News & Analysis as of

Genetic Materials

Continuing Coverage of FDA’s Crackdown on Stem Cell Clinics: Florida Clinic Cited for Unapproved Marketing and Inadequate...

by Hogan Lovells on

On the same day that FDA’s Commissioner, Dr. Scott Gottlieb, announced new policy initiatives regarding stem cell therapies and regenerative medicine, FDA announced stepped up enforcement in this area and posted a warning...more

The Domestication History of Apples Revealed by Genomic Analysis

A major conceit of the "genomics" revolution, involving the various species-specific genome projects epitomized by the one for Homo sapiens was the idea that decoding a genome would tell us everything there was to know about...more

Developments in Regenerative Medicine: FDA Announces Plans to Clarify Its Oversight of Cellular Therapy Products and Approves...

by Holland & Knight LLP on

FDA Commissioner Scott Gottlieb, on Aug. 28, 2017, announced steps the agency is taking to begin rolling out policies and guidance documents to clarify its oversight over regenerative medicine products. Dr. Gottlieb...more

Using Genetics to Uncover Human History

Human history is often something modern man only sees as through a glass, darkly. This is particularly the case when that history did not occur in the Mediterranean, the Nile Valley, India, or China, or when there is no...more

Silver Birch Genetics Explained

A recent report in the scientific journal Nature Genetics 49: 904–12 (May 2017), doi:10.1038/ng.3862, disclosed the results of genomic DNA sequencing and analysis of Betula pendula, the silver birch tree....more

Researchers Complete First EPA-Sanctioned GE Algae Field Trial

by Bergeson & Campbell, P.C. on

Researchers at the University of California San Diego (UCSD) and Sapphire Energy completed the first EPA-sanctioned outdoor field trial for GE algae, which was focused on understanding how GE algae perform in outdoor...more

Nations Press for International Restrictions to Govern Genetic Sequence Data

by WilmerHale on

A clash over access to and use of genetic sequence data (GSD) is currently brewing on several international fronts. To date, GSD has been routinely deposited in open-source databases such as GenBank of the National Center for...more

Sovereign immunity shields university from inventorship dispute

by Hogan Lovells on

In a case involving medical methods invented by two Nobel laureates, the U.S. Court of Appeals for the Federal Circuit has ruled that sovereign immunity prevents a third researcher from pursuing his claim of co-inventorship...more

Freedom to Utilize Genetic Resources? The Nagoya Protocol Two Years Later

by WilmerHale on

Two years ago today, the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits from their Utilization to the Convention on Biological Diversity (“Protocol”) entered into international...more

US Environmentalist And Organic Crop Farm Groups Want Overhaul Of Federal Biotechnology Strategy

by Bergeson & Campbell, P.C. on

On August 3, 2016, 24 farmer and public interest organizations wrote to the Obama Administration expressing their disappointment with the direction that the White House Office of Science and Technology Policy (OSTP) has taken...more

Advertising Law - August 2016

Court Awake To Plaintiff’s Deceptive Sleep-Tracking Claims Against Fitbit - A challenge to Fitbit’s claims that certain models of its exercise monitoring device tracked users’ sleep patterns will move forward after a...more

FDA Issues Guidance on Use of Public Human Genetic Variant Databases and Their Use in Personalized Medicine

by Foley & Lardner LLP on

Next Generation Sequencing (NGS) permits the analysis of millions of genetic variants at a time and has proven to be invaluable for the development of personalized or precision medicine. Analysis of whole genomes is providing...more

President Signs Federal GMO Food Labeling Bill

by Morrison & Foerster LLP on

On July 29, 2016, President Obama signed into law the federal genetically engineered (GE) food labeling bill (S. 764). The bill passed the U.S. House of Representatives on July 14, 2016, 306-117, with broad bipartisan...more

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

by Ropes & Gray LLP on

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

by BakerHostetler on

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

by Franczek Radelet P.C. on

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

by DLA Piper on

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

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