However, it is necessary to find and determine whether each component or part of the drug combination has been able to achieve therapeutic effects. For example, a drug has three components ABC, and diseases can be treated by searching for A, so the addition of BC should improve the curative effect of the drug. In this case, although your ABC is novel, it is still difficult to obtain patent authorization.
The patent application has nothing to do with the Food and Drug Administration. Many ancestral secret recipes have not been approved by the Food and Drug Administration, but they have also successfully applied for patents.
As a licensed patent agent in the medical field, I suggest you not to apply for a secret recipe patent, because the disclosure of the secret recipe can not bring you direct economic benefits. Unless you have the strength to develop this medicine yourself or have a pharmaceutical factory to buy this formula, once it is made public, the secret recipe will lose its value.
Supplementary answer:
Materials prepared include formula, preparation method, usage method, dosage, animal experiment or clinical trial report. The above materials are written as specifications, claims and abstracts.
In terms of funds, it costs several thousand yuan in the early stage. If you don't entrust an agent, you only need a few hundred yuan if you apply in your own name. However, the consequence of not entrusting an agent is that you may not get authorization, or authorization is very difficult, and the scope of protection after authorization is very small. The entrusted agency may not be able to authorize it. It depends on whether the invention itself can be patented, and it is necessary to find a professional patent agent. At least the agent should be a medical major, not a mechanical, electronic, chemical and other professional background. After the patent is granted, you have to pay a registration printing fee of 255 yuan, and the annual fee for that year is 900-8000 yuan, increasing year by year. Therefore, if the invention patent is to remain valid for 20 years, you need to prepare about 865,438+10,000 yuan.