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

News from Abroad: High Court of Australia Hears Myriad Appeal

The High Court of Australia today heard the long anticipated appeal from the unanimous decision of a 5-judge bench of the Full Federal Court to allow Myriad's claims to isolated nucleic acids. The question before the...more

Federal Circuit Holds Sequenom Diagnostic Method Patent Invalid Under 101

On Friday, June 12, 2015, the Federal Circuit issued its decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc., affirming the district court's finding that Sequenom’s claims are invalid under 35 USC § 101. The court's...more

Koepsell and Noonan on Gene Patenting

In 2009, the first edition of Dr. David Koepsell's book "Who Owns You: The Corporate Gold Rush to Patent Your Genes" was published. With the second edition of his text about to be published, Dr. Koepsell allowed Patent Docs...more

Is Biotech Patentable Subject Matter? [Video]

The issue of patent eligibility has been a hotly litigated issue in the field of intellectual property law, and both the Federal Circuit and the Supreme Court have issued numerous decisions in recent years--particularly in...more

Protecting food industry innovations as the scope of patentable subject matter narrows

Strong intellectual property increases the value of a company. Copyrights, trademarks, patents, and trade secrets are some avenues to protect intellectual property, but understanding when they’re available and understanding...more

Game Over for Myriad - (Or, and then there was one)

As discussed at the end of January, Myriad has given up its Quixotic quest to validate its BRCA gene testing franchise and has abandoned its several lawsuits (many of which were consolidated before the District of Utah under...more

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

Validity of Sequenom Patent Still to Be Decided

Although Sequenom has settled its dispute over U.S. Patent 6,258,540 with some parties, its case against Ariosa Diagnostics, Inc. remains active. Thus, we all should be waiting with bated breath to see whether the Federal...more

Can Any DNA Claims Still Be Patented?

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

Five Things You Need to Know About the USPTO Interim Guidelines on 101

The USPTO issued interim guidelines on 101 (“Interim Guidance”) on December 15, 2014. We summarized the Interim Guidance in this post, and now highlight five things practitioners and stakeholders need to know as they consider...more

An Early Test for the USPTO’S Eligibility Analysis

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

Myriad Disappointments for Biotech, but Hope Remains

CAFC extends the reach of subject-matter ineligibility under Myriad - Following Myriad Genetic’s 2013 loss at the Supreme Court (Ass’n for Molecular Pathology v. Myriad Genetics, 133 S. Ct. 2107 (2013), herein “Myriad...more

USPTO Issues New Guidance with Fewer Limitations on the Subject Matter Eligibility of Patent Claims

The U.S. Patent and Trademark Office (USPTO) today released its latest iteration of guidance—referred to as the "Interim Eligibility Guidance"—to its examiners. This guidance is aimed at assessing whether an invention claimed...more

USPTO to Release Revised Subject Matter Eligibility Guidance

In a conference call this morning, Drew Hirshfeld, U.S. Patent and Trademark Office Deputy Commissioner for Patent Examination Policy, announced that the USPTO would be releasing revised guidance on subject matter eligibility...more

Guest Post: Myriad -- A Direct and Unexceptional Approach

Is there a chain of reasoning that leads to the outcome in Myriad more shortly and directly than that outlined by Justice Thomas and without invoking judicial exceptions? It is strongly arguable that this is indeed the case...more

Myriad Set for Another Round

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

Full Federal Court confirms isolated genetic material is patentable in Australia

In D'Arcy v Myriad Genetics Inc [2014] FCAFC 115, an expanded bench of five judges of the Full Federal Court of Australia has unanimously upheld Justice Nicholas' decision in Cancer Voices Australia v Myriad Genetics Inc...more

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

Breaking News – Full Federal Court Confirms Patentability of Isolated Genes

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

Will the USPTO Respond to Public Feedback of Its Eligibility Guidance?

Periodically, the USPTO holds open meetings with the public to discuss its thinking on current topics relating to the patent procurement process. Late last week, the Biotechnology, Chemical and Pharmaceutical Customer...more

Airing the USPTO's Naturally Occurring Dirty Laundry — the Subject Matter Eligibility Stain

It has been five months since the USPTO issued its Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products to aid examiners in applying the...more

Examination of Myriad-Mayo Guidance Comments -- International Bioindustry Associations

On March 4, the U.S. Patent and Trademark Office issued a guidance memorandum, entitled "Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural...more

Examination of Myriad-Mayo Guidance Comments -- ACLU

On March 4, the U.S. Patent and Trademark Office issued a guidance memorandum entitled "Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural...more

The USPTO Patent Subject Matter Eligibility Guidance TRIPS Over Treaty Requirements

The “Myriad-Mayo” patent subject matter eligibility guidance issued March 4, 2014 reflects the USPTO’s interpretation of Supreme Court cases interpreting and applying 35 USC § 101 to claims involving laws of nature, natural...more

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