The genes, BRCA1 and BRCA2, have been associated with hereditary forms of breast and ovarian cancer. The plaintiffs argue that Myriad Genentics' patent hinders potentially life-saving cancer research and patient access to diagnostic testing. They are also pushing for the courts to recognize genes as “products of nature” and, therefore, unpatentable.
Conversely, Myriad argues that they do not own the patent on the gene itself; rather, they own the patent on the process for isolating the gene. The company also argues that patents on genes create a financial incentive for companies to fund genetic research.
The plaintiffs include genetic counselors and researchers, patients, cancer and women’s health organizations, and medical professional organizations.
Lisbeth Ceriani, a breast cancer survivor and plaintiff in the case, had to pay Myriad over $4,000 to receive genetic testing to see if her breast cancer was hereditary. “Women should not have to go through what I went through in order to take care of themselves and continue to take care of their families,” said Ceriani. “My genes belong to me. Knowledge about my own body should not be held hostage by a corporation.”
A federal patent court invalidated the patents in 2010. However, the United States Court of Appeals for the Federal Circuit (CAFC) has upheld the patent twice, even after they were ordered to reconsider their ruling in light of the Supreme Court’s decision in Prometheus Laboratories v. Mayo Collaborative Services, which held that the patenting of certain medical diagnostics was unconstitutional.
“It’s wrong to think that something as naturally occurring as DNA can be patented by a single company that limits scientific research and the free exchange of ideas,” said Chris Hansen, my personal hero, and staff attorney with the ACLU Speech, Privacy and Technology Project . “The Court of Appeals failed to consider the Supreme Court’s most recent ruling on patent law.”
The basis for patent law in the Constitution lies in Article I, Section 8, which says, “Congress has the power…to promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries.” Congress has delegated to the federal patent courts the responsibility to implement this power.
If the Supreme Court rules in favor of the plaintiffs, gene patent owners will no longer be able to threaten to shut down clinics that offer genetic testing, doctors and researchers will be able to test multiple genes at once to determine the ways they work together, and patients wouldn’t be barred from gaining a second opinion or lower cost test because of the current monopoly on single genes.
While patenting genes is extremely profitable, and may motivate some companies to enter in to genetic testing, the monopoly on scientific research these patents induce cripples the scientific community. Essentially, the Supreme Court must rule in favor of the plaintiffs for the progress of science to prevail.
While the Rehnquist court heard a spate of patent cases and basically smacked down CAFC for their overly broad rulings, it appears as though (with the exception of Prometheus) the Roberts court is more favorable to CAFC’s rulings.
Over 20% of human genes have already been patented. That means that certain companies own knowledge of tiny cells inside of every person in America. While this case may not be as high profile as others on the Supreme Court docket this term (gay marriage, affirmative action), its results will affect every American.