Send in the clones

LONDON — Dolly the sheep, Gene the bull and a pig known as 'The Man' might sound like the cast of a Disney animation. Instead, the three are the unlikely stars of a high-profile and potentially far-reaching debate over who should own the US patents to certain aspects of animal cloning technology. The dispute, involving the three US biotech firms Geron Corporation, Advanced Cell Technology and Infigen Inc, centers on who was first to invent nuclear transfer technology — the process by which cloned mammals are produced. Each company believes it has a valid claim and the issue is important because, at stake is the highly lucrative opportunity for licensing the technology to authorized users. Now the US Patent and Trademark Office has the unpalatable task of deciding who's right. It has issued two 'declarations of interference ' concerning certain patents. This means that it has initiated proceedings to ultimately decide who was first to invent the processes in question. But don't hold your breath — the proceedings could take at least two years. "The US, unlike most other countries, gives the rights to an invention to the 'first to invent', rather than the 'first to file' in the patent office," said US Patent and Trademark Office spokeswoman Brigid Quinn. "An interference proceeding determines who was the 'first to invent' among two or more applicants and/or patent holders. The agency is precluded from talking about specific interference cases — since they normally involve at least one patent application and these are confidential — but I can tell you the process takes about two years. However, about 75% settle within the first year." California-based Geron Corporation obtained the rights to the nuclear transfer technology used to clone Dolly the sheep when, in 1999, it bought Roslin Bio-Med, the commercial arm of the Roslin Institute in Scotland. But it faces stiff competition from Infigen Inc, a Wisconsin-based biotech firm exploring advances in animal agriculture and human health. Infigen claims it invented the technology used to produce a bull named Gene before the Dolly scientists, even though Gene was born several months after Dolly in early 1997. The same technology was later used to produce 'The Man', who, along with another pig called 410k, became the first cloned swine. In June last year, Infigen was granted a patent entitled 'Parthenogenic oocyte activation'. The patent relates specifically to activation — the step at which the 'programmed' egg (the egg into which the donor nucleus has been transferred) is stimulated to grow into an embryo. The company claims it has solved previous problems in initiating this process through "the application of specific electrochemicals and other steps." Meanwhile, Massachusetts-based Advanced Cell Technology (ACT), which cloned cattle in 1998, is also staking its claim. It is already licensed to use a patent held by the University of Massachusetts entitled 'Cloning using donor nuclei from proliferating somatic cells', which defines how to replicate genetically altered animals. At stake is whether Infigen and ACT are the justifiable holders of these patents, or whether Geron can prove it has a stronger claim. As things stand, the 'declaration of interference' applies only to the use of proliferating somatic cells to clone cows, sheep or pigs. According to Geron, it has a very strong case. In a recent statement the company's vice president of intellectual property, David Earp, said: "While these interferences involve only limited aspects of our nuclear transfer technology, we want to ensure that all aspects of the technology invented at the Roslin Institute and covered by the Roslin/Geron patents can be made available to others through our licensing activities." Already, said Geron, it has the upper hand. The USPTO has designated it as the 'senior party' in the dispute. This means it filed its patents earlier than its rivals and that the onus is now on them to prove their case. "Unless a junior party can prove that despite its later filing date, it actually invented the technology before the senior party, the patent is awarded to the senior party," Earp explained. In the case of Infigen, he added, it will bear the burden of proof and will "have to show its scientists invented the cloning technology ahead of the Roslin scientists." But Geron's rivals are being equally bullish. Mike West, president of ACT, says he is confident the company's patents will "hold up well" to this and any future challenges. "Much of what we do is related to human therapeutics. This interference does not currently involve human claims. "We have a US patent on human therapeutic cloning (US 6,235,970) and pending patents on parthenogenesis, ooplasmic transfer and interspecies nuclear transfer for human therapeutic uses. So this interference is not a significant threat either to us or to Geron. It may be more of an issue for Infigen, since all their work is animal. As for senior and junior parties, I don't think filing dates are going to be an issue. In my opinion, us being the junior party doesn't have any significant consequence." The various combatants may be keen to play down the significance of the USPTO's intervention but there can be little doubt the ruling, when it eventually comes, will have important repercussions for all those seeking to exploit cloning technology. Beyond the immediate effect of the decision, there is bound to be speculation that it will give rise to other patent challenges if biotech companies feel they have a strong case to argue.

Send in the clones

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