June 14, 2013

BRCA1 and BRCA2 Genetic Testing Field Expanding Rapidly After Invalidation of Myriad Gene Patents

Within a day of the Supreme Court’s decision in AMP v. Myriad, invalidating patent claims to isolated genes (see here), the genetic testing environment for the BRCA1 and BRCA2 genes has shifted noticeably. Before elaborating on that, it’s worth noting some of the characterizations of the decision from the mainstream press, which reveals public perception of the issues and/or significance of the case. Soon after the opinion was released, the Drudge Report shouted “You Can Keep Your Genes” – a type of headline that appeared in other forms around the country – a mistaken impression that patent rights in human genes translated to any ownership of anyone’s person or bodily materials. But in the sense that the “in vitro” BRCA1 and BRCA2 genes could not be used without permission of the patent holder, the headline had some accuracy. Other news accounts noted the bifurcated nature of the decision, invalidating patents on isolated genes, while upholding patent claims to semi-synthetic cDNA molecules, creating a mixed picture for biotech companies, depending on business models (e.g., genetic testing for single genes or producing recombinant proteins?).

Several companies have announced their intention to offer BRCA1 and BRCA2 testing: in the day since the ruling, DNA Traits has already posted “Proud to Bring BRCA1 and BRCA2 Testing to You” on their website; other go-aheads include Quest Diagnostics, Ambry Genetics and GeneDx, which announced “its intention to launch a suite of comprehensive genetic tests for inherited cancers including BRCA1 and BRCA2 genes, given the Supreme Court's ruling in the Association for Molecular Pathology vs. Myriad Genetics case.” Academic researchers are also gearing up, notably Dr. Mary-Claire King of the University of Washington (see here) and Dr. Wayne Grody of UCLA, who noted that his laboratory would also offer tests on other genetic diseases covered by gene patents, such congenital hearing loss, spinocerebellar ataxia and various muscular dystrophies. Reaction from professional organizations that had participated in the case was enthusiastic. From the Association for Molecular Pathology (AMP), lead plaintiff: 
AMP is very pleased with the Supreme Court’s decision in the case. The Court’s decision that human genes are not patentable is a great step forward for the field of molecular pathology, for genomic science, and most important for our patients. We look forward to exciting future advancements in diagnostic testing and therapeutics that will accrue to the benefit of our patients and our field. 
The American Medical Association (AMA), which filed an amicus brief) reacted: 
The AMA is pleased that the justices saw through the flawed premise that resulted in Myriad’s exclusive patent awards and affirmed that human genes are products of nature and not patent eligible. Removing the patents on the building blocks of life ensures that scientific discovery and medical care based on insights into human DNA will remain freely accessible and widely disseminated, not hidden behind a vast thicket of exclusive rights.  
The College of American Pathologists (CAP) noted the significance for advances in genetic testing:
Genomic medicine has the potential to be a cornerstone of medical testing, treatment, and clinical integration, but the question of ‘who owns your genes’ needed a definitive answer. Now we have it. 
International reaction includes efforts to push for the amendment of the Patent Act in Australia to prohibit gene patents, following a February court decision in that country that had upheld Myriad patent claims against a patentable subject matter-type challenge from Cancer Voices Australia. Testing access is not the only issue at stake in the gene patent controversy. Myriad Genetics, in establishing itself as the central provider and repository for U.S. genetic testing for the BRCA1 and BRCA2 genes, did not maintain a reliable, accessible database of all the mutations in these genes that it had collected over the years. The Sharing Clinical Reports Project, a public effort to get patients and physicians to report genetic mutations to a public database, was announced in April, 2013. The loss for Myriad of its gene patent claims will certainly accelerate the efforts to establish a credible, dynamic BRCA1 and BRCA2 database which is critical for identifying the sites of genetic mutations, their frequency, and the associations between mutations and diagnosis or prognosis. It’s fair to say, at this point, that the BRCA1 and BRCA2 field is now supercharged as a result of yesterday’s decision, and will rapidly correct for the lag and underdevelopment that it has experienced in the nearly 20 years since the first Myriad patents issued.

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