A patent for a medicinal product is the main tool for protecting the rights and interests of a developer company and must be obtained before entering the market.
It is the patent for the drug, and not the primacy in development, that gives exclusive rights to the production and sale of a new drug. Otherwise, others or pharmaceutical companies can copy it and market it under their own brand name and at a significantly lower cost. After all, they did not have billions of dollars in costs and many years of work to create and test the formula.
If a generic (that is, a copy) appears on the market at the same time as the original, the developer of the drug for which the patent was not obtained in time loses market share and is often unable to even cover its costs.
Moreover, a generic manufacturer can himself apply to Rospatent and become the owner of the rights to your invention.
Medicines patent protection removes these risks.
According to Russian legislation, the subject of intellectual property in the pharmaceutical industry can be:
• chemical compound - that is, the formula
• method of obtaining it
• pharmaceutical composition based on the formula
• method of using a formula or composition - that is, it is possible to patent a new use of an already known compound
• a method of treating patients using the given formula and composition - here it is also possible to protect the rights to a new method of treatment with a known drug
What exactly needs to be protected? This is the first slippery moment a pharmaceutical company faces.
Most often, a patent for a medicinal product means the protection of a formula. This option gives the patent holder the most adequate scope of rights and protection. In addition, the formula may include various substances - for example, different additives from the same group without specifying specific names. Thus, one patent will apply to several drug variations at once.
However, it is also possible to combine several objects of intellectual property. IPS experts assess the situation in each case and help clients find the most reliable option for the primary and secondary protection of their inventions.
The second difficult moment is associated with dietary supplements. They can be classified both as a medicine used to treat diseases and as food, which is not provided for by current legislation. Rospatent, as a rule, rejects such applications, citing a violation of the unity of invention.
To obtain protection, you must choose what will be indicated in the application: food or still a drug with a therapeutic purpose. It is necessary to weigh, according to which classification the dietary supplement is more likely to pass the test.
It is difficult for laymen to do this, which is why so often manufacturers of bioactive supplements waste time and get rejections. To minimize delays, it is easier to immediately contact a specialist. IPS experts have significant experience and successful practice in patenting dietary supplements. We will immediately assess the prospects and fill out the application correctly, saving you from stress and wasted time.
To protect the invention, an application is filed with Rospatent.
The department verifies:
• The novelty of the invention (it is important that it has not been previously patented or described in the public domain)
• Inventive level
• Possibility of industrial application
After the examination is completed, the applicant is issued a title of protection, and information about this is entered into a special register.
Legal protection of patented drugs in Russia is valid for up to 25 years. After this period, generics can freely enter the market.
