MoFo Life Sciences shares timely legal and business insights and in-depth analyses on trends and the complex technologies at the heart of the global pharmaceutical, biotechnology, diagnostics, medical devices, digital health, and AgTech fields.
The pharmaceutical market presents unique challenges to pharmaceutical companies seeking to launch new products. One such challenge involves the lengthy process of executing clinical trials as a prerequisite for obtaining market authorization. In this context, the fact that trademark laws in most jurisdictions …›
The Administrative Regulations of the People’s Republic of China on Human Genetic Resources (the “Regulations”), promulgated by China’s State Council, went into effect on July 1, 2019, superseding prior regulations on China’s human genetic resources (“China HGR”), particularly the 1998 Interim Methods of Human …›
In particular for commercial reasons, pharmaceutical companies have an interest in the confidentiality of documents submitted in connection with the marketing authorization for medicinal products vis-á-vis its competitors as well as vis-á-vis the public. The Court of Justice of the European Union (“CJEU”) ruled in …›
In response to the opinion of European Data Protection Board (EDPB) (see our alert), the European Commission has issued its Question and Answers on the interplay between the Clinical Trials Regulation (CTR) and the General Data Protection Regulation (GDPR) (Q&A). The non-binding Q&A offers …›
On July 3, 2019, in a 7-5 en banc decision, the Federal Circuit declined to reconsider its decision in Athena Diagnostics v. Mayo Collaborative Services,[1] finding that claims to a diagnostic method were patent ineligible for being directed to a law of nature. The …›
On June 21, the Food and Drug Administration (FDA) released a report titled “Statement on agency’s efforts to increase transparency in medical device reporting.”[1] This report describes updates to FDA’s Medical Device Reporting (MDR) Program, namely the conclusion of the Alternative Summary Reporting (ASR) …›
Five Morrison & Foerster attorneys recently participated in the 2nd Annual Blockchain Healthcare Summit in our New York City office, and provided an overview of the current state of the industry, including a discussion of blockchain-enabled applications for compliance, privacy, practitioner credentialing, patient medical …›
Ms. Hills brings a full-service FDA practice to the firm rounding out its market-leading Life Sciences Group Morrison & Foerster, a leading global law firm, is pleased to announce that Bethany J. Hills has joined the firm in the New York office as a partner …›
On May 9, the United States Patent and Trademark Office (“PTO”) published a notice in the Federal Register that it is modifying its patent term adjustment (“PTA”) procedures in view of the Federal Circuit’s decision in Supernus Pharmaceuticals v. Iancu.[1] Under the PTO Duty …›
The United States Supreme Court finally clarified its 11-year-old “clear evidence” standard for pharmaceutical preemption. In its much-anticipated opinion delivered by Justice Breyer, the Court unanimously reversed the Third Circuit’s holding that questions of pharmaceutical preemption should be decided by juries. Merck …›