Stem Cell Patent To Reach Supreme Court

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The U.S. Supreme Court will be asked to intervene over a controversial embryonic stem cell patent, opponents of the patent said Thursday.

Jeanne Loring, a stem cell scientist at The Scripps Research Institute, said the court will be asked Friday to overturn a lower court decision and allow the opponents to seek cancellation of the patent held by the Wisconsin Alumni Research Foundation, or WARF.

Loring and two public interest groups, Consumer Watchdog and the Public Patent Foundation, have been trying to get that patent overturned since 2006. Another patent giving rights over induced pluripotent stem cells has been waived by WARF.

Loring, who is researching the use of induced pluripotent stem cells to treat Parkinson's disease, said the remaining patent impedes development of embryonic stem cell therapies.

Embryonic stem cell therapies are reaching the clinical stage, such as San Diego's ViaCyte, which recently began trials of its therapy for Type 1 diabetes, derived from human embryonic stem cells.

"We think that now embryonic stem cells really are showing their worth in clinical studies, it's very important to just wipe this thing off the books, so nobody can either shut down trials or require huge licensing fees for successful efforts," Loring said.

The foundation got the patent for work by James Thomson of the University of Wisconsin-Madison. He was the first to derive human embryonic stem cells, in 1998.

Opponents say Thomson's feat, while significant, was not a patent-worthy technological advance. Loring has said other qualified scientists could have isolated the cells with methods used for finding animal embryonic stem cells, so the advance was obvious.

Moreover, embryonic stem cells are a product of nature and therefore not patentable according to a 2012 Supreme Court ruling, they say.

In the petition to be filed Friday, Consumer Watchdog, represented by the Public Patent Foundation, asked the high court to overturn a ruling by the U.S. Court of Appeals for the Federal Circuit that blocked the challenge. The opponents had asked the court of appeals to overturn WARF’s patent 7,029,913 last year, closely following a Supreme Court ruling that natural gene sequences can't be patented.

The appeals court said Consumer Watchdog lacked legal standing to challenge the patent, because it was not directly harmed. The group says a law explicitly allows such challenges.

The group's petition for certiorari can be downloaded here:

“The Court of Appeals’ refusal to allow Consumer Watchdog to appeal the PTO’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,” Dan Ravicher, executive director of the Public Patent Foundation, and Consumer Watchdog's counsel in the case, said in a statement. “It also conflicts with the clear intent of Congress and the President to empower the public to seek revocation of invalid patents.”

WARF has maintained that it doesn't seek to thwart research, but it is entitled to compensation for the commercial use of technology it spent money and time developing.

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