News & Analysis as of

Myriad Patents Mayo v. Prometheus

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

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

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

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

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

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

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

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

Foley & Lardner LLP

Australia High Court Rules Against Gene Patents

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Colleagues in Australia have been spreading the bad news: The High Court of Australia followed the lead (?) of the U.S. Supreme Court and determined that Myriad cannot patent the isolated BRCA1 gene in Australia. Thanks to...more

Patterson Belknap Webb & Tyler LLP

Strong Support for Sequenom’s Petition for Rehearing En Banc

In Ariosa Diagnostics Inc. v. Sequenom Inc., 788 F.3d 1371 (Fed. Cir. 2015), a Federal Circuit panel held that Sequenom Inc.’s prenatal diagnosis patent claims patent ineligible subject matter under the two-step test of Mayo...more

Foley & Lardner LLP

Protecting Diagnostic Innovation – Two Actor Infringement Liability

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In Akamai Techs. Inc. v. Limelight Networks, Inc., (August 13, 2015 Fed. Cir.) an en banc Federal Circuit unanimously held that direct infringement under Section 271(a) can occur...more

Foley & Lardner LLP

Sequenom Seeks Rehearing En Banc

Foley & Lardner LLP on

Sequenom, Inc. has filed a petition for rehearing en banc of the Federal Circuit decision that held its diagnostic method claims invalid under 35 USC § 101. (You can read my synopsis of that decision here). Stakeholders in...more

Foley & Lardner LLP

Federal Circuit Holds Sequenom Diagnostic Method Patent Invalid Under 101

Foley & Lardner LLP on

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

Robins Kaplan LLP

Is Biotech Patentable Subject Matter?

Robins Kaplan LLP on

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

Snell & Wilmer

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

Snell & Wilmer on

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

Wilson Sonsini Goodrich & Rosati

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

McDonnell Boehnen Hulbert & Berghoff LLP

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

McDonnell Boehnen Hulbert & Berghoff LLP

Examination of Myriad-Mayo Guidance Comments -- University Community Joint Comment

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

McDonnell Boehnen Hulbert & Berghoff LLP

USPTO Expected to Issue Revised Myriad-Mayo Guidance in October

During a session at today's biotechnology/chemical/pharmaceutical (BCP) customer partnership meeting, the U.S. Patent and Trademark Office provided an update on the status of the Myriad-Mayo Guidance. ...more

Foley & Lardner LLP

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

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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

McDonnell Boehnen Hulbert & Berghoff LLP

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

McDonnell Boehnen Hulbert & Berghoff LLP

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

Foley & Lardner LLP

The USPTO Patent Subject Matter Eligibility Guidance TRIPS Over Treaty Requirements

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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

Foley & Lardner LLP

Why Are Method of Treatment Claims and Method of Manufacture Claims Subject to Scrutiny Under the USPTO Patent Subject Matter...

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The USPTO has asked for written comments on its patent subject matter eligibility guidance by July 31, 2014. In this article, I discuss why therapeutic method claims and method of manufacture claims should not be subject to...more

McDonnell Boehnen Hulbert & Berghoff LLP

Docs @ BIO: The Rest of the Story - Bloomberg BNA Hosts Panel on Subject Matter Eligibility

Last month at the BIO convention, Randy Kubetin, Managing Editor of Bloomberg BNA's Life Sciences Law & Industry Report moderated a panel entitled "Patent Eligibility from the Trenches: Practical Implications of the Supreme...more

Neal, Gerber & Eisenberg LLP

USPTO Issues Guidance on Patentability of “Nature”-Related Patent Claims

The U.S. Supreme Court has recently taken a keen interest in whether certain subject matter is eligible to be patented under U.S. law1. In June 2013, the Supreme Court held in Myriad2 that patents on naturally-occurring DNA...more

Foley & Lardner LLP

Patent-Eligibility of Stem Cells Under New USPTO "Myriad-Mayo" Guidance

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In March, the U.S. Patent and Trademark Office (USPTO) implemented new procedures to address whether inventions that relate in whole or in part to laws of nature and naturally occurring products are patent-eligibility in...more

King & Spalding

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

King & Spalding on

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

McDonnell Boehnen Hulbert & Berghoff LLP

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

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