News & Analysis as of

Physiology/Medicine Nobels Awarded for Discoveries of “Natural Products”

In re Roslin Institute, a Fed. Cir. panel consisting of Judges Dyk, Moore and Wallach ruled that methods of isolating cffDNA were not patent eligible. Judge Dyk, writing for the panel endorsed the “markedly different”...more

PTO Releases Report on Confirmatory Genetic Diagnostic Testing

More than three years after the June 15, 2012 deadline for providing it, the U.S. Patent and Trademark Office has issued its report on so-called "second opinion" genetic diagnostic testing, mandated by Section 27 of the...more

Fireworks for Animal Drug Compounding at ACI’s Inaugural Animal Health and Veterinary Drugs and Therapeutics Conference-Part Two...

The second day began with a deep dive into the development of advanced biological drugs for animal use. David Brake, Ph.D., Founder and Principal, BioQuest Associates, LLC, helped explain the split between USDA and FDA...more

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

Claims Are Construed After Interference Proceedings

The court first determines that when a party is challenging a claim’s compliance with the written description requirement during an interference, the originating disclosure provides the meaning of the pertinent claim...more

Octopus Genome Sequenced

Invertebrate zoology is in many ways the most comprehensive survey course on biology, encompassing most multicellular life on the planet. (Indeed, the study of the Order Coleoptera alone, comprising the beetles, would...more

Fetal DNA Test Cannot Give Birth to a Patent - Ariosa Diagnostics, Inc., et al. v. Sequenom Inc., et al.

Addressing the issue of patent eligibility of a pre-natal testing invention, the U.S. Court of Appeals for the Federal Circuit unanimously affirmed the district court’s judgement of invalidity under 35 U.S.C. § 101 with...more

Trustees of Columbia University v. Illumina, Inc. (Fed Cir. 2015)

One of the first IPR petitions ever filed, IPR2012-0006, was related to biotechnology -- specifically DNA sequencing. Illumina, Inc. filed that petition, and two others, IPR2012-00007 and IPR2013-00011, against patents owned...more

Modernizing and Coordinating the Regulatory System of Biotechnology Products

On July 2, 2015, the U.S. Office of Science and Technology Policy (OSTP) of the Office of the President issued a memorandum to initiate a process to coordinate, update and modernize the federal regulatory system governing...more

When it comes to personalized medicine (or precision medicine!), there seem to be more questions than answers

Over the course of four days at the BIO 2015 Convention, there were at least half a dozen sessions and countless speakers directly and peripherally addressing issues of personalized medicine, including reimbursement,...more

Big sweepstakes scam artists don’t cry

According to the Edmonton Sun newspaper, Nigerian-born Richard Mmah Chukwu, a resident of Edmonton, was recently convicted of implementing a multi-million dollar sweepstakes scam. Chukwu was found guilty in the Canadian...more

Federal Circuit’s Latest Patent Subject Matter Decision in Ariosa v. Sequenom Renders Many Biotech Patents at Risk

On June 12, 2015, the Federal Circuit issued its decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc., finding that Sequenom’s patent claiming methods of using cell-free fetal DNA (“cffDNA”) for prenatal diagnosis test is...more

The Impact of Ariosa Diagnostics v. Sequenom on the Patent Eligibility of Biomarker Detection Methods

Under the Patent Act, one can patent “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” Common exceptions to what can be patented include laws of nature,...more

What Constitutes Patentable Subject Matter in Biotechnology? New Federal Circuit Decision Says “Even Less Than You Thought!”

With its recent (June 12, 2015) decision in Ariosa v. Sequenom, the Court of Appeals for the Federal Circuit affirmed the Northern District of California’s broad interpretation of the U.S. Supreme Court’s Prometheus v. Mayo...more

Jury Hits Employer With $2.2 Million Verdict For GINA Violations in Workplace Defecator Case

In a previous post we discussed the Northern District of Georgia’s decision in Lowe v. Atlas Logistics Group Retail Services, LLC, (N.D.Ga. May 5, 2015), holding that an employer violated the Genetic Information...more

Federal Circuit Invalidates Diagnostic Method Claims for Prenatal Test Under 35 U.S.C. 101

On June 12, 2015, the Federal Circuit affirmed the finding of U.S. District Court for the Northern District of California (“District Court”) that the method claims in U.S. Patent 6,258,540 (‘540 patent) for detecting...more

Federal Circuit Holds Medical Diagnostic Method Patent Invalid as Claiming Ineligible Subject Matter

Background - In two recent cases, Mayo v. Prometheus and Alice v. CLS Bank, the Supreme Court established a two-part test for determining eligibility for patenting. In step one, the court asks whether the claim is...more

Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015)

Disaster survivors, and even people who just hear about a disaster, are often first overwhelmed by it; they can only rationally process its significance after some time. During that time they overcome the initial visceral...more

Recent Cases Consider Patent Eligibility Under Mayo/Alice “Two-Step” Test: Invoking Routine and Conventional Elements Is Not...

In a series of cases addressing whether inventions are eligible for patent protection under 35 U.S.C. § 101, the U.S. Supreme Court has adopted a two-step analysis. Two recent decisions by the U.S. Court of Appeals for the...more

Patent for Technology that “Revolutionized Prenatal Care” Nonetheless Invalid as Patent Ineligible

The Federal Circuit Friday held in Ariosa Diagnostics, Inc. v. Sequenom, Inc. that Sequenom’s patent directed toward its MaterniT21 test—involving methods of detecting and using cell-free fetal DNA— was invalid for lack of...more

Federal Circuit Finds Revolutionary Non-Invasive Fetal DNA Test Method Unpatentable Under Mayo

On June 12, 2015, in Ariosa Diagnostics, Inc. et. al. v. Sequenom, Inc. et. al., the Court of Appeals for the Federal Circuit invalidated claims in U.S. Patent 6,258,540 directed to methods for detecting paternally inherited...more

Fed Circuit: Sequenom’s Diagnostic Method Claims Invalid Under §101

On June 12, 2015, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit affirmed the Northern District of California’s finding that the method claims in U.S. Patent 6,258,540 (‘540 patent) for detecting...more

U.S. Appeals Court Finds Prenatal DNA Test Unpatentable

The United States Court of Appeal for the Federal Circuit in the District of Columbia came down with another blow for the patentability of biotech testing products on Friday, June 12, 2015. The Court affirmed the 2013...more

Billion Dollar Question Before the USPTO in CRISPR-cas9 Fight

A revolutionary biotechnology tool is the focus of an intense biotechnology patent dispute that will have far-reaching impact in coming years. The dispute is over the rights to the CRISPR-cas9 system, a versatile molecular...more

Another Sequenom Patent Appeal Heads to the Federal Circuit

While Sequenom’s appeal of the district court’s summary judgment of invalidity of U.S. Patent 6,258,540 under 35 USC § 101 has been pending at the Federal Circuit, the USPTO has been considering the validity of the patent...more

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