Sunday, January 22, 2006

What the New Scientist said about the Hwang PCT application

The PCT application of Hwang that is subject to discussion is WO 2005 / 063972 published July 14, 2005, which is after the date of publication of the 2005 Hwang article in Science. The title is "Embryonic Stem Cell Line and Method for Preparing the Same." Priority is claimed to PCT filing PCT / KR03 / 002899, filed December 30, 2003, which is before the date of publication of both the 2004 and 2005 Hwang publications in Science. The international application number is PCT / KR2004/ 003528. The applicant (other than in the US) is Seoul National University. The first line 72 inventor is Sung Il Roh.

The New Scientist article says absolutely nothing about the patent application filed by Gerald Schatten in the United States. As pointed out earlier on IPBiz, 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. In an odd coincidence, the date of publication of the Schatten application, Dec. 30, 2004, is the same date as the international filing date for the Hwang PCT (Dec. 30, 2004). Further, in terms of priority issues, recall that the Schatten application claims priority to a provisional application: The present application claims the benefit, under 35 U.S.C. .sctn. 119, of U.S. Provisional Patent Application Ser. No. 60/461,139, filed 9 Apr. 2003, the contents of which are incorporated herein by reference. April 9, 2003 is before the first Korean filing of December 30, 2003. As to claims relating to human stem cells, neither Hwang nor Schatten had enabled such entities through nuclear transfer in 2003, so that question would be present in prosecution of either case. Further, in light of the failure of everyone to create such stem cells through the present time, there would be a question of undue experimentation.

[Schatten's pertinent claims: 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. Also, 47 and 49.]

Note also
WO/2004/091288 (Magee Womens)

Text of New Scientist article of Jan. 18, 2006:

A patent application, filed by disgraced stem cell scientist Woo Suk Hwang and colleagues and based on work now admitted to be fabricated, may nevertheless be granted, a New Scientist investigation has found.

Furthermore, the filing of the application could present a substantial obstacle to anyone seeking future patents in the same field.

The application was filed on 30 December 2003 by Hwang, along with 19 other researchers at Seoul National University. SNU has publicly apologised for Hwang’s misconduct, but told New Scientist that it "does not currently intend to abandon the patent applications as some incorrect news media report". However, Jung-Hye Roe, Dean at the SNU Office for Research Affairs adds: "We are considering modifying the applications based on the report from the SNU committee", which found Hwang's work to be falsified.

Hwang's patent submission (in pdf format) stakes a claim in over 120 countries for a legal monopoly on the broad concept of “an embryonic stem cell (ESC) line derived from a nucleus-transferred oocyte prepared by transferring a nucleus of a human somatic cell into an enucleated human oocyte”. Or, in simple terms, an ESC line derived from a cloned human embryo – a technique which, if achieved, could prove crucial to future therapeutic cloning methods.

In support of the claim, the application details experimental methods and cites a sample ESC line deposited with the Korean Cell Line Research Foundation. The sample, number KCLRF-BP-00092, has since been discredited by the SNU investigation committee. The committee's report was published on 10 January.

Flying saucer
The UK Patent Office has taken a leading role in trying to clarify what aspects of stem cell research can be patented in Europe. Lawrence Smith-Higgins at the UKPO says: “European patent examiners are not interested in whether something will work or not. The commercial world, which is where patents belong, will judge. 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.”

Unproven ideas are often be easily patented because there is a good chance no one has previously filed the same claim. In 1973, for example, the British Railways Board was granted a patent on plans for a notional nuclear-powered “space vehicle” that was unashamedly a flying saucer.

The New Scientist article has quotes from a number of patent attorneys:

George Schlich, a patent attorney and counsel for leading stem cell company Stem Cell Sciences agrees with Smith-Higgins: “Europe takes a matter-of-fact view. Does it really matter if the man made up his results? Let him try and sell it."

Not enforceable
But while the patent application appears to stand a good chance in Europe, the situation in the US is different, explains David Wilson, a biotech litigator with international law firm Bird and Bird.

“In Europe, what matters is whether an invention is novel, inventive and sufficiently described. Fraud is not a ground for invalidating a patent," he says. “In the US an applicant has an obligation to give the US Patent and Trademark Office (USPTO) any material information. 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”.

Because of this, it has become common practice in the US for anyone accused of infringing a patent to accuse the inventor of “inequitable conduct” or “fraud on the Patent Office”, by withholding or misrepresenting information. However, even in cases where information was misrepresented, the patent holder has not always lost the case.

Undue experimentation
Oren Livne, a registered patent agent and associate director for licensing at the University of California, Santa Barbara, US, adds: “The bottom line is, even if the results are faked, he might still get a patent – if his method for making a stem cell line describes how to do it in a way that someone else could make a stem cell line without 'undue experimentation'."

Furthermore, warns Robert Berliner, a patent lawyer with US law firm Fulbright & Jaworski in Los Angeles: “The USPTO was once much more pro-active in dealing with fraud or inequitable conduct. The present view is that examiners do not have the resources."

Greg Aharonian, author of the Internet Patent News Service and outspoken critic of the USPTO, is pragmatic: “If the patent office is paying any attention, they will ask for some experimental results and further enablement details, like they do for perpetual-motion machine patent applications”.

But even if the Hwang patent is now abandoned, or proved worthless in some countries, or found un-enforceable in court, there is still a sting in its tail. Once a patent application has been published anywhere in the world, it becomes a permanent prior disclosure.

“The Hwang publication could block subsequent patents on work that constitutes an obvious extension of what Hwang described, even if the Hwang work proves unworkable itself," says Wilson. "But whether it could block patents to the same work depends on whether what Hwang described works or not.”


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