The Gene Patents Debate
The issue of gene patents has been simmering for decades but came to a boil in 2009 when the American Civil Liberties Union (ACLU) and the Public Patent Foundation filed suit against Myriad Genetics, a genetic testing company, the University of Utah Research Foundation and the U.S. Patent Office. The case, Association of Molecular Pathology v. U.S. Patent and Trademark Office, sometimes referred to as the "Myriad case," was directed at a handful of Myriad's numerous patents on BRCA1 and BRCA2, human genes that are very reliable in predicting breast and ovarian cancers, and the genetic test for detecting the genes.
The ACLU suit claims that patents on human genes violate the First Amendment and patent law because genes are "products of nature" and therefore can't be patented. The ACLU further charged that the BRCA gene patents limit women’s access to the genetic screening because of its cost and that Myriad's monopoly on the test prevents women from getting a second opinion.
Both sides in the case were joined by interested allies; patient groups, scientists and medical associations on the plaintiff's side and the biotech industry and patent holders and lawyers on the side of Myriad. The U.S. Department of Justice (DOJ) submitted an amicus brief in December 2010 that supported ACLU's case. The DoJ argued that patents should only be awarded to genes that have been modified.
In March 2010, Judge Robert W. Sweet of the U.S. District Court in New York ruled that the patents were invalid. He found that isolating a molecule did not make it novel, a requirement for a patent. However, on July 29, 2011, the Federal Appeals Court in New York overturned Sweet's ruling. The 3-judge panel ruled 3-0 that complementary DNA (cDNA), an altered type of DNA, is patentable; 2-1 that isolated DNA is patentable; and 3-0 that Myriad's methods for therapeutic screening of breast and ovarian cancer genes are patentable.
The majority (about 80 percent) of DNA patent holders are universities and nonprofits that have never enforced a patent. Academic researchers apply for patents to protect their research as well as to claim the recognition that comes with scientific discovery. Failure to apply for a patent for a discovery could result in inhibited access to their research should a competing lab make a similar discovery, apply for a patent, and exercise their rights as patent holders.
That's how the Myriad case came about. Myriad Genetics, a private firm, exercised its legal right as a patent holder. Myriad's charges about $3,000 for the cancer screening test and retained the exclusive right to the test until its patent expired in 2015. The issue was further complicated when one considers the back story. Myriad Genetics co-owns the patents for the BRCA1 and BRCA2 genes along with the University of Utah, which discovered the genes while financed by a National Institutes of Health (NIH) grant.
As is common practice, the University of Utah licensed the technology to a private company for commercial development.
What's at Stake?
The issue of whether or not genes should be patented affects patients, industry, researchers, and others. At stake are:
- Since the Human Genome Project was completed in 2001, the U.S. Patent Office has granted patents to nearly 60,000 DNA-based patents covering genetic variations and related gene sequencing technologies. About 2,600 patents are for isolated DNA.
- Research scientists' liability for using patented genetic technologies in basic research and diagnostic testing.
- Patient access to genetic tests limited by both cost and ability to obtain a second opinion.
- Potential investments in biotech firms for development of gene-based therapies and screening technologies
- The ethical and philosophical question: Who owns your genes?
The Biotechnology Industry Organization, a trade group, has stated that gene patents are necessary for attracting investments that lead to innovation. In an amicus brief to the court relating to the Myriad case, the group wrote:
“In many cases, gene-based patents are critical for a biotech company’s ability to attract the capital and investment necessary for the development of innovative diagnostic, therapeutic, agricultural and environmental products. Thus, the issues raised in this case are of great importance to the U.S. biotechnology industry.”
The plaintiffs in the Myriad case argue that seven of Myriad’s 23 BRCA gene patents are illegal because genes are natural and therefore not patentable, and that the patents inhibit the diagnostic testing and research of inherited breast and ovarian cancer.
Scientists opposed to gene patents contend that numerous patents obstruct research because of the need to license or pay for patented technologies.
Some physicians and medical institutions are concerned that the growth in enforceable patents is limiting patient access to genetic diagnostic screening tests for Alzheimer’s disease, cancer, and other hereditary illnesses.
Where It Stands
The Myriad case was decided by the U.S. Supreme Court on June 13, 2013. The court ruled unanimously that naturally isolated DNA is not patentable, but that synthetic DNA (including the cDNA for the BRCA1 and 2 genes) is patentable.
An excerpt from the court decision:
"A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring....cDNA is not a “product of nature,” so it is patent eligible under §101. cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments. Its creation results in an exons-only molecule, which is not naturally occurring. Its order of the exons may be dictated by nature, but the lab technician unquestionably creates something new when introns are removed from a DNA sequence to make cDNA."
The Supreme Court's decision leaves many patent-holders and the U.S. Patent and Trademark Office holding a mixed bag, with more litigation likely. About 20 percent of all human genes are already patented, according to the National Society of Genetic Counselors.