News & Analysis as of

Gene-by-Gene Cries Uncle, Settles with Myriad Genetics

Gene-by-Gene, Inc. was one of the first direct-to-consumer (DTC) genetic diagnostics companies to announce that it would offer BRCA1/BRCA2 testing after the Supreme Court's decision last June that certain of Myriad Genetics'...more

Sequenom Files Opening Brief in Appeal of Summary Judgment on Section 101 Grounds

Earlier this week, Sequenom, Inc. filed its opening brief in Ariosa Diagnostics, Inc. v. Sequenom, Inc., appealing summary judgment that its licensed claims to a genetic diagnostic method for detecting fetal diseases and...more

Why a Class Action Lawsuit Against 23andMe? Quick Hit Q&A With Audet & Partners

The bad news for 23andMe keeps coming. In late November, we learned that the U.S. Food and Drug Administration had ordered the company to stop selling its $99 DNA testing kit owing to a number of accuracy and validity...more

23andMe Named in Class Action Lawsuit

Things are getting worse for genetic diagnostics company 23andMe. On the heels of receiving a Warning Letter from the FDA over its Personal Genomic Services (PGS) test (see "FDA Threatens Agency Action Against 23andMe Over...more

Bioethicists "Urge Maximal Transparency" in Response to 23andMe Patent

Last week, we discussed a patent, recently issued to 23andMe, Inc., that has created some controversy. The patent, U.S. Patent No. 8,543,339, is directed to a system for identifying a preferred gamete donor from among the...more

Bay Area Genetic Diagnostics Company Files Declaratory Judgment Action against Myriad Genetics

Whether relying on Carl von Clausewitz or Jack Dempsey for the sentiment, Counsyl, Inc., a genetic diagnostic testing company has decided that the best defense against Myriad Genetics is a good offense and, accordingly, has...more

Defendants' Response to Myriad's Preliminary Injunction Motions - Myriad Genetics v. Ambry Genetics Corp. and Myriad Genetics v....

Last month, Ambry Genetics and Gene By Gene responded to Myriad's motion for preliminary injunction in a 109 page brief that sets out its invalidity case as well as the basis for its antitrust counterclaims. Supported by...more

Authors of Genome Medicine Article Form Genetic Testing Company

In a paper published in March in the journal Genome Medicine, Dr. Jeffrey Rosenfeld of the University of Medicine & Dentistry of New Jersey and Dr. Christopher Mason of Cornell University contended that due to the...more

NIH Implements New Policy on HeLa Genomic Data

On Wednesday, the National Institutes of Health (NIH) announced that the agency had reached an understanding with the family of Ms. Henrietta Lacks regarding access to genomic data for the HeLa cell line, which was derived...more

Myriad Genetics Files Infringement Suit Against Gene by Gene for Genetic Diagnostic Testing of BRCA Genes Hidden Field

A day after Myriad Genetics sued Ambry Genetics for patent infringement, the company filed suit in the District of Utah, Central Divisions against Gene by Gene Ltd. (Case No. 2:13-cv-00643-EJF; complaint). The complaint is...more

McAfee & Taft tIP Sheet - June 2013: Big or small, the loss of gene patents may affect us all

On June 13th, 2013, the U.S. Supreme Court unanimously held in Association for Molecular Pathology v. Myriad Genetics that isolated DNA is not eligible for patent protection....more

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