SME Lunch and Learn - Intellectual Property and Government-Funded Research: Navigating the Bayh-Dole Framework

For many emerging life sciences and technology companies, government grants and sponsored research programs provide critical funding to accelerate innovation. However, inventions developed with federal support are subject to unique intellectual property requirements that can impact patent ownership, licensing rights, commercialization strategies, and investor diligence. During this session, attendees will gain a practical understanding of the Bayh-Dole Act and the obligations that accompany federally funded research. We will discuss key compliance requirements, government-retained rights, SBIR and STTR funding considerations, common due diligence pitfalls, and strategies for protecting and maximizing the value of IP assets developed through government-supported innovation. Drawing on real-world scenarios, this program will help startups, research institutions, and commercialization teams navigate the intersection of funding and intellectual property with confidence.  

Learning Objectives

• Understand how the Bayh-Dole Act affects ownership of inventions arising from federally funded research.
• Identify key compliance requirements that can impact patent rights and commercialization opportunities.
• Recognize how government-retained rights may affect licensing, fundraising, partnerships, and acquisitions.
• Avoid common IP diligence issues related to federally funded research and academic collaborations.
• Learn practical strategies for managing government-funded IP throughout the innovation lifecycle.

Meet the Subject Matter Experts

Paul A. Calvo, Ph.D., Director in Sterne Kessler Biotechnology & Chemical Practice Group

Paul advises a diverse group of biotechnology and pharmaceutical companies, with a particular focus on counseling European life sciences clients as they navigate U.S. intellectual property concerns. He works closely with innovators on global patent portfolio strategy, licensing, patent validity, infringement, and design-around strategies. Paul has a particular focus on technologies that include large molecule therapies, such as therapeutic antibodies, chimeric antigen receptors, and polypeptide therapeutics, antibody drug conjugates, genomics applications, and medical devices.

Paul’s practice spans U.S. and international patent procurement and enforcement matters (particularly patent prosecution and oppositions), FDA/ANDA matters, technology transfer, and due diligence investigations as well as invalidity, noninfringement, freedom-to-operate (FTO), and patentability opinions. Paul is also counsel to many start-up companies, guiding them through early-stage portfolio development, strategic partnerships with multinational pharmaceutical companies, and SEC filings on their way to becoming publicly traded entities.

Additionally, Paul has extensive experience providing diligence support for both venture-backed start-ups and their investors as companies progress through seed to growth financings. He provides assistance with identifying and remedying ownership issues, prosecution strategy and scope alignment, FTO and competitive landscape, and diligence packaging that makes it easy to pressure-test risk without encumbering a potential deal. From the company side, Paul assists management teams build portfolios that track scientific and commercial milestones. 

Peter A. Jackman, Director in Sterne Kessler’s Biotechnology & Chemical Practice Group

Peter A. Jackman is a director in Sterne Kessler’s Biotechnology & Chemical Practice Group. He effectively works with clients to identify IP opportunities and solve IP business challenges. His practice focuses on counseling clients in areas such as global patent portfolio procurement, management and enforcement strategies, technology transfer, invalidity, non-infringement, freedom-to-operate and patentability opinions and due diligence investigations. He has represented clients in patent reexaminations and inter partes review proceedings and has prosecuted patent applications domestically and internationally in areas such as immunology, genomics, molecular and cell biology, cell and gene therapy, recombinant DNA and fermentation technologies, transgenics, pharmaceutical formulations, bioprocessing, nutraceuticals, food science and industrial and agriculture biotechnologies such as advanced biofuels, bio-based chemicals and fertilizers, and molecular farming.

Peter is also a leader in the firm’s CleanTech Industry Group. He frequently lectures and publishes on intellectual property issues surrounding renewable technologies, and he was an associate editor for Clean Tech Law & Business, the first peer-reviewed journal devoted exclusively to the pursuit of environmentally sustainable technology. He serves as a Good Food Institute mentor to emerging alternative protein companies and served as a member of the BIO World Congress on Industrial Biotechnology Program Committee.

Additionally, Peter is a contributing author of Patent Office Litigation, Second Edition,published in 2017. The book provides a fresh and comprehensive exploration of patent office litigation proceedings, including how the proceedings interact with other aspects of patent procurement and enforcement, while delivering practical analysis and advice. This second edition of Patent Office Litigation is the follow up to the first version of the book that was published in 2012 by Thomson Reuters Westlaw that focused on the contested proceedings that were introduced under the America Invents Act that year.

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