The Supreme Court recently declared that naturally occurring human genes (ie genes isolated from you or me) can’t be patented but forms of DNA that have been manipulated in the lab in a way that alters their natural state can. The court’s ruling came in a challenge launched by medical researchers and other concerned parties to seven patents owned by or licensed to Salt Lake City, Utah-based biotechnology company, Myriad Genetics Inc. on two genes linked to breast and ovarian cancer (BRCA1 and BRCA2).
Myriad appears to be partly relieved with the compromise outcome, as the ruling will have less impact on Myriad than if the court had barred patents for all types of human genetic material. The ruling was also a partial victory for patients and the biotechnology industry, making it easier for people to get cheaper genetic tests for disease risk. The BRCA1/BRCA2 test at the center of this case was supposedly the same one that Angelina Jolie used to determine that she had the mutation (along with a family history) and an extremely high risk of developing breast cancer; she subsequently got a double mastectomy.
Even though this case will almost certainly be beneficial for patients and allow for better access to testing in the future, the implications for current patentable (if not already patented) therapeutic and diagnostics and future research is less clear.
First of all, the court did not provide guidance on the boundary between “natural-made” and “man-made”. Does changing one base pair constitute enough change? (Probably not, and I think most genetic mathematicians would argue that somewhere, in somebody, that mutation exists). What if you put the gene into a vector? That is probably patentable. For many protein therapeutics, the goal is to make them as much like they occur in nature as possible; are these (current therapies) still patentable? What about the upcoming area of stem cell therapies? Scientists are inducing stem cells to become other cells that naturally occur in our bodies. Perhaps more researchers and companies will look to file “method” and “use” claims to protect their technologies.
When I first heard about this case, I was interested, as Myriad Genetics is one of the only bioscience industries in my old stomping ground, Salt Lake City (and the professional home to many University of Utah alums). In the end, both companies and researchers need to make money so they can continue to invest in their R&D and continue to develop great new technologies, therapeutics, and diagnostics. However, there needs to be a balance that keeps the ultimate goal in mind: patient health. Had Myriad licensed out their test to other parties so that patients could get a 2nd opinion on a test, would the lawsuit have even occurred? Of note, Myriad’s patent on their cDNA expires in 2015, and I would like to know the math: licensing their technology (for a fee, of course) or paying for a lawsuit only to have partial success that might be financially irrelevant in 2 years [Note: Myriad stated the decision left intact 24 different patents that relate to the BRACAnalysis test*].
Finally, in this world of sequesters and bipartisanship, the fact that this was a unanimous rule by nine Supreme Court Justices in our government feels like a small victory in itself. It will be interesting to see how future rulings play out and what the long-term effects are on research and drug development.
* Reference: http://investor.myriad.com/releases.cfm
Another interesting ruling was Mayo v. Prometheus (2012): http://www.insidecounsel.com/2012/05/30/mayo-v-prometheus-cuts-back-on-patentable-inventio