Giant reined in by landmark judgment;

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A decision by the US patent office offers encouragement to small-scale research units

The Australian (Australia)

Sometimes what goes around comes around. Take the case of Lindsay Williams. In January the HES tracked down the former molecular biologist in his veterinary clinic in rural Victoria. Why? The HES had learned that an Australian patent he obtained in 1992 while working as a researcher for Melbourne-based biotech Amrad, now Zenyth Therapeutics, was being used to challenge three of the most powerful US patents granted in the field of biomedical research.

”You’re kidding,” he said when told that his patent was central to an effort to knock out US Patent numbers 6200806, 7029913 and 5843780. These patents had been granted to University of Wisconsin scientist James Thomson and the Wisconsin Alumni Research Foundation, the university’s technology transfer
arm. Through the patents Thomson and WARF had tied up the rights to nothing less than primate — read human — embryonic stem cells and techniques to grow them in the laboratory.

Although the patents hold only in the US, they are the law in the biggest and most influential biomedical market in the world. Even Australian stem cell scientists were concerned they’d be hit with huge licence fees — or worse — if they tried to sell laboratory or clinical products based on ES cells into America’s WARFed world. The result, many researchers claim, is that the so-called WARF patents are severely — and wrongly — holding back potentially lifesaving research.

Last week Williams received another call from HES. This time it was to ask if he’d heard that he was indeed a giant killer. ”It’s just wonderful,” he said of the unexpected news that on April 2, the US Patent and Trademark Office had ruled the WARF patents invalid. It found that WARF‘s methods for isolating primate stem cell lines were obvious and based on previous work. Williams’s patent, based on mouse ES cell lines, was undeniable proof. ”I think it’s just great for science. It means they can develop the medical applications all that much sooner,” Williams says.

Ideally, a patent is to protect innovators who’ve put in long hours and often big bucks to advance their field. The idea is that knowing they can recoup costs and make a healthy profit spurs on researchers. And as Queensland University of Technology scientist and intellectual property expert Jonathan Izant notes: ”Patents allow the little dogs to run with the big dogs.” Ultimately, everyone benefits, public and private.

As the WARF challenge shows, it’s far from easy to keep the balance between rewarding innovators and allowing others to build on their insights and technologies. That’s especially so when patents reach back into laboratories and choke off the fundamental research that underpins innovation, patents and profitable applications.

Such was the situation with WARF‘s patented stranglehold on ES cell technology. It took an enormous effort to shake it off, specifically a collaboration between the Los Angeles-based Foundation for Taxpayer and Consumer Rights and New York City’s Public Patent Foundation.

Clearly, Australian research institutions and biotech firms lack the clout and hard currency to tackle such heavy-duty intellectual property matters. They also lack a national innovation framework that reflects the vital link between basic and (patentable) applied research.

A report from the Australian Government’s Productivity Commission, released late last month, makes the point that Canberra’s push for commercialization of science and innovation may have gone too far. The report highlights the importance of providing public support for research with a ”public good orientation”. That sounds like a plea to give public research outfits such as the CSIRO and the Australian Stem Cell Centre sufficient funding to explore the outer realms of science. With the basics under our national belt, such knowledge could translate into solutions for problems that don’t seem to offer any financial pay-off. Yet these too can ultimately generate patents and profits.

As Lindsay Williams discovered, the odd bit of giant killing doesn’t go astray. It may breathe new life into research.
Leigh Dayton is The Australian’s science writer.

Consumer Watchdog
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