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 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 in order 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 own 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 retains exclusive right to the test until its patent expires in 2015. The issue is 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.
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 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?