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Pitt researcher again pursues cloning patent

by Walter F. Roche Jr.Pittshburgh Tribune-Review
April 4th, 2009

Gerald Schatten (right) with Woo-Suk Hwang

A University of Pittsburgh stem cell researcher has renewed his efforts to win a patent on a process to clone human embryonic stem cells, despite lingering questions from his past efforts.

Patent Office records show an amended patent application filed by Gerald P. Schatten and two colleagues was published Jan. 1, the same day a rival application was published by Oregon researcher Shoukhrat M. Mitalipov.

"They are just going through the process," Pitt spokeswoman Anita Srikameswaran said when asked about the filing. She noted the original application was filed several years ago.

Schatten did not respond to requests for comment. Under standard university policy, Schatten would share any royalties from the patent with his employer. Srikameswaran said Magee-Womens Research Institute has a financial interest in the patent.

His application refers to a stem cell cloning process developed by his one-time colleague, disgraced South Korean researcher Hwang Woo-suk. Patent reviewers challenged a number of claims in his earlier submission.

Those claims, along with several others, were eliminated in the amended patent application.

Hwang, with Schatten by his side, claimed in 2005 to have successfully cloned embryonic human stem cells.

The study was discredited and the paper describing it was retracted by Science magazine. South Korean officials subsequently concluded the cloning effort was fraudulent.

An internal Pitt investigative panel concluded in February 2006 that Schatten "did not intentionally falsify or fabricate experimental data." Though he did not engage in "scientific misconduct," the panel said he was guilty of "scientific misbehavior" because of "his lack of oversight and critical judgment."

It noted Schatten accepted $40,000 in honoraria payments from Hwang, including $10,000 in cash. Following the panel's report, Pitt officials said they would take appropriate action, but never made public any disciplinary action against Schatten.

University of Pennsylvania bioethicist Arthur Caplan said that though competition for a patent on a stem-cell cloning process is likely to be "ferocious," it is not helpful to the field.

"Since there has been no successful demonstration of human embryonic cloning, I do not see why a patent extending to this domain makes any sense," Caplan said.

Experts expect competition to intensify with President Obama's lifting of restrictions on stem cell research backed with federal money. Both Schatten's and Mitalipov's patent applications note their research utilized federal money to some extent.

Caplan said it is too early in the development process "to tie these techniques down with patents."

"The techniques involved in cloning should be widely and freely available to all researchers at this point in time whether they wish to work on animals, primates or people," he said.

Caplan said Mitalipov's application appeared to be "more detailed" than Schatten's, but the same issues would apply.

Mitalipov, of the Oregon National Primate Research Center, reported last year that he was the first to successfully clone primate embryonic stem cells from a monkey. He did not respond to a request for comment.

When his cloning effort was made public in 2007, Mitalipov said he was "quite sure" the process would work with humans.

His application describes processes that could use human embryonic stem cells to produce cloned humans and animals, and even replacement organs. He lists diseases ranging from cancer to Parkinson's disease that the invention could treat.

Under the Schatten and Mitalipov processes, nuclei from adult stem cells would be transferred to unfertilized eggs.

According to patent law, the timing of the original patent application could be a critical factor in determining royalty rights. Schatten's patent claims date to 2003 and Mitalipov's, to 2007.

The Schatten application states the invention provides "a practical means for producing embryos with desired characteristics."



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