Last week, a unanimous U.S. Supreme Court held that human genes are not eligible for patenting and that patent claims to isolate genes from DNA are invalid.
WHY IS THIS A BIG DEAL? Because it prevents any one company from monopolizing testing for a particular gene mutation once they have discovered the gene, which is exactly what the defendant in Association for Molecular Pathology, et al. v. Myriad Genetics, Inc., et al. tried to do. The Court’s decision allows for a healthy competition between companies offering testing for genetic diseases. It also allows patients to obtain a second opinion regarding any genetic test results. If Myriad had prevailed, it would have been the only owner of the two genes it tried to patent and it would have paved the way for other companies to monopolize other genes that they had identified. The Supreme Court’s decision, therefore, is a great victory for all the people affected by hereditary conditions that require genetic testing.
In this case, the defendant, Myriad, discovered the precise location and sequence of two genes related to breast and ovarian cancer – BRCA1 and BRCA2. Using this discovery, it developed a battery of tests for detecting mutations in these genes in a particular patient and assessing the patient’s cancer risk. Myriad then filed several patent applications, which, if valid, would allow it to have an exclusive right to (1) isolate the BRCA1 and BRCA2 genes and (2) test them for mutations. Other laboratories offering genetic testing either had to abstain from testing for BRCA1 and BRCA2 because of Myriad’s patents or received cease and desist letters threatening litigation if they did not stop the testing of these two genes. The above lawsuit was filed seeking a declaration that Myriad’s patents were invalid under 35 U.S.C. §101. After percolating through the courts, the case ended up before the U.S. Supreme Court.
Section 101 of the U.S Patent Act provides: “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.” The U.S. Supreme Court has previously made it clear in Mayo Collaborative Services v. Medical Laboratories, et al., that “[l]aws of nature, natural phenomena, and abstract ideas are not patentable.”
Myriad admitted that it did not create or alter any genetic information encoded in BRCA1 and BRCA2. Nor did it create or alter the genetic structure of DNA. It’s sole contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2. The U.S. Supreme Court concluded that unaltered human DNA was a product of nature and could not be patented by Myriad. Moreover, the genes and the information they encoded are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material.
The Court, however, clarified, that DNA that has been scientifically altered or modified and that is not naturally occurring can be patented. Specifically, Myriad’s patents for cDNA – a string of DNA where nucleotides that do not code for amino acids have been removed by a lab technician – were patent eligible because they were not a “product of nature.” The Court’s decision does not affect the companies’ ability to seek patents for methods of use of isolated DNA, manipulation of DNA or testing for gene mutations, and ends up striking the important balance between “creating incentives that lead to creation, invention and discovery” and “impeding the flow of information that might permit or spur invention.”
For more information, contact Leiza Dolghih.