Patents DNA

News & Analysis as of

FDA Releases Outline of Guidance for Developing Tests Based on Human Genetic Variants

The FDA is charged with regulating “Next Generation Sequencing (NGS) Tests,” and has just released draft guidance on what needs to be regulated. (A copy of the first draft and second draft can be found at the end of this...more

Carry on as Before: Supreme Court Refuses Sequenom’s Petition

To the surprise of many, including myself, the Supreme Court denied Sequenom’s petition for writ of certiorari (“Petition”). Sequenom asked the Court whether the inventive concept required under the Mayo/Myriad framework can...more

Subject Matter Eligibility Guidance -- Example on Screening for Gene Alterations

Last month, the U.S. Patent and Trademark Office issued further guidance for determining subject matter eligibility under 35 U.S.C. § 101. In addition to a memorandum on subject matter eligibility determinations that was...more

The Government Whittles Away at Life Sciences Patents

The current U.S. Supreme Court has been noted for its hostility to patent holders in general, but the Supreme Court has been especially hostile to any sort of life sciences or software invention. The Court has attempted to...more

Novel Applications of Natural Laws Remain Unpatentable Under 35 USC §101

In Genetic Technologies (GTG), the U.S. Court of Appeals for the Federal Circuit (CAFC) held the line in the patent eligibility saga in the field of biotechnology. GTG asserted U.S. Patent No. 5,612,179 against Merial and...more

Supreme Court Asked to Clarify Limits on Diagnostic Method Patents

Arguing that the current state of the law weakens the patent system and poses a danger to life science innovators, biotechnology company, Sequenom, Inc., has filed a writ of certiorari with the U.S. Supreme Court, asking the...more

Can Science be Copyrighted? You Might be Surprised…

Biotechnology. For many, the mere mention of the word stirs up a thought of people in white lab coats working in underground bunkers trying to create superhuman mutant weapons, with beakers of green goo bubbling in the...more

Claims Directed to Detection of Gene Variants Patent-Ineligible, Notwithstanding Mental Activity Requirement

Genetic Technologies Ltd. v. Merial L.L.C., __ F.3d __ (Fed. Cir. Apr. 8, 2016) (Prost, DYK, Taranto) (D. Del.: Stark) (4 of 5 stars) - Federal Circuit affirms judgment that patent claims are invalid under § 101. Genetic...more

Genetic Technologies Affirms Ariosa/Myriad With An Introduction By The Sequenom Petition for Cert.

On April 1st, Lilly filed an amicus brief in favor of Sequenom’s petition for cert. seeking to reverse Ariosa, that caused a lot of buzz in the IP community. (A copy is available at the end of this post.) To summarize, it...more

CRISPR Interference Motions Set

The Patent Trial and Appeal Board has made its decision regarding the motions each party will be able to bring in Interference No. 108,048 between the Broad Institute and the University of California ("University") over...more

Sequenom Petitions for Certiorari

Sequenom filed its anticipated petition for certiorari today for Supreme Court review of the Federal Circuit's decision in Ariosa v. Sequenom. The petition advises the Court that it "should take this opportunity to provide...more

The Genetics of Gender Discrimination in Date Palm Patenting

You’re driving south out of Indio along the Grapefruit Boulevard towards Thermal and Mecca because their names sound promising.  A parched desert plain extends to your left, leading up to the austere ridgelines of Joshua Tree...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

“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

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