If you ever want to release a pharmaceutical to the public, you’ll need to patent it. If you don’t patent your drug, someone else will copy it and release it for cheaper, and all of the effort you spent on clinical trials will be coopted by your imitator.
And, unlike the software industry, you can’t solve this problem by iterating more quickly than your competition. The FDA will need you to go through years of clinical trials before they allow you to release a new drug, or even a new form of your drug. Whatever drug form you submit to the FDA is the one you’re stuck with releasing to the public; there’s no such thing as a MVP.
Unfortunately, the process of writing and filing a patent is non-obvious, if you’ll forgive my unfunny joke. I know this because I just successfully filed my first drug patent for my biotech startup, Highway Pharmaceuticals (side note: interested in development of therapies for autoimmune or neurodegenerative diseases? Reach out!)
Here’s what I wish I knew when I started my journey.
1. Your patentable idea needs to be novel, non-obvious, and concrete.
These three criteria are the three most fundamental criteria of any patent and the most frequently misunderstood. They are very stringent standards.
First: novelty. A novel idea is one that nobody has ever thought of before. That means that there’s nothing whatsoever in the literature about it. If some scientist in the Discussion of a random paper mentioned your idea, it’s no longer patentable.
Next: non-obvious. The full phrase is “non-obvious to a skilled practitioner of the art”, or, as I like to think of it, surprising. Your idea needs to be one that an expert would be surprised to hear that you invented it/made it work. The judgment on what’s surprising is up to your patent examiner, but it’s usually easiest if you can find papers by experts that would seem to suggest your idea is impossible.
Finally: concrete. This is a weird one for pharma. Most pharma patents say, “This drug cures this disease,” but it’s basically impossible to actually have concrete evidence for that, as in-human trials come way after patents in standard pharma development. So, the patent office has very weak standards for “concrete” evidence. You just need to have an experiment that vaguely supports your idea, and that’s generally good enough.
So, unlike other fields, the hardest part about a drug patent is the novelty, and that’s where most patents fail. There are a lot of pharma papers, and it’s very tough to find an idea that hasn’t been done before.
Non-obvious is the next toughest thing. This can usually be figured out if you think hard enough about what could be seen as surprising with your drug, though. If it’s novel, it’s probably surprising.
Then, once you have those two, the concrete evidence is generally a walk in the park.
2. Get a provisional patent as soon as you come up with an idea.
Not many people are aware of this, but the US has kind of a neat system when it comes to patents. Like almost all countries, the US has a “first-to-file” system: the first person to file a patent for an invention in the US is granted the invention.
Unlike most countries, however, the US also has a provisional patent system. This means if you come up with an idea that you’d like to patent, but you haven’t finished your experiment yet, you can file a provisional patent instead. This counts as your filing date, as long as you submit a formal, completed patent within a year of filing the provisional patent.
Not only this is helpful to prevent someone from scooping your idea, it’s also very helpful if you want to employ someone else to do the experiment for your patent.
If you’re a non-institutional inventor like me, you are almost certainly going to need to employ a contract research organization (CRO) to carry out your patent-enabling experiment. Having a provisional patent in place prevents anyone affiliated with the CRO from scooping your idea, along with the NDA that you’ll presumably have them sign.
3. Get a patent lawyer who specializes in drug patents, but don’t have them write the whole patent.
Drug patents are, of course, really technical documents. They are also strangely and specifically written.
You will not be able to write one all on your own. You need an expert, preferably one with a PhD and a JD, or at least a JD and published papers. However, unless you’re rich, you will not be able to have a patent lawyer write your whole patent.
My advice, then, is to write the first draft of your patent yourself. The best way to do that is to find a drug you’re interested in, go to patents.google.com, and find the patent for that drug. Then copy as much of the format and wording of that patent as possible for your drug. Don’t worry about plagiarism: nobody’s copyrighting patent language.
Then submit it to your patent lawyer. Ideally, you’ll only have some minor back and forth after this. Unfortunately, minor back and forths still cost a lot of money, so you’ll end up spending like $15k. Still, that’s less than if you used them for everything!
4. Your patent’s only worth what you can sue over.
This is probably the least frequently understood part of patents, even by biotech people.
The only way to enforce a patent is by suing people. Any patent that would be difficult to enforce by suing is not worth having.
For drug patents, that especially applies to use patents. I see patents on use all the time that would literally be impossible to enforce by suing. For example, if you try to patent a method of prescribing a common drug, you may, in fact, get that patent.
However, given that the only way of enforcing that patent would be to sue the doctors who prescribe the drug, it’s probably not a patent worth getting. Imagine the headlines: “Pharma company sues doctors helping patients!”