With protracted litigation over the ownership of NOX66 no longer a threat, it is timely to look at the patent position for NOX66.
It is quite common for a small biotech company to start clinical trials before a patent is granted. In fact if a company waited until a patent was granted and then spent 10+ years getting marketing approval, the 20-year life of a granted patent would already be halved.
It is very important to know that an invention must be 'reduced to practice' before it can be patented. While suppositories have been listed in ambit claims as a potential mode of delivery for isoflavone drugs, there is no record of the LIPROSE technique being reduced to practice.
The first Noxopharm application states that: "... the objective of the manufacture process is not to admix, or to mingle, or to blend the suppository base with the isoflavonoid as generally occurs in pharmacy practice of admixing components, as it is believed that the resulting admixture would have a lower likelihood of providing therapeutic benefit".
It goes on to state that: "In a preferred embodiment, all of the isoflavonoid added to a dosage unit is DISSOLVED in the base (my emphasis). In this embodiment, no isoflavonoid is left to admixture with the suppository base. This is believed to increase the likelihood of the uptake of all the isoflavonoid given in the dosage unit".
The preliminary examination opinion states that claim 23 is inventive because "none of the prior art documents disclose dissolving the isoflavonoid compounds in the oleaginous base" but rejects all other claims because the scope of these claims include compounds "contained" in the base (rather than being "dissolved" in the base). This seems to be splitting hairs, because the text clearly stated that isoflavonoids must be dissolved in the base but in the claims this is at times described as "contained or dissolved in the base".
It is open to Noxopharm to substitute a new set of claims in which "dissolved" is substituted for "contained", which would appear to make all claims inventive.
And to those here who consider themselves to be patent experts, I gently suggest that they wait to see what the principal of one of the top IP firms in Australia has to say when he returns serve to the patent examiner.
NOX Price at posting:
97.5¢ Sentiment: None Disclosure: Held
