Two nonprofit groups are continuing their challenge to one of the Wisconsin Alumni Foundation's key embryonic stem cell patents by asking a federal appeals court to invalidate it.
The Public Patent Foundation, based in New York, and Consumer Watchdog, Santa Monica, Calif., filed a brief Tuesday with the U.S. Court of Appeals for the Federal Circuit. The Public Patent Foundation was one of the successful challengers in the recently decided case in which the Supreme Court ruled that genes cannot be patented.
"WARF's broad patent on all human embryonic stem cells is invalid for a number of reasons and we are confident the Court of Appeals will agree," said Dan Ravicher, the foundation's executive director. The groups believe that all researchers should have unfettered access to embryonic stem cells, which scientists believe could help treat many diseases.
A WARF spokeswoman declined to comment, saying the foundation needed to review the filing with its attorneys.
The Public Patent Foundation and Consumer Watchdog, then known as the Foundation for Taxpayer and Consumer Rights, in 2006 filed a challenge with the U.S. Patent and Trademark Office over WARF's three key embryonic stem cell patents. The groups argued that the pioneering work done in the mid-1990s by James Thomson, a University of Wisconsin-Madison scientist, could have been done by any good scientist with access to embryos and funding.
The patent office rejected the challenge to two of the patents in 2008. It rejected the challenge to the third patent in May, said John Simpson, director of Consumer Watchdog's stem cell project. However, the third patent is governed by different rules than the other two because of its filing date, and received what is known as an inter partes review. After that type of review, challengers are allowed to file appeals with the federal appeals court.
Despite the fact that the three patents expire in less than two years — in April 2015 — the groups believe it is important to continue their challenge, Simpson said.
In light of the U.S. Supreme Court's June decision in a case involving Myriad Genetics that genes cannot be patented, the groups have also added another argument to their challenge.
Arguing against patent
Human embryonic stem cells are found in nature, and therefore should not be patented either, Simpson said.
"We don't want to do anything that gets in the way of funding treatments for some of the biggest killers today," said Alan Trounson, president of the California Institute for Regenerative Medicine. "So we feel that all patients with all kinds of diseases deserve to have access to these kinds of cells."
"Human embryonic stem cells hold great promise for advancing human health, and no one has the ethical right to own them," said Jean Loring, director of the Center for Regenerative Medicine at the Scripps Institute in La Jolla, Calif. Loring and Trounson were among four stem cell scientists who filed affidavits supporting the groups' challenge when it first began.
WARF is required to respond to the public interest groups' brief by Aug. 15, Simpson said.
If the court found the WARF patent to be invalid, some of the companies that have licensed embryonic stem cell technologies from the foundation might be able to ask for their money back, Simpson said.
"It would send signals for others related to stem cell patents," he added.
When the patent office rejected the challenges to two of the patents in 2008, WARF said that it had negotiated more than 30 embryonic stem cell licenses with more than 20 companies, and had granted licenses to more than 900 academic institutions.