Elated Over US Supreme Court Decision Barring Human Gene Patenting? Umm…Not So Fast

dnaTwo months ago, in these pages, I wrote an article entitled “Patent my jeans, NOT my genes”. This was written on the eve of the United States Supreme Court hearings about whether human genes should be entitled to patent protection. Despite being a holder of United States patents related to human genes myself, I was then, and remain today adamant that this practice is wrong and should be discontinued.

Yesterday, in a much anticipated ruling, the United States Supreme Court published its decision.

I was out and about all day yesterday so I missed the announcements about this decision. I became aware of the ruling late in the evening, and based on a couple of the initial news reports that I read I was thoroughly elated at the decision. This one, for example, entitled “Supreme Court rules human genes may not be patented” in the New York Times was typical of the initial reports. Although it is actually a balanced report, as befitting the New York Times, the tone of the headline and the text of the first paragraph had me, and no doubt others, drawing a more positive conclusion than perhaps was warranted by the actual ruling.

The first paragraph of the story reads:

“Human genes may not be patented, the Supreme Court ruled unanimously on Thursday. The decision is likely to reduce the cost of genetic testing for some health risks, and it may discourage investment in some forms of genetic research.”

Citing Justice Clarence Thomas who wrote for the Court:

“Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.”

This would lead the reader to assume that the patenting of all human genes has now been struck down by the Supreme Court.

In fact, I was so happy about this decision, that I quickly e-mailed some friends and former colleagues about this, Tweeted about it, and I even posted on my Cancer Research 101 Facebook page how this landmark ruling took even me by surprise, by being a 9-0 unanimous decision. Even I was surprised at the unequivocal nature of the ruling (or so I then thought).

As often happens, things look a little bit different in the morning. I had the chance to read a bit more about this decision, and I went to the actual Supreme Court website and read the ASSOCIATION FOR MOLECULAR PATHOLOGY v.MYRIAD GENETICS, INC. (June 13, 2013) ruling for myself.

For those of you who, like me, perhaps jumped the gun a wee bit in thinking that a great victory has just been wrought, I unfortunately now have to say “not so fast”…

While it is true that the US Supreme Court said that the patenting of an isolated human gene should not be permitted, it also went on to say that a copy or cDNA version of the gene is indeed eligible for patent.

The following passage, taken directly from the ruling could not be clearer:

”For the reasons that follow, we hold that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that cDNA is patent eligible because it is not naturally occurring. We, therefore, affirm in part and reverse in part the decision of the United States Court of Appeals for the Federal Circuit.”

To me, despite the fact that the ruling was unanimous, this decision seems and feels more like a cop-out. Some may well applaud the compromise nature of this, and indeed for two months now many have been predicting exactly this outcome. Personally, however, I feel that this decision, when seen in the full light of day, actually is more defeat than victory for those of us that feel that patenting of human genes is just plain wrong on the face of it.

Now, after the initial reactions of victory for the “anti-patent” forces, we are seeing articles like this one that proclaim a “Partial victory for biotech sector after gene patent ruling”.

Myriad Genetics itself was even more upbeat, proclaiming in a press release that the “Supreme Court Upholds Myriad’s cDNA Patent Claims”. According to this press release from the company,

“following today’s decision, Myriad has more than 500 valid and enforceable claims in 24 different patents conferring strong patent protection for its BRACAnalysis test.”

This is not good news at all for all of the genetic testing advocates and breast cancer advocates in particular who felt that Myriad Genetics’ holding an essential monopoly on all testing of the BRCA1 and BRCA2 genes was simply wrong. It does not seem like this Supreme Court ruling is going to affect very much of Myriad’s business that is based on cDNA copies of the BRCA1 and BRCA2 genes that is the basis of their BRACAnalysis tests in the first place. It might well mean that other companies have an opening to be able to create (and commercialize) other tests for the BRCA1 and BRCA2 genes, as long as they are not based on the cDNA versions that Myriad has created. This might end up as good news if more competition is created because Myriad can no longer claim an absolute lock over anything and everything related to these breast cancer genes.

What does this ruling mean for the future? There are better experts out there who can answer that question, but it seems to me that this ruling is going to have very little impact in the future. Genome sequencing has progressed leaps and bounds since the days when isolated cDNA was used in the way that Myriad and others have done. So while this ruling may well protect a large number of patents that have already been issued concerning cDNA copies of human genes, the future of human genome sequencing and of genetic testing and treatments based on those sequences has long ago eclipsed the need for cDNA cloning for the most part. International accords of the type highlighted in this article are by far the way of the future as opposed to isolating cDNA and cloning of individual genes.

I still believe that the US Supreme Court has advocated a very important point of principle, namely that a naturally occurring gene is indeed a product of nature and cannot therefore  be patented. Whether that makes any real difference for the future as we use the technologies of today and tomorrow, remains to me a bit of a moot point.

Bottom line for me, as the holder of patents on human genes that were derived from cDNA, that means that my patents are still protected by this ruling.

In one of those sad ironies, I wish it were not so…





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