1. US Legal and Regulatory Update.
- Author
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Schlapkohl, Walter A.
- Subjects
- *
TECHNOLOGY transfer , *MEDICAL masks , *SICKLE cell anemia , *PRICE regulation , *PATENT suits - Abstract
The article discusses the use of march-in rights to lower drug prices in the United States. March-in rights, which were established by the Bayh-Dole Act in 1980, allow the government to license patents to others if the recipient of federal funding fails to make reasonable efforts to use the patented technology. The Biden administration has proposed a framework for considering the exercise of march-in rights in situations where drug prices are deemed unreasonable. The draft guidance does not specify what prices are considered reasonable, but it provides a hypothetical scenario to illustrate the considerations involved. The article acknowledges the challenges of balancing access to affordable treatments with the promotion of innovation in the pharmaceutical industry. The proposed framework has received criticism, and the debate on this issue is ongoing. [Extracted from the article]
- Published
- 2024
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