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 -
On November 13, 2025, the Genetic Technology (Precision Breeding) Regulations 2025 (“2025 PB regulations”) took effect, completing the United Kingdom’s (UK’s) post-Brexit framework for gene-edited plants. The Regulations...more
For autologous cell and gene therapies (CGTs), the collection of patients‘ cells is the first step in the manufacture of the medicinal product. In Germany, this step is usually conducted by specialized treatment centers that...more
California Breaks New Ground with First-Ever AI Companion Chatbot Safety Law - “SB 243 sets mandatory safety protocols to shield children and at-risk users from documented dangers tied to AI chatbot interactions.”...more
Confirmatory adoptions are an easy and accessible way to create security and peace of mind for families formed via assisted reproduction. Assisted reproduction refers to a broad range of medical procedures used to address...more
This article is the third in our new series, “Trends in Cell, Tissue, and Gene Therapies,” which aims to help you stay informed about the broad array of legal and regulatory issues affecting companies operating in the...more
On Wednesday, the U.S. Food and Drug Administration (FDA) published three new draft guidances that aim to offer greater clarity to sponsors of cell and gene therapies (CGTs) on issues related to clinical trial design,...more
In 2025, Life Sciences and Health Care (LS&HC) companies face rapidly evolving regulatory paradigms that create transactional risks and require daily monitoring. After more than 70 national elections in 2024, the dust hasn’t...more
Recent reviews of genetic research continue to challenge long-held assumptions about the causes of malignant mesothelioma. While plaintiffs’ attorneys often cite to asbestos exposure as the only cause of mesothelioma, a...more
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