Sunday, January 08, 2006

Allegation that Schatten stole ideas in Hwang's patent applications [?]

US patent application 10/821200, filed April 9, 2004 by Gerald P. Schatten and Pittsburgh (but not Korean) colleagues, contains claims (but not actual examples) which cover work disclosed in the first and second Hwang papers in Science. The Korea Times states that the Hwang group filed a PCT application in December 2003. None of these applications have become issued patents. The Times also states: Korean experts say Schatten's move is an outright outrage.

The Korea Times reports:

Prof. Gerald P. Schatten at the University of Pittsburgh is suspected of attempting to patent technology to create embryonic stem cells without crediting his now-estranged colleague, Korea's disgraced cloning scientist Hwang Woo-suk.
The Pittsburgh Tribune Review reported in its online Saturday edition that the U.S. Patent & Trade Office is processing a patent application filed in April 2004 by Schatten on the stem cell technology.

``Schatten and two University of Pittsburgh researchers listed as co-inventors, Calvin Simerly and Christopher Navara, state their methods would make human cloning a practical procedure,'' the Tribune said.

The Korea Times indicates outrage by Koreans:

In response, Seoul National University, where Hwang works, said the right for the patent belongs to the Seoul team, which already applied for a patent for the stem cell technology in Dec. 2003.

``Hwang's team filed the patent application in late 2003 to the World Intellectual Property Organization. The 2004 application was made to complement it,'' a university official said.

Anyway, Korean experts say Schatten's move is an outright outrage.

``It is not sure what technology the journal is talking about but I think it is about our homegrown technique of softly squeezing human eggs for cloning,'' estimated Park Se-pill, head of Seoul-based fertility clinic Maria Biotech.

``If so, Schatten can be regarded as an astute political man who put his interest first at the expense of his colleagues regardless of the authenticity of Hwang's research,'' claimed Park who harvested stem cells from frozen eggs in 2000 for the third time in history.

Hwang claimed to have created human embryonic stem cells in his 2004 paper featured by Science. He also insisted that his team established patient-specific stem cells in a 2005 Science paper.

From the Pittsburgh Tribune-Review:

The U.S. Patent & Trademark Office is processing a application -- still active as of Friday [Jan. 6, 2006] -- 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.

"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 Goozman, 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. [It is true that application 10/821200 mentions US government support.]

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, Goozman said. [One should review earlier reports by Goozman on the Hwang work.]

"It sets up arbitrary financial roadblocks to research," Goozman 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. [One notes that Schatten is NOT a co-author on Hwang's 2004 paper in Science. Schatten is a co-author on the 2005 paper in Science, but that is not prior art to the application filed in April 2004. Schatten did file later IDS statements with the USPTO (on 2 Sept 2004, citing US 5,843,780; 5,874,301; 6,011,197; WO 97/37009 AND on 19 Jan 2005 citing US 5,945,577).

It was unclear yesterday which patent would hold the most sway under an international patent treaty. [IPBiz note: This is a stupid comment. A PCT application designating the US is a US application and will be treated the same way as a US application filed directly. An issue of Schatten's application is whether it is enabled as to humans, because it is not clear that one can extrapolate the animal work, in the absence of human data. Further, if Schatten took the position it were obvious to go from animal to human, one would have the counter-argument, why doesn't the Scottish work on Dolly render obvious Schatten's claims?]

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.

Tribune-Review author Jennifer Bails can be reached at or (412) 320-7991.

The US patent application in question is published application 20040268422 (published December 30, 2004), based on US application 10/821200, filed April 9, 2004. Gerald P. Schatten is the first listed inventor.

There are government interests implicated: This invention was made, at least in part, with U.S. government support under grant numbers NIH R37 HD 12913 and 2 R24 RR013632-06, awarded by NIH. The U.S. government may have certain rights in the invention.

Claim 1 recites: 1. A method comprising the steps of: introducing nuclei along with one or more molecular components into an egg; culturing said egg to produce a viable embryo; transferring said embryo to the oviducts of a female; and producing a cloned animal.

[For reference, paragraph 26 of the application: The term "animal" includes all vertebrate animals such as mammals (e.g., rodents, mice and rats), primates (e.g., monkeys, apes, and humans), sheep, dogs, rabbits, cows, pigs, amphibians, reptiles, fish, and birds. It also includes an individual animal in all stages of development, including embryonic and fetal stages.]

Of relevance are dependent claims 24-27, especially claim 27:

24. An animal produced by the method of claim 1.

25. The animal of claim 24, wherein said animal is a primate.

26. The animal of claim 25, wherein said primate is a non-human primate.

27. The animal of claim 25, wherein said primate is a human.

Claim 28 recites:

28. A method comprising the steps of: introducing nuclei along with one or more molecular components into an egg; culturing said egg to produce a viable embryo; dissociating blastomeres from said embryo; and culturing said blastomeres to produce stem cells.

Claim 32 recites:

32. The method of claim 28, wherein said introducing step comprises performing SCNT.

[There are no examples in the application that include humans; however, the claims cover humans.]

Bettyann Holtzmann Kevles in the Washington Post mentions fraud but forgets to mention Jan-Hendrik Schon.

These experiments occurred outside the circle of Western science, raising questions, too, about the regulation of research elsewhere. There are thousands of scientists working in Asia, many of whom, unlike Hwang, were trained in the United States. There are also more scientific journals than ever before (although the journals Hwang published in are the oldest and most respected of them all). While everyone in the field agrees that the experiments have to be confirmed, they do not agree that the review process was inadequate. They suggest that the system does work because, with these results under suspicion, efforts will soon be made to replicate Hwang's techniques. To suggest, as has been done, that the global spread of science, and of scientific error, accidental or deliberate, is due to the non-Western scene of the alleged crime smacks of racism. The real significance lies in the swift action of the Korean press in exposing the irregularities in the paper and in the procedures used to procure the human eggs -- and that this happened before damage extended beyond the reputations of the scientists involved.


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