Posts Tagged: "Congress"

Tillis Tells Judiciary Committee That Hyper-Focus on Patents Has Led to Lack of Progress on Drug Pricing

The full Senate Judiciary Committee met today to discuss ways to make U.S. prescription drugs more affordable, with a focus on the role patents play in high drug prices. Three of the five witnesses who testified pushed for various legislative and agency actions they claimed would help, while two of the witnesses said the patent system is working and that major changes like the ones proposed would gravely hinder incentives for innovation.

Why are the FDA and USPTO Ignoring Requests for Info on I-MAK?

Senator Thom Tillis (R-NC) has been unsuccessfully trying to obtain information from the Food and Drug Administration (FDA) and the United States Patent and Trademark Office (USPTO) on data being used to support drug pricing proposals for nearly two and a half years. More specifically, in a January 31, 2022 letter, Senator Tillis requested an independent assessment and analysis of the sources of data that are being relied upon by those advocating for patent-based solutions to drug pricing. Tillis requested the assessment be completed and provided no later than December 31, 2022—giving the agencies 11 months. The December 31, 2022, deadline has long since come and gone, and according to another letter sent from Tillis to the FDA and USPTO earlier this week, it appears as if the agencies are giving Tillis’ staff the run-around.

Tillis, Issa, Kiley Ask Vidal to Investigate Issues Raised by ‘Patent Examiner’ Reddit Thread

Last week, IPWatchdog’s CEO and Founder Gene Quinn exposed a “Patent Examiner Reddit” thread in which a purported examiner asked peers for advice on how to approach examination of patents that have purposes they may fundamentally disagree with politically. Now, Senator Thom Tillis (R-NC) and Representatives Kevin Kiley (R-CA) and Darrell Issa (R-CA) have sent a letter to U.S. Patent and Trademark Office (USPTO) Director Kathi Vidal asking the Office to conduct a review into that matter, as well as “a broader investigation into whether there is a pattern of patent examiners substituting their own preferences and beliefs for the law and USPTO guidance.”

USPTO Steps in for Congress in Attempt to Legislate on Terminal Disclaimers

By now, you are aware that the U.S. Patent and Trademark Office (USPTO) released a Notice of Proposed Rulemaking (NPRM) on May 10, 2024 (89 Fed. Reg. 40439), that would dramatically alter patent applicant and patentee statutory rights in their patent filings by proposing a draconian change to the requirements for submission of a terminal disclaimer (TD). Several blogs, including IPWatchdog, have reported on it. Comments are due by July 10, 2024.

Making Licensing Harder Doesn’t Boost U.S. Manufacturing

While it’s appropriate to lament the lack of bipartisan cooperation in Washington, just because something’s bipartisan doesn’t mean it’s a good idea. Exhibit A could be Senator Tammy Baldwin (D-WI) and Senator J.D. Vance’s (R-OH) “Invent It Here, Make It Here” bill. Despite the name and its good intentions, it condemns promising federally funded inventions to waste away without doing a thing to build our domestic manufacturing base. It’s scheduled to be considered this Thursday in the Senate Commerce, Science and Transportation Committee.

Tillis Doubles Down on Calls for Biden to Scrap March-In Plan

Senator Thom Tillis (R-NC) sent a letter yesterday to President Joe Biden again condemning the Administration’s December 2023 proposal to allow agencies to consider pricing in deciding whether and when to “march in” on patent rights. Under the proposed framework, which sources have told IPWatchdog is close to being finalized, an agency may consider “[a]t what price and on what terms has the product utilizing the subject invention been sold or offered for sale in the U.S.” and whether “the contractor or licensee [has] made the product available only to a narrow set of consumers or customers because of high pricing or other extenuating factors”.

Witnesses Tell Senate IP Subcommittee They Must Get NO FAKES Act Right

The U.S. Senate Judiciary Committee’s Subcommittee on Intellectual Property met today to hear from six witnesses about a recently-proposed bill to curb unauthorized uses via artificial intelligence (AI) of an individual’s voice and likeness.   The “Nurture Originals, Foster Art, and Keep Entertainment Safe Act of 2023” (NO FAKES Act) was introduced in October 2023 by Senator and Chair of the IP Subcommittee Chris Coons (D-DE) and Senators Marsha Blackburn (R-TN), Amy Klobuchar (D-MN), and Thom Tillis (R-NC). The goal of the bill is to “protect the voice and visual likenesses of individuals from unfair use through generative artificial intelligence (GAI).”

Intel-Commerce Deal Includes Nearly $20 Billion in Funding Under CHIPS Act

On March 20, American semiconductor developer Intel Corporation and the U.S. Department of Commerce jointly announced that the chip giant had entered into a preliminary memorandum of terms (PMT) that could make Intel eligible for nearly $45 billion in federal investments into chip production facilities and workforce development. At least $19.5 billion of this funding comes from money appropriated under the CHIPS and Science Act, making Intel an early beneficiary of the landmark legislative package enacted in 2022 to establish U.S. dominance in chip production.

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.

The Year Ahead: Where Do We Stand on the USPTO’s ANPRM and the PREVAIL Act?

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.

Tillis Demands Answers from Biden on March-In Proposal

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.

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