News & Analysis as of

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

Full Federal Court confirms isolated nucleic acids are patentable in Australia

• The Full Federal Court has unanimously confirmed that isolated nucleic acids, either DNA or RNA, are patentable in Australia. • The decision is in contrast to the recent decision of the US Supreme Court, which held a...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

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

How to Protect a Product of Nature

"The more things change . . ." is the beginning of an old saw, and that saying has particular relevance just days after the USPTO stopped accepted comments on its Subject Matter Eligibility Guidance. After all, this isn't...more

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

Dolly Was a "Natural Phenomenon"

In re Roslin Institute (Edinburgh) - Addressing patent eligible subject matter under 35 U.S.C. § 101, the U.S. Court of Appeals for the Federal Circuit affirmed the decision of the U.S. Patent and Trademark Office...more

Docs @ BIO: USPTO Provides Update on Myriad-Mayo Guidance

At last week's BIO International Convention in San Diego, Andrew Hirshfeld, USPTO Deputy Commissioner for Patent Examination Policy, and June Cohan, a Legal Advisor with the USPTO's Office of Patent Legal Administration, took...more

Myriad - One Year Later

The Supreme Court decision last year on June 13, 2013 in Association of Molecular Pathology v. Myriad Genetics may have been a watershed moment for the biotechnology industry. So far the effects have been hard to detect, but...more

Federal Circuit Dismisses WARF Stem Cell Case – A Missed Opportunity

Recently in Consumer Watchdog v. Wisconsin Alumni Research Foundation, No. 2013-1377 (Fed. Cir. 2014), the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) dismissed Appellant Consumer Watchdog’s appeal on the...more

Guest Post: Myriad -- An Obvious and Patent-Friendly Interpretation

MyriadIs Myriad truly authority for the proposition that naturally occurring nucleic acid sequences and a host of other naturally occurring materials are no longer patent-eligible? Was it really the intention of the Supreme...more

Is Dolly the Sheep Dead Again?

The exceptions to patent eligibility under 35 USC 101 always fell into three distinct categories: laws of nature, abstract ideas, and natural phenomena. In deciding a case about whether claims of farm animals may be...more

“Natural” Clones Are Ineligible for Patent Protection

Last week, in In re Roslin Institute (Edinburgh), the Federal Circuit affirmed the rejection by the United States Patent and Trademark Office (USPTO) of product claims covering cloned mammals. This case relates to Dolly,...more

All We Like Sheep Have Gone Astray

The CAFC extends Myriad beyond DNA claims - Much ink has recently been spilled arguing that the PTO’s new guidelines go further than they should, and that Myriad’s reasoning should not be applied to proteins, cells,...more

Clones Not Patent-Eligible?

Thanks to recent advances in cloning technology, treating degenerative diseases with replacement tissue that matches a patient’s genetic makeup exactly is no longer science fiction. Just last month, for example, two research...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

No Patent for You

Patent eligibility restrictions hit life sciences and tech - After years of issuing rulings limiting what can be patented, the Supreme Court turned its attention squarely toward patent eligibility in the life sciences...more

Sequenom Files Opening Brief in Appeal of Summary Judgment on Section 101 Grounds

Earlier this week, Sequenom, Inc. filed its opening brief in Ariosa Diagnostics, Inc. v. Sequenom, Inc., appealing summary judgment that its licensed claims to a genetic diagnostic method for detecting fetal diseases and...more

Sanofi-Aventis v. Pfizer Inc. (Fed. Cir. 2013)

Last week, in Sanofi-Aventis v. Pfizer Inc., the Federal Circuit affirmed an award of priority to Pfizer by the Board of Patent Appeals and Interferences in an interference involving the cDNA for the human interleukin-13...more

Patent Eligible Subject Matter in the District Courts: Ariosa Genetics v. Sequenom (N.D. Cal. 2013)

Last Wednesday, Judge Susan Illston of the Northern District of California granted summary judgment to declaratory judgment plaintiff Ariosa Diagnostics Inc. in Ariosa Diagnostics v. Sequenom. The legal basis of the court's...more

Federal Circuit Holds Full Sequence Not Required for Invention of DNA

In Sanofi-Aventis v. Pfizer, Inc., the Federal Circuit affirmed the USPTO’s determination that Pfizer had proven an earlier date of invention of the DNA sequence at issue, even though it did not have the full, correct...more

California Court Holds Diagnostic Claims Not Patent-Eligible

In one of the first district court decisions applying the U.S. Supreme Court’s new Myriad patent-eligibility standard, the Northern District of California held that diagnostic claims containing only conventional and existing...more

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