My thoughts on the most recent patent application . . ..
I think this new neurodevelopmental patent application serves two purposes. First, it redefines the medical use of 2-73 on the basis of symptoms and biomarkers, rather than disease names. Second, it restarts the full patent protection clock on the medical use of 2-73 for this category of diseases. (We should expect a similar patent app coming for the neurodegenerative diseases in the not too distant future.). Both prongs are important.
The first prong is not as obvious as the second. Aside from demonstrating Anavex's commitment to a platform-based pharmaceutical, it also indicates that the company's research shows the best treatment regime correlates according to symptom and biomarker, rather than by disease diagnosis. (Shades of Mayomobile's predictive matrix are appearing to me.) Put another way, I think this means that the company has found the dose-response curve to track symptoms and biomarkers better than diseases. This is consistent with the Anavex position that it has an upstream, platform-based solution acting above specific indications.
Take Rett, for example, where some here have raised dose-response concerns. Rett patients are not all alike, either in the specific underlying disease causes or in the combinations of their symptoms. This from a fairly recent study in Norway, entitled "Rett Syndrome: A more heterogenous group than previously thought?": "91 individuals were included; 72 had classic RTT, 12 atypical RTT and seven did not fulfill the diagnostic criteria. Mutations in MECP2were found in 77 individuals. In addition, mutations in SMC1A, SYNGAP1, SCN1A, CDKL5, FOXG1and Chromosome 13q were found. Comparison of individuals with RTT with and without MECP2mutations revealed significant differences in early development, loss of hand use and language, intense eye gaze and the presence of early onset epilepsy."
If AVATAR and EXCELLENCE dose response curves weaken or fail according to a Rett Syndrome diagnosis among a heterogenous group of patients, they may strengthen or appear if the problem is redefined, as in this patent application, as a variety of neurodevelopmental symptoms and associated biomarkers, each responding to somewhat different dosages of 2-73. Will Anavex have sufficiennt data to support this kind of Rett analysis? I think that's the direction they intend to go, if possible.
Second, if Anavex is preparing the scientific methods for medical treatment for neurodevelopmental disease through this patent, anyone else selling the pharmaceutical will inevitably fall within its scope of the 2-73 neurodevelopmental medical manual. Every year of patent protection is golden.
Hello, 2040's.
