As UpCounsel reported on April 16, 2013, the Supreme Court is set to decide the Association for Molecular Pathology v. Myriad Genetics case–the gene patent case–in June 2013 based on the oral arguments it heard on April 15. The case was originally fired up in the media and public mind in large part due to the controversy surrounding patents on the BRCA1 and 2 genes, also known as the breast cancer susceptibility genes. Especially given the radical ethical conflicts stirred up by the discovery of the genes—preventive mastectomies, for example, which have been elected since the discovery even by women who do not carry the genes—have stirred heated debate.
The question of human gene patents is now before the court. The issue is whether human genes are unpatentable as products of nature or if, instead, they are somehow created by the hands of humans. This means that the court will only be deciding whether genes themselves are patentable; it does not touch whether or not any specific applications for patents should be granted. The “inventor” of each proposed gene patent (like any other proposed patent) would still need to show that their gene was novel, nonobvious, and explicitly described.
The Myriad case is interesting in part because the claim in the case is that human genes are subject to product patents, not that method patents should be granted to those that discover human genes, isolate them, or ascertain the function of the genes using their own processes. Since the owner of a product patent can stop any other person or company from making, selling or using the patented product without his permission and the “product” in question here is a human gene that can stop a deadly cancer, there are many ethical issues raised by the case. The product patent prohibits use without permission, and it doesn’t matter what kind of use it is.
On the other hand, a method patent simply prohibits exact copying of a specific process. In the case at bar here if a researcher came up with a different way to test for and isolate the breast cancer gene there would be no violation of a method patent. It should come as no surprise to anyone that IP lawyers enjoy product patents as the stronger form of protection.
It seems most likely that simple isolation of human DNA will not be enough for product patentability and the granting of human gene patents. However, the court may well decide to take the middle road and allow product patents for cDNA, a synthesized type of DNA made without the non-coding sequences that natural genomic DNA has. While it is certainly worth noting that there is little functional difference between DNA and cDNA, the cDNA is synthesized and wouldn’t exist without human intervention. Furthermore, this compromise of sorts would balance the fears of human gene patent advocates that without patent-related profits innovation will be stalled.
Ethical and philosophical considerations aside, who will actually care about or be impacted by this decision? Frankly, even Myriad probably won’t care that much. Sequencing technology is growing by leaps and bounds, and it won’t be long before isolating individual genes isn’t even necessary for diagnostic testing. These advances will render the existing gene patents and the rule handed down by the court irrelevant to other companies. And even Myriad is using different strategies as it moves forward. Since expansion in Europe is a particular goal of Myriad and the public health systems in European countries are hostile to gene patents like those on the BRCA genes, the company has no choice but to pursue different avenues of innovation.
Of course the ethical and philosophical considerations do remain interesting enough to keep us all on the edges of our seats. It’s simply worth noting that the excitement isn’t because the case is going to reshape the legal landscape in a major way.