1. When applying for a patent for a traditional Chinese medicine formula, the following information must be provided:
①. Stability test data and conclusions of the drug, as well as relevant research data and literature on the drug’s shelf life.
②. Clinical research summary information compiled by the unit responsible for clinical research, and attached with clinical reports and other information from each clinical research unit.
③. Quality standards and drafting instructions for pharmaceutical raw materials (medicinal materials) and finished products for production, and provide reference materials and information (reserved for review by the preliminary review unit).
④. At least 3 batches of continuously produced samples (pilot products) and their quality inspection and health standard inspection reports (the quantity of each batch of samples should be at least 3 times the amount required for full inspection).
⑤. Design samples and descriptions of the performance, specifications and labels of pharmaceutical packaging materials. Sample product instructions for use (trial), including drug name, specifications, main components (ingredients), explanation of traditional Chinese medicine theory or basic experiments, functions and indications, usage and dosage, adverse reactions, contraindications, precautions, storage, shelf life, production Enterprise and product batch number. The logos of special drugs and external drugs must be clearly marked on the packaging and instructions for use. New drugs (preparations) from Category I to Category V are required to declare all the above information.
2. Traditional Chinese Medicine Formula Patent Search and Analysis Before applying for a patent, it is best to conduct a search to determine which inventions belong to the "existing technology". If the content to be applied for has been recorded in the searched patent documents or other public publications, it may affect the prospect of authorization of the application. In addition, even if there is no documentation, if others can determine that it is common knowledge in the field, it will lead to the rejection of the patent application.
3. Patent writing plan for traditional Chinese medicine formula: After searching the disclosure information, if it is believed that the technology or medicine has the three properties of "novelty, creativity and practicality" required for a patent, then the patent application documents can be started. of writing.
4. Submit the invention patent application documents to the National Patent Office, get the acceptance notice, and confirm the application date and application number.
5. It will take about 4-6 months from the application date to pass the preliminary review and be made public.
6. When entering substantive examination, the Patent Office will issue a notice of examination opinion and you need to write a reply.
7. If no reason for rejection is found during the substantive examination, an authorization notice will be issued and the authorization registration fee and annual fee will be paid.