Impact on U-M inventors of Supreme Court ruling on genomic DNA
A recent U.S. Supreme Court ruling about whether DNA can be patented is not expected to significantly impact research being conducted at U-M, according to licensing officials at the university's Office of Technology Transfer.
The court's June 13 ruling in the case of Association for Molecular Pathology v. Myriad Genetics Inc. held that genomic DNA as it exists in nature — e.g., having the same nucleotide sequence as that within a person — is not patent-eligible subject matter. However, complementary DNA (cDNA) is eligible for patent protection.
The ruling was another in a line of decisions in the lawsuit relating to the validity of Myriad Genetics' patents covering BRCA1 and BRCA2 genetic testing for certain cancers.
Myriad had identified the location of human BRCA1 and BRCA2 genes on two chromosomes, as well as the typical nucleotide sequence of those genes. This knowledge led Myriad to file a variety of patent applications in the mid-1990s, and the company later received patents claiming various DNA and cDNA compositions, methods, kits, primers, vectors, etc.
While the decision will force a change in the U.S. Patent and Trademark Office's policy of granting patents on "isolated DNA" gene sequences, the court agreed with Myriad that cDNA, artificially constructed DNA excluding certain sections (introns) of isolated genomic DNA, is patent-eligible subject matter.
What does this mean for the university? Because the ruling only impacts one type of patent claim ("isolated DNA"), "we do not foresee much of an impact to our research," says Robin Rasor, director of licensing for the Office of Tech Transfer.
"University researchers discovering genetically-related inventions should not hesitate to contact the Office of Tech Transfer, because while we apparently will be unable to file claims directed to isolated genomic DNA, we often protect cDNA, manipulated DNA, methods, non-genetic material, kits, proteins, vector, primers, and other types of claims relating to researchers' biotech inventions that are not affected by this ruling," Rasor says.
The Supreme Court's decision relates only to the issue of what types of inventions qualify for patents under U.S. laws (Section 101 of the U.S. patent statute), and does not address other requirements for receiving a patent, such as that claimed materials must be sufficiently different (novel and non-obvious under Sections 102 and 103) from materials already known to scientists working in the area.
Applicants for patents covering cDNA, for example, still must show why their claimed cDNA sequences are enough of an advancement over known DNA sequences, techniques, and other scientific knowledge to be deserving of patent protection. Also, the decision does not affect the patentability of other types of patent claims, such as methods, that were not at issue in this appeal.
As for the particular Myriad tests at issue, the decision will invalidate some of Myriad's patent claims relating to its BRCA1 and BRCA2 gene testing and therefore it may open the market for competitors to offer BRCA testing. However, the precise type and success of such competitive testing remain to be seen because some Myriad patent claims, particularly certain method claims, have so far withstood legal challenges.
Myriad noted in a statement after the decision that "many of Myriad's unchallenged claims are method claims applying knowledge about the BRCA1 and BRCA2 genes." Further, Myriad is said to have the advantage of a proprietary database of mutations that it uses in its testing.