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Australian agency proceeds cautiously with Hwang patent

The head of Australia's patent office has admitted to being “uncomfortable” about granting a patent to a group from Seoul National University Industry Foundation that includes the disgraced researcher Woo-Suk Hwang.

The patent application is for a stem cell line, which the group of 18 researchers claimed was produced by a procedure known as somatic cell nuclear transfer but has since been revealed to have been created by parthenogenesis (the development of an embryo in the absence of fertilization).

Philip Noonan, the director-general of IP Australia, the country's patent-granting agency, told a Senate committee in Canberra that the application had passed the examination stage and might have to be granted, despite his misgivings.

“I am uncomfortable about granting a patent where the applicant has engaged in behavior like this,” Noonan said. “The Patents Act does not deal directly with this type of situation.”

Noonan was responding to questioning on 23 October by Australian Senator Ron Boswell of the conservative National Party. Boswell was a vocal opponent of legislation passed in 2006 that allowed licenses to be granted to Australian researchers who want to clone human embryos for therapeutic purposes using somatic cell nuclear transfer.

Senator Boswell began his questioning by pointing to IP Australia's stated commitment to a “robust and reliable” rights granting process. “Is it robust and reliable to grant a fraudulent researcher a patent on fraudulent work?” he asked.

However, although the application made false claims about the method used to create the stem cell line, Noonan said this did not alter the status of the product: “it is generally accepted that the line of stem cells exists and is a new invention. But it is now generally accepted that they were not derived by somatic cell nuclear transfer but by another process called parthenogenesis.”

“The Patents Act requires IP Australia to be satisfied that there is an invention [...] that [has] not been discovered before. The new line of stem cells is such an invention,” Noonan added. He said the application was still being investigated by IP Australia even though it had passed examination after no objections were lodged. According to him, suspension of the decision might continue through early December “or longer if necessary.”

Australian law does not allow government ministers to intercede in the patent application process. Noonan said that if the patent is granted, IP Australia will “have to advise the minister about what can be done about that.”

Once granted, the minister or any other person may begin legal action to have a patent revoked.

“The grounds upon which the court can revoke a patent are somewhat broader than the grounds upon which the grant of a patent can be refused in the first place,” Noonan said.

Matthew Rimmer, an intellectual property specialist at the Australian National University in Canberra, disagrees with IP Australia's position that there is no basis to refuse a patent if the supporting data was fabricated.

“If Woo-Suk Hwang has engaged in criminal conduct, the patent application will be contrary to law, and able to be rejected,” Rimmer says.

According to Rimmer, the Australian patent regulator's difficulty in this case flowed from the Australian government's failure to amend intellectual property legislation to comply with a free trade agreement signed with the US in 2004.

“IP Australia is really using the current dispute to push for the standard of utility to be considered at the stage of examination,” he says.

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Grose, S. Australian agency proceeds cautiously with Hwang patent. Nat Med 14, 1300 (2008).

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