On May 12, 2009, the ACLU and the Public Patent Office submitted a brief to the Southern District Court of New York. The legal action involved twenty plaintiffs, including organizations like the Association for Molecular Pathology along with medical doctors and private individuals. They all had one goal in mind — to invalidate the claim of a Utah-based company over genes that affect the fate of every woman in America.
The company in question, Myriad Genetics, owns the BRCA1 and BRCA2 genes associated with hereditary forms of breast and ovarian cancer. They also own the only currently available diagnostic test for these genes, which they sell for a little over three thousand dollars. And they control the right to allow testing and experimentation on these genes. It is no exaggeration to say that Myriad controls every facet of those genes. As a result, many women have been unable to get vital health information, and scientists have been unable to perform important research without paying large sums of money to Myriad.
According to a statement issued by the ACLU, they and the Public Patent office have stepped in to challenge Myriad because “Gene patents undermine the free exchange of information and scientific freedom, bodily integrity and women’s health.” The statement further claims that the granting of gene patents “interferes with a person’s right to know about his or her own genetic makeup.” They’ve set loose a team of legal experts to attack the validity of the patents on BRCA1 and 2. In their brief, they claim that the patents violate the First Amendment and Article 1, Section 8, Clause 8, of the Constitution — the section that provides for the creation of patents. Because the ACLU claims that the patents violate constitutional law it is likely that the case will end up in front of the Supreme Court. If that happens, the decision could have consequences that reach far beyond the individual case.
According to Luigi Palombi, Project Director of the Genetic Sequence Right Project and author of the book Gene Cartels: Biotech Patents in the Age of Free Trade,“If this case makes it to the U.S. Supreme Court… I am confident that the Supreme Court will rule that these patents [gene patents in general]… will be confirmed as non-patentable subject matter.”
He cautions, however, that the case against Myriad may not make it all the way to the Supreme Court. In a similar case prosecuted by Palombi in Australia against Chiron over their patent on hepatitis C genes, Chiron settled out of court once they realized that if they lost it might threaten their chances of getting a patent in America. The case abandoned, the question of the patent’s validity was left unanswered. While it is uncertain whether Myriad will try to settle, Daniel Ravicher, a lawyer representing the plaintiffs, has said that they would be willing to settle if they get everything they want.
Myriad certainly doesn’t look, as yet, like they’re backing down and looking for an out-of-court settlement. The company has thrown its first punch by bringing a motion to dismiss the case on the basis that there is no controversy and that the plaintiffs lack standing. Myriad told h+ that it doesn’t comment on ongoing litigation.
Palombi noted that while the patents themselves may be invalidated, the patent of any invention derived from them will still be valid, so Myriad will still own the patent on the BRACAnalysis® test.
So what would an ACLU victory mean? Advocates believe that researchers will be free to develop and market other tests, bringing competition and driving down costs. It would also mean researchers could spend more money on research, since they would no longer have to pay Myriad. And life-saving treatment may be developed more quickly for thousands of women. Beyond that, it could close the door on more gene patents, if not invalidating all previous patents and opening up legal debate about the limits of patents and intellectual property.
…the case against Myriad opens the door for some serious legal questions about intellectual property and patentability.
Companies involved in this type of patenting take a different view. They say that a favorable verdict could do more harm than good. Large companies claim that they need gene patents to provide incentive to perform research and make such exploration possible. They also point to several studies conducted on intellectual property that state that so called “patent thickets” do not hinder competition or impede research.
Regardless of the results, the case against Myriad opens the door for some serious legal questions about intellectual property and patentability. It will answer the question of whether or not it is legal to patent a gene. You might say that the Supreme Court could decide just who owns you.