The Daily Dose • Saturday, May 18, 2024

Patent Pathways: Navigating the Maze of Innovation in Perioperative Medicine

Christian S. Guay, MD

The importance of intellectual property (IP) in advancing medical research and the challenges and rewards of translating scientific discoveries into impactful innovations in clinical practice were underscored at the session, “Ensuring Patients Benefit from Your Intellectual Property, Patents and Commercialization,” on Saturday, May 18 at the 2024 Annual Meeting, presented by IARS and SOCCA. Attendees were left with practical knowledge on the process of translating discoveries into products and real-life insights into the path of academic entrepreneurship.  

Beverley Orser, MD, PhD, chair of the department of anesthesiology and pain medicine at the University of Toronto, opened the session by introducing the speakers and setting the stage for a series of insightful talks on the journey from discovery to intellectual property and commercialization in the field of perioperative medicine.

Jason Maynes, PhD, MD, chief of anesthesia and pain medicine and the associate chief of perioperative services (research) at the Hospital for Sick Children, commenced his presentation by highlighting the vast potential for intellectual property in perioperative medicine, citing 12,610 records for “Anesthesiology” in the US Public Patent Search. He emphasized that innovation in this field has a broad range, from incremental improvements to revolutionary advances. However, not all good science is meant for commercialization, and not everything commercialized stems from great science. Anesthesiology, he noted, is a medical specialty that is particularly conducive to innovation and invention. Dr. Maynes provided a comprehensive overview of what constitutes IP, defining it as “intangible creations of the human intellect.” He outlined the four main forms of IP: 1) patents, which exclude others from making, using, or selling an invention; 2) copyrights, which protect creative works; 3) trademarks, which are recognizable designs representing specific products; and 4) trade secrets, which include formulas, processes, and algorithms with inherent economic value. He pointed out that patents and trade secrets are most relevant to innovators in anesthesiology.

The importance of protecting IP and benefits of academic entrepreneurship were then underscored, including faster translation of research to patient care, increased and new funding streams, sustained scholarship levels, and enhanced student success both inside and outside clinical medicine. In fact, academic commercialization contributes significantly to the US GDP, accounting for approximately $1 trillion, and academic medical centers (AMCs) now play a crucial role in IP development. Dr. Maynes noted a progressive decline in the R&D budgets of large pharmaceutical and biotechnology companies, coupled with greater availability of high-risk venture capital for academic innovators. Spin-outs from AMCs have now become an accepted model, facilitating collaborative private-public funding and licensing. This diversification of funding streams can help sustain research programs by complimenting traditional grants with venture capital.

For researchers looking to capitalize on their IP, Dr. Maynes advised first consulting their institution’s technology transfer office. Understanding the extent of ownership and the best licensing strategy — whether through assignment or licensing — is crucial. While assignment involves transferring the entire IP bundle and control over its exploitation, licensing can be exclusive or nonexclusive and typically involves fewer upfront funds to commercialize.

Continuing the discussion, Patrick L. Purdon, PhD, a professor of anesthesiology, perioperative, and pain medicine and bioengineering at Stanford University School of Medicine, opened his presentation by sharing his personal journey, offering practical insights into the process of IP development and commercialization. He emphasized the importance of self-advocacy early in the process, particularly when dealing with tech transfer offices that may not always respond promptly. He recounted his experience working at Massachusetts General Hospital (MGH) with Emery N. Brown, MD, PhD, where they developed IP related to brain monitoring of anesthetic states. After an unsuccessful attempt to license the IP to an existing company, MGH reclaimed the license, leading Dr. Purdon to establish PASCALL Systems.

Starting his own company made the stakes feel significantly higher and required him to acquire new skills. Dr. Purdon stressed the necessity of understanding the process thoroughly — reading manuals and building relationships with tech transfer offices. Ultimately though, starting a company is in some ways like raising a child: you can read all the books you want, but there will inevitably be experiential lessons learned along the way. He also highlighted several regulatory constraints that any academic entrepreneur should keep in mind, such as not being able to hold an executive position in the company while maintaining a primary academic appointment or being the principal investigator on a clinical trial involving one’s own invention.

Dr. Purdon also shared his enriching experience at Stanford Byers Center for Biodesign, which structured the process of identifying needs, inventing solutions, and implementing them. The program’s approach — crafting need statements and filtering criteria — helped refine and validate innovative ideas effectively.

Laura Niklason, MD, PhD, founder, president and CEO of Humacyte, Inc. concluded the session by discussing her transition from the operating room to industry, where she is now growing arteries from scratch. Dr. Niklason’s journey began with a critical question during her anesthesiology training at Massachusetts General Hospital: Could a brand new artery be grown for patients needing coronary artery bypass graft surgery, rather than harvesting veins and arteries from other parts of their body? Her postdoctoral research at Massachusetts Institute of Technology, published in Science in 1999, led to the founding of Humacyte in 2005. The company progressed its technology over the years and filed for FDA approval of engineered arteries in 2023, with the review still ongoing.

Dr. Niklason shared her framework for innovation: identifying and solving real, important problems in medicine, creating simple prototypes, securing intellectual property, improving prototypes, obtaining funding, and persevering through the long process of gaining support for an idea. She emphasized the three key ingredients for innovation: optimism, realism, and tenacity. Common pitfalls to avoid include creating a product and then looking for a problem to fix with it, and pursuing ideas that you aren’t completely in love with. The path of an academic entrepreneur is long and ultimately no one will love your idea as much as you do, so the decision to pursue this trajectory must be very deliberate and considerate of input from trusted mentors and colleagues.