Posts in Legislation

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

Panelists on day one of IPWatchdog’s Artificial Intelligence Masters 2024 program painted a sometimes-grim picture of the current state of generative AI (GAI) tools and the ways in which they are being deployed in the United States, but seemed convinced overall that the kinks would be worked out once lawmakers and courts catch up, as they have done with past disruptive technologies.

On February 20, 2024, a Brazilian congress member, Antônio Luiz Rodrigues Mano Júnior (known as Júnior Mano), introduced a bill to amend the national IP Statute (Law #9,279/96) and regulate the ownership of inventions generated by artificial intelligence systems. Bill #303/2024 proposes the addition of a paragraph to Article 6 of the IP Statute, which regulates ownership of inventions, with the following wording: “in the case of inventions autonomously generated by artificial intelligence system, the patent can be requested in the name of the artificial intelligence system that has created the invention, being the artificial intelligence system considered the inventor and owner of rights arising from the invention.”

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.

A bipartisan group of 28 members of congress, including Senate IP Subcommittee Chair Chris Coons (D-DE), Ranking Member Thom Tillis (R-NC) and House IP Subcommittee Chair Darrell Issa (R-CA), sent a letter yesterday to President Biden urging the administration to reconsider its December proposal to allow agencies to consider pricing in deciding whether and when to “march in” on patent rights. Also yesterday, four bipartisan senators wrote to National Security Advisor Jake Sullivan in opposition to the negotiating text of the World Health Organization (WHO) Pandemic Agreement, warning that it “would undercut—if not destroy—the very aspects of our innovation ecosystem that just recently produced such positive results.”