Tag: Pharmaceutical industry
Chamber Advocates for March-in Proposal Amid IP Community’s Anticipation of Biden’s Decision
The U.S. Chamber of Commerce's Global Innovation Policy Center (GIPC) has been actively advocating for the expansion of the march-in rights provision under the Bayh-Dole Act as the intellectual property (IP) community eagerly anticipates...
Navigating the Debate: Life Sciences Innovation vs. Drug Pricing Advocates
The U.S. Patent and Trademark Office (USPTO) is currently in the midst of a public comment period regarding proposed rule changes on terminal disclaimers, which are used to overcome non-statutory double patenting rejections. As...
Skinny Labeling: Impact of GSK v. Teva on Regulatory Compliance and Generics Market
Congress enacted the Hatch-Waxman Act to strike a balance between promoting generic competition and encouraging pharmaceutical innovation. The Act requires innovators to disclose patents to the FDA for listing in the Orange Book, while...
FDA Center for Clinical Trial Innovation: Improving Trial Processes and Patient Safety
In April 2024, the U.S. Food and Drug Administration Center for Drug Evaluation and Research (CDER) introduced the Center for Clinical Trial Innovation (C3TI) to enhance communication and collaboration in clinical trials. C3TI aims...