DNA

News & Analysis as of

Potchain 1.0 and Blockchain

This is not a post about marijuana, weed, dope, pot or whatever you want to call marijuana. Well, maybe it is, but from a technological perspective on how the legal cannabis industry is embracing blockchain technology. If you...more

Patenting in Canada: Do These Genes Fit?

The Supreme Court of Canada has commented on the issue but no Canadian court has directly answered the difficult question of whether genes are patentable. So the answer appears to be yes, for now. Identifying genetic...more

Court Denies Preliminary Injunction in Light of Pending IPR of Similar Patent Claims

A district court judge denied a plaintiff’s motion to preliminarily enjoin a defendant from selling saliva collection kits for DNA testing....more

Energy Technology Connections Newsletter: Your Law Firm Link to Industry News - September 2016

Leaders in the News: EnerNOC - This month we’d like to highlight EnerNOC, a leading provider of energy intelligence software (EIS) that supports decision-making around energy costs and sustainability issues. EnerNOC...more

Bad Science Makes Bad Patent Law—No Science Makes It Worse (Part II)

In Part I, I explained some general criteria for laws of nature, considering the prototypes of Newton's laws and Einstein's E=mc2. Now I'll turn to whether there are laws of nature in biology. Biological generalizations,...more

"Assuming" the Obvious: Exclusion for “Assumption of Liability in a Contract” Does Not Apply to Breach of Professional Services

In what it described as a case of first impression, the Northern District of California ruled that a professional liability policy that excluded the insured’s “assumption of liability obligations in a contract or agreement”...more

The Supreme Court to Tackle Extraterritorial Reach of U.S. Patents

The Supreme Court recently granted certiorari in Life Techs. Corp. v. Promega Corp., 14-1538, to resolve: “[w]hether a supplier can be held liable for providing ‘all or a substantial portion of the components of a patented...more

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

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

Keeping Up To Date On CRISPR – July 2016

CRISPR is a gene editing technique that promises to revolutionize genetic engineering, but already is raising ethical, business, and legal issues. This is the first in a monthly series of articles on CRISPR. ...more

FDA Issues Draft Guidance To Streamline Regulatory Oversight Of NGS-Based Tests For Diagnosing Germline Diseases

Personalized or Precision Medicine needs reliable and accurate diagnostic tests to guide clinical intervention and treatment decisions. Traditional testing of germline variants is site-specific and therefore only provides...more

FDA Issues Draft Guidance as Part of Precision Medicine Initiative

The two draft guidance documents are intended to streamline the review of next generation sequencing-based tests. On July 8, the US Food and Drug Administration (FDA or Agency) issued two draft guidance documents...more

FDA’s new Next Generation Sequencing Draft Guidance leaves fundamental questions unanswered: key points

The Food and Drug Administration has released a 25-page Draft Guidance document addressing FDA oversight of certain applications of Next Generation Sequencing (NGS)-based technology. The Draft Guidance - "Use of Standards in...more

Next-Generation Sequencing: FDA Issues New Guidance for Genetic Tests

On July 6, 2016, the U.S. Food and Drug Administration (“FDA” or “Agency”) released the following two draft guidance documents on the oversight of next-generation sequencing (“NGS”) tests...more

FDA Comes Through on Promise to Release NGS Device Draft Guidelines Expeditiously

Building on last year’s public workshops related to Next-Generation Sequencing (NGS) and expanding its efforts to advance the Obama Administration’s Precision Medicine Initiative, the FDA late last week released two draft...more

FDA Releases Outline of Guidance for Developing Tests Based on Human Genetic Variants

The FDA is charged with regulating “Next Generation Sequencing (NGS) Tests,” and has just released draft guidance on what needs to be regulated. (A copy of the first draft and second draft can be found at the end of this...more

Carry on as Before: Supreme Court Refuses Sequenom’s Petition

To the surprise of many, including myself, the Supreme Court denied Sequenom’s petition for writ of certiorari (“Petition”). Sequenom asked the Court whether the inventive concept required under the Mayo/Myriad framework can...more

Supreme Court Denies Sequenom’s Cert Petition, Leaving the Federal Circuit’s Interpretation of the Mayo/Alice Patent Eligibility...

The Supreme Court today denied Sequenom Inc.’s petition for writ of certiorari, in which Sequenom asked the Court to review a decision of the Federal Circuit invalidating its patent on a breakthrough prenatal diagnostic...more

EMA’s New Draft Guideline On Good Pharmacogenomic Practice - Implications For Personalized Medicine

Embracing personalized medicine, the European Medicines Agency (EMA) released a draft guidance document titled Draft Guideline on Good Pharmacogenomic Practice (“Guidance”) on good pharmacogenomic practice with the stated...more

Privacy Tip #38 – Genetic Privacy and the Use of Genomic Information

Genetic information is basically one’s DNA sequence, which includes health information and genetic information about the individual and their family. It is at the core of one’s individual privacy, as well as providing...more

Subject Matter Eligibility Guidance -- Example on Screening for Gene Alterations

Last month, the U.S. Patent and Trademark Office issued further guidance for determining subject matter eligibility under 35 U.S.C. § 101. In addition to a memorandum on subject matter eligibility determinations that was...more

IP Developments In Biotechnology And Trade Secrets

2016 has been a year of IP changes and these changes have had an effect upon biotechnology as well as trade secrets. Patents: Will the U.S. Supreme Court Grant Cert. In Ariosa v. Sequenom? Ariosa v. Sequenom was...more

Ariosa Files Opposition to Sequenom’s Cert Petition

Ariosa Diagnostics, Inc., Natera, Inc., and DNA Diagnostics Center, Inc. have filed briefs in opposition to Sequenom’s petition for writ of certiorari to the Supreme Court for review of the Federal Circuit’s decision holding...more

The Government Whittles Away at Life Sciences Patents

The current U.S. Supreme Court has been noted for its hostility to patent holders in general, but the Supreme Court has been especially hostile to any sort of life sciences or software invention. The Court has attempted to...more

Biotech Industry Supports Cert in Sequenom to Avert “Crisis of Patent Law and Medical Innovation”

The biotechnology and life sciences community has voiced broad support for Sequenom’s recent request that the Supreme Court review the Federal Circuit’s decision holding Sequenom’s diagnostic fetal DNA patent ineligible under...more

Sequenom v. Ariosa Diagnostics: A Supreme Court Petition that Requests Clarification on the Patent Eligibility of Diagnostic...

UUnder 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

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