The Bayh-Dole Act (“Bayh-Dole” or the “Act”) 1 governs the licensing of federally funded and federally owned inventions. A key requirement, referred to as the “Domestic Manufacturing Requirement,” is that the licensing of such inventions to private sector entities should benefit U.S. industry, specifically by requiring manufacture of products that embody or are made through such inventions “substantially in the United States.” Unfortunately, the plain language of the Act and its implementing regulations does not provide any definition or other guidance on what if any threshold should be exceeded in order for manufacturing to be deemed “substantially in the United States.” Further, the legislative history is only minimally helpful in the interpretation of the language and, as of the writing of this article, there are no published decisions providing guidance on the proper interpretation of this language. This article proposes that, in the absence of a specific binding statutory regulatory or judicial definition, it is appropriate to look to analogous U.S. government acquisition statutes and their implementing regulations for a workable definition.

The Bayh-Dole Act (“Bayh-Dole” or the “Act”) 1 governs the licensing of federally funded and federally owned inventions. A key requirement, referred to as the “Domestic Manufacturing Requirement” is that licenses of such inventions to private sector entities should benefit U.S. industry, specifically by requiring manufacture of products that embody or are made through such inventions “substantially in the United States.” If an invention will not be “manufactured substantially in the United States,” a waiver must be sought. The Act and its implementing regulations provide two grounds for agencies to grant waivers: (1) if the applicant demonstrates that “reasonable but unsuccessful efforts have been made to grant licenses to potential licensees that would be likely to manufacture substantially in the United States,” or (2) “if domestic manufacture is not commercially feasible.” Waiver requests must granularly address the grounds for the waiver, why a waiver is necessary under the specific circumstances, and why the grant of a waiver would advance the agency’s mission and the policy behind the Act.

In 2015, Instacart was already a successful U.S.-based Unicorn (a Unicorn is defined as a pre-exit startup with valuation in excess of $1 billion). At the time, Instacart had a valuation of $2 billion, and had already raised more than $250 million in funding. It also had no published patent filings, neither pending nor issued. Another member of the U.S.-based Unicorn cohort of 2015, GitHub, also had a valuation of $2 billion, and raised $350 million in funding. GitHub had no published U.S. patent filings either (pending or issued), nor did 26 additional U.S. Unicorns in 2015. As a matter of fact, as seen in Figure 1(a), a study conducted in 2015 by Foresight Valuation Group found that 30 percent of all U.S. Unicorns in 2015 had no published U.S. filings (pending or issued),1 and another 32 percent had less than 10 assets assigned to them. All in all, over 60 percent of U.S. Unicorns did not have a significant patent position (defined as 10 or less published U.S. filings, either pending or issued).

A new regulatory proposal in the European Union (EU) may soon have major impacts on small- and medium-sized enterprises (SMEs).1 The regulation is meant to shape business practices related to the license of standard-essential patents (SEPs). SEPs protect inventions that have been selected for incorporation into technical standards, such as the 4G and 5G standards for telecommunications networks.

The European Innovation Council (EIC) was established to address the European Paradox, i.e., the “Innovation Gap” in Europe, by aiding researchers, startups, and SMEs in translating high-impact technologies into successful businesses. With a budget of EUR 10.1 billion, it supports scientific innovations from early research to market scale-up through funding, strategic networking, and business acceleration services to equity investments. The EIC has supported numerous groundbreaking companies. Licensing has a key role for many EIC beneficiaries, serving as a vital mechanism facilitating technology transfer, accelerating market entry, and enabling revenue generation. The Innovation Radar analysis revealed that 37 percent of EIC-supported innovations required or would benefit from licensing. Licensing is portrayed as a robust business strategy providing access to technology and intellectual property, highlighting various models like development partnerships, freedom to operate agreements, and horizontal as well as vertical commercial licensing strategies. Case studies illustrate the need for access to: (i) IP (Intellectual Property) and strategy training, (ii) licensing mentors, (iii) model agreements, and (iv) sector-specific experts. That kind of support facilitates an alignment of the licensing strategy with the overall business strategy as well as coping with a complexity of tailored licensing agreements that comply with national and international regulations.

In today’s knowledge-driven economy, it is not a surprise that intangible assets play a crucial role in the performance of companies. Among the latter, IP is one of the most recognized in balance sheets, even if that recognition is most generally not representative of the real IP assets of a given enterprise.

On April 22, 2024, the Federal Trade Commission issued its final Non Compete Clause Rule, which bans most non-competes in the United States. It will become effective 120 days after it is published in the Federal Register. If it becomes effective—which is far from certain— the Rule will have a sweeping impact on the U.S. economy and employers’ hiring and compensation practices. The FTC estimates that 30 million employees in the U.S. are subject to non-competes.

If you read my last article, “Why Focusing On Brand Licensing Will Help Your Clients Succeed,”1 you already know that brands are so much more than just products or services. A brand can also be an event, a celebrity, a film, a TV series or a political party. You also know that if brands want to stay relevant, they have to grow. But with that growth comes tremendous pressure. I call this “the expansion riddle,” because growth is a slippery slope, and many brands don’t know the path to take to get to their optimal point in the marketplace. Standing still is dangerous, but so is staying in one market, and so is diversifying into other markets. Knowing how to grow is key.

While AI has been successful for narrow applications in the past, general reasoning models only reached human-level capabilities within the past couple of years. Due to the creation of large language models and the advancement of computing infrastructure, AI models can solve complex, multi-disciplinary problems at the level of humans,1 a feat which was not possible just a few years ago. In fact, current state-of-the-art models are showing more creativity potential than humans.2 See Figure 1.

In the rapidly evolving ecosystem of startups, intellectual property (IP) is both a formidable asset and a complex challenge. The ability to manage IP effectively can dictate a startup’s path from inception to market leadership, or to obscurity. Despite its critical importance, the management of IP often remains an enigma to many founders, veiled in layers of legal intricacies and strategic considerations. This article delves into the essentials that founders need to know to navigate the multifaceted landscape of IP management, laying a solid foundation for sustainable growth and mitigated risks.

Wearable technology is any technology that is designed to be used while worn and includes smart watches, fitness trackers, wearable cameras, smart fabrics and e-textiles, and augmented and virtual reality headsets as well as implantable devices. These technologies are frequently networked, integrating electronics and computer technology, such as sensors to collect real time data. This is often sent to apps on the wearer’s smartphone to provide insights into their sleep, health and movement activities as part of a trend known as the “quantified self.”