Two patents entitled “Methods and Compositions Utilizing RRx-001 for Radioprotection” and “Cytokine Receptor Fusion Proteins (TGF-beta trap) and Virus Expressing Them” were recently issued in several countries, which is always a cause for celebration.
The purpose of patents or intellectual property (“IP” for short) is to establish territorial boundaries, marking and claiming pharmaceutical data, compounds and therapeutic niches as proprietary. For example, paramount for EpicentRx is to safeguard and insulate its lead therapies, RRx-001 (nibrozetone) and AdAPT-001, with layers and layers of IP, which the company has done and continues to do—and pursue—aggressively.
Under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), an international legal agreement between all the member nations of the World Trade Organization (WTO), patented inventions including RRx-001 and AdAPT-001 must receive a minimum of 20 years of protection.
In addition to 20 years of patent protection, the small molecule RRx-001 will receive a 5-year new chemical entity (NCE) regulatory exclusivity plus a 3-year new formulation regulatory exclusivity on approval by the FDA, which prevents generic versions from entering the market during that time span. Moreover, since RRx-001 has been granted orphan drug status in acute radiation syndrome (ARS), neuroendocrine disease, small cell lung cancer (SCLC), and glioblastoma (GBM), it will receive an extra 7-years of exclusivity (10 years in the European Union) on top of the NCE and new formulation exclusivities for these indications. RRx-001 may also qualify for 6-months of pediatric drug exclusivity (PDE).
As a biologic, AdAPT-001 has a considerably longer exclusivity period on FDA approval—12 years as compared to 5 years for an NCE. This exclusivity is in addition to any orphan designations, good for 7 years in the U.S. and 10 years in the European Union, that AdAPT-001 may receive as well as the potential for pediatric drug exclusivity.
For a more in-depth description on the patent and regulatory exclusivities that are available to RRx-001 and AdAPT-001, we refer you to this informative EpicentRx-authored manuscript here entitled “Patent and Marketing Exclusivities 101 for Drug Developers.”