Posts Tagged: "Congress"

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.

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.

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.

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.

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.

As we enter 2024, major policy initiatives are pending at the United States Patent and Trademark Office (USPTO) and in Congress aimed at overhauling certain aspects of Patent Trial and Appeal Board (PTAB) practice. These initiatives—the Advance Notice of Proposed Rulemaking (ANPRM) and PREVAIL Act, respectively, are at a critical point, with elections less than a year away. This article discusses the current state of both.

Senator Thom Tillis sent a letter today to President Joe Biden asking him to answer three broad questions related to his proposal earlier this month that would allow government agencies considerable discretion in deciding whether and when to “march in” on patents. As we previously reported, the National Institute of Standards & Technology (NIST) and the Department of Commerce published a Federal Register Notice on December 8 seeking comments on a proposed framework for exercising march-in rights under the Bayh-Dole Act that would significantly broaden the criteria for compulsory licensing of patented technology developed with federal funding, particularly with respect to drug pricing.

Throughout 2023, a number of legislative initiatives impacting intellectual property rights were introduced in the United States Congress or signed into law by the President. In some instances, these efforts are meant to try and re-balance the various, sometimes competing, interests of the public and the innovators. In other instances, the legislation is aimed at weaponizing the intellectual property right procurement process to reward some and punish others. Various pieces of legislation as well as Executive Directives directed at artificial intelligence also have been introduced at different levels. This piece, however, leaves those AI issues for others to address. Below is a summary of some of the key legislative efforts in 2023 touching on U.S. IP rights.

In a laudable effort to curtail rampant corporate IP theft, a bipartisan group of U.S. Senators has called on a hesitant Department of Justice (DOJ) to step up its enforcement. As reported in Forbes, Senators Thom Tillis (R-NC), Chris Coons (D-DE), and Marsha Blackburn (R-TN) recently issued a letter to the DOJ identifying the core gap in its prosecution habits. Their primary complaint was “the DOJ’s focus on individual, as opposed to corporate, offenders.” This is an oversight that must be corrected. 

If you’re reading IPWatchdog, you probably have some familiarity with intellectual property rights, such as patents, copyrights and trademarks. However, one distinct type of intellectual property is often left out and misunderstood. It’s called the right of publicity. While publicity rights are often confused with other types of intellectual property or privacy rights, or mistakenly associated only with famous individuals, they are incredibly important, far-reaching, and deserve much more attention.

One might think that we had enough crises already without creating a new one, but apparently that’s not the case. To much fanfare, the Biden Administration unveiled its long awaited “guidelines” for agency use of the march in rights provision of the Bayh-Dole Act. Ironically, it started this exercise just as it had joined every other administration in dismissing attempts to misuse the statute as a pretext for the government to micro-manage the price of a successfully commercialized government funded invention.

An event held Monday by the Center for Strategic & International Studies (CSIS), and moderated by former U.S. Patent and Trademark Office (USPTO) Director Andrei Iancu, featured a number of high-profile political and professional figures in the intellectual property space debating approaches to strengthening the U.S. patent system, with an emphasis on national security. Representative Deborah Ross (D-NC), who serves on the U.S. House of Representatives’ Judiciary Committee’s Subcommittee on Courts, Intellectual Property and the Internet, first joined Iancu to discuss her reasons for supporting the Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act.

On September 13, the Global Innovation Policy Center of the U.S. Chamber published its “IP Principles” paper declaring the Chamber’s “Beliefs about Intellectual Property.” It was promptly endorsed and signed by 32 external IP thought leaders, including the heads of nearly all major IP associations and organizations, and individual experts such as a former Director of the U.S. Patent and Trademark Office (USPTO), two retired judges (including myself), and leading IP academics…. In my view, the Chamber was exactly right to call for a “reset” in the policy debate over IP rights.

This week in Washington IP news, the House and Senate are having a quieter week after the Thanksgiving break, but a House subcommittee delves into the critical software supply chain. Elsewhere, the USPTO celebrates Hispanic innovators, discusses fashion and IP and continues its tutorial series on Patent Center.