Is Messenger RNA Patent-Eligible?
Amid ongoing patent disputes over the mRNA platform, a significant scientific question remains unanswered: whether mRNA itself even is patent eligible.
mRNA
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Read more: Unlocking the mRNA Platform Technology: Walking the Talk with Investment Protection Unlocking the mRNA Platform Technology: Walking the Talk with Investment Protection
Recent articles emphasize the need to reform intellectual property protections for government-funded inventions of public health significance.
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Read more: The Secret World of mRNA: HDT Bio Corp v. Emcure and Access to Next-Gen mRNA The Secret World of mRNA: HDT Bio Corp v. Emcure and Access to Next-Gen mRNA
The future of public health in an “RNA world” is on trial in a trade secrecy dispute worth $950 million.
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Read more: Accessing COVID-19 mRNA Vaccines for Research: The Re-emergence of the Tragedy of the ‘Anticommons’ Accessing COVID-19 mRNA Vaccines for Research: The Re-emergence of the Tragedy of the ‘Anticommons’
COVID-19 vaccine manufacturers refusing to share samples may be the latest example of the tragedy of the “anticommons” in biomedical research.
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Read more: Will NIH Learn from Myriad when Settling Its mRNA Inventorship Dispute with Moderna? Will NIH Learn from Myriad when Settling Its mRNA Inventorship Dispute with Moderna?
The NIH, which funded much of Moderna’s research on the COVID-19 vaccine, should be assertive in exerting control over the results of this research.
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Read more: Why Do Differences in Clinical Trial Design Make It Hard to Compare COVID-19 Vaccines? Why Do Differences in Clinical Trial Design Make It Hard to Compare COVID-19 Vaccines?
Because of differences in how they were tested in clinical trials, it is difficult to make apples-to-apples comparisons for COVID-19 vaccines.
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Read more: What’s the Difference Between Vaccine Approval (BLA) and Authorization (EUA)? What’s the Difference Between Vaccine Approval (BLA) and Authorization (EUA)?
A Biologics License Application, or BLA, is FDA’s standard “full approval” mechanism for biological products, including therapeutics and vaccines.
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Read more: How Can Policymakers Overcome the Hurdles to Scaling up Antibody Manufacturing? How Can Policymakers Overcome the Hurdles to Scaling up Antibody Manufacturing?
The difficult manufacturing issues involved in the therapeutic antibody context, and what might be done to address them.
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Read more: Why Aren’t Therapeutic Antibodies Being Used More to Treat COVID-19? Why Aren’t Therapeutic Antibodies Being Used More to Treat COVID-19?
The rapid development of therapeutic antibodies is a triumph of biomedical innovation. But they won’t help unless they make it to patients.
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Read more: What Can Policymakers Learn from the Slow COVID-19 Vaccine Rollout? What Can Policymakers Learn from the Slow COVID-19 Vaccine Rollout?
In this post we explain what went wrong and how policymakers can correct course for COVID-19 and avoid such disasters in the future.
