foundation, which markets its university’s discoveries, does not appear to have had similar financial success with its patents on human embryonic stem cells. Those cells, which are early-stage cells that have the potential to grow into a variety of different cell types in the human body, were first derived in 1998 by James A. Thomson, a biologist at the University of Wisconsin.
Their discovery raised hopes for treating a range of ailments that include cancer, diabetes, and heart disease. But research was held back in part by government restrictions on harvesting the cells from human embryos. And in 2011, Geron, the one biopharmaceutical company working with the Wisconsin patent rights, abandoned the world’s first clinical trial using human embryonic stem cells, which had hoped to use stem cells for treatment of spinal-cord injuries.
‘Substantial Chilling’
The Wisconsin foundation initially sought payments from university researchers studying potential uses for embryonic stem cells, then backed off after encountering negative publicity, Ms. Loring said. The foundation, however, still keeps close track of research, with the apparent intent of staking a financial claim in the event of any commercial successes, she said.
That has caused “substantial chilling” of research, said Daniel B. Ravicher, executive director of the Public Patent Foundation. Even with Wisconsin patent rights on human embryonic stem cells due to expire in a couple years, the case remains very much worth pursuing because of the potential dampening of research for each day the patent rights remain in effect, said Mr. Ravicher, whose group fought for years through the U.S. Patent and Trademark Office before gaining the legal right to bring a court case.
Other experts agree with the need to end patent rights on human embryonic stem cells, even if they’re less clear on what benefit Wisconsin has actually won for itself.
No products have yet made it to market using such cells, said Robert Cook-Deegan, a research professor of public policy at Duke University. The main benefit that the Wisconsin foundation has realized, therefore, could just be the distribution network it set up for parceling out the stem cells, Dr. Cook-Deegan said. It’s not clear what financial benefit even that network will produce, he said.
