Intellectual Property

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Focus: Genomic DNA not patent eligible in the US

8 July 2013

In brief: A recent US Supreme Court decision has provided some important guidance on the patentability of human genomic material in that country. Partners Sarah Matheson (view CV) and Dr Trevor Davies (view CV), and Law Graduate Israel Cowen report on a ruling that puts the US at odds with most of its trading partners.

How does it affect you?

  • The US Supreme Court's decision, Association for Molecular Pathology v Myriad Genetics Inc,1 handed down on 13 June 2013, has clarified the legal landscape in the US regarding the patentability of human genomic DNA.
  • In a unanimous decision, the court held that a naturally occurring DNA segment is a product of nature and is not patent eligible merely because it was isolated. Importantly, artificially produced complementary DNA (cDNA) was held to be patent eligible as it is not naturally occurring.
  • Given considerable differences in Australian and US patent law and movement in the international biotechnology industry away from patenting naturally occurring genomic DNA, the decision should have little bearing on the Australian legal and biotechnology landscape. Australian biotechnology innovators may need to revise their patenting strategy for the US in the light of this decision to ensure they are seeking protection for patent eligible subject matter.    

The background

A recent decision of the US Supreme Court has clarified the legal position in relation to the patentability of human genomic DNA in the United States. The decision related to a challenge by a number of applicants, including the Association for Molecular Pathology, to the validity of certain claims in patents held by Myriad Genetics Inc (Myriad). The claims related to inventions concerning the isolation of the BRCA1 and BRCA2 genes which resulted in the development of molecular tests to detect predisposition to breast and ovarian cancers.

Association for Molecular Pathology argued that isolated DNA is not a 'new and useful...composition of matter'2 as required by US law, and fell within the 'law of nature' exception3 to patentability.

Myriad countered by arguing that the isolated nucleic acid segments were chemically different from the cellular genome and also relied on the long standing practice of the US Patent & Trademark Office to grant patents for such technology.

In litigation preceding the Supreme Court hearing, the District Court and Federal Circuit both held that isolated DNA was patent eligible. The reasoning in those decisions centred on the differences in the isolated BRCA-encoding nucleic acid brought about through its extraction from the DNA sample, which effectively created a 'new and useful...composition of matter'4 not found in nature.

The decision

In a unanimous decision, the Supreme Court reversed the Federal Circuit's approach, and held that isolated genomic DNA was not patentable subject matter, as it fell within the 'law of nature' exception to patentability. In doing so, the court applied long-held US case law to conclude that:

  • natural phenomena are not patentable since they are 'basic tools of scientific and technological work'5 without which innovation would be impossible. As such, allowing patenting of natural phenomena would be at odds with the purpose of patent law, which exists to promote innovation.6
  • natural phenomena are not deemed patentable simply because they involve 'extensive effort'7 or a '[g]roundbreaking, innovative or even brilliant discovery'.8   

The court considered that the isolation of the genomic DNA did not create or alter the genetic information carried by the BRCA genes or the structure of the DNA, contrasting it with a 1980 US case9 in which modification of a naturally occurring bacterium was held to have 'markedly different characteristics from any found in nature'.10 

The court looked at the patent descriptions that were directed to the discovery of the location and sequence of the BRCA genes as the inventions. The court suggested that Myriad's claims may have been upheld if the claims were 'expressed in terms of chemical composition', or relied 'on the chemical changes that result from the isolation of a particular section of DNA'.11

Importantly, the court held that synthetically produced cDNA was not naturally occurring and was therefore patent eligible under US law.

The impact of the decision

The US is now out of step with the majority of its trading partners with the finding that isolated genomic DNA is not patent eligible. As very few, if any, patent applications are being filed for naturally occurring human genomic DNA, the decision should have minimal impact on this field of biotechnology. It is unclear at this stage whether the decision will influence future US court consideration of patent eligibility of other biological materials that may also exist in nature.

Although the decision has been hailed by some in the popular press as a landmark decision for the genetic testing lobby, the decision turned on the nucleic acid claims in question and does not adversely impact patents for uses of nucleic acid for genetic testing or treatment.

US patents granted solely with claims directed to isolated human genomic DNA may now be considered invalid if challenged in a US court.

An Australian perspective

Earlier this year, in proceedings in Australia concerning similar Myriad patent claims, the Federal Court held that isolated, naturally occurring DNA is patentable subject matter in Australia as it involves an artificial state of affairs, it has some discernable effect, and has utility in a field of economic endeavour. (See Focus: Federal Court win for gene patents, their creators and patients.)

In August, the Full Federal Court will hear the appeal of this decision. While the Full Federal Court is likely to consider the US Supreme Court decision, that decision relied heavily on US statute and case law authorities which differ considerably to the binding law applicable in Australia11, so it should not impact the Australian case. Allens is closely following the Australian situation and will report on the Full Federal Court decision when it is handed down.

  1. Association for Molecular Pathology v Myriad Genetics Inc 569 US - (2013).
  2. 35 USC §101.
  3. See, eg, Mayo Collaborative Services v Prometheus Laboratories, Inc 566 US - (2012).
  4. 35 USC §101.
  5. Association for Molecular Pathology v Myriad Genetics Inc 569 US - (2013), 11.
  6. Ibid.
  7. Ibid, 14.
  8. Ibid, 12.
  9. Diamond v Chakrabarty 447 US 303 (1980).
  10. Association for Molecular Pathology v Myriad Genetics Inc 569 US - (2013), 12.
  11. Ibid, 14.
  12. See also Cancer Voices Australia v Myriad Genetics Inc [2013] FCA 65, [135].

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