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Domestic Cat Genome Sequenced

Earlier this month, an international effort* led by Stephen J. O'Brien at the Oceanographic Center, Nova Southeastern University, Ft. Lauderdale, Florida reported the complete genomic sequencing of the domestic cat, Felix...more

8/21/2014 - DNA Genetic Materials

How to Protect a Product of Nature

"The more things change . . ." is the beginning of an old saw, and that saying has particular relevance just days after the USPTO stopped accepted comments on its Subject Matter Eligibility Guidance. After all, this isn't...more

8/4/2014 - DNA Patent-Eligible Subject Matter Patents Roslin USPTO

Dr. Cook-Deegan Brings the Medical Community Up to Date on the Myriad Case

In an article in The Cancer Letter entitled "Robert Cook-Deegan's Viewers' Guide To the Super Bowl of Gene Patent Cases," Professor Robert Cook-Deegan (at right) of the Institute for Genome Sciences & Policy and Sanford...more

4/1/2014 - AMP v Myriad DNA Genetic Materials Human Genes Patent Litigation Patent-Eligible Subject Matter Patents

Myriad Appeals Adverse Preliminary Injunction Decision

On March 13, Myriad Genetics filed a Notice of (interlocutory) Appeal with the Federal Circuit. Myriad is seeking to have the Court review and reverse the District Court's denial of the company's preliminary jnjunction...more

3/21/2014 - BRCA DNA Genetic Materials Genetic Testing Myriad Patent Litigation Patents Preliminary Injunctions

Panel on Multidistrict Litigation Consolidates Myriad Cases in Utah District Court

The old adage "Be careful what you wish for" comes to mind regarding Myriad Genetics' motion to the Judicial Panel on Multidistrict Litigation under 28 U.S.C. ยง 1407, that cases relating to the company's BRCA gene patents be...more

3/20/2014 - AMP v Myriad BRCA DNA Multidistrict Litigation Myriad Patent Infringement Patent Litigation Patents

Utah Judge Denies Myriad's Preliminary Injunction Motion

In a 106-page opinion, U.S. District Court Judge Robert J. Shelby on Monday denied Myriad Genetics motion for preliminary injunction in Myriad Genetics v. Ambry Genetics. Characteristic of its aggressive defense of its...more

3/12/2014 - AMP v Myriad BRCA DNA Genetic Materials Human Genes Myriad Myriad v Ambry Patent Litigation Patents Pharmaceutical Preliminary Injunctions

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

2/10/2014 - AMP v Myriad BRCA DNA Gene-By-Gene Genetic Testing Human Genes Myriad Patent Infringement Patent Litigation Patents

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

1/31/2014 - DNA Genetic Materials Genetic Testing Human Genes Mayo v. Prometheus Patent Applications Patent Litigation Patent-Eligible Subject Matter Patents SCOTUS Section 101 Sequenom Summary Judgment

FDA Threatens Agency Action Against 23andMe Over Personal Genetic Testing

As reported in Fierce Medical Devices by Damian Garde, the FDA has issued a Warning Letter to personal genomics company 23andMe, demanding that the company stop selling its Personal Genomic Services (PGS) product without...more

11/26/2013 - 23andMe DNA FDA Human Genes Medical Devices

Patent Eligible Subject Matter in the District Courts: Ariosa Genetics v. Sequenom (N.D. Cal. 2013)

Last Wednesday, Judge Susan Illston of the Northern District of California granted summary judgment to declaratory judgment plaintiff Ariosa Diagnostics Inc. in Ariosa Diagnostics v. Sequenom. The legal basis of the court's...more

11/7/2013 - DNA Genetic Materials Patent Litigation Patent-Eligible Subject Matter Patents

Where Do We Stand?

Some of our commenters have asked (with greater or lesser degrees of stridency) that we "take a position" on claims like the Myriad method claims at issue in the lawsuits brought against Ambry Genetics, Gene-by-Gene, and...more

11/1/2013 - Ambry DNA Genetic Materials Human Genes Myriad Patents Pharmaceutical

Defendants' Oppose Myriad's Motions to Dismiss Antitrust Counterclaims

In responding to Myriad Genetics' complaint for patent infringement, both Ambry Genetics and Gene-by-Gene asserted counterclaims under the Sherman Antitrust Act, predicated on Myriad's filing its patent infringement lawsuit. ...more

10/29/2013 - Antitrust Litigation Counterclaims DNA Genetic Materials Motion to Dismiss Myriad Patent Litigation Patents

Myriad Genetics Sues Quest for Patent Infringement

Turnabout being fair play, Myriad Genetics today filed suit against Quest Diagnostics, Inc. and Quest Diagnostics Nichols Institute for patent infringement in an action brought in the Federal District Court for the District...more

10/23/2013 - DNA Genetic Materials Human Genes Myriad Patent Infringement Patents

Myriad Sues GeneDx on BRCA and Other Genetic Diagnostic Patents

After a brief hiatus that saw Counsyl and Quest Diagnostics file declaratory judgment actions in alternate venues, Myriad has filed yet another lawsuit against a genetic diagnostics company that brought its own BRCA gene...more

10/22/2013 - BRCA DNA Genetic Materials Human Genes Myriad Patent-Eligible Subject Matter Patents

Genes and Information: The Problem of Disease-specific Databases

One of the many untruthful positions taken by the ACLU in the AMP v. Myriad Genetics case was that DNA is merely information, like a computer program, and as such Myriad's patent claims were invalid as reciting...more

10/16/2013 - ACLU AMP v Myriad DNA Genetic Materials GINA HIPAA Human Genes Myriad Patent-Eligible Subject Matter Patents

Preliminary Injunction in Myriad v. Ambry and Gene-by Gene: Myriad Replies

Not to be outdone by defendants Ambry Genetics and Gene-by-Gene's 109-page brief in opposition to Myriad's Preliminary Injunction Motion, Myriad has now filed a Reply Brief weighing in at 140 pages (page limits in briefs...more

10/10/2013 - AMP v Myriad BRCA DNA Genetic Testing Myriad Myriad v Ambry Patents Preliminary Injunctions

Myriad Moves to Dismiss Ambry's Antitrust Counterclaims on Noerr-Pennington Doctrine

The Supreme Court, in Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 570 (2007), and Ashcroft v. Iqbal, 556 U.S. 662 (2009), has in recent years focused the requirements for pleadings under the Federal Rules of Civil Procedure...more

8/29/2013 - Ambry Antitrust Litigation Bad Faith Biotechnology Counterclaims DNA Federal Rules of Civil Procedure Genetic Materials Myriad Noerr-Pennington Doctrine Patents Twombly/Iqbal Pleading Standard

Aria Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2013)

The Federal Circuit vacated and remanded a District Court decision denying a preliminary injunction to patentee Sequenom over the claims of U.S. Patent No. 6,258,540. While the Court rendered its decision based on...more

8/15/2013 - AMP v Myriad DNA Genetic Testing Injunctions Patent-Eligible Subject Matter Patents Preliminary Injunctions

Ambry Responds to Myriad Lawsuit

Asserts Affirmative Defenses and Antitrust Counterclaims and Asks for Declaratory Judgment - On Monday Ambry filed its Answer to Myriad's complaint for patent infringement, and asserted patent misuse as an affirmative...more

8/8/2013 - Ambry AMP v Myriad Antitrust Litigation DNA Genetic Materials Human Genes Myriad Patent Infringement Patent-Eligible Subject Matter Patents SCOTUS Sherman Act The Clayton Act USPTO

Myriad Genetics Files Suit Against Ambry Genetics for Genetic Diagnostic Testing of BRCA Genes

Today Myriad Genetics sued Ambry Genetics, Corp. in the District of Utah, Central Division for patent infringement of ten patents relating to genetic diagnostic testing (Case No. 2:13-cv-00640-RJS; complaint). ...more

7/10/2013 - Ambry AMP v Myriad DNA Gene Patenting Genetic Materials Genetic Testing Myriad Patent Infringement Patents

Does the Myriad Decision Presage a Golden Age of Patent-Free Personalized Medicine?

The Supreme Court's decision in the Myriad case has been almost universally hailed as being a great victory for patients, doctors, personalized medicine, and research. Precluding patenting for "merely" isolated human DNA,...more

6/20/2013 - AMP v Myriad DNA Human Genes Myriad Patent-Eligible Subject Matter Patents SCOTUS

U.S. Supreme Court Rules Human Genes Cannot Be Patented While Approving Patentability of Synthetic Genes in Issuing Key Myriad...

The Supreme Court ruled unanimously June 13, 2013 in favor of Plaintiffs/Petitioners in Association of Molecular Pathologists v. Myriad Genetics on the question of whether isolated DNA is patent eligible. The opinion found a...more

6/18/2013 - AMP v Myriad DNA Human Genes Myriad Patent-Eligible Subject Matter Patents SCOTUS

Association for Molecular Pathology v. Myriad Genetics, Inc. (2013)

The Supreme Court rendered its opinion in Association for Molecular Pathology v. Myriad Genetics, Inc. ("the Myriad case"), and in many ways it was anticlimactic: the Court adopted the Department of Justice's position...more

6/14/2013 - AMP v Myriad DNA Human Genes Myriad Patent-Eligible Subject Matter Patents SCOTUS

The Myriad Case and "Gene" Patents: Much Ado about Nothing?

The biggest concern of the biotechnology industry caused by the impending Supreme Court decision in the AMP v. Myriad Genetics case is the threat to existing patents having claims to isolated human DNA (and the DNA from other...more

5/15/2013 - AMP v Myriad Biotechnology DNA Gene Patenting Human Genes Myriad Patents

What We May Learn from the Myriad Oral Argument

The U.S. Supreme Court heard oral argument in Association for Molecular Pathology v. Myriad Genetics, Inc. on Monday, and many have commented on the Court's interrogation of the parties' representatives (and the government)...more

4/19/2013 - AMP v Myriad DNA Litigation Strategies Myriad Oral Argument Patent-Eligible Subject Matter Patents SCOTUS

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