Posts Tagged: "Congress"

Three Congressional Letters Show the March-In Debate Has Shifted

When the Biden Administration unleashed its proposed march-in guidelines last December, it claimed they would be a powerful tool for lowering drug prices by allowing the government to “march in” to license copiers under the authorities of the Bayh-Dole Act. It did so despite previously joining every other Administration denying price control petitions as not authorized under the law. It should have known the proposal would have minimal impact on drug prices—but would have a devastating impact on American innovation. That’s because the guidelines apply to all federal R&D agencies—not just the National Institutes of Health — so they cover inventions across the spectrum, not just the life sciences.  Now the chickens are coming home to roost. Three Congressional letters illustrate the point.

HELP Committee Grills Pharma Reps on U.S. Drug Pricing Problems

The U.S. Senate Committee on Health, Education Labor & Pensions held a hearing today on why the United States pays “by Far, the Highest Prices in the World for Prescription Drugs.” Patents came up throughout the hearing as one barrier to lowering prescription drug prices, while pharmaceutical industry representatives underscored the cost of bringing innovative and life-saving drugs to market and the superior access Americans have to such drugs compared with other countries.

Witnesses Clash Over Potential Pros and Cons of PERA in Senate IP Subcommittee Hearing

The Senate Judiciary Committee’s Subcommittee on Intellectual Property today held a hearing featuring eight witnesses who testified about the need to restore certainty to U.S. patent eligibility law. Most, but not all, agreed such a need exists and urged quick passage of the Patent Eligibility Restoration Act of 2023 (PERA). Senators Chris Coons (D-DE) and Thom Tillis (R-NC) introduced PERA in June of last year. The bill would eliminate all judicially-created exceptions to U.S. patent eligibility law.

Tillis and Coons Introduce Bill to Study Bayh-Dole Reporting Processes

Senators Thom Tillis (R-NC) and Chris Coons (D-DE) have introduced a bill to study the inefficiencies in the reporting system required under the Bayh-Dole Act, with an eye toward streamlining processes. Titled the “Improving Efficiency to Increase Competition Act of 2023,” the bill would direct the Comptroller General of the United States to submit a report to Congress on the impact of the various reporting requirements implemented by different agencies under Bayh-Dole for intellectual property developed by federal grantees.

No AI FRAUD Act Would Create IP Rights to Prevent Voice and Likeness Misappropriation

Today, U.S. Representatives María Elvira Salazar (R-FL) and Madeleine Dean (D-PA) introduced the No Artificial Intelligence Fake Replicas And Unauthorized Duplications (No AI FRAUD) Act of 2024 to create legal mechanisms by which Americans can prevent unauthorized uses of their likenesses and voices by generative AI platforms. The bill seeks to provide for intellectual property (IP) rights in an individual’s voice and likeness as well as remedies including statutory damages and disgorged profits.