|July 14, 2012|
Previously published on July 10, 2012
On March 26, 2012, the U.S. Supreme Court postponed answering the question of whether isolated DNA is patentable. Instead, the Supreme Court vacated the Federal Circuit's decision in AMP v. Myriad Genetics, and remanded the case for consideration in light of the Supreme Court’s March 20, 2012 decision in Mayo v. Prometheus.
In their original Myriad decision, the Federal Circuit held that isolated DNA is patentable, rejecting the arguments offered in the amicus brief by the Justice Department, which argued that isolated and unmodified genomic DNAs are not patent eligible. The majority in the Federal Circuit’s 2-1 decision agreed that “isolated DNAs, not just cDNAs have a markedly different chemical structure compared to native DNAs” and constitute a “distinct chemical entity” distinguished from their corresponding DNAs in nature by cleavage from native DNAs through removal of covalent bonds. Judge Kimberly Moore, in a concurring opinion, pointed out that such material is not automatically patentable subject matter per se, since “the isolated DNA sequences have markedly different properties which are directly responsible for their new and significant utility.”
In Prometheus, the Supreme Court affirmed the Federal Circuit’s decision that patents involving correlations between natural phenomena (the metabolization of an administered pro-drug into an active drug) must do more than simply recite the natural correlation (between the pro-drug and the active drug in patient blood). However, in Myriad the claims required more than “correlations between natural phenomena”, they required physical isolation of naturally occurring DNA from a test subject.
The fact that the Supreme Court remanded the Myriad case back to the Federal Circuit for further consideration, suggests that the Supreme Court is not ready to decide the issue of the patentability of isolated genes. Patent protection for isolated genes is important to the pharmaceutical industry, and a strong patent system is vital to incentivizing innovation. The public dispute over the Myriad case focused on the balance between patent protection and the accessibility of a patented product. Regardless of the immediate outcome of Myriad after remand to the Federal Circuit, the case is likely to once again be brought to the Supreme Court. Perhaps that is exactly what the Supreme Court intended: a more thorough analysis from the Federal Circuit, before making a final decision on this important subject.