In a major victory for womens health, the Supreme Court has unanimously ruled that isolated human genes may not be patented. The case concerned the firm Myriad Genetics patent on genes linked to higher risks of hereditary breast and ovarian cancer. The firm owned patents to a gene called BRCA1, or Breast Cancer One, and a similar gene called BRCA2, meaning it had the authority to stop all research on those genes and was the only company that could conduct life-saving tests revealing if women had mutations in those genes.
the Supreme Court sided with the American Civil Liberties Union in saying Myriad Genetics discovery of the precise location and sequence of the genes did not constitute a “human-made invention” eligible for patenting. The ACLU and the Public Patent Foundation filed the case four years ago on behalf of 20 plaintiffs, including organizations representing over 150,000 medical professionals, geneticists, breast cancer and womens health advocacy groups, and patients.
Judge Robert Sweet:
I think the principle thats enunciated by Justice Thomass opinion is a very powerful one. And I think it will have an immediate effect on people like those represented by the plaintiffs groups and so on. But the court itself recognized that the study of genomics is one of the leading areas of research in the United States, and its very important to everybodys health. This decision, I believe, will free up the ability of researchers and others to experiment, to deal with genomegenomes, generally. And that, I think, will expand the area of knowledge and research. So I think its a very important decision. Its one that, frankly, I just feel so delighted that I was able to have a part in it, because I think this issue of knowledge and the freedom of genomic knowledge is something that will be critical in the years to come.
the court has made it clear that there are areas in research that can perhaps be patented. Thats for another day, with respect to each one. But that is because they have made a change in the gene. And its that changeso, the court has not closed down the ability of people to advance medical research through patents, but at the same time, it has made it clear that thethat no one can patent a genome in itself. So that, I think, will open up a greater ability of people to obtain information on the BRCA1 and 2, and it will also enhance the ability of the researchers to deal with genomic research, which is now, as I understand, not only a question of one genome, but the effect genomes on each other. So that freedom, I think, is very important.
Lisbeth Ceriani talking:
I had difficulty obtaining the BRCA analysis test because I was told by the genetic counselor that they wouldnt accept my insurance, that my insurance wouldnt cover it, actually. When I contacted my insurer, they said they would cover it if it was provided by a contracted lab. And I contacted Myriad and said, “Please contract with my insurance.” And that wasnt happening. They chose not to contract with my insurance, which was at the time Massachusetts MassHealth. And, you know, that was within their right, but, as you know, the test was extremely expensive, so it did take over a year and a half for me to finally access the test through a grant, luckily.
In my case, it would have been close to $4,000 for me to access the test in 2009. They wereMyriad was choosing not to contract with Massachusetts Medicaid at the time. And many negotiations went back and forth between the contracting people with MassHealth and the contracting people at Myriad. So, in my case, it would have been close to $4,000. And apparently, they werent allowed to offer me any financialfinancial deals on the price, because I did have MassHealth, so they were prohibited from offering me any financial discounts. So that was just prohibitive for me to pay at that time. So, luckily, I was able to access a grant in enough time to get the information I needed in order to assess whether I had an increased risk of developing ovarian cancer. And in my case, it turned out I did have a rare mutation, so it was lucky I was able to access the test when I did, but it did take over a year and a half for me, actively working on it like a part-time job. And I just knew that there were other women, whodefinitely other women in Massachusetts with the same issues.
Sandra Park talking:
Its a huge victory. I think that what we had up to this point is a company that monopolized two human genesgenes that we all have in our bodiesand with that monopoly, dictated the terms of testing. So what youve heard from Lisbeth is they decide what the price was, with absolutely no competition. And they also decide which mutations that are looked for. They decide the quality of the test.
And what we now know is that there are many laboratories that are fully capable of offering this kind of testing, that would offer it in very different ways, so that they would be looking at the many genes that are connected with breast and ovarian cancer, and not just screening two. And so, with the ruling today, we fully expect much better access and much better options for patients, as well as for scientists who want to look at different parts of the genome. They no longer now need to deal with patents on the thousands of genes on our genome when theyre engaging in their scientific work.
with these two genes, weve already heard two or three different laboratories have announced they plan to offer testing on the BRCA genes within the year. So its already had that immediate effect. But youre absolutely right, the patent office has issued patents on thousands of human genes connected with diseases like muscular dystrophy, colon cancer. And so, what we expect to see is that patents on those genes willare seriously under question with the ruling, and more options will become available.
Judge Robert Sweet:
what the fundamental issue wasthe issue was: Can you patent something that is a product of nature? Can you patent gold, andfor example? And what this decision has affirmed is that there are things in nature that cannot be patented. And one of those things in nature is your genome. It is a peculiar development that is natural. It is not the product of any outside influence. It is your genome, and that cant be patented.
So the issue really is the extent to which your genome can be, if you will, grasped for some other purpose. And I think the courtI attended the argument. The justices were marvelously attentive. And I think the simple, direct and powerful nine-to-nothing decision indicates that they believe the genome is something that is important to be, if you willnot using it in a legal sensebut free. And it will make a difference, I believe, both in terms of availability for those who want the tests and also in terms of research. So, my view of it is that it is quite anwell, I know its an important and long-range decision.
– source democracynow.org
Judge Robert Sweet, senior federal judge for the Southern District of New York. He ruled against Myriad Genetics in 2010 and invalidated their patents on the BRCA1 and 2 genes in a case that ultimately made it to the Supreme Court.
Sandra Park, senior attorney with the ACLUs Womens Rights Project. Shes one of the lead counsels in the Supreme Court case on gene patenting.
Lisbeth Ceriani, one of the plaintiffs in the ACLU lawsuit. In May 2008, she was diagnosed with an aggressive form of breast cancer. Her oncologist noted she was also at high risk for developing ovarian cancer and recommended she get the BRCA genetic test. However, due to patent laws, the test was prohibitively expensive even though she was insured by MassHealth at the time.