Judicial Activism, WARF and Embryonic Stem Cell Patents

The Corporate Counsel Web site/magazine today called up some interesting history involving an appellate court judge in the California-based challenge to an important patent on human embryonic stem cells.

The case involves WARF, the Wisconsin Alumni Research Foundation, which holds the patent on the work done by Jamie Thomson of the University of Wisconsin. Challenging the patent is Consumer Watchdog of Santa Monica, Ca., and Jeanne Loring, head of the stem cell program at Scripps, and Daniel Ravicher of Public Patent Foundation of New York.

Today they filed a petition with the U.S. Supreme Court to overturn an appellate court ruling that they had no standing to sue (see here and here). That ruling was written by Randall Rader, one of three judges on the appellate panel.  

Lisa Shuchman, a reporter for Corporate Counsel, wrote,

“It was one of the last decisions written by then-Chief Judge Rader before he resigned (as head judge) amid an ethics controversy.”

She continued,

“WARF did not raise the issue of standing in its Federal Circuit briefs. But about 20 seconds into Ravicher’s oral argument before the court, Rader interrupted, asking him, ‘Do you have standing to be here?’ That question eventually led the panel to rule against the advocacy group.

“On Twitter, Ravicher on Friday called that ruling ‘judicial activism at its finest.’

“'Statutes expressly say non profit groups like @ConsumerWD can challenge patents in court. Fed Cir decision judicial activism at its finest.— Daniel B. Ravicher (@danravicher) October 31, 2014’ 

“A year before the Federal Circuit’s June decision, the Supreme Court reversed the Federal Circuit in Association for Molecular Pathology v. Myriad Genetics Inc., ruling that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.

“'Under Myriad, there’s no way WARF’s patent would survive,’ Ravicher said. ‘Rader was on the record saying he thought the Supreme Court got Myriad wrong, and he looked for a way to avoid hearing this case on the merits because he didn’t want to further enforce the Myriad rule.’”

U.S. Supreme Court Action Being Sought in Major Human Embryonic Stem Cell Patent Case

The California-based  challenge to WARF’s patent on human embryonic stem cells is headed for the United States Supreme Court.

The nation’s highest court is expected to be asked Friday to overturn an earlier appellate court decision and allow two public interest groups to seek to cancel the patent held by WARF, the Wisconsin Alumni Research Foundation.

The specific issue is whether the California parties have the right to sue. But at the heart of the matter is the question of who profits from stem cell research along with whether the Wisconsin patents stifle scientific research.

As far back as 2006, executives of biotech firms in California complained that the Wisconsin patents were onerous and posed a significant obstacle to private investment.  That year the royalties from California alone generated an estimated $200 million for WARF.

Consumer Watchdog of Santa Monica, Ca., and Jeanne Loring, head of the stem cell program at Scripps, are pushing the eight-year-old case along with the Public Patent Foundation of New York, which is doing the legal lifting.  In 2013, the patent foundation won the famous Myriad case in which the Supreme Court ruled that genes cannot be patented because they occur naturally in nature. 

In a statement about Friday’s appeal to the high court, Dan Ravicher, executive director of the

Dan Ravicher and Jeanne Loring at Post Office when
they made the first filing in the WARF case in 2006.

foundation, said,

“The Court of Appeals’ refusal to allow Consumer Watchdog to appeal the (Patent and Trademark Office’s) faulty decision to uphold a patent on human embryonic stem cells is a clear violation of the express language of statutes passed by Congress and signed by the President to empower the public to seek revocation of invalid patents.”

John M. Simpson, stem cell project director for Consumer Watchdog, said,

“The patent should clearly be rejected because it covers ineligible subject matter and was obvious in view of earlier research.”

Loring said,

“This is an important battle. Human embryonic stem cells hold great promise for advancing human health, and no one has the ethical right to own them,”

Others who have filed affidavits supporting the challenge include Douglas Melton and Chad Cowan of Harvard and Alan Trounson, who was then with Monash University. He later became president of the $3 billion California stem cell agency but left that organization earlier this year to return to Australia.

The research that led to the patents was performed by Jamie Thomson at the University of Wisconsin. Thomson has a lab at UC Santa Barbara as well, where he is also a professor.

Coincidentally the Supreme Court filing comes during the week when Jonas Salk, who developed the polio vaccine, would have turned 100. He famously commented in 1955 about patenting the vaccine.

In a televised interview, Salk was asked who owns the patent on the vaccine. Salk replied,

"Well, the people, I would say. There is no patent. Could you patent the sun?"

That statement has led to a range of interpretations about what Salk meant. Michael Hiltzik, a Pulitzer Prize-winning columnist for the Los Angeles Times, wrote earlier this weekabout the issue. 

He quoted from a 2005 book on the vaccine that reported that Salk dissuaded his backers from seeking a patent because his techniques weren’t novel. He said his work was based on years of prior work by others.

The patent attorney looking into the matter for Salk and the backers said,

"If there were any patentable novelty to be found in this phase, it would lie within an extremely narrow scope and would be of doubtful value."

That is not much different than the argument being made by Loring, Consumer Watchdog and the Public Patent Foundation.