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Gene patenting: Australian court rules BRCA1 patent is legal

“The issue that arises in this case is of considerable importance. It relates to the patentability of genes, or gene sequences, and the practice of gene patenting”. So began the reasons for judgement of…

The BRCA1 gene is thought to account for 45% of hereditary breast cancer, and at least 80% of hereditary cancer involving both breast and ovarian cancers. Tips Times

“The issue that arises in this case is of considerable importance. It relates to the patentability of genes, or gene sequences, and the practice of gene patenting”. So began the reasons for judgement of the Federal Court of Australia in Cancer Voices Australia v Myriad Genetics Inc, published on Friday.

This is the first Australian court decision on the patentability of isolated DNA or RNA sequences. Myriad Genetics, claiming a patent related to the BRCA1 gene, won the case and the challenge to their patent was dismissed.

Three things will help understanding why.

What is BRCA1?

It’s a human breast and ovarian cancer-disposing gene. According to the disputed patent, mutation of the BRCA1 gene is thought to account for 45% of hereditary breast cancer, and at least 80% of hereditary cancer involving both breast and ovarian cancers.

Can genes as such be patented?

No. Patents cannot be granted for products of nature. There’s no doubt that naturally occurring DNA and RNA as they exist inside the cells of the human body cannot be the subject of a valid patent.

Was this particular patent valid?

This was the core of the debate. Myriad Genetics argued that its patent related to isolated DNA and RNA, extracted from cells removed from human body and purged of other biological material with which it is associated in the cell.

Cancer Voices Australia argued that there’s no significant or material difference between nucleic acid in its natural and isolated states. Scientific experts gave evidence on these issues, to assist the court.

Key question

In analysing the competing arguments, the Court said that a composition of matter may be patentable if it consists of an artificial state of affairs, with some discernible effect, of economic utility and the result of some human intervention.

The Judge said:

The real problem lies in knowing, or rather not knowing, what degree of human intervention is necessary before it can be concluded that the requisite artificial state of affairs exists. It is an especially difficult problem in the present case, not so much because the authorities provide no clear solution to it, but because the problem has an almost metaphysical dimension to it.

The outcome

Ultimately, the court decided that there was the necessary artificial state of affairs, explaining:

  • earlier cases binding on the court regarding similar issues had used expansive language,

  • in the absence of human intervention, naturally occurring nucleic acid does not exist outside the cell, and isolated nucleic acid does not exist inside the cell, and

  • it would lead to very odd results if a person whose skill and effort culminated in the isolation of an DNA sequence could not be independently rewarded by the grant of a patent.

An appeal

The Australian judicial system is transparent and reviewable. Transparent, so anyone can freely access online the full reasons for judgement in Cancer Voices Australia v Myriad Genetics Inc. Reviewable, so dissatisfaction with the outcome may be tested in an appeal from the decision - perhaps even two appeals, should the issues warrant determination by the High Court.

Changes to the law

The Patents Act is crafted by the Australian parliament. Should it wish, the parliament may amend the legislation to provide a different balance between private and public rights. Reform in this area has been considered in the past.

In its report Genes and Ingenuity: Gene Patenting and Human Health, the Australian Law Reform Commission recognised that concerns could be raised in relation to patents for isolated biological materials.

The Australian government’s 2011 response accepted the recommendation that the legislation not be amended to exclude genetic materials and technologies from patentable subject matter, though some other amendments to intellectual property laws have recently been made.

What next?

Similar arguments about gene patients are soon to be considered by courts elsewhere. CNN quickly reported the recent Australian decision, noting that that the same gene, along with BRCA2, is at the centre of a high-profile lawsuit set to be heard by the United States Supreme Court in April of this year.

The frontier of genetic medical research seems likely to remain on the Australian and international judicial and parliamentary agenda for some time to come.