The world of the pharmaceutical industry is a world of science, manufacturing, and doing studies. It also is a world of patents. A good part of H. M. Pharma Consultancy’s business is rooted just in this fact: we help small and/or virtual companies with their strategic patenting, we draft patent applications, we try to find gaps in intellectual property and we try to avoid them. With new molecules, this is a boundless field.
And then, there is drug repurposing which we increasingly believe to be a viable alternative strategy in small molecule development. Here we identify known compounds, take a hard look at their (demonstrated and/or potential) pharmacological properties, and think up new medical uses. In many cases these would involve different doses and/or different routes of administration.
Now you can safely assume that whatever compound you pick – approved drugs, late-stage clinical candidates, discontinued drugs – they will be covered by at least one patent, for the simple reason that no developer in his right mind would have made any public disclosure without having at least filed a patent application. Your scrutiny of these documents will have to match you scientific considerations in intensity and thoroughness.
You might well find that your repurposing idea has been mentioned there, at least to some degree. Thats for another simple reason: once you know a compound’s pharmacological activity it is easy to extract whatever medical condition has been reported to show some response to this activity. Listing these conditions as potential uses effectively costs nothing. We have seen cases where entire sections had been copies from the ICD or DSM classifications.
In earlier times developers might have got patents issued with such broad claims — but not today. All major patent offices now insist on (non-prophetic) examples and biological data that support concrete claims. So the originators’ strategy became narrower: never mind even making a formal claim. Simply mentioning compound X in the context of condition Y might throw a stick into the gears of a subsequent developer by preempting novelty and/or inventive content. Well, even this doesn’t really work anymore today; there are countless examples from infringement proceedings showing that patent courts will not consider the mere contemplation of potential uses that are based on indiscriminate combinations of lists as being preemptive.
But in any case, by filing a second use patent application you will pull the originator’s tail once it is published. It might be a tiger’s tail. Of course this doesn’t mean you shouldn’t do it. What needs to be considered in advance is your strategy: do you want to risk a fight? Or would you rather approach the compound’s originator pragmatically, and suggest a cooperation? Or would you rather avoid all that by focusing on compounds that are so old that all patents have expired? (Don’t laugh. Unexploited opportunities of this type abound, with sufficiently unconventional thinking.) We have helped many of our customers in that respect.
So if you have a drug repurposing idea, consider… And DO IT.