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Patent controversy: what the US decision about breast cancer gene patent means for Australia

A US court has recognised Myriad Genetics’ patent for an isolated gene, which plays a role in breast cancer. Mel Rowling

The recent US Federal Court of Appeals decision relates to the patent law status of inventions based on the discovery that particular mutations in BRCA genes predispose women to breast and ovarian cancer.

While likely to be appealed, the decision is an important one for Australia. It has relevance here because of existing Australian litigation and a Private Members Bill currently before the Commonwealth Parliament.

The owner of the patent in both the United States and Australia is Myriad Genetics.

Myriad undertook extensive study of families with histories of breast and ovarian cancer and was able to identify particular inherited genetic mutations correlating to the incidence of cancer.

The company is neither a government body nor a philanthropic trust. It undertook the research because the promise of the patent system underpins commercial exploitation of useful inventions related to such discoveries.

It’s therefore unclear if the BRCA breakthrough, and the diagnostic testing it permits, would be available today if not for the patent system.

This is not to deny that patents in the medical field can give rise to difficult questions of access. But the patent system exists in part because we, as a society, want new medicines, therapies and diagnostics – they boost our overall welfare. And we seek to achieve that outcome by providing patent incentives so private capital assumes the risks involved in medical research and development.

The US decision, and related Australian litigation and law reform, deal with a basic question: what should be eligible to be considered for patent incentives?

This is merely a threshold question. It doesn’t provide an answer to whether any specific invention is supported by a valid patent right. That involves a more detailed consideration of the merit of the invention, such as whether it involves a requisite inventive step.

The relevant Myriad patents comprise many more inventions than those challenged in court with the basic eligibility question.

Two types of inventions were considered at length in the recent US decision – isolated genes and diagnostic methods. Of these, only the former is currently at issue in Australia.

The diagnostic methods that were purely analytical in nature were found by the US court to be outside the patent system. Only the methods involving some transformation of matter fell within the system. One such method entailed inserting a mutant gene into a host cell to monitor the rate of cell division.

Should a molecule, derived from nature and put into an isolated form, be protected by a patent?

The key example in Myriad’s case is an invention comprising an isolated form of a BRCA gene mutated in a particular way. (This molecule was useful for diagnostic testing.)

In the US decision, the court reasoned that once the chemical bonds in the gene’s (metaphorical) backbone had been severed, the resulting molecule had a markedly different character.

On the court’s reasoning, this gave the molecule sufficient artifice to be eligible for further merit-based assessment under patent law. (But to be clear, even if a patent were to be granted on grounds of inventive merit, patents can never give rights to anything naturally present within a human body.)

Soon an Australian court may have to consider essentially the same eligibility question. It may also have to consider an additional exclusion under existing Australian law – whether isolated human genes are not patentable because they are “biological processes for the generation of human beings”.

It’s also noteworthy that the Private Member’s Bill before a Parliamentary Committee seeks to reform the law by specifically excluding from the patent system “biological materials … whether isolated or not and however made, which are identical to such materials as they exist in nature.” The term “biological materials” is defined to include DNA.

Importantly the US Court of Appeals decision, in finding that an isolated mutant BRCA gene is able to be assessed under the patent merit criteria, did so on the basis that once isolated it is not identical to a mutant BRCA gene integrated within its native chromosome.

If this conclusion was shared by Australian courts, a similarly isolated and useful molecule would not be excluded from our patent system even if the Bill were to be enacted.

Read an alternative view of the US Court of Appeals decision.

Read the argument against Australia’s Patent Amendment (Human Genes and Biological Materials) Bill 2011 by Douglas Hilton, Director and Julian Clarke, Business Development Manager of the Walter and Eliza Hall Institute (WEHI).

Read the argument for Australia’s Patent Amendment (Human Genes and Biological Materials) Bill 2011 by Dr Luigi Palombi, Director of the Genetic Sequence Right Project at Australian National University.

Leave your thoughts about gene patenting below.

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