Genetic Materials

News & Analysis as of

CMS Issues Final Rule on Overhaul of Clinical Diagnostic Laboratory Test Payment System

On June 17, 2016, the Centers for Medicare & Medicaid Services (“CMS”) issued a final rule (the “Final Rule”) that makes significant changes to Medicare reimbursement for clinical diagnostic laboratory tests (“CDLTs”)....more

July Fireworks: Federal Circuit Finds Claims to Cryopreservation Method Eligible Under 35 USC §101

On July 5, the Federal Circuit found claims directed to cryopreservation methods for hepatocytes patent eligible under 35 USC §101, reversing the district court decision finding the claims invalid on motion for summary...more

CAFC Hands Down Significant § 101 Decision in Bascom Global Internet

In Bascom Global Internet v. AT&T Mobility LLC, Bascom Global sued for infringement of US Patent No. 5,987,606, titled “Method And System For Content Filtering Information Retrieved From An Internet Computer Network,”...more

Sometimes we get to see miracles…

I returned from being out of town for work for most of the week, tired from traveling across the country, when my cell phone rang. I answered to hear the high-pitched, somewhat squeaky, but excited voice of Hannah Sames say,...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

PTAB Denies IPR Petitions against Cold Spring Harbor Laboratory Patents

Cold Spring Harbor Laboratory (CSHL) is a storied institution in molecular biology, being the site of annual meetings related to this view of life since Schrodinger proposed to use quantitative methods to examine biology in...more

Will "Open Source" be the Future of Genetic Diagnostics?

One of the effective arguments made by the ACLU in the AMP v. Myriad case was that somehow permitting patents on genes implicated a patient's privacy right in her genetic material. This was also the theme of their public...more

New GE Ingredient Labeling Bill Intensifies Food Fight in Congress

The latest salvo in the legislative food fight over genetically engineered (GE) ingredients came from the Senate, where Agriculture Committee Chairman Pat Roberts (R-KS) has introduced a bill that would instruct the Secretary...more

News from Abroad: IP Australia Releases Myriad Examination Guidelines

Following the recent public consultation in view of the Australian High Court's decision in D'Arcy v Myriad Genetics ("Myriad"), IP Australia has released new Examination Guidelines for applications which may be affected by...more

EEOC Issues Proposed Rule on Wellness Programs and GINA

The Equal Employment Opportunity Commission (EEOC) has issued a proposed rule amending prior regulations under the Genetic Information Nondiscrimination Act of 2008 (GINA) to address incentives in workplace wellness programs....more

FDA to Host First Public Meeting on Biotech Regulation Overhaul

On October 15, 2015, the Food and Drug Administration (FDA) posted notice of a public meeting to be held on Friday October 30th, in order to clarify the current roles and responsibilities described in the Coordinated...more

Health Alert (Australia) - October 12, 2015

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgments: Australia. High Court 7 October 2015 - D'Arcy v Myriad Genetics Inc [2015] HCA 35 The High Court has unanimously...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

News from Abroad: Australian High Court Has Ruled in Myriad Gene Patent Case

The Australian High Court yesterday unanimously overturned six lower court judges and dismissed some very careful reasoning to not only follow the U.S. Supreme Court in invalidating claims to the BRCA1 and 2 gene sequences,...more

News from Abroad: High Court Rules Myriad's BRCA Genes Not Patentable Subject Matter in Australia

Just over one year after the Full Federal Court of Australia unanimously upheld an earlier Federal Court decision that naturally occurring nucleic acid molecules are patentable in Australia, the High Court of Australia has...more

Australia High Court Rules Against Gene Patents

Colleagues in Australia have been spreading the bad news: The High Court of Australia followed the lead (?) of the U.S. Supreme Court and determined that Myriad cannot patent the isolated BRCA1 gene in Australia. Thanks to...more

News from Abroad: Isolated Nucleic Acids Not Patentable in Australia

D'Arcy v. Myriad Genetics Inc & Anor [2015] HCA 35 - The High Court of Australia today handed down its decision in D'Arcy v Myriad, deciding once and for all that isolated nucleic acids do not define patent-eligible...more

News from Abroad: Isolated Gene Sequences Suffer A Cruel Fate in the Hands of the High Court of Australia

D'Arcy v Myriad Genetics Inc [2015] HCA 35 - The High Court of Australia has today handed down its decision in D'Arcy v Myriad Genetics Inc [2015] HCA 35, unanimously striking down the validity of the first three claims...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

EPA Announces Beginning Of Public Dialog For Synbio Algae Development And Use

The U.S. Environmental Protection Agency (EPA) announced last week that it is developing a project intended to support public dialog concerning the development and use of synthetic biology (Synbio) algae. EPA has oversight...more

EPA Posts Information on GM/Synbio Algae Project

The U.S. Environmental Protection Agency (EPA) announced last week that it is developing a project intended to support public dialog concerning the development and use of synthetic biology (synbio). EPA has oversight...more

White House Announces Plans To Revise the Coordinated Framework for the Regulation of Biotechnology

The White House, through the Office of Science and Technology Policy (OSTP), announced a major initiative to overhaul the regulation of biotechnology products (OSTP Memo), which are products developed through genetic...more

European alliance of plant breeders fails to halt the march of the Nagoya Protocol

The CJEU has rejected two challenges to the EU Regulation implementing the Nagoya Protocol. This piece of international law has changed significantly the way that biological natural resources are accessed, researched and...more

News from Abroad: High Court of Australia Hears Myriad Appeal

The High Court of Australia today heard the long anticipated appeal from the unanimous decision of a 5-judge bench of the Full Federal Court to allow Myriad's claims to isolated nucleic acids. The question before the...more

What Does Pharmacogenomics Have To Do With Product Liability? – Potentially Everything

Recently, Bexis attended the DRI drug and device committee spring conference. Among other things he heard a bang-up presentation on genomics and personalized (also known as “precision”) medicine from Paige Sensenbrenner. On...more

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