• Pharmaceutical products patent strategy

    For many years, we have been working with different sectors of the chemical industry, in particular, with pharmaceutical chemistry, and all too often faced with a gap in understanding of patents in these industries.

    This publication will consider why the fields need patents and what they might be.

    The opportunities that the patents provide to generic manufacturers are following:

    1. Enter the market on an equal footing with the originator (if the patent for a chemical formula (substance) has ended) as a result of developing your own method of a substance production.
    2. Enter the market in a safe manner without falling under the originator patents.
    3. Predict the launch of the new drugs on the certain territory market for 3-7 years ahead.


    • A patent is a monopoly.

    After the exclusive patent for the chemical formula of the originator’s active substance (AS) has expired, the market belongs to those who own the patents for the method of AS production and compositions, namely, formulations of the drugs.

    With such patents, the generic company is able to enter the market on equal terms with the originator.

    According to the norms of the international law, the patent for the method of the substance/product production gives the owner the right to the product itself. Thus, the market is controlled not by one owner, but a group of the owners of the rights to the AS and/or drug.


    Before developing a new method, a search needs to be conducted, and the methods that have been already covered by patents need to be identified, so as not to be sued by the owners of such patents. Since scientific and patent searches are fundamentally different, a new method can be developed from the scientific side, but not from the patent one.

    • Market entry of the new products can be anticipated via conducting the search among the patents of the competing companies and analyzing the data obtained. The search results show the directions of the investments and the country of the interest for each product and each company.
    • Additionally, the search by the direction (for example, the search for hemostatic agents, anti-tuberculosis, etc.) enables finding compositions that are not covered by the patent, or planning the market launch due to the expiration of the patent for a composition or substance.
    • Moreover, recommendations based on the search can be provided for:

    – a list of the substances that cannot be used in a preparation with particular AS;

    – a list of the methods that have been already covered by the patents (in order to develop a new method of the production);

    – recommended formulation, indications, use of the drug.

    • The originators generally operate using a patent package divided in time, and the package include:

    – a patent for a chemical formula;

    – a patent for a method of the production;

    – the patents for the particular compositions.

    To be the first on the newly opened market, the generics enter the patent field after the patent for the chemical formula (substance) has expired, or 5 years before the expiration.

    The generics generally bear an innovative component including:

    – a new composition of the drug (excipients or their quantity have been changed);

    – a new method of the substance production;

    – a new method of the drug production;

    – a new dosage form.

    Today, still novel options have emerged, for example:

    – crystalline forms;

    – pharmaceutically acceptable salts, hydrates, etc.;

    – amorphous form.

    It is this innovative component that allows the generics to enter the patent market and secure their monopoly on the methods and compositions.



    We have been working with generic products for over 20 years on the former USSR countries and Bulgaria markets. Our own Research Department was created to work with the pharmaceutical and agricultural industries. We develop strategies for our clients to enter the markets, as well as approaches for conducting the patent searches and preparing patent applications, and prosecuting them in all countries of our clients’ interest. Since only the central office prepares responses to the office actions (requests) and makes amendments to the application materials, the safety of the materials and information is fully ensured. Our applications have received patents in the EU, USA and more than 30 countries around the world, not least due to support by Research groups from the USA, China, Canada, Iran and Ukraine.

    Our highly qualified specialists will be happy to assist you in the implementation of your patent strategy and contribute to your prosperity on the world markets