Advising on intellectual property for precision medicine diagnostics

Challenge

A new academic spin-out company in Europe had acquired the rights to the intellectual property covering a new diagnostic agent. This molecular MRI imaging tool is envisioned to be useful in oncology indications for the early identification of certain tumors, particularly in precision medicine initiatives that target tumor-specific alterations. The burgeoning management team needed guidance on the value of the agent, the clinical path to its development, and which companies might be future licensees.

Solution

Numerous facets of intellectual property and business development must be considered in order to determine the optimal development path for a molecule. Our consultant first analyzed the strengths and potential weaknesses of the intellectual property. He then examined the business case for the new agent, including the cost:benefit ratio, which, combined with our analysis of the competitive landscape for similar products, determined whether this particular agent is likely to be widely used. We highlighted that this diagnostic agent could potentially be adapted as a drug delivery system, bringing therapeutic agents such as radiotherapy to the tissue of interest. We advised our client on the potential of adapting the imaging reagent in this manner. Alternatively, the agent could be used as a companion diagnostic, paired with a therapeutic regimen that is known to be effective in particular tumor types. With the advent of precision medicine, the opportunities to identify subsets of patients that respond to a particular therapy are vast, and MRI diagnostics could play a substantial role.

A small company like our client can either develop the agent themselves or pass it on to another company in a licensing or acquisition deal. Our consultant advised on the clinical trials process for diagnostics, which would include dosing and proof-of-concept studies as well as trials to determine efficacy and superiority over existing agents. Late-stage clinical trials for diagnostic agents are different from those for investigational new drugs, as diagnostic agents require the scans to be read and interpreted by 3 radiologists, which introduces an additional complexity.

Should the company choose to out-license the agent, our consultant identified potential licensing partners, and will make connections between these companies and our client.

Our full report to this company includes the analysis of the intellectual property, the current and future market environment, and the multiple potential paths that could be used to develop this drug. These data should enable our client to take the best possible next steps in efficiently moving this diagnostic into the clinic.

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