Human genes and naturally occurring mutations cannot be patented as ruled by the US Supreme Court on June 13 2013. This is a successful milestone for patients as it will open up competition within the genetic testing world and prevent restrictions in research and companion diagnostic development. This case originated when Myriad Genetics acquired patents for the breast cancer genes BRCA-1 and BRCA-2 in the 1994 and 1995. The company successfully developed a genetic test to determine if patients have mutations that predispose them to breast or ovarian cancer. The problem however was that Myriad had a monopoly on the BRCA testing market.
So in 2009 a lawsuit was filed against Myriad by the American Civil Liberties Union and the Public Patent Foundation. Justice Clarence Thomas favoured against Myriad indicating that “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” and furthermore “we hold that genes and the information they encode are not patent eligible”.
What can be patented?
The Court ruled that synthetic or complementary DNA (cDNA) can be patented, a decision that saved Myriad’s skin as indicated by its stock price jumping to a four year high the day after the ruling. Peter Meldrum, president/CEO of Myriad commented “We believe the Court appropriately upheld our claims on cDNA, and underscored the patent eligibility of our method claims, ensuring strong intellectual property protection for our BRACAnalysis test moving forward”.
Definition of synthetic DNA within the Supreme Court promoted confusion. Scientifically, cDNA is an altered form of DNA if created by mRNA as it does not contain introns. It does however contain the exact genetic sequence of the original DNA template – should this then be un-patentable? cDNA units are smaller in sequence than actual DNA genes and so are easier to work with scientifically and so are important for companion diagnostic testing.
How does this affect the genetic testing market?
This ruling will have significant implications for the biotechnology industry. It will open competition, potentially drive down genetic test prices and also allow for second opinions and comparison of test results. It will also open up genetic research and increase the amount of cDNA patents in the future. This will lead to highly innovative work and have a positive impact on the industry. Investment into R&D will increase significantly. In 2012 genetic testing generated $5 billion in the US. This is set to increase to $25 billion by 2021, which will certainly be influenced by the US Supreme Court’s decision.
A recent analysis by Nature Biotechnology revealed that prior to the June 2013 ruling, approximately 3,500 human genes were patented – all of which are now invalidated. This will have a huge impact on current and future research projects and pipeline companion diagnostics. Future tests will be based on multi-gene test panels which will screen hundreds of mutations and potentially predict which therapies will have an impact on the cancer in question. An example of this is the University of Washington UW-OncoPlex test which determines the presence of mutations in 194 cancer genes related to diagnosis, treatment and prognosis. This gene panel can now include BRCA-1/2 testing. Currently this assay has a turnaround time of eight weeks, however with the advance of sequencing technologies future multiplex genetic assays will be completed faster.
Deirdre Kelly Guest Blog with Bioportfolio http://www.bioportfolio.com/news/article/1543429/How-is-BRCA-Genetic-Testing-shaping-the-personalized-medicine-market.html
Not quite a myriad of gene patents, Nat. Biotechnol. 31, 404–410, 2013. http://www.nature.com/nbt/journal/v31/n5/full/nbt.2568.html
Myriad BRCA Patents Ruled Invalid by US Supreme Court http://www.medscape.com/viewarticle/805756
The Myriad Decision Is Huge Because Genetic Medicine Is About to Explode http://www.nationaljournal.com/healthcare/the-myriad-decision-is-huge-because-genetic-medicine-is-about-to-explode-20130613
Why Is Myriad’s Stock Booming After the Supreme Court Rejected Its Right to Patent Natural DNA?
A victory for genes http://blogs.nature.com/spoonful/2013/06/a-victory-for-genes.html#more-5067