Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 164: Emily Chee, US General Manager of Novartis Gene Therapies
Yours, Mine and Ours (not yet!): An Update on the Patentability of Human Genes -
In the legal industry, handling business transactions is part of our daily routine. Managing the transfer of personal data during acquisitions, sales, mergers or bankruptcy proceedings has become second nature to us. We...more
The court-appointed Consumer Privacy Ombudsman (CPO) in the 23andMe bankruptcy last month released a 200-plus-page report assessing the privacy implications of the proposed sale of 23andMe’s assets as part of its Chapter 11...more
Welcome to the Summer of Privacy! As we hit the middle of 2025, California is once again the focus of our attention, as both its legislators and regulators are attempting to square privacy protections with developing...more
On June 18, 2025, the U.S. Food and Drug Administration (“FDA”) announced an immediate review of new clinical trials that export American citizens’ biological materials to countries of concern, such as China, for genetic...more
In Potovsky v. Lincoln Benefit Life Co., the Ninth Circuit Court of Appeals affirmed the dismissal of the insureds’ complaint for failure to sufficiently allege damages regarding the denial of a long-term care claim....more
Several state attorneys general (AGs) and the Federal Trade Commission (FTC) have begun scrutinizing ancestry tracking company 23andMe following its recent announcement that it has filed for Chapter 11 bankruptcy. As part of...more
Last May, the World Intellectual Property Organization (WIPO) adopted a new treaty related genetic resources and traditional knowledge thereof (the “Treaty”). The Treaty will impose new disclosure requirements on patent...more
The new Massachusetts Parentage Act goes into effect in less than a month, on January 1, 2025. While much of the conversation has appropriately been around the changes it brings to laws for LGBTQ+ families, the bill also...more
Direct-to-consumer (“DTC”) genetic testing companies are faced with more scrutiny than ever over their privacy practices, security practices, and data use policies. In December 2023, 23andMe experienced a data breach...more
In November 2023, a class action lawsuit was filed against the genetic testing company, 23andMe. The plaintiffs alleged that a data breach resulted in the unauthorized disclosure of 6.9 million users’ personal and genetic...more
The U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...more
Following nearly twenty-five years of negotiations, members of the World Intellectual Property Organization (WIPO) recently adopted a treaty implementing the new requirement for international patent applicants to disclose in...more
There’s a new wave of class action lawsuits hitting Illinois employers, based on a law that has been under the radar for more than 25 years: The Genetic Information Privacy Act, also known as GIPA. Passed in 1998, GIPA...more
In an important privacy law development, United States District Court for the Northern District of Illinois, Judge Sharon Coleman, has issued two of the first federal decisions applying a substantive analysis to provisions of...more
Precedential and Key Federal Circuit Opinions - 1. NATERA, INC. v. NEOGENOMICS LABORATORIES, INC. [OPINION] (2024-1324, 2024-1409, 7/12/2024) - Moore, Taranto, and Chen Moore, C.J. The Court affirmed the district...more
The United States Patent and Trademark Office (USPTO) released a Notice on the Federal Register (“the Notice”) today requesting public commentary and input on the current state of the experimental use exception. The USPTO is...more
Intentional genomic alterations (IGAs) in animals refer to deliberate changes made to the genetic material of animals. These alterations are designed to introduce, remove or modify specific traits in animals for various...more
On May 24, 2024, after nearly 25 years of negotiations, the World Intellectual Property Office (WIPO) announced that member states, including Canada, had agreed to a new Treaty on Intellectual Property, Genetic Resources and...more
The World Intellectual Property Organization announced on May 24, 2024, a treaty on intellectual property, genetic resources, and associated traditional knowledge that was twenty-five years in the making. As WIPO’s press...more
On Friday, June 14, the Texas Supreme Court declined to consider a case that asked the Court to determine whether frozen embryos are persons or property under Texas law....more
Federal Agency Charged Pharmacy Pressured Employees and Applicants to Fill Expensive Hemophilia Prescriptions with the Company - DENVER – Factor One Source Pharmacy, LLC, a pharmacy providing specialized pharmacy services to...more
After nearly a quarter of a century, the World Intellectual Property Organization (WIPO) has approved the passage of a new IP treaty: the WIPO Treaty on Intellectual Property, Genetic Resources and Associated Traditional...more
Efforts to curtail U.S. reliance on biotechnology companies in the People’s Republic of China (PRC) and prevent certain data of U.S. persons from being provided to the Chinese Communist Party (CCP) have come to the fore this...more
After years of waiting, China’s Ministry of Science and Technology (MOST) finally released the final version of the Implementing Rules on the Human Genetic Resources Administration Rules (Implementing Rules) on 1 June 2023,...more
We have written a couple of times about the 23&Me phenomenon and the chance that those who enter this unknown world come back not just surprised but possibly creeped out by their quest for ancestral knowledge. USA Today...more