Myriad Patent-Eligible Subject Matter

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 -
News & Analysis as of

USPTO Tries to Address Public Misunderstandings Regarding Myriad-Mayo Guidance

The U.S. Patent and Trademark Office spent the entire afternoon session of today's biotechnology/chemical/pharmaceutical (BCP) customer partnership meeting focusing on the guidance memorandum for determining the subject...more

U.S. Patent Office Issues Extensive Subject Matter Eligibility Guidelines

The United States Patent Office periodically issues guidance for examiners (“Examiners”), often in response to a recent court decision or new statute. These guidelines do not have the force of law, but nevertheless establish...more

USPTO Issues New Guidelines for Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural...

On March 4, 2014, the United States Patent and Trademark Office (USPTO) issued final guidance to the Examining Corps regarding patent eligibility of claims involving laws of nature, natural phenomena and natural products. The...more

District Court Doubts Patent Eligibility of Myriad BRCA Claims

In a decision issued March 10, 2014, Judge Shelby of the U.S. District Court for the District of Utah denied Myriad’s motion for a preliminary injunction against Ambry Genetics Corp. While Ambry had challenged the validity of...more

Thoughts on the USPTO's Patent Eligibility Guidelines (and What to Do About Them)

The U.S. Patent and Trademark Office recently issued (without public notice or opportunity to comment) its interpretation of the standards for subject matter eligibility in view of the Supreme Court's recent decisions in Mayo...more

USPTO Issues New Patent Subject Matter Eligibility Guidelines

The USPTO has issued new patent subject matter eligibility guidelines to aid examiners in applying the principles of Myriad and Prometheus to any claim “reciting or involving laws of nature/natural principles, natural...more

In Defense of Patenting

Fritz Machlup, an economist, once said that if we didn't have a patent system it would be irresponsible to recommend one, but since we have one, it would be irresponsible to abolish it. An Economic Review of the Patent...more

Salient Lessons For Australian Applicants Of US Diagnostic Patent Applications

In the latest decision concerning diagnostic method claims a US Court1 has provided some guidance to the diagnostics industry on the interpretation of the recent Supreme Court decisions in Mayo v Prometheus2 (Mayo) and AMP v....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 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

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

Federal Circuit Remands Sequenom Down Syndrome Test Platform Patent for Consideration Under Myriad

In Aria Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit vacated and remanded the district court’s decision denying Sequenom’s motion for a preliminary injunction relating to a patent covering the non-invasive...more

BakerHostetler Patent Watch: Aria Diagnostics, Inc. v. Sequenom, Inc.

While the facts may show that damages would be reparable, this assumption is not sufficient [for purposes of a preliminary injunction analysis]....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

Intellectual Property Legal News -The Supreme Court Holds Human Genes Are Unpatentable

In a unanimous decision written by Justice Thomas, the Supreme Court held that naturally-occurring DNA sequences are unpatentable. The Court has long held that certain subject matter is not patent eligible under 35 USC § 101....more

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

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

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

Post-Myriad Strategies for Claiming Biotech Inventions in the United States

The United States Supreme Court recently ruled that genes or other naturally-occurring pieces of DNA are patent ineligible subject matter in Association for Molecular Pathology, et al. v. Myriad Genetics, Inc., et al. No....more

The Future Of Patentable DNA: A Myriad Of Possibilities

In This Issue: - Summary - Case Analysis - Implications ..Prokaryotic Nucleic Acid Sequences ..Short Segments of Eukaryotic DNA ..Promoters/Regulatory regions ..Isolated Proteins ...more

Patent-Eligibility of hESC Challenged

Now that the U.S. Supreme Court has determined that isolated, naturally-occurring genes are not patent-eligible (see, Ass’n. for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __ (2013))(“Myriad”), Consumer Watchdog...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

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