Genetic Materials

News & Analysis as of

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

Healthcare & Life Sciences Private Equity Deal Tracker: CardioDx Secures $35 Million in Financing

CardioDx, headquartered in Redwood City, Calif., is a molecular diagnostics company specializing in cardiovascular genomics. Participants in this round of financing included Alberta Investment Management Corp. and the...more

CAFC Delivers Another Decision on Patentability of Myriad Patents

In Univ. of Utah Res. Foundation et al. v. Ambry Genetics Corp., No. 2014-1361 (Fed. Cir. Dec. 17, 2014), the Federal Circuit once again has weighed in on the patent eligibility of Myriad Genetics, Inc.’s patents related to...more

European Court of Justice: landmark decision on patentability of stem cells

The European Court of Justice (CJEU) has handed down a landmark judgment concerning the patentability of stem cells in Europe. Stem cells have the potential to revolutionize the treatment of human disease because of their...more

Patent Office Issues New Examination Guidelines for Subject Matter Eligibility

On December 16, 2014, the United States Patent and Trademark Office (PTO) published new guidelines for determining patent eligibility under 35 U.S.C. § 101. These guidelines do not have the force of law, but nevertheless...more

Impact of USPTO Interim Guidance on Chemical, Pharmaceutical, and Biotech Inventions

The recent interim guidance issued by U.S. Patent and Trademark Office (USPTO) provides applicants and practitioners with more helpful information about which types of claims the USPTO will find to satisfy subject matter...more

Patentability of isolated nucleic acid: US vs. Australia

Patents directed to genetic material have been t­­­­he subject of significant public discourse and legal challenge worldwide, leading to a divergence of governing law between jurisdictions and heightened industry uncertainty...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 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

Another Patent Challenge for Personalized Medicine

The U.S. Supreme Court’s recent trilogy of patent-eligibility decisions (Prometheus, Myriad and Alice) have called into question the validity of many U.S. patents on diagnostic medical methods. Nevertheless, legal battles...more

Examination of Myriad-Mayo Guidance Comments -- The Coalition for 21st Century Medicine -- Part II

On March 4, the U.S. Patent and Trademark Office issued a guidance memorandum, entitled "Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural...more

Canada Joins the Gene Patenting Debate

Canada has joined the gene patenting debate. Children’s Hospital of Eastern Ontario (“Children’s”) sued the University of Utah Research Foundation, Genzyme Genetics, and Yale University (“Defendants”) in Canada’s Federal...more

BIO IPCC Panel Discusses Impact of Myriad-Mayo Guidance

Yesterday, we reported on a session of the Biotechnology Industry Organization (BIO) Intellectual Property Counsel's Committee fall conference, which took place earlier this week in Nashville, TN, in which the U.S. Patent and...more

USPTO Provides Update on Status of Revised Myriad-Mayo Guidance

During a session of the Biotechnology Industry Organization (BIO) Intellectual Property Counsels Committee (IPCC) fall conference, which took place this week in Nashville, TN, the U.S. Patent and Trademark Office provided a...more

Ariosa v. Sequenom -- Ariosa's Responsive Brief

The Federal Circuit heard oral argument in the Ariosa v. Sequenom case last Friday, and a discussion of that argument will be posted in due course. Having posted on Sequenom's opening brief and the amicus brief filed by BIO,...more

District Court Finds Genetic Technologies Patent Invalid Under 101 on Motion to Dismiss

Judge Stark of the U.S. District Court for the District of Delaware granted defendants’ motion to dismiss Genetic Technologies, Ltd.’s patent infringement suit with regard to claim 1 of U.S. Patent 5,612,179 on the basis that...more

A Peek at the 60 Minutes GenePeeks Patents

On October 26, 2014, 60 Minutes aired a story called “Breeding Out Disease” that included a segment about GenePeeks, a company that uses genetic information from prospective parents to make thousands of “digital babies” and...more

Examination of Myriad-Mayo Guidance Comments -- BIO Joint Comment

On March 4, the U.S. Patent and Trademark Office issued a guidance memorandum, entitled "Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural...more

What Employers Need to Know - Requests for Medical Information and the Genetic Information Nondiscrimination Act: Avoiding a...

The Genetic Information Non-discrimination Act took effect in November 2009. It should also be noted that many States, including Maryland, have separate statutes prohibiting the acquisition of genetic information and...more

Privacy Issues in the Sharing of Genetic Information

Scientific breakthroughs and technological advancements have led to the emergence of personalized medicine — a practice based on the use of an individual's genetic profile to guide health care decisions made about 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

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

Isolated Nucleic Acids are Patentable in Australia, Again

On Friday the Full Federal Court affirmed that isolated nucleic acids are patentable subject matter in Australia. While an appeal to the High Court of Australia may be possible, absent an appeal, isolated nucleic acids will...more

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