On March 26, 2012, the U.S. Supreme Court remanded the closely
watched Assn. for Molecular Pathology v. Myriad Genetics
case to the Federal Circuit for further consideration in light of
its decision in Mayo Collaborative Servs. v. Prometheus
Labs., Inc, No. 10-1150 (March 20, 2011).
Myriad involves claims directed to human genes related to
breast cancer. In 2010, the Southern District of New York
invalidated the claims as being drawn to non-patentable subject
matter under 35 U.S.C. § 101. On appeal in 2011, the Federal
Circuit reversed the district court's invalidity decision as to
some of the claims (claiming "isolated DNA" encoding a
naturally occurring polypeptide and methods for screening potential
cancer therapeutics) and affirmed as to others (claiming methods
for detecting cancer-predisposing mutations).
In the Prometheus case, the Supreme Court invalidated
method claims for adjusting dosage amounts of a drug depending on
the amount of drug present in the patient's blood stream,
despite the presence of limitations requiring administration of the
drug and determination of amount of the drug in the patient's
blood stream. Notably, the Supreme Court dismissed the
administering and determining steps for the purposes of the
patentable subject matter analysis as already
"well-understood, routine, conventional activity" in the
scientific community.
What This Means for You
The Federal Circuit's decision about the validity of the claims at issue in Myriad could have a significant impact on the subject matter eligible for patenting in the life sciences area. The apparent shift towards discounting well-known claim elements for the patentable subject matter analysis may present a significant challenge to claims containing such elements. For example, in the Federal Circuit's previous analysis, the patentability of Myriad's composition claims hinged on the requirement that the claimed DNA be "isolated," a technique that could very well be found to be common and well-known in the art. If the "isolated" limitation is set aside for the patentable subject matter analysis, the remaining claim limitations, which are directed to naturally occurring DNA sequences, could be in jeopardy.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
