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 …›
“What can be a better day to talk about the complex CRISPR/Cas9 patent landscape than the big day that the Nobel Prize was awarded to pioneers of this revolutionary technology? The story of the continuing dispute on the fundamental CRISPR/Cas9 patents offers a lot …›
By: Michael R. Ward, James J. Mullen III, Bethany J. Hills, Matthew Karlyn, Janet Xiao, Matthew A. Chivvis, Jie Zhou, Anna Yuan, Jillian A. Pesin-Fulop, and Yan Qi
More than 120 life sciences graduate students, post-docs and industry professionals attended the first class of a six part Patent Law Course offered by Morrison & Foerster and the GSAS Harvard Biotech Club on September 16, 2020.
The Harvard Biotech Club is a student organization …›
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 …›
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 …›
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 …›
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 …›
By: Sejin Ahn, Desmond P. O'Sullivan, and James J. Mullen III
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 …›
By: Bethany J. Hills, 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 …›
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