Monday, April 15, 2013

Patents on Human Genes: U.S. Supreme Court Oral Argument in Myriad Genetics Case Indicates Natural Genes Will be Found Unpatentable as a Matter of Composition but Genes Worked by Human Ingenuity May Be Patentable as to Use

Oral argument on U.S. Supreme Court case 12-398, Association for Molecular Pathology v. Myriad Genetics, Inc. (see the transcript) took place today, Monday, April 15, 2013.

Essentially, it appears to us that the ultimate decision of the Supreme Court Justices in this case could fall along the following line of decision-making:
A natural human gene, i.e. DNA, is NOT patentable,
but a gene worked by human hand, such as cDNA,
could be patentable subject matter ....
That is an alternative weighed by Justice Kennedy during oral argument:
"And -- and that avoids giving special industries special subsidies, which is very important it seems to me. Let me ask you this, and it's consistent with my -- my preface. If we were to accept the Government's position that the DNA is not patentable but the cDNA is, would that give the industry sufficient protection for innovation and research? And if not, why not?"
Viewing cDNA to be patentable has two judicial options, i.e.

1) as "patentable" composition of matter in its own right, limited by the doctrines of prior art and obviousness, but without any monopolistic patent attaching to the actual DNA involved, whether in whole or part (i.e. snipped or unsnipped)

The problem with that option is Justice Sotomayor's question:

"Now, how do you understand Judge Bryson's dissent with respect to cDNA? I think he's saying that a gene created from -- into cDNA as a whole is okay, but that he had a problem with the description of that claim because it included 15 nucleotide long segments or fragments which he says reoccur in nature."

There is no convincing good answer to that question. Just try copying 15 notes exactly from one song into a "new" song and then try to claim you are not infringing on the original. No way.
or (the alternative which we prefer)

2) as patentable subject matter in terms of the use to which the genetic discovery, e.g. the cDNA, is put, limited by the doctrines of prior art and obviousness, but excluding its patentability as patentable composition of matter, i.e. a finding of the narrowest possible scope of patentability in the "use" of the cDNA.

Justice Sotomayor asked about the value of the isolated cDNA:

"That's the whole point, isn't it? The isolation itself is not valuable; it's the use you put the isolation to. That's the answer, isn't it?
MR. HANSEN: That's exactly correct. Thank you. Yes, that is the answer."

Justice Scalia said nearly the same thing in the argument about recombinant DNA:

"Yes. But, of course, to profit from -- from that recombinant DNA, you have to not just isolate the gene, but then you have to do something with it afterwards."
In other words, our view here at LawPundit is that DNA is not patentable subject matter, whereas cDNA could be, but only for a specific, narrow use discovered by the inventor. Nothing more.  cDNA should be free for use by others for other uses, including, e.g. discovering improved tests via further research, also as regards breast and ovarian cancer, as in the case of BRCA.

No selfish lab like Myriad should ever be allowed by law to shut down competing labs engaged in genetic research just because they are using the same genes, or cDNA. Competing BRAC tests of course can not be carbon copies of the Myriad tests, but improved tests should be welcomed and encouraged, also by competing labs in the industry. That is the nature of invention and discovery and always has been, especially in the pharmaceutical and biochemical sector. Monopoly means stagnation, paid for by those who suffer needlessly. Patents should always be granted for the narrowest possible claims, not for the broadest. Monopolies should be avoided.

In general, we most closely thus accord with the basic reasoning of Justice Breyer in questioning Gregory A. Castanias, counsel for Myriad, in James Baker-like fashion [excerpted and with more paragraph division than in the original transcript], where Breyer observed:
"I had thought ... and ... I'd be interested in your view -- that the patent law is filled with uneasy compromises, because on the one hand, we do want people to invent; on the other hand, we're very worried about them tying up ... a thing that itself could be used for further advance. And so that the compromise that has been built historically into this area is:

Of course, if you get a new satisfying process to extract the sap from the plant in the Amazon, patented.

Of course, if you get the sap out and you find that you can use it, you manipulate it, you use it, you figure out a way to use it to treat cancer, wonderful, patented. 
But what you can't patent is the sap itself. 
Now, in any individual case that might be unfortunate or fortunate. But consider it in the mine run of things. 
It's important to keep products of nature free of the restrictions that patents [trigger? ("there are" in the transcript can not be correct)], so when Captain Ferno goes to the Amazon and discovers 50 new types of plants, saps and medicines, discovers them, although that expedition was expensive, although nobody had found it before, he can't get a patent on the thing itself. He gets a patent on the process, on the use of the thing, but not the thing itself. 
Now, that's my understanding of what I'd call hornbook patent law, which you I confess probably understand better than I."
Counsel countered by citing the ignominious "precedent" of USPTO practice on gene patents over the years, saying that the "decision by the Patent Office is entitled to respect", i.e. he "begs the question" by offering the thing in dispute as proof of its correctness, or, to put it into Bakeresque terms, he puts the cart before the horse. It is is an argument which in our opinon has no chance in the decision-making on this case, and, indeed, as Justice Ginsburg then correctly rebutted: "even though the Government has disavowed it".

For more about the oral argument, see e.g. Amy Howe at SCOTUSblog in Justices debate gene patenting issues: In Plain English.

See also Patently-O.

See also Greg Stohr & Susan Decker at Bloomerg in High Court Justices Seek Compromise in Gene-Patent Case.

We posted previously about the Myriad gene patent case at LawPundit in:

Can Human Genes Be Patented? U.S. Supreme Court Answer Likely to Be "No", but the Ultimate Issue Down the Road is the Patentability of cDNA (Complementary DNA) viz. Is a Split Hair viz. Split Gene an Invention? 

The Unteachables on the Federal Circuit: If Citizens Are Obligated to Obey Laws They Do Not Agree With, Are Lower Courts Also Not Obligated to Follow the Precedents of the United States Supreme Court Even if The Judges Disagree?

Myriad Human Gene Patent Case Vacated and Remanded by U.S. Supreme Court in Light of Prometheus

Split Federal Circuit in Myriad Case Partially Reverses District Court and Finds Isolated Human Genes to be Patentable: Subsequent Supreme Court Review of this Case is Surely Essential

How SWEET It Is! Gene Patents Ruled Invalid as Genes are Found to be Non-patentable Subject Matter

Stephen Colbert on Gene Patents and the Myriad Case : Humor

The Body Snatchers are Alive and Well : In ACLU v. Myriad, the Battle over DNA Patents Rages

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