News & Analysis as of

Australia Upholds Patent Eligibility of Isolated DNA

The Full Federal Court of Australia affirmed that isolated nucleic acids, i.e. whether it be DNA or RNA, are patentable subject matter in Australia. While an appeal to the High Court of Australia may be possible, absent an...more

News from Abroad: Myriad Patent Upheld by Full Federal Court of Australia

The Full Federal Court of Australia has handed down its long awaited decision in D'Arcy v Myriad Genetics Inc today, affirming that isolated DNA and RNA are patentable subject matter under Australian law....more

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

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

"Intellectual Property and Technology: Patent Issues to Watch in 2014"

With key provisions of the America Invents Act (AIA) taking effect and a host of controversial U.S. Supreme Court decisions, 2013 was another active year for intellectual property law. Big cases and big changes will continue...more

Top Stories of 2013: #7 to #10

Reflecting upon the events of the past twelve months, Patent Docs presents its seventh annual list of top biotech/pharma patent stories. For 2013, we identified fourteen stories that were covered on Patent Docs last year...more

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

Myriad Beyond The US: Patent Eligibility Of Genes In Australia, New Zealand And South East Asia

This article discusses the patent protection of isolated, naturally occurring nucleic acids in Australia, NZ and a number of South East Asian countries. In these jurisdictions there is no express exclusion of these molecules...more

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

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

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

Diagnostics Giant Quest Files Declaratory Judgment Action against Myriad Genetics

Myriad is facing yet another challenge to its remaining BRCA gene testing franchise, this time from Quest Diagnostics joined by its R&D arm, Nichols Institute. Quest is "the world's leading provider of diagnostic information...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

Can Your DNA Be Patented? The Supreme Court Draws a Delicate Balance

In Ass’n for Molecular Pathology v. Myriad Genetics, Inc., the United States Supreme Court held that a naturally occurring, isolated segment of DNA is a product of nature and is not patentable....more

Myriad Preliminary Injunction Hearing to Be Held September 11, 2013

The hearing on Myriad’s motion for a preliminary injunction against Ambry Genetics is scheduled for September 11, 2013, before Judge Robert A. Shelby at the U.S. District Court for the Central District of Utah....more

Supreme Court corner - Q3 2013

RECENT DECISIONS - Federal Trade Commission v. Actavis - Decided: 6/17/2013 Patent Holding: (5-3) reverse payment settlement agreements should be reviewed based on a “rule of reason. In a split...more

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

Why Does Myriad Think It Can Win BRCA Gene Lawsuits?

Earlier this month, Myriad Genetics filed patent infringement lawsuits against Ambry Genetics (on July 9th) and Gene-by-Gene (on July 10th). Filed with the complaint in the Ambry lawsuit was a Motion for Preliminary...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

After Myriad: A Herd of Elephants in the Room

As we all know by now, the Supreme Court last month decided that isolated genes are not eligible for patenting. Although seemingly drawing a clear-cut distinction between DNA molecules having the same sequence as that which...more

Supreme Court Rules that a Naturally Occurring DNA Segment Is Not Patent Eligible, But cDNA May Be Patent Eligible

After years of uncertainty about the patent eligibility of DNA under §101, the Supreme Court in Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. _____ (2013), has held that "a naturally occurring DNA segment...more

Supreme Court Rules on Validity of Patents for Genetic Information

On June 13, the U.S. Supreme Court handed down a ruling in Association for Molecular Pathology et. al. v. Myriad Genetics, the outcome of which was considered crucial in the development of genetic research....more

IP Update, Vol. 16, No. 6, June 2013

Patents / Patent Eligible Subject Matter - Supreme Court to Myriad: Isolated DNA Sequences Are Not Patent-Eligible Subject Matter -- AMP et al. v. Myriad Genetics, Inc.: In a 9–0 decision the Supreme...more

Supreme Court Rules on Human Gene Patent Debate

Angelina Jolie recently made headlines for her preemptive mastectomy after learning that she carried the BRCA genes, which are linked to breast cancer....more

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