Korean researcher Hwang Woo-suk electrified the science world 10 years ago with his claim he had created the world’s first cloned human embryos and had extracted stem cells from them. But the work was later found to be fraudulent, and Hwang was fired from his university and convicted of crimes.
Despite that, Hwang has just been awarded a U.S. patent covering the disputed work, leaving some scientists dumbfounded and providing fodder to critics who say the Patent Office is too lax.
“Shocked, that’s all I can say,” said Shoukhrat Mitalipov, a professor at Oregon Health and Science University who appears to have accomplished what Hwang claims to have done. “I thought somebody was kidding, but I guess they were not.”
Jeanne Loring, a stem-cell scientist at the Scripps Research Institute in San Diego, said her first reaction was: “You can’t patent something that doesn’t exist.” But, she added, she later realized that “you can.”
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Daniel Ravicher, executive director of the Public Patent Foundation, which challenges patents it believes are invalid and obstruct innovation, said the issuance of the patent to Hwang was more evidence that the Patent Office “is a rubber-stamp, fee-motivated government agency.”
A spokesman for the U.S. Patent and Trademark Office, and some outside patent lawyers, said the system operates on an honor code and that patent examiners cannot independently verify claims.
The patent is “definitely not an assertion by the U.S. government that everything he is claiming is accurate,” the Patent Office spokesman, Patrick Ross, said of Hwang. He said the agency was aware of Hwang’s history and took steps to make sure the claimed invention complied with patent statutes.
Hwang created headlines and became a national hero in South Korea with his claim of creating embryonic stem cell lines through cloning, which was published in the prestigious journal Science 10 years ago this month.
Such embryonic stem cells would be genetically identical to the person being cloned. They could conceivably be grown into tissues that could be transplanted into a patient to help treat diseases, without being rejected by the patient’s immune system. The next year, 2005, Hwang and his team made headlines again when they reported, also in Science, that they had made 11 embryonic stem-cell lines from people with various diseases.
Questions soon arose over the work. A committee at Seoul National University, where Hwang worked, concluded in 2006 that evidence in his papers was faked. Science retracted both papers, and Hwang lost his job. He was later sentenced to a suspended two-year prison term for embezzlement of research funds and violations of bioethics rules.
The patent, No. 8,647,872, which was issued Tuesday, covers a human embryonic cell line derived through cloning and the methods for creating that line. It appears to be the cell line that was the subject of the first Science paper.
Kevin Noonan, a biotechnology patent lawyer in Chicago and co-author of the blog Patent Docs, said he did not think the patent would pose a problem.
If applicants misled the Patent Office, he said, the patent can later be invalidated. Also, if the claimed method does not work, the patent holder cannot easily enforce the patent, and the patent would not impede others from patenting a method that does work.
“If it’s bad, it’s not going to be worth very much,” Noonan said. “Who is going to sue on this patent?”
The granting of the patent might allow others to investigate whether the cell line really was created by cloning. As a condition of getting the patent, Hwang had to agree to make the cell line available to the public, according to the Patent Office.
Hwang is trying to make a comeback. He now heads the Sooam Biotech Research Foundation outside Seoul, where he is cloning dogs and other animals. According to Korean news media, he still maintains that the cell line was created by cloning and is hoping the U.S. patent will help persuade the Korean government to allow him to once again pursue human cloning for therapeutic purposes.
Mitalipov, of Oregon Health & Science University, published a paper last year that appeared to establish him as the first to create human embryonic stem cells using cloning.
That approach, however, is no longer considered as important as it was when Hwang first made his claims. There are newer methods to create versatile stem cells that are genetically matched to a patient but that do not require the creation of an embryo.