Commercialization of Phage Therapeutics: the Value of Intellectual Property and Patents
Fabien Palazzoli, Michael Koeris and Shawna McCallin
from: Bacterial Viruses: Exploitation for Biocontrol and Therapeutics (Edited by: Aidan Coffey and Colin Buttimer). Caister Academic Press, U.K. (2020) Pages: 663-692.
The time is ripe for a transition of bacteriophage (phage)-based products and services from a laboratory setting to commercial markets, yet there remain lingering doubts and questions as to if, how, and when this passage will occur. Exorbitant sunk costs to pay for the research and testing required to secure marketing authorizations for sales and distribution, and thus generate money, require high early-stage amounts of investment. The return on that initial investment, in turn, calls for high price tags and defence of intellectual property to ensure a certain market-share. Yet the market of antibacterials is conventionally low-cost, low-tech, and low-value, and phage therapies are furthermore not your standard pharmaceutical. Due to their historical discovery and use, many foundational aspects of phage R and D and applications fall in the public domain, therefore excluding patentability. Newer methods and techniques in areas in need of innovation for phage development, however, do offer a chance for intellectual property (IP) protection. While natural phages and phage combinations remain the most-heavily patented area, the volume of patent applications and their geographical origin show signs that there is indeed growing interest in protecting phage-based technologies, a key step before commercialization. The following chapter aims to provide the reader with a basic overview of different IP rights and agreements that are pertinent to the biotech industry and discuss their associated strengths and weaknesses. Current examples of product and business development in the areas of natural phages, genetically-modified phages, bioproduction and formulation, and therapeutic strategies will be highlighted. In the absence of evidence of efficacy from well-designed clinical trials, however, the value of patents and IP protection for phage products and their associated process is difficult to evaluate. The performance of phage therapy in the next few years will be decisive for sustainable and scalable commercialization read more ...