The U.S. Supreme Court has recently been handing down a series of controversial decisions (as if you hadn’t noticed). But a less contentious decision, nonetheless meaningful in bioethics, was the unanimous decision two weeks ago in Association for Molecular Pathology et.al. v. Myriad Genetics, Inc., et.al.
Myriad Genetics has marketed a test for the cancer susceptibility genes BRCA1 and BRCA2, certain mutations of which greatly increase the risks of breast and ovarian cancer in women. Their patent included the full sequence of these genes, as found in nature. Enforcing that patent meant that any other company or lab—including a university lab or independent lab—was guilty of infringement if they attempted to test a woman for mutations of these genes in the course of her medical care, regardless of the method of testing used. That in turn meant that in practice the Myriad Genetics test, along with its high price, had to be used. The patents were challenged in court.
Myriad Genetics had discovered the naturally occurring gene sequences and claimed them in their patents. The court held this part of the company’s patents invalid; one may not patent a discovery from nature, without creating a new substance or a new method of using that substance in an invention. This opens the door for competing tests. In “bumper sticker” terms, “life,” as it is encountered in nature, is not patentable.
What may be patented, among many other things in biotechnology, is something that Myriad Genetics and many other scientists and companies create from naturally occurring genes; namely, complementary DNA, or “cDNA.” cDNA is the sequence of coding regions of a gene, with the non-coding regions spliced out, that is “complementary” to that gene’s messenger RNA (mRNA). (In nature, a gene’s coding regions, called “exons,” are interrupted by noncoding regions called “introns.” The introns are spiced out in the course of transcription, or reading, of the DNA to form mRNA.) This part of the ruling limits the overall impact on the patent estates of biotechnology firms, which in turn means that the ruling is unlikely to impair the discovery and development of new treatments or diagnostic tests. Similarly, the methods used in such discovery and development also may still be patented.
Something else that may still be patented is a genetically engineered organism—for example, a bacterium with a gene inserted so that it will produce a protein of interest that it would not naturally produce. This represents a lot of activity; many such organisms are patented, including microbes and genetically altered higher animals like mice created for specific experimentation.
What of the future? Could human tissues, made from adult stem cells for an alternative to organ transplant, be patented? I would think that they could. At a minimum, the procedures for growing such tissues could be patented. If some future human embryo were enhanced with a gene to improve vision, what could be patented then? My guess is that the process could be, but the actual person could not be. This seems commonsense but of course one would need to see the actual cases, if and when they arise.
Commodification of life, including human life, remains an urgent concern, but it seems that, even if some altered organisms are patentable, it is unlikely that people, though they may be “made,” could be considered to be “invented.” My guess is that this decision would help set a limit. In any event, I think the court got this one right.