DNA Patents

News & Analysis as of

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

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

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

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

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

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