The two key tests in being awarded a patent over any intellectual property (IP) are novelty and inventiveness. In the drug development world, proving both is much easier where there is no pre-existing IP…. For example, no-one had described the new molecule before (known as a New Chemical Entity), so it is novel; or no-one had thought that something with that shape would treat a certain disease, so it is inventive. The process becomes potentially longer where the new IP relates to an improvement on existing IP. The outcome can be exactly the same in terms of the strength of the granted patent …. just the length of time and amount of effort it takes to get there.
The drug, NOX66, falls into the latter group…. Noxopharm has taken a molecule (idronoxil) that failed to work in a Phase 3 clinical study, and has potentially found a way to make it work. By any test, that should represent an improvement. The reason for that improvement is the basis of our patent application program, and while we don’t under-estimate the length of the path ahead, Noxopharm is optimistic that it will achieve approved patent claims that will protect what it regards as very valuable intellectual property.
A Preliminary Opinion on some early patent applications relating to NOX66 was made public a couple of days ago. Some claims were considered likely allowable, others were not. What does it mean?
First, it is an opinion. It is not binding. It is meant to provide guidance for the applicant. It gives the applicant the opportunity to amend claims in a way that makes them more likely to be granted. It also means that a company can then prepare its arguments so it can hopefully more successfully prosecute its case. It is process that many patent applications for new drugs go through. I am the Inventor on a large number of granted drug patents, and every one of them involved addressing and eventually overturning comments by patent examiners in many territories around the world.
Second, and this is the most important factor to bear in mind, this opinion refers just to the first round of patents we lodged that explain how to make idronoxil work. Since then, we have lodged a further family of patent applications that contribute to the discovery of why NOX66 works.
It is these later patents that we regard as the most relevant to our future given that this is entirely new IP, unrecognised in any previous patents.
This is the nature of R&D. The further the drug candidate progresses in the clinic, the more we expect to learn about NOX66 … how it works as a radio-sensitiser, who it helps, how it interacts with other treatments etc. I fully anticipate that we are going to generate a lot of new intellectual property all of which will feed into new patent applications. The ultimate aim is a portfolio of patents that collectively forms a solid patent wall around our technology platform.
It also is possible that NOX66 will achieve a marketing license before all relevant patents have been granted. In our opinion that situation will not affect the Company’s ability to commercialise NOX66.