Both are connected to recent news stories and debates surrounding the BRCA1 and BRCA2 genes, which when mutated show the likelihood of a woman developing breast or ovarian cancer. The Supreme Court will soon be evaluating whether or not it was legal for the government to grant Myriad Genetics the patents for the BRCA1 and BRCA2 genes (Association for Molecular Pathology v. Myriad Genetics), whereas actress Angelina Jolie tested positive for these genes and recently had a double mastectomy to significantly reduce her chances of developing cancer.
Argument One- Patents Should Not Have Been Granted
The first argument against the patents is that they violate the First Amendment as they stifle diagnostic testing and research that leads to cures. One example occurred in 1998, when the University of Pennsylvania’s Genetic Diagnostic Laboratory stopped testing patient samples for BRCA genes because of the threat of a patent infringement action. The opposition also contends that human genes, like BRCA 1 and 2, cannot be patentable because they are classic products of nature and to be patent eligible, a composition of matter must also have a distinctive name, character, and use, making it “markedly different” from the natural product. The BRCA genes are classic products because they embody the same genetic information as those found in the human body. Finally, those against the patent argue that they prevent lives from being saved because with only one laboratory allowed to administer these lifesaving tests and 1 in 8 women diagnosed with breast cancer, the tests are extremely costly and difficult to obtain, especially as most women do not have the financial resources of Angelina Jolie
Argument Two- Patents Are Valid
The owners of the patents argue that they were legally granted as isolated DNA and cDNA sequences, like BRCA 1 and 2, are not products of nature since their chemical structure is “markedly different” from the DNA inside humans. Additionally, they opine that the patents should be upheld as patenting human genes incentivizes investment in biotechnology and promotes innovation in genetic research by not keeping technology shrouded in secrecy. Finally, those in support of the BRCA1 and BRCA2 patents fear an expansive Supreme Court ruling could threaten billions of dollars in investments.
No matter what the Court decides, Congress will need to make policy changes on this issue to make the tests more accessible to all so that all women who have risk factors like Angelina Jolie can have affordable access to the test, and make any preventive decisions they feel necessary to save their lives.
As Lawline's VP of Business Operations, Michele helps Lawline recruit and retain A players, and works to create an engaging, vibrant, collaborative work environment for Lawliners and the other like minded companies who share its open tech work space. Michele recently completed her first triathlon with Team Triumph, a women's only tri-group and looks forward to her next competition.