ASSOCIATION FOR MOLECULAR PATHOLOGY V. MYRIAD GENETICS (Fed. Cir. 2011): Claims directed to comparing or analyzing gene sequences should include one or more transformative steps as part of the claim.
by Brian Bathurst and Leah Molera
On July 29, 2011, the Court of Appeals for the Federal Circuit reversed the Southern District of New York's court's holding that patent claims directed to isolated DNA sequences were invalid and reversed the lower court's holding that claims directed to screening potential cancer therapeutics were invalid. The Federal Circuit, however, affirmed the Southern District of New York's court's holding that claims directed to comparing or analyzing gene sequences were invalid. We wish to briefly focus here on the Federal Circuit's rationale for affirming that claims directed to comparing or analyzing gene sequences were invalid.
In the Federal Circuit's 105 page decisionhttp://www.cafc.uscourts.gov/images/stories/opinions-orders/10-1406.pdf
, the Federal Circuit held that the claims at issue "...do not include the step of 'determining' the sequence of BRCA
, isolating the genes from a blood sample and sequencing them, or any other necessarily transformative step." Because the claims at issue were directed to comparing or analyzing gene sequences, the court reasoned "...the comparison between the two sequences can be accomplished by mere inspection alone. Accordingly, Myriad’s claimed methods of comparing or analyzing nucleotide sequences fail to satisfy the machine-or-transformationtest, and are instead directed to the abstract mental process of comparing two nucleotide sequences. The claims thus fail to claim a patent-eligible process under § 101."
Although the Federal Circuit's decision is likely going to be appealed, the take home message here for claims directed to comparing or analyzing gene sequences is to include one or more transformative steps as part of the claim. Alternatively, including a processor or machine that performs the comparison or analyses would also likely render the claim valid.
K. Brian Bathurst
K. Brian Bathurst is a senior attorney in the Intellectual Property Practice Group of Carr & Ferrell. Mr. Bathurst's experience includes patent and trademark prosecution, litigation and licensing. Mr. Bathurst has extensive experience in several technological areas including biotechnology, pharmaceutical, medical device, hardware, software and e-commerce.
Leah Molera is an associate in the Intellectual Property Practice Group of Carr & Ferrell LLP. Ms. Molera specializes in intellectual property law matters including the preparation and prosecution of U.S. patent applications, strategic intellectual property planning and patent portfolio management for both established and start-up clients.