Unpacking the Science and Legal Considerations of COVID-19 Testing

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 Patent Group, discusses the issues, among other topics, with:

• James Mullen, partner, founder, and head of MoFo’s Antibody Patent Group, and head of the San Diego Patent Group: What exactly is COVID-19 and why does it spread so quickly? Where did the name for the coronavirus originate? How does COVID-19 compare to the flu? What kinds of tests are available, and what can they tell us? What causes test-result delays?
• Bethany Hills, partner and head of MoFo’s FDA Regulatory + Life Sciences Compliance practice: What types of COVID-19 tests are there on the market? How do Emergency Use Authorizations (EUAs) work to lower the barrier for products to make it to market? How many EUAs has MoFo secured for its clients, and how long did they take?
• Matt Karlyn, partner in MoFo’s Commercial Life Sciences Transactions + Licensing Group and in the firm’s Technology Transactions practice: The many pharma, biotech, and tech companies collaborating to test, treat, and track COVID-19 are joining forces faster than usual. When cloud based technologies are involved, MoFo often starts with assessing the criticality of the service and the sensitivity of the data that will be used, stored, or processed. What contingencies do supply agreements need to address? If the collaborations don’t achieve their strategic objectives, what happens to the data?
• Kristen Mathews, partner in MoFo’s Global Privacy + Data Security practice: Can employers require employees to take COVID-19 tests? How must they protect the test results and how do U.S. Equal Employment Opportunity Commission guidelines and state laws apply?