Axcentua’s drug development strategy takes compounds that occur in nature and exploits their therapeutic properties. Axcentua’s intellectual property strategy takes those naturally-occurring compounds and builds a patent estate by re-engineering their physical form. As they exist in nature, naturally-occurring compounds are not patentable. But, when they are purified or made into useable form, that new useable form can be patented. Axcentua re-engineers its natural products to produce new forms of the compound, which can serve as active pharmaceutical ingredients (API). Novel salts or crystalline forms (e. g. polymorphs, crystalline salts, co-crystals etc.) do not occur in nature. These forms typically possess new or improved properties that make the compound all the more attractive as an API. For example, the new form may possess better bioavailability, better processing characteristics, or increased stability. The new form, with its unique properties and advantages, becomes the foundation for a patent estate.
Axcentua’s patent strategy then builds on the new form itself, pursuing claims to the new form, pharmaceutical formulations containing the new form, and methods of treatment/uses of the new form. Axcentua, however, does not only look to the final API for its patent estate but also considers upstream opportunities (e.g., intermediate compounds, novel processes for re-engineering the new form etc.) to establish further patent positions. For example, where the API is a new crystalline salt, crystal forms of the natural free base may exist and be subject of separate patents as well as other synthetic intermediates.
In sum, although a compound as it exists in nature may not itself be patentable, re-engineering that compound into a new, usable form creates an opportunity to establish meaningful patent protection to protect Axcentua’s API’s and to commercialize them.