News & Analysis as of

DNA Pharmaceutical Industry Diagnostic Tests

Robinson+Cole Data Privacy + Security Insider

Privacy Tip #314 – Got a Genetic Testing Kit for Christmas? Read this Before you Send In That Swab

I have written about genetic testing kits before, but this subject matter is worth repeating. I find that people don’t always understand the consequences when sending a swab to a genetic testing company.  Consumer Reports...more

Womble Bond Dickinson

The Analysis of Cell Free DNA in Urine for Cancer Diagnosis – A Prospective Alternative to Liquid Biopsy?

Womble Bond Dickinson on

A promising new technology may make the diagnosis of cancer and genetic mutation testing as easy as performing a urinalysis as part of an annual physical exam.  Cancer could be detected at its earliest stages, when treatment...more

McDonnell Boehnen Hulbert & Berghoff LLP

Appendiceal Cancer Shows Age-related Somatic Gene Variants with Potential Diagnostic Relevance

Cancer of the appendix is a very rare form of cancer, having an incidence of 0.12 per 1,000,000 person-years (Siegel et al., 2020, Cancer statistics 2020 70:7-30).  Incidence is rising (by 232% from 2000-2016 in the U.S.)...more

Hogan Lovells

California Governor vetoes bill to establish the Genetic Information Privacy Act

Hogan Lovells on

California’s “Genetic Information Privacy Act” (SB 980), vetoed on September 25, 2020 by Governor Gavin Newsom, would have established obligations for direct-to-consumer (“DTC”) genetic testing companies and others that...more

Robins Kaplan LLP

Section 101 Love in the Time of COVID-19, with Apologies to Gabriel García Márquez

Robins Kaplan LLP on

It is a good bet that everyone has a heightened appreciation for diagnostic technology right now. The countries that have fared reasonably well during the ongoing pandemic are those with meticulous testing regimens. After...more

Mintz

Federal Circuit Invalidates Diagnostic Method Claims for Prenatal Test Under 35 U.S.C. 101

Mintz on

On June 12, 2015, the Federal Circuit affirmed the finding of U.S. District Court for the Northern District of California (“District Court”) that the method claims in U.S. Patent 6,258,540 (‘540 patent) for detecting...more

Goodwin

Federal Circuit Holds Medical Diagnostic Method Patent Invalid as Claiming Ineligible Subject Matter

Goodwin on

Background - In two recent cases, Mayo v. Prometheus and Alice v. CLS Bank, the Supreme Court established a two-part test for determining eligibility for patenting. In step one, the court asks whether the claim is...more

Dorsey & Whitney LLP

Patent for Technology that “Revolutionized Prenatal Care” Nonetheless Invalid as Patent Ineligible

Dorsey & Whitney LLP on

The Federal Circuit Friday held in Ariosa Diagnostics, Inc. v. Sequenom, Inc. that Sequenom’s patent directed toward its MaterniT21 test—involving methods of detecting and using cell-free fetal DNA— was invalid for lack of...more

Foley & Lardner LLP

California Court Holds Diagnostic Claims Not Patent-Eligible

Foley & Lardner LLP on

In one of the first district court decisions applying the U.S. Supreme Court’s new Myriad patent-eligibility standard, the Northern District of California held that diagnostic claims containing only conventional and existing...more

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