I follow all patent applications closely. On at least two occasions, the rationale of a Final Rejection was demolished by the Noxopharm patent attorney, whereupon the Patent Examiner started the whole process again, withdrew the Rejection, then raised a completely new set of objections. I note that on the last occasion, Noxopharm was invited to call the Examiner’s boss, which suggests that raising new objections at this stage is controversial.
Examiners often state that it would have been obvious to an expert to conduct experiments along the line of the invention claimed. But Professor Kelly WAS the pre-eminent expert in these fields, having lodged most of the relevant patent applications that constitute Prior Art. How can it have been obvious when Professor Kelly – who was suffering from terminal cancer – took years to work out that Idronoxil had to be dissolved in a special suppository base to work. Many of the objections, to me, seem based on hindsight.
As for strategy, it is not uncommon for inventive step objections to be raised during the international phase and for applicants to elect not to respond, but wait until the national phase to address inventive step (if raised by the national offices) as the test for inventive step varies between jurisdictions.
Note also that a “provisional application” provides provisional protection for 12 months, then automatically lapses. If an applicant wishes to gain the benefit of the priority date of the provisional application, they must file a complete/PCT application within that 12 month period. This occurred twice in recent times, when more robust data enabled Noxopharm to file updated applications within the 12-month window.
The following comments from GK show some of the strategy behind patent applications:
We see our patent portfolio as being in two parts – Gen 1 and Gen 2.
Gen 1 patents were lodged in the early days (2016-2019) and Gen 2 in the last 2 years.
Gen 2 patents are around use claims, as per the recent Veyonda/COVID-19 patent application. These cover combination treatments with other anti-cancer agents (eg. checkpoint inhibitors) and for specific uses (eg. induction of abscopal responses). These patents are only now being examined by International Examiners and we remain confident that we have the novelty and inventiveness to go to grant. Patenting is always about compromise and giving some to get some and we anticipate that will be the case here. Nevertheless, Gen 2 patents are where we see Veyonda achieving its key IP protection.
Gen 1 patents were lodged before we had much preclinical data and before we had any clinical data, so they were based around formulation/pharmacokinetics. They were always going to be challenging and our expectation was that different territories would take different positions, which is exactly what we have experienced with Australia and certain others being supportive, the U.S. being difficult and Europe somewhere in the middle.
Gen 2 patents have essentially surpassed Gen 1 patents and so we can afford to take a pragmatic approach to the Gen 1 patents. We will pursue aggressively where we believe we can win, take anything that others are prepared to give, and walk away where there is no point. We expect to take something out of the Gen 1 patents that will provide additional benefit, not key benefit.
But I warn people not to read too much into published patent office responses. Patent applications are largely horse-trading exercises with multiple layers of appeals and compromise. Back in 1996, the U.S. Patent Office issued a final rejection on the original Idronoxil patent. I got on a plane, went to Virginia and sat down in the office of the examiner. Three hours later I was able to convince him that he had got it wrong. It turned out that I was the first patent applicant in his patent career who had bothered to sit down and talk to him. We got the patent granted in the U.S.
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