Licensing a pharmaceutical product

[NNR]

Hey guys,

I have a question regarding the sale of products marketed as medicine.

Me and this guy have a formula and product for a non-curable (but not life threatening) condition. It isn't conventional medicine nor does it involve any synthetic drugs, it is completely herbal and "natural". He currently sells it locally without a patent or a license and manufactures it himself.

My idea is to package it and distribute it worldwide as this truly works better than all the products I've tried (I have the condition). I was thinking of marketing it online and maybe eventually selling the patent or license once I get the significant sales volume.

How would I go about doing this? What procedures would one need to take and would it be much different to licensing any other type of product? Any start up advice or correction would be greatly appreciated as I am new to all of this.

Thank you.

 

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[youngtrep]

I really hope he isn't manufacturing dietary supplements in his garage. Unless my reading of the regulations is off, all dietary supplements must now be manufactured in a cGMP certified facility (current good manufacturing practices). Failure to do so puts you both at a huge liability risk and frankly isn't fair to consumers from a safety standpoint. Just my two cents.

 

[NNR]

It isn't dietary it's related to hair loss and something you apply to the scalp or beard.

Alopecia Araeta is the name of the condition if that helps.

And yes that's exactly what I'm asking for as what regulatory bodies and legal formalities do I need to go through before I can manufacture and distribute this. Like what kind of certificates and what-not do I need to obtain before it becomes legit and does it matter from what country you're exporting from?

Also I'm in a country at the moment where no one really gives a shit what you do, but I'll be moving back to Australia soon (just some background information). 'Cause this really works man it could help a lot of people including children.

 

[youngtrep]

Got it, I didn't want to be too harsh but you don't want to mix chemicals in some dirty room and then have unassuming customers ingesting it (not saying that is what you're doing). I am not sure about Australian regulations but I have read that they are more stringent than other countries. Finding a contract manufacturer will be your best bet. They know all of the regulations and can produce exactly what you want while within the law. There should be several who can accommodate your formula.

 

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[NNR]

How would I go about finding a contract manufacturer? I don't really want to divulge any information to someone before I can assure that product is actually mine first and they can't legally screw me over or anything. Like If I pay them to manufacture it for me, and they do it all by the rules and everything, would I then have the right to sell/distribute it or would I need to go through something else? How would the product be legally licensed to me? Thanks.

 

[youngtrep]

Here is one I found after about 2 minutes of Google searching http://www.tripak.com.au/hair-care-manufacturer.html. Just look for Australian haircare contract manufacturers. If you are truly concerned about the formula being stolen, you can either get a thorough NDA (non disclosure agreement) signed or try to patent the formula first which would probably be a lot more expensive/time consuming. Contract manufacturers literally just make what you want and then it is yours to do whatever you want with. They don't own the rights or have any control.

 

[NNR]

Thanks man. Would I be able to sell it legally though? Like without FDA approval or anything like that?

 

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[youngtrep]

FDA wouldn't come into play if selling outside of the United States. If you are selling in the US dietary supplements are not under FDA approval but you must follow certain guidelines like the claims you make on the bottle and how it is manufactured. If you are going to jump into the industry for real, I would suggest reading everything you can get your hands on. There is a ton to be learned and it will make starting the business much easier.

 

[TopChef]

What exactly is patentable here? You didn't invent the herb or other natural ingredients. So unless he is formulating this in a unique way it should be no more patentable than a bread recipe.

Your best bet to eventually license this is to focus on your trademark and build the brand. If you are successful you will get people copying your formula. But your value will be in your trademark and brand, not in the patent.

 

[NNR]

What exactly is patentable here? You didn't invent the herb or other natural ingredients. So unless he is formulating this in a unique way it should be no more patentable than a bread recipe.

Your best bet to eventually license this is to focus on your trademark and build the brand. If you are successful you will get people copying your formula. But your value will be in your trademark and brand, not in the patent.

I don't understand...By that extension of logic every ingredient ever used was found naturally including say the plastic on the monitor I'm reading off which was made from hydrocarbons derived from oil - but the item as a whole is a unique product is it not? I don't mean to be patronizing I'm just confused.

Well if a patent is not required then that's all the more better. I was under the impression that I needed to get one in order to sell it worldwide, I suppose I just need to work on the manufacture and distribution side of things, but since this is used as medicine I just assumed I needed to go through a myriad of regulations before it would be legal or allowed.

 

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