Posts in Legislation

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.

Today, the U.S. Department of Health and Human Services (HHS) made its initial offers to pharmaceutical companies pursuant to the Biden Administration’s Inflation Reduction Act of 2022 (IRA), which allows the U.S. Government to “negotiate” Medicare drug prices under a set framework based upon the amount of time a drug has spent on the market. Opponents of the program, including the U.S. Chamber of Commerce, which is suing the government over the plan, argue it cannot be characterized as a voluntary negotiation since the affected companies would be subject to onerous excise taxes for refusing to participate and because it would have devastating consequences for patients if companies were to actually pull the affected drugs. The amounts of today’s initial offers were not revealed.

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.

At the end of 2023, Law 14,785/2023 was published in Brazil’s official gazette, creating a new regulatory framework for chemical pesticides and environmental control products. The result of decades of discussions in the National Congress, the new law brings provisions that represent improvements to the system, such as the mandatory use of risk analysis in the process of granting registration of products and the requirement to harmonize with internationally established standards.

In Vidal v. Elster, No. 22-704, the United States Supreme Court has heard argument and is expected to decide in the next several months whether Section 2(c) of the Lanham Act can prevent the federal registration of TRUMP TOO SMALL as a trademark for shirts and hats. Section 2(c) prohibits, inter alia, the registration of the name of a particular living individual without his consent. The issue in Elster is whether the First Amendment’s guarantee of free expression transcends Section 2(c)…. To the extent that Section 2(c) survives, in whole or in part, and apart from weighty constitutional concerns which the Court is expected to resolve, there are numerous other problems lurking in this old, dark and dusty subsection—which  are not particularly “small” at all—which only Congress can fix.

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.

Recently, amendments to the Implementing Regulations of the Chinese Patent Law were issued and will take effect from January 20, 2024. The Regulations align with the revisions made to the Patent Law in 2020 and provide further guidance. The main changes to the new Regulations, as compared with the 2010 version of the Regulations,  can be summarized as follows.

On December 8, 2023, provisional agreement was reached between the European Union (EU) Parliament and the EU Council on the basic content of the new AI Regulation (the “AI Act”) to be implemented as legislation in the EU. The text is still not publicly available as it is subject to certain further refinement over the coming weeks. However, there is information available in the public domain (including press releases issued by the European Union) as to the likely format of the AI Act. Additional background on the legislative process towards the AI Act is available here.

On day one of the new year, we continue the IPWatchdog tradition of asking readers what they would like to see happen if their every IP wish could come true. Some commenters stuck with more realistic asks, such as for patent eligibility reform to move forward or that an extension of the waiver of IP rights under the Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS) will be opposed. Others went out on a limb by pulling for a new central patent court based in Hawaii or that congress will get its act together, for instance. Of course, the most popular dream articulated below is once again that patent eligibility certainty will be restored, either by the courts or congress.

We are less than 24 hours out from 2024 and, after reflecting on what mattered in 2023 and other year-in-review recaps, it is now time once again to ponder what lies ahead. From exciting patent legislation to Supreme Court trademark and copyright cases that could have big implications, here is what the IPWatchdog community will be keeping on its radar in the new year. 

The most significant development in IP in Europe in 2023—indeed arguably the most significant in nearly 30 years—was the launch of the Unitary Patent and Unified Patent Court on June 1. The full implications of this are explored here. Beyond the UP and UPC, however, there were a number of. important developments in Europe affecting all the main IP rights.

Another year of IP is behind us, and it is time to reflect on what mattered most—what decisions will affect practice for years to come and/or continue to play out in the courts as we move into 2024? Below are reflections on milestones from this past year—some positive, some negative, and some neutral–at least for now.

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.