Gene patents: pathologists call on govts to challenge GTG

A row is brewing between the Royal College of Pathologists Australasia and Genetic Technologies, the Melbourne-based biotechnology company that last year obtained an exclusive license to offer Myriad Genetics' BRCA1 and BRCA2 breast cancer susceptibility tests in Australia and New Zealand.

The RCPA has thrown down the gauntlet, sending a letter to state and federal attorneys-generals calling for a challenge to the validity and the scope of the GTG patents and questioning whether they represent a patentable invention.

The letter was signed by RCPA president Dr David Weedon, as well as the presidents of the Human Genetics Society of Australasia, the Australasian Association of Clinical Geneticists, Committee of Presidents of Medical Colleges, National Coalition of Pathology Practices, Australian Association of Pathology Practices, and the Australasian Association of Clinical Biochemists.

GTG has responded by requesting that the RCPA withdraw the letter and provide an apology to the company.

"The letter disregards the mission of GTG, and ignores the related statements which have been previously published in the media: namely that the company's goal is to build partnerships between the public and private sector to bring world class high-throughput genetic testing to all Australians," said GTG executive chairman Dr Mervyn Jacobson in a statement.

Jacobson said the RCPA letter appeared to demonstrate a lack of understanding of the patent process, noting that patents allowed companies such as GTG to protect their inventions and generate revenue for the company and its shareholders. In addition, he said, GTG was using the revenues from its patents to finance the establishment of a state-of-the-art genetic susceptibility testing service in Australia, which would improve the standards of care for all members of the population.

Among the concerns listed in the RCPA letter are the potential for increased healthcare costs and restrictions on research.

"The demand for genetic testing is continuing to grow, and high costs will delay or curtail the application of these tests in many areas of healthcare. Experience in both the US and Canada is that enforcement of gene patents that impact on medical diagnosis resulted in increased costs, a marked reduction in genetic testing, medical and social consequences for those patients denied testing, and increased costs necessitated by using less efficient or less accurate tests," reads the RCPA letter in part.

But GTG announced recently that it was committed to working with the public testing services to provide Australian women with more accurate and more timely tests, and while it is seeking to license academic researchers using its non-coding DNA patents, the company plans to charge a token fee for the license. The first research license, to the University of Utah in Salt Lake City, was granted last week.

In addition, the company was actively involved in research, including a number of collaborations with academic groups at the University of Melbourne and other research institutions.

RCPA CEO Dr Debra Graves said that the college had been concerned about gene patenting for some time, but was unwilling to comment further at this time. A position paper on the issue was published by the RCPA in July 2001, she said.

According to patent lawyer Dr Bill Pickering, a partner at Blake Dawson Waldron, it was a lot to ask of a government to retrospectively revoke patents that had already been granted. The Australian Law Reform Commission is already in the process of examining the issues surrounding gene patenting, with a report due in June 2004.

"If they [the RCPA] really think its a problem, then they're free to do something about it themselves, including challenging the patents in court," said Pickering. Typical grounds for challenge, he said, include claims that the invention is not novel or is obvious.

The RPCA is claiming that patents on natural DNA sequences should not be allowed, as they are discoveries rather than inventions. However, Pickering pointed out that DNA sequences patented for use in screening typically contain reference both to the sequence itself and to probes for use in diagnostic tests and drug development processes.

DNA sequences may also be patented for use in producing a therapeutic product such as an antisense drug or a therapeutic protein like Epogen, Amgen's recombinant erythropoietin, but Pickering noted these types of patents rarely raise public concern.