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Pitt biologist trying to patent human cloning process

Pittsburgh Tribune-Review
January 7th, 2006

A University of Pittsburgh researcher embroiled in an international cloning scandal is seeking to patent technology to create embryonic stem cells without crediting his now-estranged colleagues in South Korea, government documents show.

The U.S. Patent & Trademark Office is processing a application -- still active as of Friday -- filed on April 9, 2004, by reproductive biologist Gerald Schatten, who heads the university's Pittsburgh Development Center at Magee-Womens Research Institute in Oakland.

Schatten and two Pitt researchers listed as co-inventors -- Calvin Simerly and Christopher Navara -- state their methods would make human cloning "a practical procedure," according to the patent application. These methods also could be used to create embryonic stem cells with the potential to cure human diseases, the application states.

Embattled Korean researcher Hwang Woo-Suk claimed to have achieved these very same scientific milestones using similar techniques. The breakthrough -- now discredited -- was announced in a paper published in the journal Science in June 2005 and co-authored by Schatten.

With the financial support of the Magee-Womens Health Foundation, Schatten served in an advisory role to prepare the landmark paper for publication, helping to analyze and interpret the results obtained by Korean scientists, the Science article said.

An international furor erupted last month when a Seoul National University panel ruled Hwang deliberately fabricated results and committed ethics violations in soliciting donor eggs. A final report is expected early next week.

Schatten publicly severed ties with the Korean scientist when these allegations surfaced. Schatten now is being investigated by Pitt for scientific misconduct.

Neither Schatten nor the University of Pittsburgh would comment on the patent application yesterday. Simerly and Navara also declined comment through university spokeswoman Jane Duffield.

The methods outlined in Schatten's stem-cell patent application were invented in part using money from two grants awarded to him by the National Institutes of Health, worth a total of about $1.8 million.

"I think that it is outrageous that the University of Pittsburgh refuses to discuss its patent claims on a technology that was funded by the U.S. taxpayers," said Merrill Goozner, director of the Integrity in Science project at the Center for Science in the Public Interest, a Washington, D.C.-based science watchdog nonprofit group.

The rush to file biomedical patents for early-stage technologies creates roadblocks to research that do a disservice to the public by requiring scientists to dish out licensing money whenever they have an idea that might be worth pursuing, Goozner said.

"It sets up arbitrary financial roadblocks to research," Goozner said. "We need new systems that make these technologies open to all scientists at the lowest possible price, and when the government funds them, it should be the government insisting that's how they are managed."

Since the scandal became public, Hwang has resigned his university post and stepped down as head of the World Stem Cell Hub, a Seoul-based project launched with Schatten and several other scientists.

But Hwang continues to assert that his cloning methods work despite the falsified data -- and that the intellectual rights to the underlying technology belong to South Korea.

Hwang and other South Korean researchers filed for an international patent Dec. 30, 2004, to protect their methods for deriving stem cells from cloned human embryos.

Schatten is not listed as an inventor on the international patent application -- filed eight months after the Pitt researcher applied for a U.S. patent for a similar method, according to documents obtained from the World Intellectual Property Organization. The 46-page international patent application also does not cite any of Schatten's previous research.

Similarly, Schatten's 18-page U.S. patent application makes no reference to Hwang's work, including another paper published by the Korean scientist in Science the month before that which outlines supposed breakthroughs in the same cloning field.

"If these people are co-authors on important articles in the scientific literature, it is difficult to see how they could file patent applications that make no mention of the work of the other," said intellectual property attorney Robert L. Potter of Pittsburgh law firm Strassburger, McKenna, Gutnick & Potter.

It was unclear yesterday which patent would hold the most sway under an international patent treaty.

Hwang did not reply to an e-mail message sent Thursday.

Attorney Don Pelto, of the Washington, D.C., law firm Preston Gates Ellis & Rouvelas Meeds, helped to file Schatten's patent. He did not return a phone message left yesterday.

Schatten has a history of filing for patents for his research. He was awarded two patents, along with Navara and Simerly, for methods for analyzing sperm quality they developed while at the University of Wisconsin-Madison. Including the stem-cell patent, Schatten has five patent applications still being considered for approval, federal records show.

Policies outlined by Pitt's Office of Technology Management on its Web site declare that the university claims ownership and control of the worldwide patent and intellectual property rights resulting from the activities of its faculty.



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