The American Civil Liberties Union (ACLU), the Public Patent Foundation, and others filed a lawsuit in 2009 (Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al.) challenging patents on two human genes associated with breast and ovarian cancer. It is the plaintiffs’ contention that these gene patents stifle research that may lead to important cures and potentially prevent options with regard to treatments.
The lawsuit against the U.S. Patent and Trademark Office (USPTO) and owners of the patents on mutations in the BRCA genes, Myriad Genetics and the University of Utah Research Foundation, has the potential to be a landmark case for the biotechnology industry.
The patents at the center of the lawsuit are based on the initial identification of mutations within two genes, called BRCA1 and BRCA2, which appear to be the cause of the majority of cases of hereditary breast and ovarian cancers. The lawsuit states that the patents on the two human genes are unconstitutional and invalid because “human genes are products of nature, laws of nature and/or natural phenomena, and abstract ideas or basic human knowledge or thought.”
The patent system has evolved over time and, at least in the U.S., is typically understood to have successfully promoted innovation in various fields, including biotechnology and the pharmaceutical industry. Patents help to stimulate investment in research and development, giving a limited monopoly to the inventor or patent owner while requiring in return full disclosure of the invention to the public.
“While it is unfortunate, I have seen quite a few technologies over the years that would be of potential great benefit to patients, but the intellectual property was simply not there to support protecting the product from fast followers in the market place,” explains Robert More, a general partner at Frazier Healthcare Ventures.
“Unfortunately, because of the enormous sums of money required to discover, develop, test, and approve anything in the healthcare sector, quite aside from the time it takes, IP is critical.” More further states that since “patents have definitive lifetimes, 20 years or less of exclusivity, and then an infinite time in the public domain, I think that is a small price for us to pay for innovation.”
Gene patents have been issued in the U.S. for decades, and they are not likely to stop being issued based on the filing of the ACLU lawsuit. In 1980, the U.S. Supreme Court upheld the first patent in the field of genetic engineering for the invention by microbiologist Ananda Mohan Chakrabarty of a type of bacteria that can ingest oil.
In 1982, the USPTO issued the first gene patent to the Regents of the University of California for work carried out on the construction of a plasmid contained in a bacterium and expression of genes for chorionic somatotropin. Thousands of patents have since been issued by the USPTO for a wide variety of biotechnology inventions.
Gene patents are patents that contain claims to nucleic acid sequences, including full-length genes or fragments of genes, vectors containing the genes (e.g., plasmids), probes, and nucleic acid sequences that inhibit expression of genes, for example. These patents were and still are the foundation of the biotech industry.
Whether patents are for genes encoding therapeutic proteins such as insulin and growth hormones, antibodies such as Herceptin® and Rituxan®, or mutated genes that are indicative of breast or ovarian cancer, precluding patents on this subject matter will halt the forward progress that has been made in the biotech industry over the past 30 years since Chakrabarty was decided.
Translational medicine, or movement of inventions and technologies from the university/nonprofit research institutes’ laboratories to partnerships with larger companies, does not occur without large investments of money and resources. Whether an invention is a new therapeutic or a molecular diagnostic, as in the Myriad Genetics test, the decision on whether to invest the time and money it takes to bring a product to market is typically dependent on having a patent or series of patents covering the product or technology.
If there were no exclusive rights in the final product, there would be little incentive to pour money into the research, development, and commercialization of a product, whether it is a new therapeutic or a genetic test such as the BRCA test.