Preparation of information
Before making the application, what we need to do is to prepare the required information, as comprehensive as possible, in one step, so as not to delay due to the lack of information at the time of application.
① production of pharmaceutical raw materials (herbs) and finished product quality standards and drafting instructions, and provide control products and information (reserved for the preliminary examination unit audit).
② drug stability test information, conclusions and the duration of the use of the drug research information and literature.
③ continuous production of at least 3 batches of samples (pilot products) and their quality inspection and health standards inspection report (the number of samples per batch should be at least three times the amount needed for the full inspection).
④ Clinical research units responsible for clinical research to organize a summary of clinical research information, and clinical reports attached to the clinical research units and other information.
⑤ The performance of pharmaceutical packaging materials, specifications and labeling design samples and instructions. Product use (trial) manual samples, including the name of the drug, specifications, the main components (ingredients), the theory of traditional Chinese medicine or basic experimental elaboration, function and main treatment, usage and dosage, adverse reactions, contraindications, attention, storage, use of the period, the producer, the product batch number. The signs of special drugs and drugs for external use must be clearly indicated on the package and instruction manual. From the first to the fifth category of new drugs (preparations) require the declaration of all the above information.
02Pre-patent search
Just in case, the key step we need to do before filing a patent application is to conduct a patent search. in order to determine what elements of the invention fall under the category of ? prior art? If the content to be applied for is already documented in the retrieved patent literature or other public publications, it may affect the prospect of the application being granted. In addition, even if it is not documented, if others are able to determine that it is common knowledge in the field, this may result in rejection of the patent application.
03Preparing Chinese medicine patent application documents
After searching in conjunction with the submission, it is believed that the technology or medicine has the three characteristics required for a patent? Novelty, inventiveness, and utility?
04Submission of the application
When everything is ready, it can be checked again, and the application is submitted after checking that there is no error. Submit the application documents to the State Patent Office, get the acceptance notice, confirm the filing date and application number.
05Examination Stage
About 4-6 months from the filing date, pass the preliminary examination and make it public. Entering the substantive examination, the Patent Office will issue a notice of examination opinion, and you need to write a reply. If the substantive examination does not find any reason for rejection, a notice of authorization will be issued, notifying the payment of the authorization registration fee and annual fee.
06Payment of Fees
The certificate will be issued about 2 months after the payment of the registration fee and annual fee. The whole process takes about 1.5 years.
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