Legal Question in Intellectual Property in Illinois
Marketing a herbal medication
My partners and I have researched an created a herbal formulation which helps to control both type I and type II diabetes. So far we have not commercialized our medication. We have been giving this medication to family and friends through word of mouth for over 5 + years now and the success rate is 100%. We have a few friends who are in medical profession using this medication successfully. In 4- 6 weeks one can see notice the effects of this medication by getting them off insuline.
One of our family friends has agreed to submit this medication to World Health Organization (WHO) however some have also asked that it can be commercialized.
I don't have any knowledge about starting or operating any kind of business but I am willing to go that route now that we are sure that this medication works. I would like a patent and some kind of marketing for this medication.
As this is a medication do I have to get additional approvals. Also how much cost are we talking about. We as a group don't have enough cash lying around.
Please advise.
2 Answers from Attorneys
Re: Marketing a herbal medication
Since this is a drug it is covered by the regulation of the FDA. Inventions of this nature are submitted to both the FDA and the USPTO for evaluation.
You need to talk to a patent attorney to begin the patent process as well as an attorney experienced in FDA matters. You only have 1 year from the time you start to market this drug to file a patent application. You might want to talk to a university such as Northwestern in Chicago about the possibility of co-development of the drug.
The costs to develop are quite expensive. Thus it would be prudent to co-develop the product with a sponsor.
Patrick Tracy
Re: Marketing a herbal medication
You need to submit an application to FDA and also USPTO. One of the biggest hurdle at the FDA will be to show that your product is safe and effective for humans. It will be your responsibility to test the formulation and submit evidence that it is safe and effective. The tests/evidence you submit have to be of a certain criteria. I am a patent attorney with a strong pharmaceutical background. Please feel free to contact me directly for further questions.
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