We have been working with pharmaceutical and agricultural chemistry industries for many years and often we encounter gaps in the understanding of patenting among them.
In this note we answer to the following questions: Why patents are required and what they can be.
Possibilities that patents give to generic medicine manufacturers:
1. If it is a developed a method to obtain a substance then entrance to markets with the equal rights with the originators is possible (if the patent for the chemical Formula is terminated).
2. It is safe to enter to market without falling under the originator’s patents.
3. Prediction of the launch of new products in the period of 3-7 years in certain territories.
A patent is a monopoly.
After the termination of the originator’s patent-monopoly of a substance’s chemical formula, markets belong to those who own patents on the method of obtaining the substance and the compositions of preparations.
With such patents, a generic company can enter to markets with the same rights as the originators. According to the norms of international law, having a patent for a method of obtaining a substance / product, the owner receives the right to the product itself. Thus, there is no longer one, but a group of owners of the same rights to manufacture the preparation.
Before developing a new method, do a search and determine methods which are blocked by patents. This is in order to not be sued by the owners of patents. Since scientific and patent searches are fundamentally different. You can develop a new scientific method but the patent will not be new.
It is possible to foresee the entrance of new products to markets by making and analyzing the data of patents search of competitive companies. As a result of the search, the directions of investment and the country of interest for each product and each company are visible.
Also from the search by direction (for example, hemostatic agents, anti-tuberculosis …), you can find a composition that is not closed by a patent or plan to enter to markets in connection with the termination of the patent composition or substance.
Also, you can conduct a search and make recommendations:
The list of substances that can not be used in the preparation.
The list of methods that have already been closed by the patent (for the development of a new method of production).
Recommended preparative form assigned for the medicine use.
Originators usually operate with a patent package separately in time:
Patent on chemical formulas.
A patent for a method for producing.
A patent on some compositions.
Generics appear in the patent field after the expiration of a patent for a substance – a chemical formula, or 5 years before the end of the patent. That is to be the first one to enter to open market.
Generics, as a rule, carry with them an innovative component:
The new composition of a medicine (modified auxiliary substances or their amounts)
The new method of obtaining a substance
The new dosage form
At present, there are more new options :
Pharmaceutically acceptable Salts, Hydrates,
It is innovative component that allows them to enter the patent market and close the monopoly on the method and compositions.
For more than 15 years we have been working with generic products in the markets of the former USSR and Bulgaria. We have created our Research Department to work with pharmaceutical and agricultural chemistry industries. We develop strategies for our customers to enter to markets, conduct patent searches and prepare patent applications, accompanying them in all countries of our client’s interest. The central office prepares responses to inquiries and makes corrections to the application materials, thus we control the safety of materials and information. Our applications have received patents in the EU, the USA and more than 30 countries of the world. We and our clients are supported by the Research groups from the USA, China, Canada, Iran and Ukraine.
Our highly qualified specialists will be happy to assist you in the implementation of the patent strategy and contribute to your prosperity in the markets of the world.