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June 14, 2013
Myriad Genetics, One Opinion
Probably the most surprising thing to me was that SCOTUS managed to craft a single unified opinion in Association for Molecular Pathology v. Myriad Genetics, Inc.
Given the complexities at issue and the previous rulings from the Court, I expected another split decision. It's even odder that they issued a unanimous ruling that both sides see as a victory (though that may be lemonade-from-lemons for Myriad). My sense is that they did so by a combination of punting the hard issues - no method claims were adjudicated - and unfortunately through a lack of understanding of the science.
See for example Mark Stern's posting on Slate, where he looks at Scalia's concurrence as an admission that he doesn't understand the science and therefore the judges with whom he is concurring likewise don't get it, but aren't as forthright in saying so. The decision does go into some biology but the points raise by Myriad and the Association are fairly esoteric for someone not versed in at least college-level molecular biology.
Steven Salzberg, a med/sci writer for Forbes, argues that in fact SCOTUS got the science wrong. He lists three major errors contributing to the wrong science that underlies the key element of this decision: the supposedly bright line between DNA (not patentable) and cDNA (patentable). This leads to a tough question: even if it got the science wrong, did SCOTUS get this decision "right"?
By "right" I refer to the idea that the decision could reflect a legal and social sense of what is the right thing to do with patents in biology. For example, Art Caplan has a short opinion piece up stating bluntly that "natural DNA" never should have been judged patentable. Allowing Myriad to hold patents on these specific genes led to a tight monopoly market where no one could bring out a competitive (and one hopes lower-priced) testing product. This exemplified the monopolistic and constricted outcome feared by people who argued that natural biology should not be patent-protected.
This sounds to me like the Court has finally come around to Breyer's view in which the validity of an intellectual property protection law or interpretation has to be done in light of its outcomes. When you make a regime that allows one company to monopolize all possible methods of testing you've done something wrong. When you create a way for multiple companies each to protect their competitive ways of testing you've done something right.
Now if they could only manage to ground that in good science.
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