By: Otis Littlefield, Bethany J. Hills, Rufus Pichler, and Michael R. Ward
In this third of a four-part podcast series, we discuss the science, regulatory framework, and commercial transactions considerations of a COVID-19 vaccine. Michael Ward, MoFo partner and global head of the firm’s Life Sciences Group and Patent Group, discusses these issues among others with: …›
By: Jean Nguyen, Kristen J. Mathews, Matthew Karlyn, Bethany J. Hills, and Michael R. Ward
In this second of a four-part podcast series on the science, regulatory framework, commercial transactions, and privacy and data security considerations of each unique aspect of the current health crisis, Michael Ward, MoFo partner and global head of the firm’s Life Sciences Group and …›
By: James J. Mullen III, Bethany J. Hills, Matthew Karlyn, Kristen J. Mathews, and Michael R. Ward
In this first of a four-part podcast series on the science, regulatory framework, commercial transactions, and privacy and data security considerations of each unique aspect of the current health crisis, Michael Ward, MoFo partner and global head of the firm’s Life Sciences Group and …›
By: Erin M. Bosman, Julie Y. Park, Bethany J. Hills, and Alexander A. Najarian
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 …›
By: Celeste M Alvarez, Desmond P. O'Sullivan, and James J. Mullen III
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 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 …›
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 …›
By: Bethany J. Hills, 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 …›
By: Bethany J. Hills, 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 to …›
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 …›
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