Tech Transfer Tip: Discovering additional uses for existing drugs

I have made a new discovery that opens up additional uses for a drug that is either currently in development or is already on the market.  How can I engage with industry to help this group of patients?

CTTC is always excited to hear about the basic research that enables these scientific breakthroughs, whether you have discovered a new mechanism of action or biological process important in a disease process.  These types of inventions are the foundations of translational science, but often have unique challenges in terms of patentability and commercialization.  Since these concepts are often misunderstood, we want to explain these challenges, and invite you to call us anytime for additional information.

For the purpose of this example, patentable subject matter can fall into the categories of a new composition of matter (such as a chemical compound) or a method of use (treating patients with a certain disease with the chemical compound).  The pharmaceutical industry relies on both types of patents to protect proprietary drugs and create competitive barriers.  However, the most valuable patents are composition of matter patents because they protect the chemical compound itself, irrespective of its use or mechanism of action.  Method of use patent claims, such as the use of a therapeutic compound for treatment of Alzheimer’s disease, for example, are more narrow patent claims because:  1) one has to also have rights to the overarching composition of matter patent to use the drug in question without infringement, and 2) they are easier to for competitors to “design around” and circumnavigate the patent rights by making incremental changes.

Applying these principles to a hypothetical scenario, let’s explore a situation where a researcher discovers that “OncoGene1” (a protein already known to be important in cancer development) is also critically important in the development of Alzheimer’s disease.  In order to test this hypothesis, the researcher employs the use of an OncoGene1 Inhibitor, made by the creatively named pharmaceutical company “DrugCompany”.  “DrugCompany” likely owns or has licensed the rights to composition of matter patents to the OncoGene1 Inhibitor compound and method patents for its use in cancers.  Thus, this new discovery, a method of using the OncoGene1 Inhibitor for Alzheimer’s disease, is eclipsed by the broader umbrella of rights conferred by the composition of matter patent.  In addition, since patent rights are an exclusionary right to keep competitors away, potential partnering or licensing relationships would be limited to those companies that either own or have licensed the rights to the composition of matter patent (for example, “DrugCompany”).  This example illustrates why composition of matter rights (which are irrespective of use or mechanism of action) are considered the most valuable rights in the pharmaceutical industry.

The process of identifying new uses for existing drug compounds, or repurposing, can significantly speed the development timeline for approval of new therapeutic uses.  The National Center for Advancing Translational Sciences (NCATS) supports such development through its “Discovering New Therapeutic Uses for Existing Molecules” program, which matches academic investigators with industry experts to explore these possibilities.

Academic institutions DO play a major role in the drug development process and industry does often engage in collaborative partnership or licensing relationships to answer questions about a drug candidate’s mechanism of action or disease processes.  In these cases, CTTC negotiates the intellectual property framework for these agreements on behalf of our researchers so that all parties are rewarded for these endeavors.