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Myriad DNA Genetic Materials

Myriad Genetics is a publicly-traded molecular diagnostic company headquartered in Salt Lake City, Utah. Myriad's business model centers around isolating particular genes and determining their role in the... more +
Myriad Genetics is a publicly-traded molecular diagnostic company headquartered in Salt Lake City, Utah. Myriad's business model centers around isolating particular genes and determining their role in the development and progression of disease. Myriad's patenting practices have elicited considerable controversy with many opponents charging that Myriad cannot rightfully patent human genes. Opponents argue that human genes are naturally occurring and not patent-eligible subject matter. Myriad counters that the practice of isolating genes is a process distinct from the genes themselves and thus, is patentable. The U.S. Supreme Court is currently considering the validity of Myriad's patents in AMP v. Myriad Genetics.    less -
Downs Rachlin Martin PLLC

Current State of Patent Eligibility and Potential Reform

Will there be patent eligibility reform following the Senate Committee hearings? Major points of contention during the hearings were (1) the patentability of human genes, (2) whether proposed changes to 35 U.S.C. § 112(f)...more

McDermott Will & Emery

Federal Circuit to Myriad: Neither DNA Primers nor Comparing Gene Sequences Are Patent-Eligible Subject Matter - In re BRCA1- and...

In the latest decision addressing the patentability of Myriad’s BRCA1- and BRCA2-related patents, the U. S. Court of Appeals for the Federal Circuit invalidated a number of Myriad’s composition of matter claims and method...more

Foley & Lardner LLP

Can Any DNA Claims Still Be Patented?

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In a decision issued December 17, 2014, in In Re BRCA1- And BRCA2-Based Hereditary Cancer Test Patent Litigation (Myriad II), the Federal Circuit invalidated Myriad’s primer claims and detection method claims under 35 USC §...more

Foley & Lardner LLP

An Early Test for the USPTO’S Eligibility Analysis

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Just last week, the USPTO released its revised subject matter eligibility guidance (2014 Interim Guidance on Patent Subject Matter Eligibility “Interim Guidance” reviewed in my prior post of December 16th, 2014). The Interim...more

Foley & Lardner LLP

Myriad Set for Another Round

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On Monday October 6th, the U.S. Court of Appeals for the Federal Circuit will entertain oral argument in another case involving Myriad’s BRCA1/BRCA2 diagnostic tests. In re BRCA1- and BRCA2- Based Hereditary Cancer Test...more

Foley & Lardner LLP

Australia Upholds Patent Eligibility of Isolated DNA

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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

K&L Gates LLP

Breaking News – Full Federal Court Confirms Patentability of Isolated Genes

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A five-judge bench of the Full Court of the Federal Court of Australia (Full Court) has today unanimously decided that Myriad Genetics Inc's (Myriad) patent covering the isolated BRCA1 gene (Patent) is patentable subject...more

McDonnell Boehnen Hulbert & Berghoff LLP

Docs @ BIO: USPTO Provides Update on Myriad-Mayo Guidance

At last week's BIO International Convention in San Diego, Andrew Hirshfeld, USPTO Deputy Commissioner for Patent Examination Policy, and June Cohan, a Legal Advisor with the USPTO's Office of Patent Legal Administration, took...more

McDonnell Boehnen Hulbert & Berghoff LLP

Guest Post: Myriad -- An Obvious and Patent-Friendly Interpretation

MyriadIs Myriad truly authority for the proposition that naturally occurring nucleic acid sequences and a host of other naturally occurring materials are no longer patent-eligible? Was it really the intention of the Supreme...more

McDonnell Boehnen Hulbert & Berghoff LLP

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

McDonnell Boehnen Hulbert & Berghoff LLP

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

Foley & Lardner LLP

USPTO to Apply Myriad Beyond Isolated DNA

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Today, the United States Patent and Trademark Office (“USPTO”) issued a Guidance, advising examiners and the public of the factors for determining whether an invention satisfies the U.S. Supreme Court’s interpretation of 35...more

Skadden, Arps, Slate, Meagher & Flom LLP

"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

McDonnell Boehnen Hulbert & Berghoff LLP

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

McDonnell Boehnen Hulbert & Berghoff LLP

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

McDonnell Boehnen Hulbert & Berghoff LLP

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

McDonnell Boehnen Hulbert & Berghoff LLP

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

McDonnell Boehnen Hulbert & Berghoff LLP

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

Foley & Lardner LLP

Myriad Preliminary Injunction Hearing to Be Held September 11, 2013

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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

McDonnell Boehnen Hulbert & Berghoff LLP

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

McDonnell Boehnen Hulbert & Berghoff LLP

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

Bradley Arant Boult Cummings LLP

The Real Impact for Healthcare and Biotechnology of the Supreme Court's Decision in Myriad Genetics

On June 13, 2013, the Supreme Court issued a decision supposedly resolving the patentability of DNA in Association for Molecular Pathology v. Myriad Genetics. Immediately, all parties on both sides of the case declared...more

Foley & Lardner LLP

Patents, Genetic Testing, and Federal Funding

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In a July 12, 2013 letter to Dr. Francis S. Collins of the National Institutes of Health (“NIH”), Senator Patrick J. Leahy urged the NIH to exercise its march-in rights under the Bayh-Dole Act to directly license the genetic...more

Foley & Lardner LLP

Myriad’s Trade Secret Trump Card: The Myriad Database of Genetic Variants

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One of the most interesting arguments that Myriad made in its Motion for Preliminary Injunctive Relief in its infringement action against Ambry Genetics Corporation relates to the database of genetic information that Myriad...more

McDonnell Boehnen Hulbert & Berghoff LLP

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

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