Gene patenting has always been a blip on the Human Genome Project radar. Indeed, the gene patenting question dates back to 1982 and the Supreme Court’s decision on Diamond vs. Chakrabarty, which dealt with a patent application for a bacterium genetically engineered to digest crude oil and clean up oil spills. Living things were not previously patentable under U.S. law, but the Court ruled that the “micro-organism plainly qualifies as patentable subject matter,” and the patent was for “a non-naturally occurring manufacture or composition of matter – a product of human ingenuity.”
But gene patents pushed the boundaries of the U.S. Code regarding patenting criteria. Generally, a patentable item must be “a new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” It must also be novel and not obvious to someone with ordinary skill in the relevant field. But consider: genes exist before their discovery (they are not invented); the Human Genome Project placed all discovered human gene sequences in the public domain within 24 hours of their generation; and, by the late 1990s, discovering a gene’s location was relatively cut and dried. Genes appeared to satisfy very few criteria for patentability. Yet patent claims for genes, as intellectual property, have been made for 20 percent of the human genome.
Research and Clinical Restrictions
For genetic technologies, as in other fields, patents are granted to encourage innovation and protect innovators’ rights to profit from their invested time, talent, and resources. But patents on genes may restrict the use of and access to genetic information with value for other medical research and clinical applications. Furthermore, patents on diagnostic tests for a given gene include the DNA sequence being tested, prohibiting others from sequencing that DNA for the length of the patent.
Congress was concerned about human gene patents early on and mandated that NHGRI include “legal issues regarding patents” among other ethical, legal, and social issues in genome research. In 2001, the directors of NIH and NHGRI urged the U.S. Patent and Trademark Office (USPTO) to develop stricter guidelines for gene patents. For example, simple identification of a gene’s sequence should not be patented; but a gene isolated from its natural state could in some cases be patented. There are also different ways to license a patented gene: Fewer restrictions exist on the use of patented genes that are widely or freely licensed than on those that are exclusively licensed.
Myriad had actively enforced their exclusive license to these genes via letters to labs and researchers perceived as infringing on their patent.
Legal issues raised by gene patents came to a head in 2009, when the Association for Molecular Pathology, the American Civil Liberties Union, and other plaintiffs sued Myriad Genetics, the USPTO, and the University of Utah Research foundation, challenging Myriad’s patents on breast cancer genes BRCA1 and BRCA2 as invalid and unconstitutional. Myriad had actively enforced their exclusive license to these genes via letters to labs and researchers perceived as infringing on their patent. The case, heard by a U.S. District Court in New York, ruled in 2010 that the BRCA1/2 genes were products of nature and so not patentable. The decision noted that the information a gene encodes, not just its molecular structure, has value for the patent holder. The decision was appealed to the Court of Appeals for the Federal Circuit, which rejected the view on information content. Instead, their ruling emphasized that breaking bonds in DNA to isolate a gene created a new substance. By this reasoning, and also to uphold patents granted to the biotech industry since the 1980s, the Court of Appeals upheld Myriad’s claims that the BRCA1/2 genes were patent-eligible. The case was returned to the Federal Circuit for reexamination, but their previous ruling was upheld.
Supreme Court’s Unanimous Decision
Finally, the case was appealed to the Supreme Court, where arguments were heard in April 2013. The Court’s unanimous decision, published June 13, 2013, ruled that “isolated but otherwise unmodified genes were products of nature and therefore not patent-eligible subject matter.” As Justice Thomas wrote in his decision: “The location and order of the nucleotides existed in nature before Myriad found them.”
The Court also ruled that patents can be obtained on complementary DNA (cDNA) – molecules synthesized in the laboratory by reversing the usual sequence of cellular reactions – as long as that cDNA met the other requirements for being patent-eligible. Synthesizing cDNA starts with a messenger RNA and finishes with a DNA sequence that would (normally) have preceded it. Although this series of events occurs naturally in retroviruses (HIV, for example), cDNA production entails an inventive step and remains patent-eligible. The Supreme Court ruling, which pleased NIH and NHGRI, removed roadblocks that could have impeded the adoption and implementation of genomic medicine. Nevertheless, the rapidly expanding applications of genomic science suggest that discussion of gene patenting is far from over.
(1) Intellectual Property and Genomics. National Human Genome Research Institute.
(2) The Supreme Court Ruling on Gene Patents. Double X Science.
(3) End of Gene Patenting Aids Many. University of Washington.
(4) Supreme Court Rejects Human-Gene Patents. Forbes.