Any info on writing a drug patent?

[...]

I have a novel idea for a wakefulness aid. I can either patent it as a drug or a nutritional supplement. Does anyone know what either of these entail?

in the US...

 

[endotropic]

Well I know that the statute of limitations on drug patents in the US means that you shouldn't apply for a patent until you're ready to start clinical trials, or unless you're sure someone is about to scoop your idea. Clinical trials take so long that if you're not ready to start ($$$) when you file the patent your drug will probably be off patent before it ever gets approved for sale.

 

[sekio]

Have you actually developed and tested your compound? If not you might well abandon this venture.

Is your compound substantially similar to another existing class of compounds which has been patented? It may be considered "prior art".

As a private individual or as a company? Are you patenting the manufacture or usage of the compound in a treatment regime? Do you have any efficacy studies? Do you have any tox data? How much of the SAR space has been explored?

Do you have $20,000-100,000 lying around to pay all the patent lawyers?

Consider also that the marketing of drugs is much more stringent in the USA than sale of supplements (you need to do things like clinical trials or prove you are making a generic of another med), but at the same time I don't think you can just put whatever chemicals into a pill and call it a "supplement". Moreover I don't think you can patent nutritional supplements?

If you want to go the FDA-Drug route, that's more $$$, in the millions to possibly hundreds of millions, depending on how you want to pursue it and how much red tape you wanna play with. Then you're also beholden to dealing with the Popo Of White Oak*, and they are nut-busters for strict hygiene and cleanliness... you're going to need to prove you manufacture your active ingredient in a cGMP facility as well as package it in a cGMP facility. And that of course is more $$$ for certification, not to mention the venture capital to build a lab in the first fucking place. (I'm not sure how many Chinese synth labs are cGMP?)

Also, consider that if you disclose your novel compound in a US patent that you give free reign for every other country to start manufacturing and selling it...

Oh also! You have to ENFORCE the patents too, or you lose them So you'd better have a deep pocket for your lawyer team!

* The FDA's enforcement squad!

 

[ThePharmacist4925]

Get a patent lawyer asap, if your idea falls into untrustworthy hands it'll be patented quickly by them and you'll never see any of the money from it. Also providing it as a supplement will be a fuck ton easier than as a drug. To get approved by the FDA as a pharmaceutical it must pass 2 clinical trials, which are expensive and odds are great for passing them. Prozac had 9 failed trials before it passed the 2 it needed to get approved. I mean even if you decided to try the pharmaceutical route, it takes years and money. You would need to patent it first and then sell it to a pharmaceutical company and honestly that's a real pain and you risk not seeing a penny for your idea. Supplement is a better route to take, however this is also difficult. I'd get in touch with a patent lawyer and have them go over the likelihood of your product being a success in either route. I'd also make sure the lawyer knows the most discreet route to get everything done, because there are idea vultures everywhere trying to steal the ideas of others; and these vultures are well funded so they can make these processes happen faster than you can. Best of luck and be careful. I tried going through this process before but I didn't have the money and I also didn't have a dedicated team with the talent to develop the product I envisioned.

 

[...]

Well I know that the statute of limitations on drug patents in the US means that you shouldn't apply for a patent until you're ready to start clinical trials, or unless you're sure someone is about to scoop your idea. Clinical trials take so long that if you're not ready to start ($$$) when you file the patent your drug will probably be off patent before it ever gets approved for sale.

Are you familiar with DSHEA? I can bypass clinical trials if I market my product as a nutritional supplement, but I don't know if that would change the way the patent is written.

Honestly, I'll be happy just to write the thing and have it accepted. Even if I never bottle a single dose, having a drug patent will look great on my CV when I graduate.

But I do want to market the thing though.

 

[...]

Have you actually developed and tested your compound? If not you might well abandon this venture.

There are studies on pubmed. Animal and human. With tox and efficacy data.

Do you have $20,000-100,000 lying around to pay all the patent lawyers?

I need lawyers just to get a patent accepted?

Moreover I don't think you can patent nutritional supplements?

5 hour energy is patented

 

[...]

Get a patent lawyer asap, if your idea falls into untrustworthy hands it'll be patented quickly by them and you'll never see any of the money from it. Also providing it as a supplement will be a fuck ton easier than as a drug. To get approved by the FDA as a pharmaceutical it must pass 2 clinical trials, which are expensive and odds are great for passing them. Prozac had 9 failed trials before it passed the 2 it needed to get approved. I mean even if you decided to try the pharmaceutical route, it takes years and money. You would need to patent it first and then sell it to a pharmaceutical company and honestly that's a real pain and you risk not seeing a penny for your idea. Supplement is a better route to take, however this is also difficult. I'd get in touch with a patent lawyer and have them go over the likelihood of your product being a success in either route. I'd also make sure the lawyer knows the most discreet route to get everything done, because there are idea vultures everywhere trying to steal the ideas of others; and these vultures are well funded so they can make these processes happen faster than you can. Best of luck and be careful. I tried going through this process before but I didn't have the money and I also didn't have a dedicated team with the talent to develop the product I envisioned.

Thanks. Was it not possible to write and file the thing yourself?

 

[ThePharmacist4925]

Surely patenting your product as a supplement would change the way the patent would be written as compared with a patent written for a pharmaceutical. One way to get the funding needed for your product would be to ensure that the patent was in place or at least submitted for processing and then approach a venture capitalist firm. What a venture capitalist firm does is take the ideas of others who lack funding and bring them into the marketplace with an agreement that they receive X% of the profit. Of course this isn't ideal, but it is a way to get the funding you need and still retain credit for the development of your product which seems to be what you are going for so any money you make from the venture is just a bonus anyway, right? I mean a friend of mine got hired as 19 years old without a college degree as a computer programmer in Silicon Valley making 100k a year and then was promoted that same year to run the companies new location in Denver making 250k a year. He was just been approached by Venture Capitalists to do a lecture series on how he programs and how to help others develop creativity within effective programming practices. He's 20 years old and only my nonexistent god knows how much he's going to make from the lecture series on top of his current salary. The point is that he has unique styles and ideas and the Venture Capitalist are going to pay him a ton of money. The downside to working with Venture Capitalists is that they are trying to squeeze your idea for every penny and pay you as little as possible for it. It is also possible that they try to take credit for your idea in there contract, this where you would need a good lawyer. I mean you could just sell the thing as long as somebody else hasn't already gotten a patent for it and just see how it goes, especially if you were selling it not for human consumption, but in your case I'd it sounds like getting your documents and data in very neat order before you see a patent lawyer is the way to go. Once you know how long it's going to take for the patent to be processed, it should be safe to talk with Venture Capitalist or Pharmaceutical Companies or just companies that sell supplements.

These are my best thoughts on the matter, I'm no professional, but I have a fairly good understanding of how business works; I've been around big business my whole life.

 

[Erikmen]

Speaking of patent, someone very close to me developed a method of learning.
A book was written about it. It works, it's within this person university education.
No patent was ever registered as it would be too expensive and it's not legally required.
The only collateral damage is seeing others copying and using it even in other countries.
It's nothing super special but it took years to be concluded and a lot of University money too.

Some schools in Chicago and Boston also uses it as extra curricular material.

 

[ThePharmacist4925]

My idea was for a computer desktop application, much like iTunes, but for 3D printable files or files that a 3D printer could use to make an object. It was more than that because with some help I developed a security system to prevent counterfeiting items or stealing the printable files, and of course there was even more than that, we were going to incorporate customization of items within the desktop application. It was going to take a ton of work with a lot of talented dedicated programmers, my idea was a mass of ideas, some of which were maybe patentable and some of which were already patented. To bring the product to market there were many patent trolls who would've needed payment to even get our feet off the ground; I was living in a residential mental health treatment facility at the time and there was no good way of organizing a team to create the product, let alone find the proper funding to bring the product to market. Alas if I had one great idea that means I'm capable of having another at hopefully an opportune time.

 

[sekio]

There are studies on pubmed. Animal and human. With tox and efficacy data.

If you can't prove you came up with the idea of using the compound as a wakefulness promoting agent, it's gonna be considered prior art.

It also seems patent costs will start at around $1000 and take approx. 3 years, plus you have to pay extra later to keep the patent.

 

[...]

If you can't prove you came up with the idea of using the compound as a wakefulness promoting agent, it's gonna be considered prior art.

If that's the case then I'm screwed.

But studies were done and good results were observed (high efficacy, negligible toxicity), and no patent was filed and no product was marketed. Seems like a waste.

 

[sekio]

I guess you can do the 5 Hour Energy thing and patent a blend of specific nutrients with your active ingredient. Or maybe develop an extended release form.

If a compound has initially promising stage 1 trials but was never developed as a commercialized drug, that's a bit of a red flag to me, indicating that someone very likely ran into something bad in later trials.

 

[serotonin2A]

If that's the case then I'm screwed. But studies were done and good results were observed (high efficacy, negligible toxicity), and no patent was filed and no product was marketed. Seems like a waste.

If the studies were published then it is too late to file for a patent. Once the results are published they are considered "prior art". You have to file a provisional application at some point BEFORE the invention is disclosed.

 

[Erikmen]

I suppose it's meant to be that challenging. See your options to see how possible that is. Don't give up if you've gone that far.

 

[serotonin2A]

^The entire point of patent law is to get people to disclose how new inventions work, so others can make use of technical innovations. Inventors get a few years of exclusive use of a new technology in exchange for public disclosure. However, if the secret of an invention has already been disclosed then society doesn't get anything in return for issuing a patent.

 

[Dresden]

I have researched this a little bit and read the book, "Patent It Yourself." You can write a patent yourself, and that costs like $400, I think, but almost everybody who gets one has at least hired a patent attorney for 10 to 20k. I am not currently associated with any company or school that could take away my patent idea by my working for them or going to school at their university; however, the compound--an antibiotic--I want to patent has not been synthesized or tested for activity as far as I know and will require FDA approval to be sold, of course. Doing so, of course, requires mega bucks. Thus, I have pretty much come to the conclusion that I am basically S.O.L. as an independent inventor. Is that conclusion right, more or less? Do big, multinational pharma companies ever sign a contract with a new drug inventor for, say, 1% of the eventual revenue his compound brings in the distant off chance that it actually comes to fruition? Or would they be more likely to simply steal the structure, patent it worldwide, and then lie about it afterwards?

 

[sekio]

If you own the provisional patent and do promising enough initial studies, the general way of things is the bigger fish buy your company wholesale.

 

[serotonin2A]

I have researched this a little bit and read the book, "Patent It Yourself." You can write a patent yourself, and that costs like $400, I think, but almost everybody who gets one has at least hired a patent attorney for 10 to 20k. I am not currently associated with any company or school that could take away my patent idea by my working for them or going to school at their university; however, the compound--an antibiotic--I want to patent has not been synthesized or tested for activity as far as I know and will require FDA approval to be sold, of course. Doing so, of course, requires mega bucks. Thus, I have pretty much come to the conclusion that I am basically S.O.L. as an independent inventor. Is that conclusion right, more or less? Do big, multinational pharma companies ever sign a contract with a new drug inventor for, say, 1% of the eventual revenue his compound brings in the distant off chance that it actually comes to fruition? Or would they be more likely to simply steal the structure, patent it worldwide, and then lie about it afterwards?

It is true that it isn't expensive to apply for a utility patent on your own. For an application filed by a small entity, with only a few claims, you might only have to pay:
1. Filing fee = $70
2. Oath fee surcharge = $35
3. Search fee = $150
4. Examination fee = $180
5. Issue fee = $240
6. Extend patent past 3.5 years = $400
7. Extend patent past 7.5 years = $900
8. Extend patent past 11.5 years = $1850

However, you will have to spend much more than that in legal feeds to prevent infringement. And if you made any mistakes in the application then your competitors can petition to have the patent declared invalid.

 

[Dresden]

sekio,

Wanna start a company with me?