Posts in Legislation

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.

Panelists Push for Predictability at IPWatchdog’s 2024 Patent Litigation Masters Program

“Make it happen.” That was the request U.S. Court of Appeals for the Federal Circuit (CAFC) Judge Pauline Newman made of attendees of IPWatchdog’s Patent Litigation Masters 2024 program on Monday, imploring them to “think creatively” to solve the intellectual property problems of today. Pointing to developments such as the Unified Patent Court (UPC), Newman said “it’s a time of change and flux, and we can learn a good deal, not only from the UPC, but the way the law is developing in jurisdictions like Japan and China.”

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).”

Updated WHO Pandemic Accord Retains Commitments for Non-Exclusive Licensing and Royalty Waivers

On April 19, the World Health Organization (WHO) released an updated draft proposal of an international agreement on the global response to future pandemics. While the WHO pandemic agreement has been met with widespread support from many of the international agency’s member nations, including the United States, it retains provisions limiting intellectual property (IP) rights that have encouraged opposition from lawmakers and pharmaceutical innovators alike.

Schiff Introduces Bill to Mandate Disclosure of Copyrighted Content Used to Train GAI Models

On April 9, Representative Adam Schiff (D-CA) introduced the Generative AI Copyright Disclosure Act of 2024 into the U.S. House of Representatives. The bill, which would require generative artificial intelligence (AI) platforms to disclose their use of copyrighted works in training AI models with retroactive effect, comes after months of growing concerns by the global creative community over the misappropriation of original works of authorship by companies collecting such content without prior authorization.

Bayh-Dole Coalition: Activist Groups’ Bid for Medicare to Make Generic Xtandi is a ‘Desperate Ploy’

On April 9, Knowledge Ecology International (KEI), the Union for Affordable Cancer Treatment (UACT) and Universities Allied for Essential Medicines (UAEM) sent a letter to Chiquita Brooks-LaSure, Administrator for the Centers for Medicare and Medicaid Services, requesting that CMS use alleged statutory authority to allow companies to make and sell generic versions of the blockbuster prostate cancer drug, Xtandi®. The letter comes two months after the Department of Health and Human Services (HHS) denied an appeal of a decision not to march in on the drug under 35 USC §203.

USIJ and Medical Device Group Urge Movement on PERA and PREVAIL

The Medical Device Manufacturers Association (MDMA) and the Alliance of U.S. Startups and Inventors for Jobs (USIJ) sent a letter today to the leadership of the Senate Judiciary Committee and the Judiciary Committee’s Subcommittee on Intellectual Property to express their support for both the Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act) and the Patent Eligibility Restoration Act (PERA). Both PREVAIL and PERA were introduced on June 22, 2023. The PREVAIL Act aims to reform Patent Trial and Appeal Board (PTAB) practices while PERA would eliminate all judicially-created exceptions to U.S. patent eligibility law.

What’s Next After Brazil’s Enactment of the Nagoya Protocol

In a significant milestone for the preservation of biodiversity, Decree 11,865/2023, published in the Official Gazette on 12/28/2023, enacted the Nagoya Protocol in Brazil. The protocol, providing for access to genetic resources and the fair sharing of benefits arising from their use, is part of the renowned Convention on Biological Diversity (CBD). The Nagoya Protocol, in force since October 12, 2014, relates to the international commitment of 140 countries, including Brazil, to implement the objective of the CBD on the fair and equitable sharing of benefits from the use of genetic resources and the traditional knowledge associated with them (TK).

An Independent Musician’s Perspective on the TikTok Legislation Before Congress

There are many loud voices making a lot of noise about TikTok right now, and as someone who makes “noise” for a living, I thought I’d provide an independent musician’s perspective on the TikTok legislation before Congress: I hope it passes, both as an American and as a music maker. First of all, this bill restricts TikTok, it does not “ban” the app. It forces the company to cut its ties to the Chinese Communist Party and prevents them from accessing the data of Americans. That’s a good thing. The bill doesn’t mandate or regulate speech, it’s focused on national security. The threat is no secret, it’s real: the Federal Communications Commission (FCC) called TikTok “a clear and present danger” to our country.

Rader’s Ruminations – Patent Eligibility II: How the Supreme Court Ignored Statute and Revived Its Innovation-Killing Two-Step

The Supreme Court has never quite grasped the distinction between patent eligibility and patentability. Eligibility involves entire subject matter categories or fields of inventive enterprise, like the categories “process, machine, [article of] manufacture, or composition of matter.” 35 U.S.C. 101. Ascertaining eligibility should therefore require little more than checking the patent title and ensuring that, in the words of the venerable Judge Giles Rich, “[the invention] produces a useful, concrete and tangible result.”  State Street Bank v. Signature Fin. Group, 149 F. 3d 1368 (Fed. Cir. 1998). In simple terms, Section 101 requires little more for eligibility than a showing that an invention has applied natural principles to achieve a concrete purpose within the expansive categories articulated by Thomas Jefferson in 1793. Patentability, on the other hand, proceeds as a detailed claim-by-claim, feature-by-feature examination of “the conditions and requirements of this title.” 35 U.S.C. 101. Ironically this fundamental distinction that eludes the Supreme Court is explicit in the statutory language of 35 U.S.C. 101 itself.

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.

Coalition Aims to Combat Biden March-In Proposal, Other IP Threats

The U.S. Chamber of Commerce today announced it is partnering with entrepreneurs and other business advocates to counter threats to innovation due to “excessive government overreach,” including the Biden Administration’s proposed framework to expand the use of so-called patent march-in rights.

Amid Approval of EU AI Act, Creators Demand Stronger Protections for Rightsholders

On March 13, the European Parliament approved the Artificial Intelligence (AI) Act, a major piece of legislation that lays the legal foundation of the European Union’s (EU) regulation of AI platforms. While the 459-page bill addresses some of the copyright and other intellectual property (IP) issues related to generative AI, European creator groups have called upon the EU’s parliamentary body to create more meaningful mechanisms for IP rightsholders to prevent their works from being incorporated into AI platform training models. Further, questions have been raised regarding the extraterritorial impact of reporting requirements and how they might implicate the development of copyright law in foreign jurisdictions.

High-Tech Groups and EFF Revive Patent Troll Narrative and Other Lies

Efforts by high-tech companies to undermine both the Patent Eligibility Restoration Act of 2023 and the Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act ramped up this week, with a joint letter sent to the Senate Judiciary Committee by a number of tech industry organizations on Monday and a campaign launched by the Electronic Frontier Foundation (EFF) yesterday.

Apple’s 1.8 Billion EU Fine Foreshadows Increased Regulatory Activity Under Digital Markets Act

On March 4, the European Commission announced that it had levied a fine of more than €1.8 billion ($1.95 billion USD) against American consumer tech giant Apple over app restrictions employed by Apple’s App Store. The massive fine, which the Commission increased to ensure it was sufficiently deterrent to Apple’s anti-competitive practices, is the latest in a series of legal actions within the European Union (EU) to target dominant Internet platforms under competition law.

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