Last week Consumer Watchdog (“CW”) and Wisconsin Alumni Research Foundation (“WARF”) squared off at the Federal Circuit over CW’s appeal of the inter partes reexamination of WARF’s U.S. Patent No. 7,029,913 (the ’913 Patent, entitled “Primate Embryonic Stem Cells”). Consumer Watchdog v. Wisconsin Alumni Research Foundation, No. 13-1377 (Fed. Cir. 2013). CW’s appeal challenges the patent-eligibility of in vitro cultured human embryonic stem cells (hESCs) claimed in the ’913 Patent. Continue reading this entry
On November 25, 2013, Consumer Watchdog (“CW”) and Wisconsin Alumni Research Foundation (“WARF”) responded to the Federal Circuit’s Order directing each party to brief whether CW, as a third party requester, has standing to appeal the U.S. Patent and Trademark Office’s (“USPTO’s”) decision in the inter partes reexamination of WARF’s U.S. Patent No. 7,029,913 (the ’913 Patent, entitled “Primate Embryonic Stem Cells). CW previously filed an appeal to the Court to raise, among other issues, the patent-eligibility of in vitro cultured human embryonic stem cells (hESCs) claimed in the ’913 Patent. For a review of the issues on appeal, see my prior posts of September 15th and July 8th, 2013. Continue reading this entry
On November 14, 2013, the Food and Drug Administration (“FDA”) issued a draft guidance document - “Draft Guidance for Industry, Tool Developers, and Food and Drug Administrative Staff” (“Draft Guidance”) reporting a voluntary process for the qualification of medical device development tools (MDDT) used in device development and evaluation programs in the Center for Devices and Radiological Health (CDRH). The qualification process is proposed to facilitate the development and timely evaluation of innovative medical devices by providing a more efficient and predictable means for collecting the necessary information to make regulatory assessments. The Draft Guidance is noted to apply to therapeutic and diagnostic devices and specifically includes biomarker tools, that are key to some personalized medicine diagnostics. This post will review key concepts of the Draft Guidance that are relevant to biomarkers and biomarker tools.
A two-stage meta-analysis of genome-wide association studies (GWAS) in individuals of European ancestry identified 11 new loci associated with Alzheimer’s disease. The multidisciplinary study, recently reported in Nature Genetics, (“Meta-analysis of 74,046 individuals 11 new susceptibility loci for Alzheimer’s disease”, published online on October 27, 2013), is a significant step toward identifying genetic risk factors for developing this devastating neurological disorder.
The study was conducted under the banner of the International Genomics of Alzheimer’s Project. The analyzed data was collected from four consortia: the Alzheimer’s Disease Genetic Consortium, the Cohorts for Heart and Aging Research in Genomic Epidemiology Consortium, the European Alzheimer’s Disease Initiative and the Genetic and Environmental Risk in Alzheimer’s Disease Consortium. The combined data sets consisted of 17,008 Alzheimer’s disease cases and 37,154 controls. 11,632 SNPs were genotyped and tested for association in an independent set of 8,572 Alzheimer’s disease cases and 11,312 controls. In addition to identifying the apolipoprotein E locus, 19 loci reached genome-wide significance, 11 of which are newly associated with Alzheimer’s disease.
In one of the first district court decisions applying the U.S. Supreme Court’s new Myriad patent-eligibility standard, the Northern District of California held that diagnostic claims containing only conventional and existing detection steps do not make the use of a natural phenomenon patent-eligible. See Ariosa Diagnostics, Inc., v. Sequenom, Inc., No. C 11-06391 SI (N.D. Cal., Oct. 30, 2013), attached here.
U.S. Patent No. 6,258,540
Sequenom is the exclusive licensee of U.S. Patent No. 6,258,540 (the ’540 Patent). The claims are based on the discovery that cell-free fetal DNA (“cffDNA”) is detectable in maternal serum or plasma samples. The patent noted that using cffDNA allows for a better detection rate than using prior art nucleated blood cell DNA extracted from a comparable volume of whole blood. Continue reading this entry