One of the most crucial and disputed issues in the pharmaceutical market are associated with launching generic drugs, i.e. equivalents of the brand-name original ones.
When a pharmaceutical company first markets a drug, it is usually under a patent protection that, until it expires, allows only the pharmaceutical company that developed the drug to sell it. Brand-name drug companies have used a number of strategies to extend the period of market exclusivity on their drugs and prevent generic competition. One common tactic is to separately patent the formulation of a drug at a later date from the patenting of the active ingredient itself. Another common response to the launch of generics is to launch improved formulations covered by new patents as the initial patents expire.
Pharmaceutical companies willing to launch a generic drug should know that generic drugs can be produced without patent infringement where:
- the brand company's patent has expired,
- the brand company's patents are either invalid, unenforceable or will not be infringed by the generic drug,
- for drugs which have never held patents, or
- in countries where the drug does not have current patent protection.
Thus, before launching a new generic drug on the market pharmaceutical companies are interested in verifying the following issues:
- if the patent for the active ingredient exists in the target country and whether it is valid;
- if the patent for the pharmaceutical composition exists in said country, whether it is valid and if it is infringed by their generic drug to be launched;
- the expected expiry date of the patent, i.e. if the additional term SPC (Supplementary Protection Certificate) has been granted for the patent.
Our company provides services on conducting various types of searches associated with launching a generic drugs on markets of all ex-USSR countries, namely Ukraine, Russia, Kazakhstan, Armenia, Azerbaijan, Belarus, Estonia, Georgia, Kyrgyzstan, Latvia, Lithuania, Moldova, Russia, Tajikistan, Turkmenistan and Uzbekistan.
We will determine if there exists a patent for the active ingredient being of interest or if there exists a patent for pharmaceutical composition with said active ingredient and provide patent infringement opinion (FTO).
We will verify the status of found patents and expected expiry date thereof as well as the information about extension of the patent term (SPC), already granted or possibility thereof in future in those countries which legislation stipulate such extension of term.
While conducting patent searches we use on-line patent databases of the Ukrainian, Russian, Armenian, Belarus, Estonia, Georgian, Kazakh, Lithuanian and Moldavian Patent Offices. In the rest of the ex-USSR countries which Patent Offices have no on-line patent database we conduct searches using database of the Eurasian Patent Office which contain information as for national patents in the limited scope as well as conduct family patents search using espacenet database. Verifying the results of such search is possible by way of requesting the official search conducted by the Patent Office.
For further information or our assistance in this respect, please contact us.