Patently problematic disputes;

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A US firm’s copyrights on stem cells pose a serious issue for researchers, reports

The Australian

Lindsay Williams doesn’t look like a giant killer. In fact, he didn’t even know he was one until the HES tracked him down at his veterinary clinic in rural Victoria. “You’re kidding” was his response when advised that an Australian patent he obtained in 1992 is being used to challenge a powerful US patent that is costing American researchers big money and triggering increasing anxiety in laboratories worldwide. “That’s great, if it’s being used to challenge the patent,” says Williams, a former molecular biologist.

The provocative patent — US Patent No.6200806 — belongs to University of Wisconsin scientist James Thomson and the Wisconsin Alumni Research Foundation, the university’s technology transfer arm. It covers the biological nuts and bolts of one of the hottest fields in medical research: human embryonic stem cells. Scientists use the cells daily in their quest for treatments for complex and debilitating conditions.

But, thanks to Thomson and WARF, it may well become a case of researcher beware. Medical ethicist Glenn McGee explains: “WARF, in this and two other patents, in essence owns virtually all imaginable characteristics of human embryonic stem cells.” And it’s definitely user pays, says McGee, director of the Alden March Bioethics Institute at Albany Medical College in New York State. Licence fees range from $US500 ($640) to $US200,000, plus royalties.

“Basically, if it looks like an embryonic cell, you’d better pay up. And if you try to make something out of your own embryo — yes, the one you made with your own body, from your own body — well, hope you have good lawyers,” McGee writes in The Scientist.

If this sounds worrisome, it is. Ethicists such as McGee believe the so-called WARF patents are stifling potentially life-saving research by boosting costs for US teams and heightening legal complexities for overseas groups, theoretically beyond the reach of the patents. “The US is an incredibly important jurisdiction,” says Matthew Rimmer, an expert in patent law and copyright at the Australian National University in Canberra. “Other patents offices around the world tend to follow the US lead.”

Concern has reached fever pitch in the US, where the Los Angeles-based Foundation for Taxpayer and Consumer Rights and New York City’s Public Patent Foundation teamed up to push the US Patent and Trademark Office to review the WARF patents.

For Australian researchers the timing is perverse. Late last year federal parliament passed legislation allowing scientists to use more powerful research techniques to explore the secrets of ES cells. They’re keen to use procedures such as therapeutic cloning to create ES cell lines based on genetic material collected from people with specific diseases. They could study what goes awry as the cells grow into disease-affected tissue. But the clear and regulated research environment at home has coincided with an increasingly muddled patent climate abroad.

That’s where Williams comes in. Before he decided “to hide in the country as a vet”, he studied mouse stem cells at the Melbourne biotech firm Amrad, now Zenyth Therapeutics. There, he developed a method of ensuring that mouse ES cell colonies, or lines, don’t follow their natural bent and develop into specialised cells, like heart or brain cells, until they’re encouraged to do so.

He patented the procedure to allow Amrad to recoup some of cost of developing it. “We sold it to whoever needed it and if they didn’t want to buy it they could use (other methods)” he says. “(he patent)was never used to restrict research.”

Fourteen years later, that patent and three publications form the core of the US groups’ submission to the PTO. Surprisingly, they don’t dispute Thomson’s claim that he grew ES cell lines, even though John Gearhart simultaneously conducted similar experiments at Johns Hopkins University. Rather, the argument is that the WARF patent is too broad and is based on “prior art”, work that’s obvious to the informed practitioner. Jeanne Loring, a scientist at the Burnham Institute for Medical Research in California, tells the Wisconsin State Journal that claiming Thomson’s work is worthy of patents “is like saying that just because heating in water works for cooking a chicken egg, it’s novel to consider using heating in water to cook a duck egg”.

The patent office has agreed to give the patents another look. The outcome is uncertain, though, and the process could take up to two years, leaving scientists in legal limbo.

Still, not everyone is worried. That includes Australian stem cell scientist Peter Mountford, chief executive of Stem Cell Sciences, a Melbourne biotech company with headquarters in London. “It’s a US-centric issue,” he says. His logic is that the WARF patent doesn’t extend to Australia and never could. Section 18 (2) of the Australian Patents Act 1990 states: “Human beings, and the biological processes for their generation, are not patentable invention.” Mountford thinks the WARF patents give his firm a competitive edge: “It means we don’t have the burden of concern over intellectual property infringement.” Matthew Rimmer sees things differently: “It’s wishful thinking to believe that those patents don’t matter,” he says.

Jonathan Izant, a molecular and cellular biologist with the Queensland University of Technology who has extensive experience in intellectual property, agrees with Rimmer.

“Patents allow the little dogs to run with the big dogs,” he says. “But that’s when the little dog holds the patent. It’s another matter when the big dog has its paws on it.”

The big dog clearly has the upper paw in this case. And because patents, like scientists, operate on a global playing field, Mountford should not rest easy. “Ultimately, deals are done at the international level,” Izant says.

Deals: there’s the rub. Clearly, if Australians develop useful research tools, drugs or therapies based on ES cells, they’ll want to do deals. They’ll want to sell their wares for cold hard cash. So where’s the biggest market? The US, home of the WARF patents. Entrepreneurial Australian scientists may find themselves accused of violating existing patents if they offer products to US customers. They could be denied access, sued, or worse.

This concerns Stephen Livesey. He founded LifeCell, a successful US-listed biotechnology company, and now heads Australia’s leading stem cell research group, the Australian Stem Cell Centre in Melbourne. “These patents are relevant to anybody in the world who is pursuing ES cell research,” he says. Not only do they threaten potential profits, when added to a web of other patents, they shape the direction of research worldwide.

“There are patents in almost every medical field you can imagine,” Livesey says. He points to the density of patents in therapeutic areas such as diabetes and Parkinson’s disease. That patent underbrush is so thick, the ASCC gives the fields a wide berth.

In contrast, Livesey says the centre is conducting extensive research into respiratory and blood disorders. “These are areas where we see scientific advantage. There are not a large number of groups in the world working on them, or cumbersome patents,” he says, confident the ASCC could hang on to any intellectual property it develops without a lot of costly legal wrangling.

All of which bemuses Williams. “It’s very exciting, like the old days when it was highly competitive.” Although Williams keeps a hand in via an associate position with Melbourne University’s vet school, does he feel the call of the big city laboratory? “No,” he replies. “I’m allergic to traffic lights.”
Leigh Dayton is The Australian’s science writer.

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