The story continues to unfold regarding the patentability of diagnostics.  At the end of last year I had reported on the Sequenom decision.  See, “Sequenom – A District Court’s Sequel to the Myriad Decision.  Are Diagnostic claims now at risk?”  Ariosa Diagnostics, Inc. v. Sequenom, Inc., Case No. C 11-06391 SI (ND CA, October 30, 2013).

Through enough digging, or rather that of my fearless paralegal, she was able to track down that Sequenom appealed their decision to the Court of Appeals for the Federal Circuit.  See, Consolidated Opening Brief of Appellant Sequenom, Inc., Nos. 14-1139, 14-1142, and 14-1144 (Fed. Cir, January 22, 2014).

At issue in Sequenom is US Patent No. 6,268,540.  This patent is exclusively licensed to Sequenom and claims non-invasive prenatal diagnosis methods using maternal blood samples.  The method provides an alternative to techniques such as amniocentesis, which can pose a risk to both the mother and child.  Last year, in reviewing the ‘540 patent, the District Court for the Northern District of California issued an Order holding that medical diagnostic method claims are not eligible for patent protection.  This District Court decision is noteworthy, because it had been made upon remand and direction from the Federal Circuit to examine the patent eligibility of diagnostics in light of the Supreme Court’s 2013 Myriad decision – the case now famous for its holding that DNA is not patentable.  See Association for Molecular Pathology v. Myriad Genetics, Inc.,133 S. Ct. 2107 (2013).

The Sequenom case will be an important one to watch.  It will be interesting to see what the Federal Circuit will say.  This case could eventually be appealed to the Supreme Court.  I will keep you apprised.


–  Anthony D. Sabatelli, PhD, JD
Check out Anthony’s bio page


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