Thursday, February 16, 2006

Seoul Times on patent issues between Hwang and Schatten

James P. Kelly writes in the Seoul Times:

Schatten filed a provisional U.S. patent application on April 9th 2003, making no mention of Hwang. Likewise, Hwang submitted an international 'human cloning' PCT along with 24 other South Koreans – but not Schatten – on December 30th 2003. [IPBiz note: Schatten filed a nonprovisional US application on April 9, 2004 and a PCT on April 9, 2004. A cip of the April 9, 2004 application was published on February 16, 2006.]

According to University of Pittsburgh Medical Center spokesperson Michelle Baum, Schatten claims ownership of the cloning process used in his December '04' Developmental Biology paper. The University of Pittsburgh claims ownership and control of patent rights resulting from activities of its faculty.

Koreans are angered by Schatten's claim.

"It is not sure what technology the journal is talking about," said Park Se-pill, head of Seoul-based fertility clinic Maria Biotech, in JoongAng Daily. "But I think it is our homegrown technique of softly squeezing human eggs for cloning." [IPBiz note: the squeezing technique (extrusion) is an element of a cloning claim in the cip application of Schatten. The cip references to Hwang's 2004 paper, of which Schatten is NOT a co-author.]

Schatten specifies in Developmental Biology that genetic material must be removed from eggs by "extrusion rather than extraction," which Park and others believe is the Korean technique. Schatten's U.S. patent application presents the following description:

"Inside the egg is the nucleus, which is removed in order to make a cloned embryo. For example, the egg is pierced with a fine needle or pipette, gently squeezed or aspirated to expel the nucleus, and the nucleus is removed."

Despite the use of false data to support Hwang's PCT, his patent application will likely be approved in Europe, says Lawrence Smith-Higgins of the UK Patent Office in New Scientist:

"European patent examiners are not interested in whether something will work or not." Smith-Higgins says. "As long as an invention is not clearly contrary to scientific laws – like time travel – research has no bearing on the grant of a patent."

However, the exposure of Hwang's fraud stands to weaken and possibly cripple his potential U.S. patent rights. New Scientist reports:

"In the US an applicant has an obligation to give the US Patent and Trademark Office any material information," says biotech litigator David Wilson of international law firm Bird and Bird. "It is all right to leave out the theory of how the invention works, or even get the theory wrong, as long as you don't say 'I have built it' when you haven't. If you do this you may still obtain your patent, but if challenged your patent may not be enforceable."

Patent attorney Lawence Ebert points out that all applicants for a U.S. patent are required to certify that material submitted as part of an application is accurate and true. "An applicant can be criminally prosecuted for attesting that fraudulent evidence is valid," says Ebert [referencing 18 USC 1001]. "However, an applicant can revise the application, removing questionable data."

Nevertheless, those accused of infringing U.S. patents often accuse inventors of "defrauding the Patent Office" or "inequitable conduct" through withholding or misrepresenting information.

If Hwang does not want his research funded "with foreign capital" and is awarded a U.S. patent, U.S cloning scientists could have public funds available for research, yet be legally blocked (by the patent) from using Hwang's technique. [IPBiz note: one will also have to worry about the cloning claims of Schatten's cip.] Initial plans for the World Stem Cells Hub were for three Korean technicians trained by Hwang to perform all nuclear transfer procedures. Resulting cells were to be sold to member scientists and institutes.

However, should Hwang be granted a U.S. cloning patent despite the frauds, their exposure may present a legal target for any who infringe the patent.

[IPBiz post 1245]


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