US Supreme Court tries to strike a balance between patentable and non-patentable genetic material

In a decision handed down overnight, the United States Supreme Court has found that naturally occurring DNA is a product of nature that is not rendered patentable by virtue of being isolated. Myriad, the patentee of a claim to the isolated BRCA1 and BRCA2 genes, was found to have not created or altered the generic information encoded in the genes, or the genetic structure of the DNA. As a result, while the discovery of the genes was ground breaking, innovative and brilliant, it did not satisfy the test for patentability.

However, synthesised composite DNA (cDNA) in which naturally occurring non-coding portions of the genes are excised, was found to be patentable. The Court was of the view that the synthesised cDNA is not a molecule that is naturally occurring. While the sequence is dictated by nature (in the sense that non-coding portions are able to be identified in nature), the Court noted that “the lab technician unquestionably creates something new when cDNA is made”. While the cDNA retains the naturally occurring coding portions, the omission of non-coding sequence creates a molecule that is distinct from naturally occurring sequence from which it is derived.

The claims

For those without a PhD in genetics, human genes are sequences of molecules (nucleotides) within long strands of DNA that encode amino acids, which in turn make up the proteins that are required for normal cell function. Sequences of DNA that encode these amino acids are known as “exons”, and sequences which do not encode an amino acid are known as “introns”. In the process by which the genetic code (nucleotide sequence) is translated into a protein, introns are excised from the code. The distinction between exons and introns was fundamental to the Court’s decision.

Myriad discovered the location and sequence of the BRCA1 and BRCA2 genes on chromosomes 17 and 13. As we all now know, mutations in these genes are associated with a significantly increased risk of ovarian and breast cancer. Myriad held a number of patents relating to this discovery, however the claims the subject of the proceedings claimed:

  1. naturally occurring DNA sequence of the BRCA1 and BRCA 2 genes, isolated from the rest of the genome; and
  2. synthetically created composite DNA (cDNA) containing only the coding information from the BRCA1 and BRCA2 sequence (exons) without the non-coding portions (introns).

35 U. S. C. §101 provides that patents may be issued to “whoever invents or discovers any new and useful … composition of matter”.  However, in an earlier decision (Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U. S.) the Supreme Court also found that “laws of nature, natural phenomenon, and abstract ideas” are not eligible for patent protection. This is intended to strike a balance between incentivising invention and discovery, while avoiding the inhibition of the flow of information that may impede invention.

Decisions below

In the lead-up to this decision, the District Court granted summary judgment against Myriad, finding that Myriad’s claims to both the BRCA1 and BRCA2 DNA sequences and the cDNA sequences were invalid because they claimed a product of nature (see our post here). The Court of Appeals for the Federal Circuit found (twice, a first time, and then a second time after the proceeding was appealed to the US Supreme Court and referred back to the Court of Appeals) that both the isolated DNA and cDNA were patentable (see our posts here and here).  The Court of Appeals concluded that the isolation of the sequence from the rest of the chromosome was sufficiently inventive to found patentability.

Was the right balance struck?

In finding that DNA is a product of nature that is not rendered patentable by virtue of being isolated, while synthesised exon-only cDNA is patentable, the Court seems to have been concerned to maintain the “delicate balance between creating “incentives that lead to creation, invention, and discovery” and “imped[ing] the flow of information that might permit, indeed spur, invention”.  Drawing the distinction between the naturally occurring sequences of the BRCA1 and BRCA2 genes on the one hand, and that sequence in which naturally occurring non-coding sections are removed, on the other, seems to be a position which the Court felt sufficiently preserved the incentive to research while precluding an exclusive monopoly over genetic material in the exact form in which it exists in nature.

What the case was not about

The Court was at pains to emphasise that the only issue that was to be decided in the case was the patentability of claims to the BRCA1 and BRCA2 genes (DNA) and the cDNA for these genes. The Court did not consider, and the decision does not affect, claims relating to methods of using genes and cDNA sequences (for example, techniques for manipulating genes when testing for mutations), or the patentability of DNA sequences which are altered from their naturally occurring state.

What does this mean for Australia?

In February, the Federal Court of Australia rejected a claim by Cancer Voices Australia that isolated, but naturally occurring, genetic material is not patentable subject matter (see our post here). In doing so, the Court upheld Myriad’s patent which claimed isolated DNA sequences of the BRCA1 gene which contained mutations. Ultimately, Justice Nicholas found that the isolation of the DNA sequences was an artificially created state of affairs that amounted to a patentable invention in Australia.

Cancer Voices appealed Justice Nicholas’ decision, and the Full Court is to hear the appeal in early August.

Will the US Supreme Court’s decision affect the outcome of the Australian appeal? Of course, determination of Cancer Voices’ appeal in Australia will turn on the application of the Australian Patents Act, and the High Court’s decisions in relation to patentable subject matter (and what amounts to a “manner of manufacture”). However, Justice Nicholas in the Australian Myriad proceedings carefully considered both the Australian Government’s consideration of the patentability of genetic material, as well as the consideration which has been given to the issue by the UK and US Courts. We anticipate that the Full Court will give close consideration to the US Supreme Court’s decision.

Once again, we will keep you updated on the next instalment of these important proceedings.

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