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US Supreme Court clarifies gene patentability

This paper discusses the recent US Supreme Court decision in Myriad and the implication that case may have for patenting genetic inventions in Australia.

On 13 June 2013 the Supreme Court of the United States handed down a much anticipated decision in the case of Association for Molecular Pathology etc al. v Myriad Genetics, Inc (Myriad case). 

The case is important because it clarifies the extent to which patents are available for DNA and other genetic material.

 The Court held that:-

(a)   a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated; and 

(b)   complementary DNA or “cDNA”, which does not occur naturally but is the result of scientific synthetic creation, is eligible for patent protection.

 

A brief overview

The patents in question were related to Myriad Genetics, Inc’s discovery of the exact sequence and location of the genes BRCA1 and BRCA2. These genes, when mutated, can lead to a distinct increase in the risk of breast and ovarian cancer developing.

Scientists are able to create synthetic DNA, or complementary DNA (cDNA). It is not a “product of nature”, rather is created due to the interception by a laboratory technician or scientist. 

It was argued that under 35 U.S.C. §101 the patents were invalid as they pertained to products of nature. Under this code

Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.

The Myriad case held that naturally occurring DNA does not meet the requirements for patent protection under this code, and the cDNA, which does not occur naturally, does meet the requirements.

 

But what about Australia?

In February 2013 Cancer Voices Australia v Myriad Genetics Inc (2013) FCA 65 (Cancer Voices case) saw the Federal Court of Australia hold that whilst “naturally occurring DNA and RNA as they exist inside the cells of the human body cannot be the subject of a valid patent”, the isolation of the gene was in itself sufficient to afford patent protection.

 

In the context of biological material, an artificial state of affairs may manifest itself in different ways. The physical properties of the naturally occurring material may have changed as a result of it having been isolated. But even if the physical properties of the material have not changed, the removal of the material from its natural environment and its separation from other cellular components may still give rise to what might reasonably be described as an artificial state of affairs.

Cancer Voices Australia v Myriad Genetics Inc (2013) FCA 65 

With the decision in the Myriad case, there is a real possibility that future Australian cases may head more towards the narrower US school of thought regarding gene patentability.

 

Conclusion

The Myriad case confirms that in the United States, mere isolation of genes is insufficient to afford patent protection. With that said, once interference occurs such that the subject matter in question is no longer a ‘product of nature’, then there is no obstacle to patent protection.

 

Authors: Christy Roth and Peter Francis