Intellectual Property as a Core Strategy in Drug Formulation and Development

*full transcript below

In this final part of our 5-part interview series on the current CDMO landscape, Dave Miller, PhD, chief scientific officer at AustinPx, discusses the growing importance of intellectual property (IP) strategy in formulation development, emphasizing how it has become inseparable from solving traditional drug delivery challenges. Miller, who brings both sponsor and CDMO perspectives to the table, highlights how IP considerations must be built into the earliest stages of formulation planning, particularly as many compounds entering the market are already late in their patent lifecycles.

As Miller explains, “It’s not just about solving the drug delivery problems but also generating additional IP to protect the asset beyond loss of exclusivity.” For clients developing molecules with patents close to expiration, composition-of-matter IP tied to the drug product itself is increasingly relied upon as a way to extend protection. By designing tailored formulations that address issues such as bioavailability, stability, and manufacturability, companies can often create unique, patentable compositions that simultaneously meet therapeutic and commercial needs.

Miller also underscores the role of proprietary platforms in providing what he calls “perpetual protection against generic competition.” Even when generics attempt to work around a formulation, they often lack access to the specialized processing technologies required to replicate the performance of the innovator product. This technological barrier, he notes, can provide a lasting competitive edge beyond traditional regulatory exclusivity.

Ultimately, Miller frames the role of a CDMO not as a transactional service provider, but as a true development partner. From the earliest design of a formulation through to commercialization, the goal is to deliver therapeutic benefit while ensuring long-term protection of the asset.

Check out previous parts of the interview series with Miller:

Part 1 - Collaborative Innovation in CDMOs: Dave Miller, PhD, on Early Engagement, IP Strategy, and Advanced Formulation

Part 2 - The Importance for CDMOs of Partnering With a Sponsor’s Mindset

Part 3 - Onshoring’s Unexpected Benefits: Quality, Efficiency, and Supply Chain Resilience

Part 4 - Sustainability Becomes Essential: Green Manufacturing and Supply Chain Resilience in Bio/Pharma

About the Interviewee

Dr. Miller brings over two decades of pharmaceutical development experience and has spent his career investigating ways to improve the bioavailability of poorly soluble molecules. As CSO of AustinPx, Dr. Miller leads the pharmaceutics and analytical development teams and oversees the application of the KinetiSol Technology. Prior to his current position, Dr. Miller served as Vice President of Research and Development at DisperSol Technologies and Senior Principal Scientist at Hoffmann-La Roche. Dr. Miller specializes in formulation and processing technologies for improving oral bioavailability of insoluble small molecules. He has applied his expertise toward advancing numerous drug candidates through all stages of development from early discovery to line extension. Dr. Miller is a co-inventor of the pharmaceutical applications of the KinetiSol technology and continues to be a key innovative driver for application and expansion of the platform. He has published over 40 research articles in peer-reviewed journals, authored 8 book chapters, and is co-editor of the First, Second, and Third Editions of the textbook, Formulating Poorly Water-Soluble Drugs. He is a co-inventor on numerous granted and pending patents worldwide. Dr. Miller holds a BS in Chemical Engineering and a PhD in Pharmaceutics from the University of Texas at Austin.

Transcript

*Editor’s Note: This transcript is a direct, unedited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

We deal with a lot of clients that have IP in the forefront as they're developing the delivery system for their molecule. So now the IP strategy is part of the formulation strategy. It's not just about solving the drug delivery problems but also generating additional IP to protect the asset beyond loss of exclusivity. And some of the clients that come to us have molecules that have been in clinical development for a long time. And, and so by the time they reach market, the IP protecting the molecule itself will be near expired.

So then we really rely on the drug product composition of matter IP to protect the asset beyond loss of regulatory exclusivity. So we do a lot of front end evaluation of the formulation development plan with IP in mind. But as I said, it's not about developing a formulation just to achieve IP.

When you develop a tailored formulation development program and a tailored composition specific to the issues of that molecule, and you do it right and you do it well, you solve the bioavailability, stability, manufacturability issues simultaneously. A natural side effect of that is the composition that you've generated specific to that molecule is novel. It's unique, it's patentable. And so IP is attainable when you take that approach, but also even without the IP, when you are using novel platforms like we have that aren't accessible to generics, even if they could formulate around, they still don't have the underlying processing tools to create that composition, to generate those performance metrics. Without access to our platforms they have generics that can't copy the performance of the product. They might be able to circumvent the formulation, but they can't achieve the same performance metrics. So that ultimately ends up being what I like to call perpetual protection against generic competition.

As long as the generic can't access the tool that makes it possible, that could never duplicate your product, and that's very attractive for a number of our clients for which drug product IP is essential to the development. Again, it's not just about, as a CDMO, transactional services, providing the pills on time for the clinical study. It's about co-development, starting at the front end with the full development pathway in mind, all the way to the commercial future of the molecule. And IP is right there at the forefront of those early considerations. So, that's the approach we take. And, again, being a sponsor ourselves, whenever we initiated a new program, especially when you're working on 505(b)(2) molecules, developing the formulation that not only checks the boxes in terms of providing therapeutic benefit and then meeting sort of the standard criteria of stability manufacturability, but also, once we prove the therapeutic benefit in the clinic, are we going to have a duration of exclusivity that allows the investors to recoup their investment?

Those were the key requirements when we started developing our own products. And so we just naturally bring that to the table that we can design a delivery system that provides more than just meeting the standard requirements of a dosage form, but also providing IP that could protect the asset for, you know, a decade after loss of exclusivity. So, it's becoming critical to a large majority of our clients and programs.