COVID-19 and the FDA Emergency Use Authorization Power
This blog post provides an overview of the FDA’s emergency authorization powers and analyzes the extent of their usage in the COVID-19 pandemic.
patents
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Read more: How are COVID-19 Vaccine Manufacturers Building Trust in the FDA’s Approval Process? How are COVID-19 Vaccine Manufacturers Building Trust in the FDA’s Approval Process?
Pharmaceutical companies are now also engaging the public themselves in an attempt to build trust in their products.
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Read more: Compulsory Licensing for Pharmaceuticals in the EU: A Reality Check Compulsory Licensing for Pharmaceuticals in the EU: A Reality Check
To secure widespread access to a COVID-19 vaccine, many countries plan to seek refuge in a long-existing strategy: compulsory licensing.
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Read more: Deconstructing Moderna’s COVID-19 Patent Pledge Deconstructing Moderna’s COVID-19 Patent Pledge
In the high-stakes market for COVID-19 vaccines, it is worth considering what motivates a private firm to relinquish valuable IP rights.
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Read more: How Does Moderna’s COVID-19 Vaccine Work, and Who Is Funding Its Development? How Does Moderna’s COVID-19 Vaccine Work, and Who Is Funding Its Development?
Moderna’s vaccine works using a completely novel mechanism, unlike any other vaccine currently approved anywhere in the world.
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Read more: COVID-19 Vaccine Advance Purchases Explained COVID-19 Vaccine Advance Purchases Explained
No vaccine for the novel coronavirus has been approved. Nevertheless, governments and organizations are making deals for tens of millions of doses.
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Read more: To Cut Prescription Drug Spending, Stop Delays for Generic Competition To Cut Prescription Drug Spending, Stop Delays for Generic Competition
While generic competition is crucial for reducing drug prices, brand-name drug manufacturers can utilize several strategies to delay such competition.
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Read more: Patent Fakes: How Fraudulent Inventions Threaten Public Health, Innovation, and the Economy Patent Fakes: How Fraudulent Inventions Threaten Public Health, Innovation, and the Economy
What if you have a great idea for a new technology, but never actually create it, test it, or determine that it works? Is that patentable?
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Read more: Opportunities and challenges for user-generated licensing models in gene-editing Opportunities and challenges for user-generated licensing models in gene-editing
By Timo Minssen, Esther van Zimmeren & Jakob Wested An earlier version of this contribution had been published in Life Science Intellectual Property Review (LSIPR). A voluntary pool or clearinghouse model may give rise to a robust commercial ecosystem for CRISPR and could include special provisions for royalty-free research use by academics. Hence, there may be a path through…
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Read more: Will the EPO’s Enlarged Board of Appeal step into the CRISPR patent battle? Will the EPO’s Enlarged Board of Appeal step into the CRISPR patent battle?
By Jakob Wested, Timo Minssen & Esther van Zimmeren Another version of this contribution has been published in Life Science Intellectual Property Review (LSIPR). The Broad Institute is facing a formidable task in defending the revoked CRISPR patent claims in their pending appeal at the European Patent Office (EPO). Ultimately, some of the issues might still be referred…