News & Analysis as of

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

NIH Releases Final Guidance on Genomic Data Sharing

The National Institute of Health (NIH) recently released its final policy related to sharing human and non-human genomic data (GDS Policy). The GDS Policy applies to all NIH-funded research, regardless of the level of...more

Weekly Law Resume: The Court Re-Affirms that the Litigation Privilege of Civil Code Section 47(b) is Absolute

Leslie Falcon, et. al. v. Long Beach Genetics, Inc. et. al. - Court Of Appeal, Fourth District (March 18, 2014) - Civil Code Section 47(b), known as the litigation privilege, provides that a ‘publication or...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

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

Gene-by-Gene Cries Uncle, Settles with Myriad Genetics

Gene-by-Gene, Inc. was one of the first direct-to-consumer (DTC) genetic diagnostics companies to announce that it would offer BRCA1/BRCA2 testing after the Supreme Court's decision last June that certain of Myriad Genetics'...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

"Intellectual Property and Technology: Patent Issues to Watch in 2014"

With key provisions of the America Invents Act (AIA) taking effect and a host of controversial U.S. Supreme Court decisions, 2013 was another active year for intellectual property law. Big cases and big changes will continue...more

Founders Pavilion Will Pay $370,000 to Settle EEOC Genetic Information Discrimination Lawsuit

Nursing and Rehabilitation Center Asked for Genetic Information from Employees, Federal Agency Charged - NEW YORK - Founders Pavilion, Inc., a former Corning, N.Y. nursing and rehabilitation center, will pay $370,000...more

Institut Pasteur Obtains Reversal of USPTO Board Decision of Obviousness of Eukaryotic Site-Directed Mutagenesis Methods

In Institut Pasteur v. Focarino, the Federal Circuit found that the obviousness determination by the USPTO Board of Patent Appeals and Interferences was not supported by substantial evidence, and rested on an “erroneous...more

Top Three Stories of 2013

Reflecting upon the events of the past twelve months, Patent Docs presents its seventh annual list of top biotech/pharma patent stories. For 2013, we identified fourteen stories that were covered on Patent Docs last year...more

Top Stories of 2013: #7 to #10

Reflecting upon the events of the past twelve months, Patent Docs presents its seventh annual list of top biotech/pharma patent stories. For 2013, we identified fourteen stories that were covered on Patent Docs last year...more

Court Report -- December 08, 2013

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Astrazeneca AB et al. v. Aurobindo Pharma Ltd. et al. 3:13-cv-07298; filed December 3, 2013 in the District Court of New...more

FDA Threatens Agency Action Against 23andMe Over Personal Genetic Testing

As reported in Fierce Medical Devices by Damian Garde, the FDA has issued a Warning Letter to personal genomics company 23andMe, demanding that the company stop selling its Personal Genomic Services (PGS) product without...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

11 New Biomarkers Identified for Alzheimer’s Disease

A two-stage meta-analysis of genome-wide association studies (GWAS) in individuals of European ancestry identified 11 new loci associated with Alzheimer’s disease. The multidisciplinary study, recently reported in Nature...more

Where Do We Stand?

Some of our commenters have asked (with greater or lesser degrees of stridency) that we "take a position" on claims like the Myriad method claims at issue in the lawsuits brought against Ambry Genetics, Gene-by-Gene, and...more

Myriad Beyond The US: Patent Eligibility Of Genes In Australia, New Zealand And South East Asia

This article discusses the patent protection of isolated, naturally occurring nucleic acids in Australia, NZ and a number of South East Asian countries. In these jurisdictions there is no express exclusion of these molecules...more

Myriad Genetics Sues Quest for Patent Infringement

Turnabout being fair play, Myriad Genetics today filed suit against Quest Diagnostics, Inc. and Quest Diagnostics Nichols Institute for patent infringement in an action brought in the Federal District Court for the District...more

Myriad Sues GeneDx on BRCA and Other Genetic Diagnostic Patents

After a brief hiatus that saw Counsyl and Quest Diagnostics file declaratory judgment actions in alternate venues, Myriad has filed yet another lawsuit against a genetic diagnostics company that brought its own BRCA gene...more

Burden of Section 101 following Myriad

The Supreme Court’s decision in Association for Molecular Pathology v. Myriad Genetics Inc., 2013 DJDAR 7484 (2013), held that Myriad’s claims directed to “a naturally occurring DNA segment is a product of nature and not...more

Genes and Information: The Problem of Disease-specific Databases

One of the many untruthful positions taken by the ACLU in the AMP v. Myriad Genetics case was that DNA is merely information, like a computer program, and as such Myriad's patent claims were invalid as reciting...more

23andMe Patent Creates Controversy

A patent issued to 23andMe, Inc. last month has created some controversy, and in response, the biotech company, based in Mountain View, California, has posted its side of the story on the 23andMe blog. The patent, U.S....more

Can Your DNA Be Patented? The Supreme Court Draws a Delicate Balance

In Ass’n for Molecular Pathology v. Myriad Genetics, Inc., the United States Supreme Court held that a naturally occurring, isolated segment of DNA is a product of nature and is not patentable....more

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