The Supreme Court is set to hear a case on who owns certain human genes. Association for Molecular Pathology v. Myriad Genetics will be a landmark decision for patent law and the ongoing battle over intellectual property law.
Myriad Genetics currently holds patents on two human genes that it discovered called BRCA1 and BRCA2, which are linked to breast and ovarian cancer. Myriad developed the test that discovered the genes, the BRACAnalysis, and subsequently patented the genes, claiming that the genes are "isolated sequences" that would only be available through the BRACAnalysis. The plaintiffs have contested this, arguing that the genes occur naturally and are thus not eligible for patent protection.
In March 2010, the District Court of New York declared the patent games invalid and handed a victory to the Association for Molecular Pathology. Myriad appealed in June 2010, and in July 2011 the Federal Court of Appeals overturned the ruling, declaring the patents valid. In December 2011, the plaintiffs appealed that decision to the Supreme Court, but the Justices returned it to the Federal Court of Appeals in March of 2012. In August of last year, the Court of Appeals rendered an identical decision to the previous appeal. The plaintiffs once more appealed to the Supreme Court, which decided last November to hear the case.
The American Civil Liberties Union is representing the plaintiffs in this case, and has argued that human genes were created by nature, not by Myriad Genetics, and thus cannot be patented. "The Supreme Court has said consistently that patents on products of nature and laws of nature are invalid, because allowing such patents stand in the way of scientific progress and innovation," said ACLU attorney Sandra Park. "If Einstein had patented the theory of relativity, or James Watson and Francis Crick had patented DNA's double-helical structure, entire fields of knowledge and scientific and technological work would have been blocked."
The American Medical Association, AARP, and various womens health groups have joined the plaintiffs in this case to free these genes from Myriad's patents. They all argue that patenting the genes are limiting the ability of scientists and doctors to advance research on cures for breast and ovarian cancer.
Myriad Genetics has argued that the "isolated molecules" were created by humans and "do not occur in nature." The U.S. Patent and Trademark Office has been issuing patents on DNA for almost thirty years, leading Myriad Genetics to claim that "the human ingenuity required to create isolated DNA molecules" needs protection for encouragement. Earlier this year, the Australian Federal Court ruled in favor of upholding Myriad's gene patents in that country, accepting this argument.
If the Supreme Court rules in favor of the plaintiffs, it could revolutionize gene patent law and potentially sink Myriad Genetics' business model. If it upholds the previous appeal and accepts that these particular genes do not occur in nature, major genetics companies will be able to continue limiting access to this scientific knowledge and fund their own research. Oral arguments will begin on April 15th.
WEIGH IN: Do you agree with Jim Dwyer in the New York Times that "it is impossible to understand how genes, the traits we inherit from our parents and pass along to our children, could become a company's intellectual property," or do you agree that patents are necessary to promote innovation and protect the fruit of the labor of scientists like those at Myriad Genetics?