Published online 4 July 2008 | Nature | doi:10.1038/news.2008.936

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Dog cloners baring their teeth

Rival companies are about to clash over who has the rights to the crucial technology.

dogsBad feelings are multiplying between two rival dog cloning firms.Getty

Last week a US dog-cloning company told a South Korean dog-cloning company to stop its commercial activities in what looks set to become a messy patent battle.

The case involves disgraced cloner Woo Suk Hwang, a former Seoul National University (SNU) professor, on the US side and SNU’s Byeong Chun Lee, formerly a junior professor on Hwang’s team who played a key role in cloning the first dog in 2005, on the South Korean side.

Lee works for RNL Bio, based in Seoul, which in February announced it was launching a cloning business with a US$150,000 order to clone a US woman’s pet. In mid-June, the company made international headlines with photos of four clones of a dog that reportedly can sniff out cancer in humans. Two of the dogs were sold to a Japanese biotechnology company for an undisclosed amount. The other two were reportedly going to be sold for a minimum 500 million won (US$480,000).

Lou Hawthorne, chief executive of BioArts International, based in Mill Valley, California, says that RNL Bio has no right to clone dogs. Last week, BioArts, along with Start Licensing, a management company for intellectual property rights, based in Austin, Texas, issued a cease-and-desist order to RNL Bio.

Start Licensing holds the rights to the ‘Dolly patents’ — the suite of patents covering the technology used to clone Dolly the sheep. BioArts International licensed exclusive rights to the technology for cloning “cats, dogs and endangered species” in 27 countries, including South Korea, says Hawthorne.

Dogs’ day

The cloning of a dog, first accomplished by Lee and Hwang in 2005, requires the basic procedure — the transfer of DNA to an egg that has been stripped of its nucleus and the timing of that transfer with a certain point in the egg’s cycle — discussed in the Dolly patents. That method was tweaked for other animals, and over the five years following Dolly’s creation nearly a dozen animals were cloned.

Dogs, however, proved difficult. Eggs of other mammals mature in the ovary, where they can be relatively easily harvested. Dog eggs do not mature until they are on the way to the uterus, and so harvesting mature eggs requires precision. To create the first cloned dog, Snuppy, the SNU team, in a technique it later patented, used a radioimmunoassay kit to measure the progesterone concentration in the blood to determine ovulation timing.

Hawthorne knows how hard it is to clone dogs. He was chief executive of a now-defunct company, Genetic Savings & Clone, that tried and failed to clone dogs — starting with his family dog, Missy — for six years.

Hawthorne’s team had focused its dog-cloning efforts on maturing eggs in vitro. It never tried the in vivo maturation process like Hwang and Lee. But Hawthorne describes that as an “off-the-shelf” technology and insists the main difference between his company’s efforts and those of RNL Bio’s researchers is the number of experiments. “They had a network of 5,000 dogs, whereas we were working with 160. They got three dogs — one was stillborn, one died soon after birth and one [Snuppy] lived. We got one stillborn.”

BioArts International’s dog cloning is contracted out to Hwang’s privately funded laboratory in Sooam, near Seoul. At Sooam, Hwang’s team has cloned “dozens of dogs”, says Hawthorne, including six clones of Missy — three of which have been returned to the United States.

In June, BioArts will auction off five cloning projects and give one away. The auction will help them set the price for future cloning business.

Border patrol

Hawthorne says BioArts will do all required to enforce the Dolly patents in Korea, the United States and elsewhere, including seizing dogs at the border. "They will not steal this technology. They haven’t earned it. They won’t get away with it,” says Hawthorne. “It’s naive to put the cherry on top of the sundae and think you can take credit for the whole thing.”

Neither Lee nor a representative of SNU’s intellectual-property office would comment. In the 16 June press release announcing the births of the four cancer-sniffing clones, RNL Bio chief executive Jeong Chan Ra said the company would stand by the SNU patents it has licensed, and stated that “the only technology that has been successful with dog cloning comes from Seoul National University. If [BioArts International and Start Licensing] seek a lawsuit, we will take strong action to protect one of the nation’s most innovative technologies.”

Resolution of the dispute, at least in the United States, would probably centre on the phrase “undue experimentation”, according to Saul Zackson, an intellectual property lawyer specializing in the life sciences at Sonnenschein Nath & Rosenthal LLP, in St Louis, Missouri. A patent can only cover practices that it “enables” to be done “without undue experimentation”. But what defines ‘undue’?

The fact that BioArts’s predecessor, Genetic Savings & Clone, tried and failed to clone dogs, could be taken as a sign that undue experimentation was necessary to extend the cloning procedure to dogs. “That won’t look good in court,” says Zackson.

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But BioArts's assertion might have a successful precedent in a 1988 case about a patent for monoclonal antibodies used for detection of hepatitis B surface antigens. The inventors needed to screen hundreds of hybridomas in order to identify a small number of antibodies that met their criteria. In that case, the court considered the amount of experimentation needed to practice the invention, although extensive, was not undue, in that the massive screening effort was an inherent part of the technology1. Likewise, BioArts could try to claim that the technology that produced Dolly laid a clear path for the backbreaking but not undue effort that the Korean group used to produce Snuppy — with the implication that anyone who had enough dog eggs available would have been able to create a clone.

“Much will depend on whether the Koreans can say ‘we did something different’,” says Zackson. “The law is very squishy about what constitutes ‘routine’ or ‘undue’ experimentation.” 

  • References

    1. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988); USPTO
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