April 16, 2013
In addition, since the Court rarely hears such cases, it’s also interesting because the bulk of this body of law has been developed by other courts and government agencies. In spite of this, Supreme Court decisions on IP law are quite often landmark rulings with a broad impact.
Such appears to be the case with Association for Molecular Pathology v. Myriad Genetics, Inc., on which the Supreme Court heard oral arguments yesterday.
The case started as a challenge by a group of individuals (“medical organizations, researchers, genetic counselors, and patients”) against Myriad Genetics and the U.S. Patent and Trademark Office over the validity of a series of patents issued to Myriad by the USPTO.
There’s actually a lot of procedural history here, so I’ll just skip to the end: the series of patents under review by the Supreme Court now are all related to certain human gene segments associated with a predisposition to breast and ovarian cancers. The question before the Court is whether human genes such as these can be patented.
Why wouldn’t these genes be patentable? Because of the “product of nature” doctrine, which holds that things produced by nature and not by human hands are not patentable subject matter.
However, it’s not as though one cannot currently patent a human gene. The USPTO has been regularly issuing patents for human gene molecules for over 30 years.
Nevertheless, this is the first time that the question of the patentability of such components has reached the Court, and, as mentioned earlier, the Court’s opinion could have far-reaching consequences should it decide to rule that human genes are unpatentable (especially considering that there are many thousands of human gene patents).
So how do things look after oral arguments? Honestly, not that great for Myriad.
The only two justices that Myriad seemed to get any sympathy from at all were Justices Scalia and Alito, Justice Scalia’s support was lukewarm at best. Specifically, after apparently challenging AMP’s position, Justice Scalia seemed to challenge Myriad’s attorney about the originality of their patents: “you haven’t created a type of gene that…does not exist in the body naturally.”
Justice Alito, in seemingly offering the most support for Myriad, appeared notably concerned that striking down this class of patents would be very detrimental to investments and innovation, but he seemed to be the only justice that was so swayed.
The remaining justices repeatedly expressed concerns over something entirely different: that Myriad’s patents on human genes were akin to finding a leaf in the Amazon that could be used for a variety of purposes and obtaining a patent on the leaf itself.
The justices further noted that there are “use” and “method” patents available to Myriad if the company had a specific use for the gene or a specific method of isolating the gene that it had developed itself.
But the patent on the gene itself – the “composition” patent – seemed to worry nearly all of the justices.
Chief Justice Roberts seemed especially skeptical, with his comments repeatedly describing it as “just snipping” something that already existed in nature. The Chief Justice continued: “you don’t have anything new, you have something that is a part of something that has existed previous to your intervention.”
That was one of the last things said by the justices during Myriad’s argument, which left the distinct feeling that human gene patents are quite disfavored by this Court.
Admittedly, the actual science behind these gene isolations is quite a bit more complex than the Court’s analogies would make it out to be, and Justices Kagan and Breyer seemed to understand that (they engaged in quite a bit of deeper scientific discussion than the other justices).
Regardless, comments from the two seemed to indicate that they were of the same opinion as the Chief Justice – that all Myriad was patenting was a segment of something that regularly occurred in nature, subject matter prohibited from patent protection by the product of nature doctrine.
Now, there is also the issue of “complimentary DNA” or “cDNA.” I haven’t been in a biology class in 12 years, so I’m a little rusty on the details, but cDNA is used to make recombinant (human-created) DNA, and it’s done by extracting messenger RNA (mRNA) from a human body and “then they simply have the…nature-driven nucleotide binding processes complement the mRNA.”
This isn’t exactly recombinant DNA, but, according to Justice Breyer, it’s not something found in nature.
Because it is not technically created by human hands, but by the mRNA extracted from a human body, AMP argued that cDNA is also not patentable. However, none of the justices got onboard with this argument.
And, perhaps, that will be how the justices decide to compromise: rule that human genes as they are found in the body are ineligible for patent protection, but rule that cDNA is, conversely, eligible because it is the product of human intervention.
My prediction is 8-1 reversing the lower court (which found that human genes are patentable). Only Justice Alito will dissent.
Are human genes are patentable?
Lower Court’s Decision
REVERSE 8-1 (Majority: Roberts, Kennedy, Ginsburg, Breyer, Sotomayor, Kagan, Scalia and Thomas; Dissent: Alito).
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