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).
The remarkable story that inventor Alan Nelson shared last week at the 7th Annual Intellectual Property Awareness Summit held by CIPU at Northwestern University was revealing in many ways. Dr. Nelson related how he overcame numerous obstacles to commercialize a landmark technology for detecting cervical cancer in the 1990s. Using artificial intelligence (AI) while at the University of Washington, Dr. Nelson automated and vastly improved how early and accurately cervical cancer is identified — he and his team invented a machine to read Pap smears.
Did you know that Brazil’s medical device market is experiencing a surge, attracting billions in imports annually? This boom, however, is attracting not only legitimate businesses but also those looking to exploit loopholes. On average, more than US$6.7 billion worth of products are imported annually, with around 14,000 new products being introduced every year. One example is the increase in sales of equipment for endoscopic surgeries, given the rise in the number of bariatric surgeries, which already exceeds 70,000 procedures per year.
The U.S. Supreme Court’s flimsy eligibility jurisprudence offers the U.S. Court of Appeals for the Federal Circuit (CAFC) several “softball pitches” to avoid a patent bloodbath. To date, the Federal Circuit has struck out at preserving the patent system — at least twice without really even taking a swing! The first softball pitch appears in the High Court’s initial decision to exalt judge-made “exceptions” over the 200-year-old statutory rule, namely, Mayo v. Prometheus.
A number of individual consumers have filed suit against Apple, Inc. in California and New Jersey courts, piggybacking on the U.S. Department of Justice’s (DOJ’s) March 21 complaint accusing Apple of “broad-based, exclusionary conduct” amounting to monopolization of the smartphone market. The DOJ’s sweeping complaint included a number of U.S. states as plaintiffs and charged Apple with “thwart[ing] innovation” and throttle[ing] competitive alternatives via its practices around the iPhone platform.
I have been critical of certain National Institute of Standards and Technology (NIST) proposals to alter the regulations related to the Bayh-Dole Act, in 2021 (Notice of Proposed Rulemaking, NPR), and specifically, the NIST “Framework” published for comments in December, 2023. My Comments submitted in February addressed numerous legal infirmities, ranging from construction analysis to demonstrated ambiguity problems of the Request for Information/Comments (RFI) itself.
It’s rare that a federal policy inspires fierce opposition from both sides of the aisle. But the Biden administration’s recent proposal to gut the Bayh-Dole Act is doing exactly that. Bayh-Dole is a pivotal and successful bipartisan law, but Biden’s proposal would effectively allow federal agencies to tear up patent licensing agreements signed between federally funded universities and private businesses. The economic consequences would be dire. Individuals from across the political spectrum, including former Obama administration officials, have warned the proposal would threaten America’s small businesses and inventors.
After a year-long process involving 38 state organizations and dozens of individual representatives, IP rights has been selected as the topic for the 2024-2025 debate competition by The National Federation of State High School Associations (NFHS). “Should the U.S. strengthen intellectual property rights” was chosen over “Nuclear Weapons Reduction” by a 25-17 vote in the final balloting process. In addition to NHFS and state debate associations, those who helped to determine the outcome included the National Speech and Debate Association, the National Catholic Forensic League, the National Association for Urban Debate Leagues and the Nation Debate Coaches Association.
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.
The U.S. Patent and Trademark Office (USPTO) today issued a Request for Comments (RFC) that will be published in the Federal Register tomorrow seeking input from the public on how to better incentivize commercialization of innovation, particularly in green and critical or emerging technologies. According to the RFC, the comments received “will be used to evaluate possibilities for amplifying the impact of our current work, and to explore new ways to support the transfer of innovation to the marketplace.”
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.
Artificial Intelligence (AI) stands at the forefront of innovation, transforming industries and shaping the future of global economies. Although AI innovators understand the value of intellectual property (IP) protection for their innovations, they often don’t know how to secure the right kind of IP protection for their innovations. Employing a process for systematically mining AI innovations to create a map of those innovations is one option for identifying the most suitable form(s) of IP protection to obtain, based on the innovation and the business model within which that innovation will be commercially deployed.