News & Analysis as of

ML Strategies Health Care Update – DNA Sequencing Workshop and Drug Pricing Developments

On Tuesday, ML Strategies (MLS) posted its weekly Health Care Update, which provides information from the previous week on a variety of important health-care-related topics....more

Employee Wellness Technology: Cool and Risky

It should come as no surprise that one of us here at the Navigator has an Apple Watch. (Hint: It’s Kate.) Although everything about the watch pleases its owner, she is a particular fan of the Activity App that tracks calorie...more

Litigation Alert: Federal Circuit’s Ariosa Decision, Good Chance for Rehearing En Banc

In June of this year, the Federal Circuit panel in Ariosa Diagnostics, Inc. v. Sequenom, Inc. invalidated a patent on the grounds of patent-ineligible subject matter. 788 F.3d 1371 (Fed. Cir. 2015). While the case is one of...more

Natera Responds to Sequenom's Petition for Rehearing En Banc

Last week, Appellee Natera, Inc. filed its response to the petition for rehearing en banc filed by Appellants Sequenom, Inc. and Sequenom Center for Molecular Medicine, LLC in August (see "Sequenom Requests Rehearing En...more

Ariosa Diagnostics Responds to Sequenom's Petition for Rehearing En Banc

On Monday, Appellee Ariosa Diagnostics, Inc. filed its response to the petition for rehearing en banc filed by Appellants Sequenom, Inc. and Sequenom Center for Molecular Medicine, LLC in August. In its response, Ariosa...more

Australian Patent Office Proposes “Coding Only” Sequence Ban

Coming soon after the High Court’s “Myriad decision” in Australia, the Australian Patent Office has proposed guidelines that would effectively limit the ban on patent-eligibility of DNA sequences to nucleic acids that code...more

Can a natural product still be patented in Australia?

Yes. While various commentaries have suggested that patentable subject matter will be restricted in Australia under the recent High Court Myriad decision to exclude naturally occurring products (whether or not isolated), my...more

Can we patent products found in nature? It's complicated. An update on Australia's Myriad decision...

It remains to be seen if this new Myriad decision in Australia will be extended as it was in the U.S. to prevent virtually any product found in nature from being patented....more

What did the Australian High Court actually say about the patent eligibility of cDNA?

As the dust from the impact of the Australian Myriad decision begins to settle, now is the time to revisit what many have said regarding patent eligibility of cDNA, against what the final appeal Court actually said. On...more

Africa Update - October 2015 #2

Leading the News - Libya: On October 8th, The Washington Post provided an update on the Islamic State of Iraq and the Levant’s (ISIL) activities in Sirte, Libya. Since taking hold of Sirte earlier this year, ISIL...more

“Does a nucleic acid constitute patent eligible subject matter under Australia law?”

That is the question that we hoped Australia’s final appeal Court to have answered in the Myriad decision that it handed down last week. Some observers have been quite forthright on the point: ‘Yes, the High Court of...more

Does a Nucleic Acid Constitute Patent Eligible Subject Matter Under Australian Law?

Clearly the High Court has given an answer to a question, but was that question the one we anticipated? That in itself is an open question!...more

Australian High Court Rules Gene Patents Unpatentable

Like the United States Supreme Court, the High Court of Australia has determined that Myriad’s patents directed to purified and isolated DNA molecules encoding the BRCA genes are unpatentable. Indeed, the Australian Court...more

Life Sciences Alert: High Court of Australia unanimously decides that isolated genetic material is not patentable in Australia

In D'Arcy v Myriad Genetics Inc [2015] HCA 35 (D'Arcy v Myriad) the High Court of Australia has unanimously held (by way of three separate judgments: majority decision (French CJ, Kiefel, Bell, and Keane JJ) and two...more

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

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