Posts in Legislation

Hikma Ruling Looms Large in House IP Subcommittee Hearing Debating Legislation Favoring Generic Drugmakers

At approximately the same moment that the U.S. Supreme Court handed down today’s landmark ruling in Hikma v. Amarin, the House Judiciary’s Subcommittee on Courts, Intellectual Property, Artificial Intelligence, and the Internet began a hearing on balancing medical innovation and access to generic drugs. Much of the hearing’s discussion was focused on proposed patent bills that favor generic drug makers–though whether they would ensure that Americans actually pay less for any drug, branded or otherwise, remains unclear.

Biopharmaceutical Innovation: The Patent Imperative

America’s $150 billion per year private sector investment in biopharmaceutical research and development (R&D) does more than offer comfort. Increasingly, American innovators are curing or effectively eliminating the medical threat from many diseases and conditions. Witness, cures for Hepatitis C, GLP-1s for weight loss, COVID-19 vaccines, and HIV prevention at virtually 100% effectiveness, alongside stem cell therapies, gene editing, and CAR-T therapies for previously untreatable cancers. For those suffering from rare or untreatable disease, as well as chronic conditions, this is an era of unprecedented hope.

As Congress Considers PERA, It Should Allow the Frustrated Inventor to Be Heard

A person recently approached me at church with excitement regarding a software process he developed. His company was so pleased with the result that it is filing a patent, listing him as the inventor. This person knew that I had some kind of patent backstory, so he asked for my thoughts. My name is Jeffrey A. Killian, and I am the patent applicant in the Federal Circuit Court case # 2021 -2113 (In Re: Killian). I took no pleasure in telling my  friend at church that his patent application will be rejected. Plus, the official notice will have my precedential case quoted all over his rejection. With friends at church like me, who needs enemies? 

EU Returns to Special 301 Report’s Watch List for First Time Since 2006

On April 30, the Office of the U.S. Trade Representative (USTR) released this year’s Special 301 Report, which surveys the effectiveness of intellectual property (IP) rights and enforcement abroad and identifies foreign nations where IP protections are uncertain or disregarded. The 2026 report marks the first time in 13 years that a Priority Foreign Country (PFC) has been named, with Vietnam being identified as a PFC for persistent failures to address several long-standing IP concerns. The USTR has also added the European Union (EU) to the Special 301 Report’s Watch List, the first time since 2006 that the continental government has been identified for IP-related concerns in addition to individual European nations.

Broader Concerns Over AI Emerge in Senate Judiciary Hearing on Chinese IP Theft

China was not the only actor being scrutinized today during a full Senate Judiciary Committee hearing, titled “Stealth Stealing: China’s Ongoing Theft of U.S. Innovation.”  Senator Thom Tillis (R-NC) stood in for Senator Chuck Grassley (R-IA) as Chair and opened the hearing with a warning that, in addition to its blatant IP theft—which is estimated to cost the United States between $400 billion and $600 billion per year—China is more recently evolving from “imitator to innovator.” “The United States must overcome its historic and ideological views that China is unable to innovate,” Tillis said.

Congress is Lagging on Innovation Policy; Americans Are Paying the Price

Intellectual property (IP) protections don’t merely shield Americans’ ideas and designs from theft—they underpin our entire economy and standard of living. Approximately 90% of the market value of the S&P 500 is in intangible assets, based on IP. Weakened IP protections erode American prosperity and human potential as IP-intensive industries support 63 million U.S. jobs and account for over 40% of America’s economic output.

Despite Growing Number of IP Advocates in Congress, C4IP Scorecard Finds Weak IP Engagement Overall

Today, the Council for Innovation Promotion (C4IP) published the third edition of its Congressional Innovation Scorecard, which provides a measure of each lawmaker in the U.S. Congress in terms of their impact on the nation’s intellectual property (IP) system. Although this year’s scorecard acknowledges higher numbers of pro-copyright bills introduced into Congress, it concludes that members of Congress are still failing to engage fully and effectively on national IP issues to the detriment of America’s future as an innovation leader.

Consumer, Patient Groups Push for Fast Markup of ETHIC Act

A number of groups and individuals self-described as “representing consumers, patients, health care providers, and academic experts in pharmaceutical policy and patent law” have submitted a letter to the U.S. House Judiciary Committee urging members to quickly advance the “Eliminating Thickets to Increase Competition  (ETHIC) Act,’’ which was introduced in the House of Representatives last May by Representative Jodey Arrington (R-TX) along with two other Republicans and four Democrats.

As ‘Pro Codes Act’ is Reintroduced, Opponents Warn of Threats to Standards Development System

Opponents of the “Pro Codes Act” are speaking out this week following its recent reintroduction in the U.S. Senate. The Protecting and Enhancing Public Access to Codes (Pro Codes) Act of 2026, S. 4145, was reintroduced on March 19 by Senators Jon Cornyn, Chris Coons, Mazie Hirono, and Thom Tillis. According to the bill’s sponsors, the legislation “ensures safety standards do not lose copyright protection when they are incorporated into law by name so long as they are accessible for free on a publicly available website.”

IPWatchdog LIVE 2026: Judge Newman and Michel Present Awards, Panelists Outline Uphill Battle for Global IP and Drug Patents

On day one of IPWatchdog LIVE 2026, panelists discussed the global IP landscape, the economics of patent portfolios, patent dealmaking and the ins and outs of drug patent critiques, before U.S. Court of Appeals for the Federal Circuit (CAFC) Judge Pauline Newman and Retired CAFC Judge Paul Michel introduced the recipients of their respective eponymous awards for 2026.

Organizations Warn Fast-Track of Bill to Separate Copyright Office from Library of Congress Would Be a ‘Grave Mistake’

Spurred by reports that House leaders are trying to fast-track a bill to separate the U.S. Copyright Office from the Library of Congress, a coalition of consumer rights, industry, open internet and library groups has again sent a letter to the House Committee on Administration urging it to consider the bill on the regular timeline to avoid “unintended consequences.” A full committee markup of the bill is scheduled for tomorrow, March 18,

Opinion: The ITC Has Lost Sight of the Public Interest

Every day, Americans rely on technologies that were unimaginable just a generation ago – from advanced medical devices and artificial intelligence–powered applications to connected consumer electronics. These breakthroughs did not emerge in a vacuum. They are the product of an innovation ecosystem shaped by policy choices. The U.S. International Trade Commission (ITC)—an agency with the extraordinary power to block imports and, in turn, influence the direction of American technology policy—has drifted out of that balance. To align with the Trump Administration’s intellectual property priorities and pro-investment agenda, the ITC is in urgent need of reform.

Analysis of March-In Rights Guidance Marks a Sad Day for the GAO

The Government Accountability Office (GAO) just released its assessment of the Biden Administration’s “Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights.” A bipartisan combination of Senators Thom Tillis (R-NC) and Chris Coons (D-DE) along with Congressmen Darrell Issa (R-CA) and Jake Auchincloss (D-MA) asked the GAO to evaluate the guidelines on three bases: what the guidelines did and how they were developed; stakeholder views on the draft; and the potential impact of the guidelines.

CLEAR Act Would Establish Notice Requirements for Copyrighted Works in AI Training Data

On Tuesday, news reports indicated that U.S. Senators Adam Schiff (D-CA) and John Curtis (R-UT) introduced the Copyright Labeling and Ethical AI Reporting (CLEAR) Act into Congress. If enacted as drafted, the bill would establish mandatory reporting requirements for companies developing artificial intelligence (AI) models that are trained using original works that are protected under U.S. copyright law, and would create an additional cause of action for copyright owners alleging that generative AI developers failed to give such notice with respect to their works.

PTAB Masters Panelists Predict Rough Road for Pending Patent Bills, Tough Questions from Congress on USPTO Rules, Warn of Widening Gap Between CAFC and USPTO

Panelists at IPWatchdog’s Virtual PTAB Masters Program 2026 last week had some cynical views on chances for pending patent reform bills, while on Friday other experts offered insights into developments at the U.S. Court of Appeals for the Federal Circuit (CAFC) with respect to review of Patent Trial and Appeal Board (PTAB) cases. Speaking on Thursday’s panel, titled “Capitol Hill & PTAB Politics: Innovation Policy, Congressional Oversight and Mid-term Elections,” panelists first addressed the chances of bills such as the Patent Eligibility Restoration Act (PERA) and the Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act advancing this year.

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