When Angelina Jolie disclosed Tuesday morning that she had undergone a preventive double mastectomy, she didn't just shine her white-hot starlight on the gene, BRCA1, that significantly increased her chance of getting breast cancer. She also indirectly raised anew profound questions the federal judiciary -- and now the United States Supreme Court -- has been pondering for years: Where does patent law stand on gene research? Where should it stand? Can the law protect patent holders while also ensuring that the marketplace can most efficiently deliver genetic testing to the people who need it most?
The timing of Jolie's op-ed in the New York Times is important. Within the next 45 days, before the last Thursday in June, the Supreme Court is expected to issue its ruling in Association for Molecular Pathology v. Myriad Genetics, Inc., a long-fought case about genes, including BRCA1 and BRCA2, which are linked to breast cancer and which Myriad Genetics successfully patented (The company's stock rose sharply Tuesday following the publication of Jolie's piece.) The federal case began four years ago, in May 2009, when the American Civil Liberties Union and others challenged Myriad's patents on the genes. From that initial complaint:
Ease of access to genomic discoveries is crucial if basic research is to be expeditiously translated into clinical tests that benefit patients in the emerging era of personalized and predictive medicine. The patents make ease of access more restricted. Because of the patents, defendant Myriad has the right to prevent clinicians from independently looking at or interpreting a person's BRCA1 and BRCA2 genes to determine if the person is at a higher risk of breast and/or ovarian cancer. Because of the patents and because Myriad chooses not to license the patents broadly, woman who fear they may be at an increased risk of breast and/or ovarian cancer are barred from having anyone look at their BRCA1 and BRCA 2 genes or interpret them except for the patent holder.
The gene-patenting case has gone back and forth. In November 2009, a federal trial judge in New York refused to dismiss the complaint. Then, in March 2010, in a 156-page opinion, the judge invalidated two of those patents, concluding that the "DNA's existence in an 'isolated' form alters neither this fundamental quality of DNA as it exists in the body nor the information it encodes." Myriad appealed. In August 2011, a panel of the Federal Circuit, which handles all patent cases, by a vote of 2-1, overturned the lower court ruling. On April 15, just one month ago, the justices in Washington heard oral argument in the case. Here's the transcript. And here's the Court's audio.
It is more likely than not that the justices will uphold Myriad's patent -- its monopoly -- over research for these genes. This is that type of Court. But no matter what the justices do in this case Congress has the authority to amend federal patent law to make it harder for companies like Myriad to control for so long the research and development of such genetic testing. In the meantime, the Affordable Care Act also will play a critical role in making it easier for women who are not Angelina Jolie to have more access to timely BRCA testing. "BRC Testing Granted Preventive Care Designation Under the Affordable Care Act," screamed Myriad's press release on March 6th. How do you like Obamacare now?
Jolie or no Jolie, the Myriad litigation is a perfect example of how poorly the law is suited to adapt quickly to biological or technical advancements. In the area of gene-patenting, like so many other areas we care far less about, the medical science is developing far more quickly than the courts can fathom. Patents are supposed to be tools to encourage the creation of things that better society as a whole. And Myriad says that these particular gene patents are economically necessary to fuel research and development. But how many more women -- and men -- might have been able over the past four years to afford BRCA1 or BRCA2 testing in the absence of those protective patents?
It's not necessarily Myriad's fault. The company is playing by the rules Congress and the courts have established. But to the extent they preclude open competition, in the ways in which they create sanctioned monopolies, these patents are the antithesis of capitalism. The societal costs may be worth it when the patent is for a new kind of chewing gum. But when the patent is for an isolated human gene, and when that gene may hold the key to diagnosing breast cancer, is the protection of the patent good public policy? I'm just asking the question. I'm not answering it.
Nearly two years ago, when I first started covering this story, I asked Gary Cohen (no relation), a bioethicist, to offer a potential solution to the problem. In August 2011, Cohen told me:
A path forward would involve a solution that respects patent rights and the system that grants them but yet enables commercialization of affordably priced multigenic diagnostic tests that physicians are seeking and will continue to seek with rapidly increasing frequency in order to make the best possible diagnoses and treatment plans for their patients. One such potential solution would involve the creation of an independent, non-profit body that would serve as a clearinghouse or pool for human gene patents. Rights holders could license their patents (royalty-free) to the patent pool, which could, in turn, sublicense those rights -- for royalties to be passed back to the licensors -- to entities wishing to utilize the various IP aggregated in the pool.
The clearinghouse, one-stop-shopping nature of the pool would greatly reduce the uncertainty, administrative expense, and burden of having to seek out hundreds of rights holders -- which would currently have to be done without any reliable roadmap for who owns what. Royalty disbursements could be set at a given percentage of net sales of the test and would be divided according to an intelligent algorithm for the relative contribution of the various IP to the value of the test. There is precedent for a similar concept with Navigenics, which, as an individual actor, sets forth on its web site a formula for how much it is willing to pay for any one gene among the thousands it sequences with its customers.
It seemed like a good idea then. And it seems like a good idea now. If only someone could get brave, candid Angelina Jolie to write about it.
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