FDA Establishes Clear Requirements for COVID-19 Vaccine
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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.
- 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... ›
Expedited Trademark Applications for COVID-19-Related Goods and Services
By: Joyce Liou and Eoin Connolly
Recognizing the need for companies to quickly get products to market that might help combat the COVID-19 pandemic, the United States Patent & Trademark Office is now paving the way for shorter examination timelines for qualifying trademark applications. This could prove especially useful in... ›How FDA Is Monitoring the COVID-19 Product Market
By: Erin M. Bosman and Julie Y. Park
FDA is actively “monitor[ing] the online ecosystem for fraudulent products peddled by bad actors seeking to profit from this global pandemic.” The agency says it has discovered hundreds of fraudulent COVID-19 products, including drugs, test kits, and PPE sold online with unproven claims. It is working... ›FTC Seeks Comments on Health Breach Notification Rule
By: Melissa M. Crespo
The Federal Trade Commission (FTC) recently announced a review and open comment period for the Health Breach Notification Rule, 16 C.F.R. Part 318 (the “Rule”), which requires vendors of personal health records (PHR) and related entities that aren’t covered by HIPAA to provide notice... ›- - United States, FDA, Medical Devices + Diagnostics, COVID-19, Product Liability + Class Action, Healthcare
FDA Signals Flexibility with COVID-19 Tests
By: Erin M. Bosman and Julie Y. Park
A bipartisan group of experts in economics, health, technology, and ethics recommended that the U.S. scale up COVID-19 testing—5 million per day by June, 20 million per day by midsummer—in order to fully re-mobilize the economy. Consistent with this, FDA has taken various steps... › Japan Moves to Tighten Restrictions on Foreign Investment in Healthcare Industries
By: Gary Mitchel Smith
Amid concerns about predatory acquisitions of weakened companies and strategic assets during the COVID‑19 crisis, more and more countries are restricting foreign direct investment (FDI) in their domestic companies, especially in the medical and healthcare industries. These restrictions tend to target Chinese investment in... ›Germany Adopts Administrative Trademark Cancellation Actions
By: Robert Grohmann
On May 1, 2020 the last part of the German Trademark Law Modernization Act ( Markenrechtsmodernisierungsgesetz – “MaMoG”), which contains practical relevant amendments to the procedural rules of the German trademark system, took effect. In particular, an administrative procedure for the revocation and the... ›Free Prioritized Examination for COVID-19 Patent Applications
The United States Patent and Trademark Office (USPTO) announced a Prioritized Examination Pilot Program for COVID-19-related patent applications. To qualify, an applicant must be a small entity or micro-entity and the application must contain at least one claim covering products or process that are... ›The USPTO Says No to Naming AI as a Patent Inventor
By: Anna Yuan and Karen G Potter Ph.D.
The increase in AI-related patent filings in the past few years has given rise to unique questions about the current patent system. In particular, the question of whether an AI system can or should be named as an inventor on a patent application has... ›COVID-19 Alert: FDA updates antibody test policy
By: Erin M. Bosman and Julie Y. Park
Serology tests could play a critical role in the fight against COVID-19. Serology tests may help determine who can donate convalescent plasma—a part of the blood containing antibodies—which is currently being explored as an investigational treatment for those with COVID-19. Convalescent plasma has been... ›