The Court has transitioned to its end-of-Term schedule, releasing opinions on two action-packed days this week. We have seven opinions and one certiorari grant. That means there are just nineteen opinions to go before we put this Term to bed – and several of them raise exceptionally high-profile and contentious issues, including affirmative action, Section 5 of the Voting Rights Act, state voter ID laws, and same-sex marriage. Here’s the rundown of what happened this week.
This week’s headline decision is Justice Thomas’s opinion for a unanimous Court in Association for Molecular Pathology v. Myriad Genetics, Inc. The Court held that naturally occurring DNA segments cannot be patented, but it reached the opposite conclusion with regard to complementary DNA – also known as cDNA, which is essentially a synthesized replica of the protein-encoding parts of natural DNA, but not of the entire DNA sequence. Myriad Genetics had isolated two genes, BRCA1 and BRCA2, mutations in which correlate to a dramatically increased risk of breast and ovarian cancer; it then developed medical tests to detect the mutationsand therefore predict cancer. The company sought patents on the naturally occurring DNA sequences themselves, as well as on synthetic cDNA that it had created from the BRCA1 and BRCA2 genes. Those patents effectively gave Myriad the sole right to isolate (or license others to isolate) the BRCA genes – which means that Myriad effectively held a monopoly on the ability to test for mutations in the genes. The patents also gave Myriad the sole right to create BRCA cDNA.
In yesterday’s much anticipated decision, the Court held that naturally occurring genes are not patentable, but cDNA is. The Court recognized the importance of isolating the natural BRCA genes, but it reasoned that “[g]roundbreaking, innovative, or even brilliant discovery does not by itself” justify a patent; instead, the question is whether a “new and useful . . . composition of matter” has been invented. Because the BRCA genes are part of the natural DNA sequence, the Court determined that by isolating the BRCA genes, “Myriad did not create anything,” and the natural BRCA genes could not be patented. However, because cDNA is created in a laboratory and does not occur in nature, those sequences could be patented.
The Court’s decision will take some time to digest in its details. For example, it suggests that a gene made of DNA is not patentable. But if the RNA from that gene is converted into complementary DNA (cDNA) in the lab, then THAT gene made of DNA can be patented.
I imagine we have not heard the last of this, especially since it appears the court itself tried to make this a narrow ruling and not a generally applicable one.
In the meantime, don’t weep tears for Myriad. The costs for their tests seem high (around $3000 but are actually not that outrageous considering that the nature of the BRCA mutations requires them to find a few bases altered in a stretch of over 10,000, just about everyone with a BRCA mutation seems to have it in a different spot so every woman needs to have deep coverage over the entire region to be sure). It is not simply a quick sequencing check.
And, what was not mentioned, was that the $3000 test also includes most of the costs for checking other family members. Because once Myriad knows where the exact mutations are for one woman, they can reaily check all the other female family members for minimal costs.
So, those who talk about Angelina having the money to pay for the test should also remember that her mother suffered from the same sort of cancer and her aunt just died of breast cancer. For around $3000, Myriad would have checked all three of them.
But the real value Myriad has now comes from the huge database it now has for BRCA mutations. No one else has such a resource and I expect them to use this over the near term.
In the mean time, I expect we have not seen the last court case on patents and life.