Patent-Eligible Subject Matter DNA

Patent-Eligible Subject Matter refers to the types of inventions that can be legally patented. The criteria for patentability varies depending on the jurisdiction. In the United States, for instance, if a... more +
Patent-Eligible Subject Matter refers to the types of inventions that can be legally patented. The criteria for patentability varies depending on the jurisdiction. In the United States, for instance, if a researcher discovers a naturally occurring substance, the substance itself cannot be patented. This issue was examined in a United States Supreme Court case, AMP v. Myriad, in regard to the patentability of human genes.  less -
News & Analysis as of

The Patent Office Clarifies the Ban on Patenting Naturally-Derived Drugs and Other Products

Since the very beginning of America’s revolutionary patent system, inventors in the life sciences have been granted patents for discovering and purifying natural products. It was taken as a given that a purified natural...more

An Early Test for the USPTO’S Eligibility Analysis

Just last week, the USPTO released its revised subject matter eligibility guidance (2014 Interim Guidance on Patent Subject Matter Eligibility “Interim Guidance” reviewed in my prior post of December 16th, 2014). The Interim...more

Intellectual Property and Technology News - December 2014 (Global)

In This Issue: - Fundamental Reform Ahead For European Patent Law - Patentability of Isolated Nucleic Acid - Patent Reform – Is It Working? - Right To Privacy In Japan - Supreme Court Corner - The FTC...more

Federal Circuit Applies Alice to Biotechnology in Striking Down Myriad Method of Screening Claims, Leaves Door Open for Narrower...

On December 17, 2014, a three judge panel of the Federal Circuit issued a ruling that may significantly narrow the scope of patent eligible subject matter with respect to method claims in the biotechnology field. The...more

More Biotech and Diagnostic Patents At Risk After Federal Circuit Decision

On December 17, 2014, the Federal Circuit Court of Appeals found that certain claims relating to Myriad’s BRCA1 genetic test for breast and ovarian cancer were invalid under 35 U.S.C. § 101 as being ineligible for patent...more

Federal Circuit Invalidates Myriad Primer and Method Claims as Lacking Subject Matter Eligibility

In a case styled as In re BRCA1- and BRCA2-Based Hereditary Cancer Test Patent Litigation (also known as Myriad v. Ambry), the Federal Circuit held four of Myriad’s “primer” claims and two of Myriad’s detection method claims...more

USPTO Issues New Guidance with Fewer Limitations on the Subject Matter Eligibility of Patent Claims

The U.S. Patent and Trademark Office (USPTO) today released its latest iteration of guidance—referred to as the "Interim Eligibility Guidance"—to its examiners. This guidance is aimed at assessing whether an invention claimed...more

Myriad’s Continuing Patent Debate

On October 6, 2014, the U.S. Court of Appeals for the Federal Circuit entertained oral argument in the interlocutory appeal of the district court’s denial of Myriad’s motion for preliminary injunction against Ambry Genetics....more

Guest Post: Myriad -- A Direct and Unexceptional Approach

Is there a chain of reasoning that leads to the outcome in Myriad more shortly and directly than that outlined by Justice Thomas and without invoking judicial exceptions? It is strongly arguable that this is indeed the case...more

Federal Circuit Hears Arguments in Other Myriad Gene Patents Case

On October 6, 2014, the Federal Circuit heard oral arguments in a case involving the claims of the Myriad gene patents that were not invalidated by the Supreme Court’s 2013 decision. The Federal Circuit is reviewing the...more

Myriad Set for Another Round

On Monday October 6th, the U.S. Court of Appeals for the Federal Circuit will entertain oral argument in another case involving Myriad’s BRCA1/BRCA2 diagnostic tests. In re BRCA1- and BRCA2- Based Hereditary Cancer Test...more

Full Federal Court confirms isolated genetic material is patentable in Australia

In D'Arcy v Myriad Genetics Inc [2014] FCAFC 115, an expanded bench of five judges of the Full Federal Court of Australia has unanimously upheld Justice Nicholas' decision in Cancer Voices Australia v Myriad Genetics Inc...more

Full Federal Court confirms isolated nucleic acids are patentable in Australia

• The Full Federal Court has unanimously confirmed that isolated nucleic acids, either DNA or RNA, are patentable in Australia. • The decision is in contrast to the recent decision of the US Supreme Court, which held a...more

Patent Protection for Isolated Genetic Sequences Upheld in Australia

Last year in AMP v Myriad Genetics, the U.S. Supreme Court concluded that isolated, naturally occuring DNA are not patent eligible, which caused considerable consternation in the biotech community. However, this does not...more

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

Breaking News – Full Federal Court Confirms Patentability of Isolated Genes

A five-judge bench of the Full Court of the Federal Court of Australia (Full Court) has today unanimously decided that Myriad Genetics Inc's (Myriad) patent covering the isolated BRCA1 gene (Patent) is patentable subject...more

How to Protect a Product of Nature

"The more things change . . ." is the beginning of an old saw, and that saying has particular relevance just days after the USPTO stopped accepted comments on its Subject Matter Eligibility Guidance. After all, this isn't...more

USPTO Issues Guidance on Patentability of “Nature”-Related Patent Claims

The U.S. Supreme Court has recently taken a keen interest in whether certain subject matter is eligible to be patented under U.S. law1. In June 2013, the Supreme Court held in Myriad2 that patents on naturally-occurring DNA...more

Dolly Was a "Natural Phenomenon"

In re Roslin Institute (Edinburgh) - Addressing patent eligible subject matter under 35 U.S.C. § 101, the U.S. Court of Appeals for the Federal Circuit affirmed the decision of the U.S. Patent and Trademark Office...more

Docs @ BIO: USPTO Provides Update on Myriad-Mayo Guidance

At last week's BIO International Convention in San Diego, Andrew Hirshfeld, USPTO Deputy Commissioner for Patent Examination Policy, and June Cohan, a Legal Advisor with the USPTO's Office of Patent Legal Administration, took...more

Myriad - One Year Later

The Supreme Court decision last year on June 13, 2013 in Association of Molecular Pathology v. Myriad Genetics may have been a watershed moment for the biotechnology industry. So far the effects have been hard to detect, but...more

Federal Circuit Dismisses WARF Stem Cell Case – A Missed Opportunity

Recently in Consumer Watchdog v. Wisconsin Alumni Research Foundation, No. 2013-1377 (Fed. Cir. 2014), the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) dismissed Appellant Consumer Watchdog’s appeal on the...more

Guest Post: Myriad -- An Obvious and Patent-Friendly Interpretation

MyriadIs Myriad truly authority for the proposition that naturally occurring nucleic acid sequences and a host of other naturally occurring materials are no longer patent-eligible? Was it really the intention of the Supreme...more

Is Dolly the Sheep Dead Again?

The exceptions to patent eligibility under 35 USC 101 always fell into three distinct categories: laws of nature, abstract ideas, and natural phenomena. In deciding a case about whether claims of farm animals may be...more

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