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Gene patent for breast cancer faces legal challenge

14 June 2010
Appeared in BioNews 562

The Australian Federal Court in Sydney is considering groundbreaking legal action on whether private companies can obtain patent on human gene.

Cancer Voices, a cancer advocacy group, and the law firm Maurice Blackburn are suing four biotechnology companies arguing that their patent on BRCA1, the so called 'breast cancer gene', is invalid.

The case follows on the heels of a New York district court decision in March invalidating seven US-issued patents held by Myriad for the same breast and ovarian cancer gene on similar grounds.

The key legal argument before the Court is that isolated genetic material is a discovery of a naturally, pre-existing substance, not an invention, and therefore cannot be patented. Rebecca Gilsenen, the principal acting solicitor, highlighted that there are also additional profound ethical and philosophical questions about whether the body should be privatised: 'It's a healthcare rights issue and an issue of freedom of research into the fundamental building blocks of our being'. The plaintiffs and many experts argue that gene patenting compromises patient healthcare by bottlenecking competition necessary to drive or maintain prices at a low level, encourage innovation and improve testing quality.

Legal experts argue that patents and resulting licensing monopolies provide the necessary incentive to attract investment and talent which fosters innovation. The Institute of Patent and Trade Mark Attorneys of Australia (IPTA) predicts a 'catastrophic' withdrawal of investment in biotechnology from the corporate sector if gene patents become unenforceable.

In the mid-1990s, the University of Utah Research Foundation (UURF) obtained patents for all variations relating to the DNA sequence for the BRCA1 and BRCA2 genes. UURF exclusively licensed these rights to Myriad. Myriad remains the only diagnostic genetic test provider to women in the US for BRAC1 and BRAC2 genetic mutations, legal battles aside.

In Europe, challenges to these patents forced Myriad to revoke or amend its rights, and European laboratories offer most BRCA gene testing for free.

An estimated one-fifth of the human genome is patented or has patent applications pending.

SOURCES & REFERENCES
Bid to halt patenting of genes
The Age |  8 June 2010
BRCA1 gene patent challenged in Australian court
Life Scientist |  8 June 2010
Cancer gene patent faces legal challenge
Sydney Morning Herald |  8 June 2010
It's patently unfair to treat genes this way
The Australian |  8 June 2010
Lawsuit to be launched over breast cancer gene patent
The Medical News |  7 June 2010
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