from the good-news dept
The unanimous ruling found that merely separating out naturally occurring genes cannot be patentable, because that would be ridiculous:
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. Instead, Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes within chromosomes 17 and 13. The question is whether this renders the genes patentable.And that doesn't make much sense under patent law:
Myriad’s patents would, if valid, give it the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes (or any strand of 15 or more nucleotides within the genes)by breaking the covalent bonds that connect the DNA to the rest of the individual’s genome.Myriad's main argument was that it basically had to put a lot of work into finding and isolating the genes, but the court noted that "Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy [the conditions for patent eligibility]."
The court also rejects the idea that just because the US Patent Office regularly granted gene patents for years, it should be allowed to continue to do so. The court does say that complementary DNA, made by Myriad, can be patentable:
... the lab technician unquestionably creates something new when cDNA is made. cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived. As a result, cDNA is not a “product of nature” and is patent eligible...The court also points out that you can still patent a form of a test for DNA, if that method is innovative, but you can't patent the underlying genetic structure if it's naturally occurring. However, Myriad's method was not new or innovative. As the court notes, it was "well understood by geneticists at the time."
On the whole this is a good ruling that will invalidate a large number of bogus gene patents. While patent extremists are complaining that this will destroy the biotech field, more reasonable minds are pointing out that it should have little effect. I'd argue that, if anything, it may drive greater efforts in biotech, since companies can now do more exploration on genes without fearing being sued by someone who discovered and isolated a particular gene first -- and this should also lead to significantly cheaper genetic testing, creating even more opportunities for biotech firms to innovate on top of widespread genetic testing.