On 04/15/2013 the United States Supreme Court hears oral arguments in Molecular Pathology v. Myriad Genetics. For background information, see previous IP Value Wire coverage.
The American Bar Association provides an excellent repository of relevant information.
Respondent Myriad Genetics (respondent) obtained patents on two human genes, BRCA1 and BRCA2, mutations of which correlate to increase risk of breast cancer. The patents claim al naturally-occurring versions of those genes, including mutations, on the theory that Myriad invented something patent-eligible by isolating the genes from the body.
Petitioners are primarily medical professionals who regularly use routine, conventional genetic testing methods to examine genes, but are prohibited from independently examining the human genes that Myriad claims to own (and for which they charge $3,40 per test). This case presents the following questions:
1. Are human genes patentable?
2. Did the court of appeals err in upholding a method claim by Myriad that is irreconcilable with this Court's ruling in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012)?
3. Did the court of appeals err in adopting a new and inflexible rule, contrary to normal standing rules and this Court's decision in MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118 (2007), that petitioners who have been indisputably deterred by Myriad's "active enforcement" of its patent rights nonetheless lack standing to challenge those patents absent evidence that they have been personally threatened with an infringement action?
Brief for petitioners.
Brief for respondents.
See here for links to all amicus briefs.
And here is the transcript of the oral argument.
The direction of biotechnology research hinges on the US Supreme Court’s finding, scheduled for June. Though most of the amicus briefs support the petitioners, most of the rest of the world allows gene patenting. For example, the Federal Court of Australia ruled in February that isolated genes are patentable subject matter and upheld the validity of an Australian patent from Myriad Genetics Inc. covering the BRCA1 gene. Justice John Nicholas reasoned that isolated nucleic acids that have the same chemical composition and structure as nucleic acids naturally found in cells represent "an artificial state of affairs" and that isolated nucleic acid is the product of human intervention and thus patentable. Justice Nicholas concluded it is consistent with intent of Australian patent law to allow a person to be financially rewarded for their "skill and effort" to isolate DNA.