[IP Hot Topics Podcast] Innovation Conversations: Dr. Claire Fraser
Clinton: SCOTUS Myriad Genetics Decision 'Terrific'
Goldstein: Expect More Litigation in Wake of Myriad Gene Patent Decision
Are Human Genes Patentable? Supreme Court Hears Oral Arguments in Myriad Case
Can You Patent Human Genes? ACLU Says No
Yours, Mine and Ours (not yet!): An Update on the Patentability of Human Genes -
Yours, Mine and Ours (not yet!): An Update on the Patentability of Human Genes
The recent $30 million settlement between 23andMe and 6.4 million users following a major data breach offers important lessons for businesses dealing with sensitive genetic and genomic information....more
Legal challenges for innovative cell, tissue, and gene therapies (CTGTs) are mainly seen in the still evolving regulatory environment. However, it is also crucial for the manufacture and supply of CTGTs to have agreements in...more
Gene editing (GE) therapies hold immense promise for treating a myriad of diseases. Like most novel products, their development and regulatory approval necessitate careful consideration of critical factors. FDA officials...more
Valentine’s Day seemed an odd time to report the subject but CNN posted a five minute story provocatively titled as “I Slept with My Half Sibling.” This recounts the story of a Connecticut social worker who had symptoms of a...more
We previously alerted readers to the fact that the most recent data compromise of 23andMe exposed data related to Ashkenazi Jews and individuals of Chinese descent. It is reported by Ars Technica, citing TechCrunch, that...more
On December 8, 2023, the U.S. Food and Drug Administration (FDA) approved two new gene therapies for the treatment of sickle cell disease. The first, Casgevy™ (exagamglogene autotemcel (exa-cel)), is the first-ever approved...more
We previously reported on the unfortunate data breach suffered by 23andMe last month and its implications. We never imagined how horrible it could be....more
Ever since Watson and Crick ended their seminal Nature paper in 1953 by saying that: "It has not escaped our notice that the specific pairing we have postulated immediately suggests a possible copying mechanism for the...more
Over the past five years, cell and gene therapies have increasingly moved from the R&D pipeline to the health care setting, putting lifesaving treatments for certain cancers and genetic diseases within patients’ reach. Over...more
A recent enforcement action by the Federal Trade Commission (“FTC”) against 1Health.io—which sells “DNA Health Test Kits” to consumers for health and ancestry insights—serves as a reminder that the FTC is increasingly...more
Gene therapy aims to treat the underlying genetic cause of a disease rather than only the symptoms. It involves the delivery of properly functioning DNA into a patient’s genetic material to correct an underlying genetic...more
The investments in Advanced Medicinal Products (ATMPs) that use gene therapy, somatic cell therapy, and engineered tissues for preventing, treating, or curing human diseases probably represent the biggest innovation in the...more
Cell and gene therapy transactions have increased dramatically over the last few years, in both number and complexity, and have given rise to a number of issues that merit further attention. In the article below, we outline a...more
The Ministry of Science and Technology of China has finally issued the draft of Implementation Rules for the Regulations of Human Genetic Resources Administration for public comments on March 21, 2022, which gives more...more
In the previous blog post, we discussed a few highlights of the Implementing Rules for Human Genetic Resources Management (draft for comment) (人类遗传资源管理条例实施细则（征求意见稿）)(the “Draft Rules”). In this blog post, we will discuss a...more
On March 21, 2022, the Ministry of Science and Technology of the People’s Republic of China published the Implementing Rules for Human Genetic Resources Management (draft for comment) (人类遗传资源管理条例实施细则（征求意见稿）)(the “Draft...more
On March 14, 2022, U.S. Food and Drug Administration (FDA) issued two draft guidances: “Human Gene Therapy Products Incorporating Human Genome Editing (GE)” and a draft guidance on Chimeric Antigen Receptor (CAR) T cell...more
Last week the U.S. Food and Drug Administration (FDA) issued a long-awaited draft guidance, Human Gene Therapy Products Incorporating Human Genome Editing, that addresses key considerations for the development of gene therapy...more
On July 1, 2019, the Administrative Regulations on Human Genetic Resources (人类遗传资源管理条例) (the “Regulations”) issued by the State Council of the People’s Republic of China (the “PRC”) came into effect. On October 17, 2020, the...more
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
2021 was a fascinating year in biotech, especially for legal issues. Of course, 2021, as the second year of a global pandemic, must be viewed in context with 2020....more
Last month, California Governor Gavin Newsom signed Senate Bill 41, the Genetic Information Privacy Act (“GIPA”), a law that regulates “direct-to-consumer genetic testing companies” that handle the “genetic data” of...more
The Sunday edition of the Philadelphia Inquirer presented a set of stories which are becoming common in a world where Americans can buy DNA kits at the drug store and begin an online search for their ancestry. The sometimes...more
Editor’s Note: In a recent webinar, Manatt Health’s Anthony Fiori, Senior Managing Director, and Alex Dworkowitz, Partner, hosted a panel of innovative thought leaders—including Dr. Sanjiv Shah, Chief Medical Officer of...more
On September 30, 2021, the U.S. Food and Drug Administration (FDA) announced final guidance titled “Interpreting Sameness of Gene Therapy Products under the Orphan Drug Regulations.” The guidance finalizes the January 2020...more