Wow, chalk this up as a pleasant surprise! The Supreme Court has unanimously decided that "naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that [synthetic DNA] is patent eligible because it is not naturally occurring.”
This has major implications across a wide range of areas, including access to healthcare, biotechnology, and biomedical research.
Back in February 2012 when the firestorm against Komen was at its apex, I wrote a diary entitled "Breast Cancer Commercialization - It's Not Just Komen" that talked about how Myriad Genetics was at the forefront of trying (and up until this Supreme Court decision, succeeding) at patenting genes.
The defendants in this case, a biotechnology named Myriad Genetics, was founded in 1990 by a group of geneticists working to discover genes that were linked to the development of breast cancer. The now well-known gene BRCA1 was the first gene identified to play a major role in the development of breast cancer (of course, only when mutations are present).
The Myriad Genetics team cloned BRCA1 and sought to use their knowledge of the gene for commercial purposes.
How does a company do this?
Since the presence of a BRCA1 and/or BRCA2 mutation renders vastly higher risk for developing breast cancer, the main test that physicians will do for individuals with a family history of breast cancer is sequencing of those two genes. Sequencing two genes costs probably $50 at most today, and most of that is labor costs.
However, because Myriad Genetics has held patents for those two genes (and all experiments and research done involving those genes), they have been able to charge outrageous licensing fees for physicians, researchers, genetic counselors, etc. in order to do anything that involves BRCA1 and BRCA2.
As I wrote in my diary in Feb. 2012:
The research has been done, and the results are clear - if you are a woman who has either a mutant copy of BRCA1 or BRCA2, your likelihood of getting breast cancer is extremely high, and if untreated, you will likely die.Myriad Genetics has priced their licensing fees at several thousands of dollars per sequencing test, far out of the reach for millions of at-risk women. Myriad also charges researchers working on BRCA1 and BRCA2 projects, which is an additional cost and barrier to getting research done in this era of NIH budget cuts.
Thankfully, with aggressive preventative screenings and other intensive medical care, women with a mutant copy of BRCA1 or BRCA2 can extend their lifespan.
Of course, the critical piece of information is knowing whether you have a mutation in BRCA1 or BRCA2 in the first place. This is where Myriad Genetics and their patents come into play. If you have had breast cancer yourself or have a direct relative (parent/grandparent) who has had breast cancer, you likely already know what I'm going to say. You see, Myriad Genetic's patents don't just cover the isolation and sequencing technique of the BRCA1 and BRCA2 gene - they are patents of the genes themselves. Which means that any screening test that sequences and checks for mutations in your copies of BRCA1 and BRCA2 owes royalties to Myriad Genetics. And according to cancer.gov, that can cost anywhere between several hundred to thousand dollars for each test (and two genes means two tests). And as expected in the war on women from health insurance companies, your test may not be covered. Don't take my word for it, it's information provided in the same cancer.gov link I provided just above.
This is a healthcare access issue!
Not to mention that the legality of patenting something as innate as our naturally occurring DNA is very questionable.
I haven't thought about it as much, but I think I'm more fine with companies being able to patent sequences that they engineer on their own. Though, a desirable "engineered" mutation - like the Delta32 mutation in the gene CCR5 that makes humans immune to HIV infection - is also naturally occurring. But that's a discussion for another time.
All in all, I am extremely pleased of this decision by the Supreme Court (and it was unanimous to boot!). From the text of the ruling:
This holding is consistent with longstanding law establishing that “[l]aws of nature, natural phenomena, and abstract ideas are not patentable,” but instead belong to all inventors and to the public at large.I couldn't agree more. Millions of women will no longer be extorted by Myriad Genetics and finally be able to get access to much needed genetic screening to assess breast cancer risk. That is a wonderful thing.