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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.
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Discussing The Supreme Court's Oral Arguments In Myriad Gene Patenting Case (Video Content)
