On April 6th of last year, I submitted a provisional patent on the use of topical ivermectin as a deterrent, a safety measure, and a chemical condom for protection and prevention of COVID. The patent offered the use of ivermectin as a spray, aerosol, solution, or the like to masks, skin, oropharynx, and nostrils. The provisional would have two lives before it was put to rest.
In truth, I hoped to sell the provisional patent in its raw form to a larger company (i.e., pharmaceutical company). I have had six full patents to date, and two related to ivermectin that I sold 15 years ago and lead to development of a commercial product named Sklice. Fifteen years later, my contacts were not as strong. After several interviews and presentations, no one made an offer for purchase.
Some background is needed. Ivermectin is the drug of choice for a variety of parasitic diseases and the oral form is FDA approved for onchcerciasis and strongyloidiasis. Also, the CDC recommends the oral form use for scabies. It is approved for the topical treatment of head lice. It has also been suggested its usage for trichuriasis, ascariasis, and lymphatic filariasis. It has been used in the veterinary field since 1981. It is manufactured in pill form, drops, creams, gels, and injectable solutions.
Ivermectin is known to have anti-parasitic activity and has also been shown to be effective against a broad range of viruses including HIV, corona 19, dengue, influenza, SARS-COV-2, and zika. The mechanism of its action is unknown although some state that it might work to stop the virus "dampening down" the host cells' ability to clear it.1 Ivermectin inhibits IN (integrase protein) and viral cell replication, inhibit nuclear import of host and viral proteins. it has been demonstrated to limit infection by RNA viruses such as West Nile Virus, Venezuelan equine encephalitis virus, and influenza with this broad-spectrum activity believed to be due to the reliance by many different RNA viruses on importin (IMP alpha/Beta 1 heterodimer) responsible for integrase protein (IN). during infection. Ivermectin has antiviral action against the SARS-COV-2 clinical isolate in vitro, with a single dose able to control RNA replication within 24 -48 hours.
1 It has been hypothesized that this is likely thru inhibiting IMP alpha/beta mediated nuclear import of viral proteins as shown for other RNA viruses. It has been suggested to give the medication early in infection to help limit the viral load, prevent severe disease progression and limit transmission. Caly et al. article1 in which many of its findings are stated above was published June 2020, although it has been in the internet news the first week of April, which prompted my interest in expanding the usage of ivermectin and the provisional patent.
A provisional patent just gives one protection that an idea might lead to a patentable product. My provisional patent had a few positive points that might be patentable by the US Patent Office. First, I suggested that ivermectin is toxic to viruses directly and not via some aspect on the host's immune system. This was based on my previous work with the drug’s effect on lice. Interestingly my claim was seconded by other researchers about 3 months later in the literature.
A second point of our patent was that ivermectin is more lethal to viruses when in a water-in-oil base. Although this was novel when I wrote my patent on head lice, this basically would hopefully be seen by the patent office as a continuation of that knowledge. Lastly, there was no present patent on the use of ivermectin in sprays and other vehicles for protection and personal use.as a safety measure against COVID. Any claims regarding formulation would complement this premise. With the help of Curt Black, my emulsion pharmacologist and co-investigator in this project, we had formulated a spray form of ivermectin for possible study purposes.
Unfortunately, our provisional also had negative points including that we had not performed any actual research (outside of formulating into a spray form) on these points which we are seeking patents. Our patent was heavy on theory, rather than actual lab work. We therefore have no specifics, or parameters, which we could document in the patent.
During the year after my submission of the provisional patent, some developments occurred. Namely nasal spray of ivermectin showed promise in pigs in October 26, 2020. Also, US government posted studies for ivermectin nasal spray and inhaled form for COVID patients.2 These two events seemed to make our provisional patent possibly more salable. And so, the provisional patent seemed to have gained a second life. I did another round of calls to my connections in the drug world. I again was given an audience, but once again, no buyers.
So, then the question arose as to whether I wanted to pursue a full patent, or just call it a day. In terms of monetary costs, a provisional patent costs about $1000 saying that one completely writes up the application (although all attorneys will feel compelled to readjust some of the verbiage). A full patent requires more legal work and will be over $10,000 even though I would write the main draft. Note these are Toledo attorney prices.
The likelihood of getting a patent which would give us a broad base of usage depends upon many factors including that no one lists any of our patentable ideas listed above in a real or pending patent prior to our claim date (i.e., who made the claim to the patent office first?). Secondly, it depends upon no prior art on these points. Or in other words, that there is not an article on point already in the literature. Now I use Ohio Link and checked this site, but there are numerous additional journals that are out there and they are not included in Ohio Link. Those journals might have damaging articles to the viability of our patent. Lastly, and most importantly, the US Patent Office would hopefully not be swayed by fact that the US Government has established two studies related to our provisional patent within months of our application date. These US Clinical Studies were posted on the internet on June 11, 2020. One might assume that the US government might have some document hurting our chances given their strong involvement with posting of these studies basically only two months after we filed our provisional on April 6, 2020.
My experience with the US Patent office lead me to conclude that they might award us a patent on the use of topical ivermectin, but they would greatly limit my usage to only the formulations which we would provide in the claims portion of the patent. This would greatly deter pharma from purchasing (as they could easily circumvent our patent in that case). Given that assessment, I opted not to pursue further.
1. Caly L, Druce J, Catton D, Kylie AJ, Wagstaff M. The FDA-approved drug
ivermectin inhibits the replication of SARS-CoV-2 in vitro. Antiviral Research
2020;178:104787.Doi: Epub 2020 Apr 3.
2. National Institute of Health, US National Library of Medicine. Usefulness of topical ivermectin and carrageenan to prevent contagion of Covid 19. Clinical Trials.gov; https://clinicaltrials.gov/ct2/show/NCT04425850