James V. DeGiulio, Ph.D.

"My approach is rooted in an unwavering commitment to delivering the highest quality of work. The foundation of effective legal representation in my practice is a deep understanding of the science behind each invention and its significance to the client's broader strategy. By fully grasping the nuances of an invention, I work to ensure that every patent application is crafted with a clear and deliberate strategy aimed at safeguarding the most vital aspects of the innovation and with the maximum term possible. I believe collaboration is key; working closely with clients as a team and aligning efforts toward a shared goal that reflects the long-term vision."

With a commitment to safeguarding innovation in the life sciences industry, Dr. James DeGiulio offers clients a strategic approach to patent portfolio development and management that aligns with their business goals. Representing mid-to-large life science companies in Boston and Chicago, he has broad experience in drafting and prosecuting patent applications for compositions, formulations and methods of treatment that span both early and late-stage clinical development.

His focus includes:

• Biofuels
• Companion diagnostics and biomarkers
• Fusion proteins
• Gene therapy applications
• Nucleic acid synthesis and sequencing
• Therapeutic antibodies and polypeptides

A deep understanding of these areas allows James to craft patent applications that protect the core value of a client's innovations and stand resilient against future challenges, including invalidity claims and litigation. His experience in Hatch-Waxman pharmaceutical drug litigation, combined with his understanding of FDA regulations and the nuances of biosimilar entry strategies under the Biologics Price Competition and Innovation Act (BPCIA), positions clients to overcome future invalidity challenges in litigation or inter partes review (IPR) proceedings, increasing success outcomes within a competitive market.

In addition to patent drafting and prosecution, James provides comprehensive freedom-to-operate and patentability searches and opinions, delivering actionable insights that help clients navigate complex patent landscapes. His ability to evaluate third-party patent portfolios and offer infringement and invalidity opinions further empowers clients to make informed decisions, whether defending their IP or exploring new avenues for innovation.

Clients benefit from James's scientific understanding, honed through graduate research in non-viral gene therapy and undergraduate studies in bacteriophage characterization. This technical foundation, coupled with years of hands-on legal experience, enables him to understand the intricacies of clients' technologies and anticipate challenges that may arise in patent prosecution or litigation.

Working with James means partnering with a seasoned advocate who protects the client's intellectual property and guides them through the complexities of the life sciences patent landscape, ensuring innovations reach their full potential in the market.

WHEN ASKED …

Why did you become a lawyer?

The practice of law allows me to stay connected to cutting-edge advancements in biological science, particularly in gene therapy, which has been an inspiration of mine since my first research experience as an undergraduate. I am passionate about understanding the science behind each invention and ensuring that these groundbreaking innovations are protected. Working as a team with clients, I strive to master the intricacies of their inventions, enabling the development of the strongest possible patent portfolio, particularly within highly competitive fields. The opportunity to learn about new advancements and play a role in their development into life-changing treatments for patients is what drives me every day.

What do you do outside of work?

When I have a break from driving my twins around, I like to dabble in carpentry and other home improvement projects.

REPRESENTATIVE EXPERIENCE

James has played a pivotal role in developing a comprehensive worldwide patent portfolio for a novel hemophilia A drug on behalf of a major biotech client.

Additionally, his experience includes:

• Biosimilars
• Biotechnology
• FDA regulatory matters
• Intellectual property litigation
• Licensing, technology transfer & commercialization
• Patent litigation & prosecution
• Pharmaceutical litigation

• Moderator, "Capitalizing IP Cost-Effectively: Sophisticated IP Counsel & Creative Pricing," ALM General Counsel Conference, April 19, 2023

• Co-author, "The TolC and Lipopolysaccharide-Specific Escherichia coli Bacteriophage TLS—the Tlsvirus Archetype Virus," PHAGE Therapy, Applications, and Research Journal, July 9, 2024
• Author, "FDA Guidance Uncertainty May Deter Use of Abbreviated Biosimilar Approval Pathway," BNA Life Science Law and Industry Report, April 20, 2012
• Author, "The Genomic Research and Accessibility Act: More Science Fiction that Fact," Northwestern Journal of Technology and Intellectual Property, Spring 2010
• Co-author, "The SP-C promoter facilitates alveolar type II epithelial cell-specific plasmid nuclear import and gene expression," Gene Therapy, April 17, 2024
• Co-author, "Micromechanical properties of keratin intermediate filament networks," Proceedings of the National Academy of Sciences of the United States of America, January 22, 2008
• Co-author, "Intracellular trafficking of plasmids for gene therapy: Mechanisms of cytoplasmic movement and nuclear import," Current Gene Therapy. Dec 2006, Vol 6, 671-81