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.
When we discussed the Public Readiness and Emergency Preparedness (PREP) Act earlier this year, we predicted that its tort liability protections would reassure manufacturers and distributors of novel COVID-19 drugs and medical products. So far, so good: the first court decisions interpreting PREP Act …›
The U.S. Food and Drug Administration’s six-month pediatric exclusivity rules that apply to drugs also largely apply to biologics (albeit with certain distinctions), which may become a valuable life cycle management strategy for biopharmaceutical companies (hereinafter “Sponsors”) in addition to patent exclusionary rights. At the …›
The United States Patent and Trademark Office (USPTO) published the latest revision to its Manual of Patent Examining Procedure (MPEP) on June 30, 2020. According to the Executive Summary, in this revision, nearly all of the 27 chapters have been updated to incorporate new …›
The ability of life sciences companies to rely on patent protection for diagnostic methods has been eroded over the last ten years, although recent court decisions evidence a rebuilding framework. While courts have consistently invalidated diagnostic methods as lacking patent eligibility, claims re-framed as …›
This week, on August 3, 2020, the California Supreme Court issued its opinion in Ixchel Pharma, LLC v. Biogen, Inc., which resolved two questions regarding the standards to be applied for non-competition agreements and disputes between businesses in California. The first was whether a …›
A proposed bill offers a potential boon to patent owners. If passed, the “Facilitating Innovation to Fight Coronavirus Act” will add ten years to the patent term of eligible inventions. However, the bill will temporarily curtail patent owner enforcement rights. Passage is not certain, …›
On June 28, 2020, the draft 11th amendment to China’s Criminal Law (the “Draft”) was submitted to the Standing Committee of the National People’s Congress for review. The Draft added a number of crimes intended to “connect” with certain provisions in China’s Human Genetic …›
Joe Adamczyk, Anita Choi, and Michael Ward authored an article for Law360 covering the U.S. Patent and Trademark Office’s (USPTO) decision to begin accepting petitions for the fast-track appeals pilot program, a new program aimed at shaving off time during ex parte appeal. “Appeals entered …›
During its April 2020 meetings, the Standing Committee of China’s National People’s Congress reviewed a number of draft legislations, among which was a draft Biosecurity Law. At the conclusion of the meetings, the second draft of the Biosecurity Law (the “Draft”) was published for …›
On June 30, 2020, the U.S. Food and Drug Administration released its much anticipated guidance on the licensure of COVID-19 (SARS-CoV-2) vaccines. According to the New York Times, there are currently over 145 COVID-19 vaccines in development across the globe with 20 in human …›