The course of technological advancement does not always run smooth, and Intellectual Property (IP) is not unshaken by the twists and turns along the way. We examine how this month's influential IP news stories reflect this theme, from the ongoing patent litigation surrounding COVID-19 vaccines to the data cracks that have appeared as the United States Patent and Trademark Office (USPTO) modernizes its trademark systems. Nonetheless, as the European Union's landmark law on artificial intelligence (AI) demonstrates, IP is able to navigate even the strongest currents.
Code of law: EU legislation on AI
In a world first, the EU has passed a comprehensive set of rules governing the development and use of AI, including, but not limited to, how the technology interacts with IP rights.
The Artificial Intelligence Act (AI Act) was accepted by the Council of the EU on May 21, having previously been approved by the European Parliament. The remaining step before enactment is for the legislation to be signed by the presidents of both bodies. Once this is complete, the AI Act will be published in the Official Journal of the EU and enter into force 20 days thereafter. It will then take another two years for the majority of provisions to apply.
Article 53 contains the regulations most relevant to IP owners in or acting in the EU. Providers of "general-purpose" AIs must "put in place a policy to comply with Union copyright law" and "draw up and make publicly available a sufficiently detailed summary about the content used for training of the general-purpose AI model, according to a template provided by the AI Office."
Similar to the Generative AI Copyright Disclosure Act introduced to the United States Congress last month, the AI Act mandates developers to be transparent when training their models. That said, the EU's legislative act differs from that proposed across the Atlantic in that it is not limited to only copyrighted material. Where the U.S. Copyright Office would receive notices of protected works used, the EU's AI Office (and public) will be informed in sufficient detail of all datasets used, with this information to be treated under confidentiality obligations so as to protect trade secrets.
"The adoption of the AI Act is a significant milestone for the European Union," commented Belgian government minister Mathieu Michel. "This landmark law, the first of its kind in the world, addresses a global technological challenge that also creates opportunities for our societies and economies."
The secretary of state for digitization, administrative simplification, privacy protection and the building regulation went on to highlight the Union's focus on "trust, transparency and accountability when dealing with new technologies while at the same time ensuring this fast-changing technology can flourish and boost European innovation."
AI systems classified as high-risk will be subject to tight regulation and reporting standards, while applications that threaten citizens' rights are banned outright. Those identified are cognitive behavioral manipulation ("techniques that subvert or impair [a] person's autonomy, decision-making or free choice"), social scoring, predictive policing and biometric categorization according to characteristics such as age, race, religion and sexuality.
IP owners in the EU can look forward to the creation of the AI Office, which will work to ensure the "safe and trustworthy" application of these technologies, governing their use and investigating suspected transgressions.
Vaccine patents under the microscope
Since biotechnology company Moderna filed patent infringement lawsuits against competitors Pfizer and BioNTech in a number of venues in August 2022, progress has been expectedly slow. Yet this sedulous pace has recently delivered two important updates.
The parallel court actions hinge upon Moderna's patents for mRNA technology, a crucial mechanism for various COVID-19 vaccines, including its own "Spikevax" and the alternative "Comirnaty," jointly produced by Pfizer and BioNTech. At the time of the initial filings, we explained the complex processes underpinning this comparatively new vaccination technique.
In light of the intricate subject matter, the U.S. District Court for the District of Massachusetts agreed last month to stay proceedings until the USPTO reviewed the validity of two of the three Moderna patents involved. When requesting this reexamination in 2023, the defendants described the grants as both "unimaginably broad" and claiming a "basic idea that was known long before" their priority date. Yet, in a curious synchronicity, the European Patent Office (EPO) confirmed the validity of one of these keystone patents this month.
The European decision was delivered orally on May 16 and, according to the Financial Times, will be published in writing in the coming months. This ruling from the EPO will surely steady some nerves on Moderna's side, given it argued that allowing a review by the USPTO's Patent Trial and Appeal Board would be "highly prejudicial" to its position.
In a statement made to Reuters on the European development, Pfizer expressed both a commitment to delivering prophylactics and a measure of defiance, "Irrespective of the outcome of this legal matter, we will continue to manufacture and supply the Pfizer-BioNTech COVID-19 vaccine."
Meanwhile, BioNTech explicitly disapproved of the decision, holding that the EPO's affirmation "does not change our unwavering and unequivocal stance that [the] patent is invalid."
Returning to Pfizer's comment, it is highly unlikely that even a loss for the pharmaceutical giant and its German partner would curtail the production and distribution of Comirnaty. If, for instance, the U.S. court eventually found in favor of Moderna, it would almost certainly allow for "voluntary infringement" – that is, in the interests of the common good, it would sanction the infringing behavior to continue in exchange for royalties to the patent holder.
Outside of the invalidation of all three patents by a review board, the litigation's two-year anniversary creeps forward without a decision in sight in any judicial theater. Although the provision of COVID-19 vaccines is not at stake, the impact on future mRNA inoculations is more open to debate.
Data disclosures at the USPTO
In June 2023, the USPTO reported a data spill comprising the private addresses of around 61,000 trademark applicants. The leak was due to an oversight in the Office's application programming interface (API) rather than any malicious outside activity. Nevertheless, contact information was inadvertently made available in datasets published for research purposes as a result of the fault.
U.S. trademark law requires applicants to submit their personal addresses to prevent fraudulent activity before the Office. However, as we reported last year, even the accidental publication of contact details increases the risk of scams against individuals and enterprises. A common extortion involves sending letters to known trademark applicants purporting to be from attorneys or the USPTO itself. These communications typically claim outstanding fees or threaten legal action for infringement and may include specific application numbers to enhance the credibility of the scam.
Regrettably, the second such event in as many years was announced by the USPTO this month and concerned some 14,000 trademark applicant addresses. In an email sent to affected users and obtained by TechCrunch, the Office took responsibility for the lapse that occurred as it "transitioned to a new IT system" – possibly referring to the retirement of the Trademark Electronic Search System (TESS) in November 2023 and its replacement with the Trademark Search tool.
At that time, some attorneys criticized the remarkably short beta-testing phase of the new Trademark Search tool as inadequate. Meanwhile, the USPTO's interim use of the old Trademark Reporting And Monitoring (TRAM) system resulted in some known data discrepancies, specifically relating to trademark statuses.
Deborah Stephens, deputy chief information officer at the USPTO, spoke to TechCrunch on the problems discovered during this latest technology transfer. "As we're modernizing and taking the legacy systems from the different decades of standards and protocols the system error happened in the creation and modernization of that bulk data set."
Referring to last year's spill, Deborah Stephens emphasized that the "fix we had in place was all in place, and remains in place," before reassuring those who interact with the USPTO that appropriate "error correction with file creation" was now in place to avoid another incident.
Anyone affected by either leak should be especially vigilant of unexpected messages concerning their trademark applications. A qualified attorney or IP service provider will be able to advise on what is a genuine office action so that business owners are not denied the full protections of trademark registration.
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