As regular readers will be aware, the Supreme Court of the United States (SCOTUS) had recently delayed any decision on a case related to the rights of Myriad Genetics to hold and enforce use patents related to the BRCA1 and BRCA2 genes associated with the diagnosis of specific subtypes of breast and ovarian cancer.
Yesterday, SCOTUS made the deferred decision. … They have referred the case back to U.S. Court of Appeals for the Federal Circuit in New York for reconsideration. Why have they done that?
They have done that because, in the interim, SCOTUS had decided another case, in which the court invalidated gene use patents held by Prometheus Laboratories, by again clearly indicating that companies may not patent observations that are based on natural phenomena. In that case it was clear that the company had sought to patent a natural phenomenon, and there was unanimous consensus within SCOTUS that the patent was therefore inappropriate.
The full implications of the decision by SCOTUS to refer the Myriad Genetics case back to the Court of Appeals are unclear. In the short term, this is certainly good for Myriad Genetics … because it may take the Court of Appeals several years before it can re-schedule this case and make a re-assessment of its prior decision. In the longer term, it remains unclear exactly what companies are going to be able to claim patents on that are specifically tied to the use of specific, naturally occurring genes, and we have no idea at all how the Court of Appeals will rule when it does get around to reconsidering the case. Nor do we have any idea whether either party to the case will re-appeal to the Supreme Court once the Court of Appeals does make a determination.
And you though only politicians kicked the can down the road!
SCOTUS appears to have implied that transformation of a law of nature into a patentable application is acceptable under certain circumstances … but that such a transformation must relay on doing more than simply stating the law of nature and adding the words “apply it.” One possibility is that the Court of Appeals could end up determining that only some parts of Myriad Genetics’ current patents related to the BRCA1 and BRCA2 genes are actually legal. It’s also possible that by the time this case is finally concluded, the current patents on the BRCA1 and BRCA2 gene may have run their course.
For other opinions on all this, see today’s Reuters report and a report on GenomeWeb on this decision by SCOTUS. As one could reasonably expect, Myriad Genetics has issued a media release that continues to argue that its patents are valid and that the company does not seek to take action against others who are researching other aspects of the role of the BRCA1 and BRCA2 genes.
The “New” Prostate Cancer InfoLink remains focused on this boring legal and technical issue because we believe it is fundamental to the potential development of tests that may actually be able to define risk for subtypes of prostate cancer with great accuracy at some point in the future.
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