Supreme Court Rules That Genes Are Not Patentable

By: Mark R. Malek

No doubt that many of you heard that the United States Supreme Court has issued its ruling in the Myriad Genetics case.  The full ruling can be found here.  After reading through the ruling, I thought it was the only ruling that could have made sense.

In short, the court held that the isolated BRCA1 and BRCA2 genes that the scientists at Myriad were able to isolate were naturally occurring and, therefore, not patentable.  The synthetically made composite DNA (known as cDNA), however, was patentable.  The opinion is quick to note, however, that it is not directed to the method of isolating the BRCA1 and BRCA2 genes.  In other words, all the hard work that Myriad did to isolate these genes was not all lost.

So what’s the big deal?  I’ll tell you what the big deal is – the genes that Myriad was able to isolate are key to determining whether or not a woman has a higher likelihood of being at risk for breast and ovarian cancer.  The Association for Molecular Pathology argued, however, that the genes that were isolated by the Myriad Scientists occurred in nature and, therefore, not patent eligible pursuant to 35 U.S.C. 101.  The argument of Myriad, however, is that the isolated gene did not actually occur in nature.  It was not isolated until the Myriad Scientists isolated them.  The Supreme Court saw it differently.  Again – all is not lost for Myriad.  The millions of dollars that they spent in research and development of a method of isolating the above referenced genes is still patentable, as is the synthetic cDNA that they created.  All thanks to Myriad for creating this early warning system for some women.

Now – to those doubters that keep on saying that patent law isn’t fun, please feel free to read the concurrence of Justice Scalia.   It’s not a long one, so I truly encourage you to read it.  Essentially, in noted that he was no microbiologist, so whatever the rest of them said is fine with him!  I love it.

If you believe that the opinion in the Myriad ruling effects you at all, please feel free to contact me. You can also follow me on Twitter, LinkedIn and Facebook for even more information.