Saturday, June 15, 2013

Isolated genes are not patentable

In an earlier post I had mentioned that the Supreme Court was considering the case of Association for Molecular Pathology v. Myriad Genetics which deals with the question of whether an isolated gene is patentable.  Now we have a decision in the case.  In a unanimous decision, the Supreme Court has ruled that an isolated gene is not patentable.  Here is Scotusblog's discussion of the case.  The decision is purposely narrow.  Here is how Scotusblog summarizes the decision:
"The scientific and legal key to the Court’s denial of patent protection to isolated, natural forms of DNA were these sentences: “It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes. The location and order of the nucleotides existed in nature before Myriad found them.  Nor did Myriad create or alter the genetic structure of DNA.” 
While that was not disputed, because the legal controversy focused rather on what Myriad claimed it did to locate and then isolate the forms of genetic DNA, those agreed-upon factors were enough to convince the Court that “Myriad did not create anything.”   As Justice Thomas commented further: “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.  Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the [patent law] inquiry.” 
The opinion conceded that Myriad probably did create something when it synthesized DNA, in a form that it called “complementary DNA,” or cDNA.  The challengers to Myriad on cDNA had contended that the sequence in that form had also been dictated by nature.  That may be so, Thomas said in reaction, “but the lab technician unquestionably creates something new when cDNA is made.” 
The opinion said in a footnote, however, that the Court was not actually ruling that cDNA is specifically entitled to a composition patent, and noted that the federal government had raised other objections under patent law to that phenomenon. 
The Thomas opinion went out of its way to make the ruling seem narrow, indeed — that is, virtually confined to the scientific specifics of what Myriad had done on natural genes and on synthetic versions.  The opinion said that the Court was not ruling on any right to a patent on methods of manipulating the genes, and was not ruling on any applications of what Myriad had learned about the two cancer-suggesting genes, BRCA1 and BRCA2.   Further, the Court had not passed upon the patentability of altering the genetic code in specific DNA forms."
The decision opens the way for much cheaper genetic tests for these cancer causing genes which should enable millions of people to have access to the tests.  

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