News & Analysis as of

Ariosa v. Sequenom -- Ariosa's Responsive Brief

The Federal Circuit heard oral argument in the Ariosa v. Sequenom case last Friday, and a discussion of that argument will be posted in due course. Having posted on Sequenom's opening brief and the amicus brief filed by BIO,...more

Examination of Myriad-Mayo Guidance Comments -- BIO 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

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

Patent Protection for Isolated Genetic Sequences Upheld in Australia

Last year in AMP v Myriad Genetics, the U.S. Supreme Court concluded that isolated, naturally occuring DNA are not patent eligible, which caused considerable consternation in the biotech community. However, this does not...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

Guest Post: Myriad-Mayo Guidance -- Consistency With International Harmonization and TRIPS

It is strongly arguable that insofar as the USPTO's Myriad-Mayo Guidance dismisses as non-eligible newly isolated substances (including small molecules), nucleotide sequences and microorganisms having new utility (US...more

Examination of Myriad-Mayo Guidance Comments -- AUTM, COGR, AAU, and APLU

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

Evolving Healthcare Trends & Patents: Charting a Safe Course for Personalized Medicine

Rapid changes resulting from personalized medicine, including the ability to use individual patient biomarker data to generate a tailored treatment, are transforming healthcare. New business structures are evolving in the...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

Guest Post: Overview of First Published Comments on Myriad-Mayo Patent Eligibility Guidance

As readers will be aware, members of the public have been invited to submit written comments to the U.S. Patent and Trademakr Office that present their interpretation of the impact of relevant Supreme Court precedent on the...more

USPTO Holds Forum on Subject Matter Eligibility -- Part IV

On May 9, the U.S. Patent and Trademark Office held a four-hour long forum to receive public feedback on the Myriad-Mayo Guidance, which was issued by the Office on March 4. According to the Office's Guidance webpage, the...more

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

Docs @ BIO: BNA Issues Report on PTO's Patent Eligibility Guidance

Sounding an appropriately alarmist note, the Bureau of National Affairs (BNA) Life Sciences Law and Industry Report issues the results of a study on how the U.S. Patent and Trademark Office is administering its March 4, 2014...more

USPTO Holds Forum on Subject Matter Eligibility -- Part III

Last Friday, the U.S. Patent and Trademark Office held a four-hour long forum to receive public feedback on the Myriad-Mayo Guidance, which was issued by the Office on March 4. According to the Office's Guidance webpage, the...more

Sherry Knowles Speaks Truth to the Power of the PTO on § 101 Guidelines

Last week, Sherry Knowles, former chief patent counsel for GlaxoSmithKline and now principal at Knowles Intellectual Property Strategies, LLC submitted to Managing Intellectual Property magazine a detailed critique of the...more

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

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

Update on Myriad Appeal and Announcing a Public Forum on the USPTO 101 Guidelines

Myriad has appealed the district court decision that denied its motion for a preliminary injunction against Ambry Genetics Corp. According to a report in Bloomberg BNA Life Sciences Law & Industry Report™, on April 14, 2014,...more

Dr. Cook-Deegan Brings the Medical Community Up to Date on the Myriad Case

In an article in The Cancer Letter entitled "Robert Cook-Deegan's Viewers' Guide To the Super Bowl of Gene Patent Cases," Professor Robert Cook-Deegan (at right) of the Institute for Genome Sciences & Policy and Sanford...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

Panel on Multidistrict Litigation Consolidates Myriad Cases in Utah District Court

The old adage "Be careful what you wish for" comes to mind regarding Myriad Genetics' motion to the Judicial Panel on Multidistrict Litigation under 28 U.S.C. § 1407, that cases relating to the company's BRCA gene patents be...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

USPTO Issues New Procedure for Assessing Subject Matter Eligibility of Patent Claims

The U.S. Patent and Trademark Office (USPTO) recently released a guidance memorandum to its examiners on a new procedure for assessing whether a patent claim contains subject matter eligible for patenting. The guidance was...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 Subject Matter Eligibility Examination Guidelines for Claims Involving Laws of Nature, Natural Principles,...

On March 4, 2014, the USPTO issued a Guidance memorandum for examination of subject matter eligibility under 35 U.S.C. § 101 in view of AMP v. Myriad (2013) and Mayo v. Prometheus (2012). Under the new guidelines, the...more

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

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