We have been working with pharmaceutical and agricultural chemistry companies for many years and often encounter gaps in understanding of patenting in the field.
In this note we answer to the most important questions: Why patents are necessary and what they can be.
Possibilities that patents give to generic drugs manufacturers:
- Market entry with the rights equal to originators by developing your own API synthesis method (if substance patent is not valid).
- Safe market entry without violation of originator’s patent rights.
- Prediction of new products launch in the period of 3-7 years on territories of your interest.
A patent is a monopoly.
After expiration of the originator’s chemical substance patent-monopoly, markets belong to companies, which own patents on API synthesis methods and pharmaceutical compositions.
With such patents, generic company can enter markets with the same rights as originators. According to the international legislation, having a patent for the method of the substance/composition production, means that the patent owner gains the right to the substance/product itself. Thus, there is no longer one, but a group of owners with the same rights to manufacture the drug.
Before developing a new production method, it is recommended to do a patent search and determine methods which are blocked by patents. This step is in order not to be sued by the patent owners. Since scientific and patent searches are fundamentally different, it is possible to develop a new scientific method, but the patent for it will not be new.
- It is possible to foresee new products entry to markets by preparing and analyzing the patent searches data 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 patent search by drug indications (for example, hemostatic agents, anti-tuberculosis, etc.), you can find a composition that is not closed by a patent or plan to enter markets after expiration of the substance or composition patent.
As another opportunity, you can conduct a patent search and make recommendations on the final product:
- The list of substances that can’t be used in the composition.
- The list of methods that have already been closed by the patent (for the development of the new production method).
- Recommended dosage forms and usage indications.
Originators usually operate with a patent package separated in time:
- Chemical substance patent.
- Method of synthesis patent.
- Composition patent(s).
Generics appear in the patent field after substance patent has expired, or 5 years before the end of the patent. That is to be the first ones to enter the open market.
Generics, as a rule, carry certain innovative component:
- The new composition (modified auxiliary substances or their amounts).
- The new method of API synthesis.
- The new dosage forms.
At present, there are more new options:
- API crystal forms.
- API pharmaceutically acceptable salts, hydrates, solvates.
- API in amorphous form.
The innovative component is that allows generics to enter the patent market and close the monopoly on the methods and compositions.
For more than 15 years we have been working with generic products in the markets of the former USSR countries and Bulgaria. We have created our Research Department to work with companies in pharmaceutical and agricultural chemistry industries. We develop for our customers strategies to enter the markets, conduct patent searches and draft patent applications, file and support applications all countries of our client’s interest. Only our main office prepares responses to Office Actions and amends application materials, thus we control safety of materials and information. Our applications have granted patents in EU, USA and more than 30 countries worldwide. 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 to contribute to your prosperity in the markets of the world.