The Right Question?

The US Supreme Court is hearing arguments today regarding gene patents, but the New York Times wonders whether the field has moved beyond that question.

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Right on several counts.

Right on several counts. Despite the multi-year efforts of journalists and perhaps even the courts to frame the question here as "whether genes, particularly isolated genes, may be patented," that has never been the issue in Myriad, however interesting that question may be. For BRCA it did indeed require human ingenuity to identify what DNA loci, and in turn what genes and ultimately what mutations were responsible for a particular syndrome of heritable breast and ovarian cancer. The method or process for knowing how to go about obtaining information that allows prediction of this category of cancer risk was indeed novel, inventive and transformative.

Nevertheless, there are now well established processes and algorithms used routinely to locate, isolate and obtain sequence info on causative mutations from many/most pathologies with genetic etiology. The vast majority of recent and future discoveries are indeed accessible to routine experimentation and well within the art of ordinary practice. The correct decision in favor of Myriad would need to be structured very carefully so as NOT to imply patentability of the vast majority or current and future discovered etiologies.

From that perspective the legitimate rights of Myriad might be seen as a trivial loss to be sure that the non-patentability of the vast majority of genomic associations becomes precedent. Plus this court isn't smart enough to grasp the distinction under patent law nor courageous enough to stand up to the Obama administration.

The impact is what others

The impact is what others have the freedom to do without paying roylaties to the patent owner, or needeing to obtain a non-proprietary license in anticipation of a commercial application. Be that diagnostics for directing patients to the right therapy or expressing the gene product in a cell line for drug discovery purposes. Not insignificant medical and commercial implications!

An interesting news story and

An interesting news story and previous post by Biotreker. However, practically speaking, this issue has already been decided. See the recent article by Rosenfeld & Mason [2013, "Pervasive gene patents cover the entire human genome." Genomic Medicine 5: 27], who demonstrate that the average gene covers, via redundant 15mers, another 264 genes in the human genomes. Such gene patenting is highly problematical for resequencing efforts, exome sequencing, genetic testing, and so on--including individual's health.

There are further ethical issues surrounding ownership and compensation raised by gene discovery, in persons with extreme phenotypes, whose genes are cloned, sequenced, manipulated as transgenes, etc.--all to be used for product development by Big Pharma and small biotech companies. A case in point is Henrietta Lacks, aka "Helen Lane" the real owner of HeLa cells. Or consider the contemporary "Sharlayne Tracy," who is homozygous for a PCSK9 mutation that confers extremely low levels (14 mg/dL) of LDL-cholesterol. (See Hall 2013, A gene of rare effect, Nature 496: 152-155; http://www.nature.com/news/genetics-a-gene-of-rare-effect-1.12773).

IMHO, Roselfeld & Mason are right in that the Supreme Court needs to determine the latitude of gene patents, lest the entire genome is determined to already be patented. This legal issue may already be moot--much to the detriment of people who actually have these original genes but much to the benefit of companies that stand to profit in our private, for-profit medical care system. So the Supreme Court deliberations and decision will have a huge impact on genomic medicine.