News & Analysis as of

Myriad

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 -
McDonnell Boehnen Hulbert & Berghoff LLP

Sanofi-Aventis Deutschland GmbH v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2023)

McDonnell Boehnen Hulbert & Berghoff LLP on

In those (in retrospect) halcyon days more than a decade ago (before Mayo, Myriad, Alice, and the subject matter eligibility quagmire arose), perhaps the most significant Supreme Court decision was KSR Int'l Co. v. Teleflex...more

Foley & Lardner LLP

Federal Circuit Weighs In On Patent Eligibility Of Isolated Vitamin

Foley & Lardner LLP on

It has been a while since the Federal Circuit weighed in on the patent eligibility of so-called “natural product” claims. While the finding of non-eligibility in ChromaDex, Inc. v. Elysium Health, Inc. is not surprising, it...more

Fenwick & West LLP

Justice Barrett to Bring Clarity to Patent Eligibility Law?

Fenwick & West LLP on

Each time the U.S. Supreme Court has addressed patent eligibility, the law surrounding what can and cannot be patented has become murkier. Most recently, the wake of the Supreme Court’s Alice ruling has led to irreconcilable...more

McDonnell Boehnen Hulbert & Berghoff LLP

Story Telling

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Patent law (and, consequently, patent lawyers) can be viewed as having at least a slightly tighter tether on concrete, factual reality than other areas of the law, at least to the extent that making patent-related legal...more

McDonnell Boehnen Hulbert & Berghoff LLP

Illumina, Inc. v. Ariosa Diagnostics, Inc. (Fed. Cir. 2020)

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The latest Federal Circuit decision on subject matter eligibility in the life sciences came down (by a divided court) in favor of eligibility, in Illumina, Inc. v. Ariosa Diagnostics, Inc.  The claims at issue fell into the...more

McDonnell Boehnen Hulbert & Berghoff LLP

A Step-by-Step Approach to Patent Subject Matter Eligibility Reform

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There is a belief in some quarters that the most significant barrier to patent subject matter eligibility reform is an implacable opposition by companies in the high tech sector because those companies are convinced that the...more

Bass, Berry & Sims PLC

Settlement Shows FCA Risks Posed by Non-Traditional Relators

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On July 19, 2019, Myriad Genetics disclosed a $9.1 million settlement agreement to resolve a False Claims Act (FCA) qui tam lawsuit alleging that it engaged in a scheme to fraudulently bill Medicare for certain hereditary...more

Downs Rachlin Martin PLLC

Current State of Patent Eligibility and Potential Reform

Downs Rachlin Martin PLLC on

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

Sterne, Kessler, Goldstein & Fox P.L.L.C.

IP Hot Topic: The Draft Subject Matter Eligibility Bill: A Work In Progress

Sterne, Kessler, Goldstein & Fox P.L.L.C. on

On May 22, 2019, U.S. Senators Thom Tillis (R-NC) and Chris Coons (D-DE), Chair and Ranking Member of the Senate Judiciary Subcommittee on Intellectual Property, and Representative Doug Collins (R-GA-9), Ranking Member of the...more

King & Spalding

Patent Eligibility for “Natural” Food and Beverage Ingredients and Products

King & Spalding on

Since the Supreme Court’s decision in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), there has been considerable uncertainty regarding what constitutes patentable subject matter. In a...more

McDonnell Boehnen Hulbert & Berghoff LLP

PTAB Life Sciences Report - July 2017

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About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Myriad Genetics, Inc. v. Johns Hopkins University - PTAB Petition: IPR2017-01102; filed March...more

Womble Bond Dickinson

Sections 101 and 112: Eligibility, Patentability, or Somewhere in Between?

Womble Bond Dickinson on

We wrote earlier about the Supreme Court’s renewed interest in patent eligibility and seemingly unintended confusion between the patent eligibility requirements of 35 U.S.C. § 101 and the remaining patentability requirements...more

Knobbe Martens

Positive Clinical Results for Using Myriad’s BRACAnalysis CDx® for Identifying Breast Cancer Patients for Treatment with Lynaparza

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Myriad Genetics recently announced clinical results showing that its BRACAnalysis CDx® test was able to identify patients with HER2-negative metastatic breast cancer who had improved response with Lynparza (olaparib),...more

McDonnell Boehnen Hulbert & Berghoff LLP

News from Abroad: Not One But Two Decisions Fine Tune the Australian Patent Office's Approach to Life Science Technologies

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Two recent Australian Patent Office decisions have provided clarity as to the patentability of isolated nucleic acid sequences following the High Court's decision in D'Arcy v Myriad Genetics ('Myriad'). The first decision is...more

Knobbe Martens

Myriad Genetics Announces an Assay that Identifies Patients for Olaparib Treatment

Knobbe Martens on

Salt Lake City-based Myriad Genetics, Inc. announced that its BRACAnalysis CDx® test accurately identifies patients with ovarian cancer for a second-line treatment with olaparib. The announcement came as a result of a...more

Blake, Cassels & Graydon LLP

Patenting in Canada: Do These Genes Fit?

Blake, Cassels & Graydon LLP on

The Supreme Court of Canada has commented on the issue but no Canadian court has directly answered the difficult question of whether genes are patentable. So the answer appears to be yes, for now. Identifying genetic...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Patent Rights in the U.S.: Is the Pendulum Finally Swinging Back to Center?

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The U.S. patent system has long struggled to strike a balance that both encourages patent rights and prevents patent abuse. Finding that balance requires giving patent owners the right amount of patent enforcement power,...more

McDonnell Boehnen Hulbert & Berghoff LLP

News from Abroad: IP Australia Releases Myriad Examination Guidelines

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Following the recent public consultation in view of the Australian High Court's decision in D'Arcy v Myriad Genetics ("Myriad"), IP Australia has released new Examination Guidelines for applications which may be affected by...more

McDonnell Boehnen Hulbert & Berghoff LLP

Top Stories of 2015: #11 to #15

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After reflecting upon the events of the past twelve months, Patent Docs presents its ninth annual list of top patent stories. For 2015, we identified twenty stories that were covered on Patent Docs last year that we believe...more

McDonnell Boehnen Hulbert & Berghoff LLP

Top Stories of 2015: #16 to #20

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After reflecting upon the events of the past twelve months, Patent Docs presents its ninth annual list of top patent stories. For 2015, we identified twenty stories that were covered on Patent Docs last year that we believe...more

Foley & Lardner LLP

Australian Patent Office Provides Patent Eligibility Guidance

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The Australian Patent Office (IP Australia) has issued final patent eligibility guidance under the Australian High Court’s decision in D’Arcy v. Myriad Genetics, Inc. Where the USPTO extrapolated from the U.S. Supreme Court...more

JD Supra Perspectives

Can we patent products found in nature? It's complicated. An update on Australia's Myriad decision...

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It remains to be seen if this new Myriad decision in Australia will be extended as it was in the U.S. to prevent virtually any product found in nature from being patented....more

JD Supra Perspectives

Does a Nucleic Acid Constitute Patent Eligible Subject Matter Under Australian Law?

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Clearly the High Court has given an answer to a question, but was that question the one we anticipated? That in itself is an open question!...more

BakerHostetler

Australian High Court Rules Gene Patents Unpatentable

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Like the United States Supreme Court, the High Court of Australia has determined that Myriad’s patents directed to purified and isolated DNA molecules encoding the BRCA genes are unpatentable. Indeed, the Australian Court...more

McDonnell Boehnen Hulbert & Berghoff LLP

News from Abroad: Australian High Court Has Ruled in Myriad Gene Patent Case

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The Australian High Court yesterday unanimously overturned six lower court judges and dismissed some very careful reasoning to not only follow the U.S. Supreme Court in invalidating claims to the BRCA1 and 2 gene sequences,...more

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