The Civil Rights Challenge to Gene Patenting
The ACLU mounted an unprecedented challenge the entire practice of gene patenting in America. And, against the odds, they won.
patents
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Read more: The Civil Rights Challenge to Gene Patenting -
Read more: Fatty Acids, Skinny Labels: Fish Oil Patent Battle Back in Court Fatty Acids, Skinny Labels: Fish Oil Patent Battle Back in Court
An ongoing patent battle over omega-3 fatty acids may have broad implications for the marketing of generic drugs.
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Read more: The Patent Trial and Appeal Board Again Survives Supreme Court Review The Patent Trial and Appeal Board Again Survives Supreme Court Review
For the generic drug and biosimilar industries, the Supreme Court’s recent decision in United States v. Arthrex, Inc. comes as a relief.
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Read more: “Stick to the Science”? FDA, Ethics, and Pandemics “Stick to the Science”? FDA, Ethics, and Pandemics
This post reflects on the ethical implications of FDA’s use of its emergency powers, and suggests opportunities for greater accountability moving forward.
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Read more: The Patent Trial and Appeal Board Returns to the Supreme Court The Patent Trial and Appeal Board Returns to the Supreme Court
How the Court decides United States v. Arthrex will have important implications for patent law and for administrative law more generally.
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Read more: 3 Challenges to Patents on Therapeutic Monoclonal Antibodies 3 Challenges to Patents on Therapeutic Monoclonal Antibodies
Three developments may have effects on the use of patents to fend off competition for therapeutic monoclonal antibodies.
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Read more: Pharmaceutical Patents on Manufacturing Methods: Groundless or Well-Supported? Pharmaceutical Patents on Manufacturing Methods: Groundless or Well-Supported?
Are manufacturing method patents warranted intellectual property protections, or groundless obstacles to competition?
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Read more: When “Pay-for-Delay” Becomes “Delay-Without-Pay”: Humira Antitrust Claims When “Pay-for-Delay” Becomes “Delay-Without-Pay”: Humira Antitrust Claims
In this post, I explore several problematic aspects of the court’s reasoning for rejecting the claims of pay-for-delay and market allocation.
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Read more: From 9/11 to COVID-19: A Brief History of FDA Emergency Use Authorization From 9/11 to COVID-19: A Brief History of FDA Emergency Use Authorization
The history of EUA involves fundamental questions about the role of public officials, scientific expertise, and administrative norms in times of crisis.
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Read more: AbbVie Wins First Round in Humira Antitrust Lawsuit AbbVie Wins First Round in Humira Antitrust Lawsuit
The purpose of the secondary patent filings was to assemble a thicket of patents, 132 in all, to prohibit competition from biosimilar companies.
