The US Supreme Court’s ruling on June 13 in the case of the Association for Molecular Pathology v Myriad Genetics will have significant implications for the future of cancer testing, molecular diagnostics, and treatment.
The 9 members of the Supreme Court had been asked to answer the question, “Are human genes patentable?” Their ruling was 2-fold: they ruled that Myriad’s patent claims on the BRCA1 and BRCA2 DNA sequences are invalid, but that sequences known as complementary deoxyribonucleic acids (cDNAs) are patentable by any company or individual. (Myriad tests women’s DNA for the presence of mutations in BRCA1 and BRCA2, which significantly increase the risk for breast and/or ovarian cancer. cDNA is created in the laboratory by annealing DNA base pairs to single-stranded messenger RNA.)
In their near-unanimous decision, the judges determined that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring….It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes,” they noted. “Nor did Myriad create or alter the genetic structure of DNA….To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.”
The judges explained that the US Patent Act states that natural phenomena are not patentable, and that “without this exception, there would be considerable danger that the grant of patents would ‘tie up’ the use of such tools” and slow down or stop innovation.
This decision was foreshadowed in the oral arguments presented before the Supreme Court on April 15, 2013, as well as in the single dissenting opinion by Circuit Judge William C. Bryson in the July 2011 decision by a 3-judge panel of the US Court of Appeals for the Federal Circuit. Although 2 of the 3 judges on that panel held that Myriad’s BRCA1 and BRCA2 DNA patents are valid (and was the decision the panel issued, which became the basis for the Association for Molecular Pathology’s appeal to the Supreme Court), Judge Bryson said that their claims were too all-inclusive.
“Extracting a gene is akin to snapping a leaf from a tree,” Judge Bryson wrote. “Like a gene, a leaf has a natural starting and stopping point. It buds during the spring from the same place it breaks and falls during autumn. Yet prematurely plucking the leaf would not turn it into a human-made invention.”
In his appearance before the Supreme Court in April, representing the federal government, Solicitor General Donald B. Verrilli, Jr, noted, “Our position…is that cDNA is patent eligible because we think, unlike the isolated DNA which is just taken from your body, cDNA is an artificial creation in the laboratory that doesn’t correspond to anything in your body.”
Value-Based Cancer Care asked Robert Cook-Deegan, MD, Director of Genome Ethics, Law and Policy at Duke University, Durham, NC, for a comment. “This is a sensible decision that tracks closely to the US government’s position and the Bryson dissent. It will shrink the shadow of infringement liability from first-generation gene patents that hangs over genomic diagnostics, while preserving strong patent rights for valuable protein therapeutics,” Dr Cook-Deegan said.
Michael J. Shuster, PhD, a partner at Fenwick & West’s Intellectual Property Practice, San Francisco, CA, was also asked by Value-Based Cancer Care to comment on the decision. Fenwick & West filed an amicus brief in support of Myriad on behalf of the National Venture Capital Association.
Dr Shuster said that the Supreme Court’s ruling leaves room for companies to patent DNA that has been manipulated for the purpose of diagnosing cancer, but that Myriad’s patents on its methods of using DNA to test for cancer susceptibility could be challenged in the future.
“All someone has to do is claim the DNA is labelled for doing hybridization-based assays for diagnostic purposes, and that will be within the parameters of what the Court ruled is patent eligible. And the Court also left open the ability to claim recombinant constructs or host cells that are transformed with recombinant constructs,” said Dr Shuster.
In addition to allowing patients to be tested by new venues for the BRCA mutations, the Court’s decision will affect cancer research and diagnosis in ways that may not yet be fully understood. Many cancer diagnostics today involve a panel of genes rather than a single gene, and treatment decisions are increasingly dependent on combination therapies and multiple gene mutations.
