What is required to file a drug patent application?
A patent is a document that describes an invention. Its main objective is to protect and give its creator the rights of commercial exploitation and exclusivity over the invention.
The types of patents existing in Brazil are:
Patent of Invention (IP) :
Products or processes that meet the requirements of inventive step, novelty and industrial application;
Utility Model Patent (MU) :
The product or process must be of industrial application and result in a functional improvement in its use or manufacture.
In the pharmaceutical sector, the process for filing a patent application works in the same way as for any other product or service. After the discovery of the chemical substance, the industries deposit the invention with the National Institute of Industrial Property (INPI), which is responsible for analyzing applications and approving or not a patent.
After granting the title to the property, only the laboratory that has the patent for the drug will be able to produce it for a period of 20 years. After that period, the patent is taken down and that's when generic drugs begin to emerge.
It is important to remember that the granting of a patent does not authorize the company holding the monopoly to market the drug in Brazil, it only gives it exclusive rights to exploit it. In order for the product to be sold, it must have a marketing record.
How is a patent registered?
The filing of a patent application for a medication follows the same steps as any other product that falls within an invention patent. Which are:
- Perform a pre-search to identify whether the object already exists in the patent database. This step is not mandatory, but it is recommended to avoid filing a patent application for a technology that has already been patented;
- Submit a patent application filing with the INPI. It must include: Application; Patent Application or Certificate of Addition; - Descriptive report about what you want to patent; - Claims; - Drawings (if any); - Biological Sequence Listing (in the case of inventions with biological sequences of amino acids or nucleotides);
- Summary; - Proof of payment of the mandatory fee (the amounts may vary according to the form of the request and the applicant's framework).
- This entire step can be done online. For this, it is necessary to create a registration, with a login and password, in the e-Patents system. After registering, the user just needs to access the following link
- Follow up your request on a weekly basis through the INPI's Intellectual Property Magazine.
- After the filing of the application for deposit, it will undergo a formal and preliminary examination and, if properly instructed, will be filed, considering the filing date of its submission.
The process for granting a patent by the INPI can take a few years. In theory, the patent application should be published within 18 months after the date on which the patent was filed.
The next step after publication is to carry out a Request for Technical Examination on what has been filed as a patent so that the product is confirmed as being the equivalent of the patent.
During the publication, and by the end of the exam, interested third parties will also be able to submit their subsidies to the technical exam. This request has the objective of demonstrating to the INPI that that object does not have the requirement of novelty, whether due to national or foreign precedence.
Three years after filing the patent application, the applicant must start paying the corresponding annuities. The annual fee is fixed until the sixth year. After this period, it varies by product and patent process.
Upon completion of the examination for the patentability of the application, the patent will be granted after the granting of the letter patent.
After payment of the letters patent, the patent will be granted on the date of publication of the act.
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