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?