Finnish patent, trademark and design agency Papula-Nevinpat has strong expertise within the Eurasian territory. The company's patent attorneys Dr Teemu Lang and Alexander Polikarpov explain the main issues to be considered when prosecuting a patent application for pharmaceutical inventions in Russia.
The examination of pharmaceutical inventions in Russia has many peculiarities. These stem from the requirement that applicants confirm it is possible to implement the claimed subject matter - for example, chemical compounds, pharmaceutical compositions, methods of medical treatment or medical use - by presenting working examples.
Applicants not familiar with these peculiarities, such as foreign companies, may run into difficulties when prosecuting patent applications for pharmaceutical inventions in Russia. According to Rule 24.5.1 of Russian Patent Rules, if a designation (the purpose or the intended use) of a claimed subject matter is not indicated in the application, and the possibility to implement it is not confirmed by examples or references, the claimed invention is not considered 'industrially applicable'. If a group of chemical compounds with a general structural formula is claimed (a Markush claim), it should be confirmed that it is possible to obtain all the compounds of the claimed group by presenting a general scheme or a method of obtaining them.
If the claimed group includes compounds with radicals of a different chemical nature, sufficient working examples confirming the possibility of obtaining compounds with such different radicals should be presented. For the obtained compounds, their chemical formulae confirmed by known methods and their physico-chemical constants, such as the melting point, should be indicated.
In practice, Russian examiners tend to restrict the scope of a Markush claim to radicals that are strictly supported by the presented working examples or are very similar to them in chemical nature. For example, if only the obtainment of a compound in which one of the radicals is ethyl is presented as an example, then this radical should be defined as 'C1-C6alkyl' and 'C3-C6cycloalkyl' in the claim. These definitions cover radicals of a similar chemical nature. If a radical is defined by a moiety, a part of which can be substituted, the possible substituents should be indicated in the claim and confirmed by examples. Furthermore, broad terms such as 'heteroaryl' or 'aryl' should be specified. Functional features such as 'prodrug' or 'mimetic' are not allowed. They should be replaced with structural features or cancelled.
Salts of claimed compounds can be claimed without presenting working examples for salts, but should be defined in a claim as 'pharmaceutically acceptable salts'. An independent claim relating to a specific crystalline or polymorph form of a known compound should include parameters characterising the claimed form, such as an X-ray or IR pattern. The application should contain data showing that it is possible to use such a new form according to its indicated designation. The data should also demonstrate that the indicated technical result can be achieved.
The biological activity of claimed compounds (and their other properties if they are essential when proving their patentability) should be confirmed by presenting specific values (for example, IC50 or EC50 data) characterising such an activity. It is not, however, necessary to indicate the purpose or activity of a claimed chemical compound in a claim. Nevertheless, according to Russian Patent Rules, if a pharmaceutical composition, polypeptide, nucleic acid, genetic construct or strain is claimed, its purpose or activity should be indicated.
According to Russian practice, in order to provide support for a claim, it is possible to present, during examination and outside the application, additional examples and experimental data to demonstrate that the indicated designation or technical result of a claimed invention can be implemented. It can be requested that the additional experimental data be kept confidential. However, when amendments are made in claims, only features literally mentioned in the original disclosure or claims can be introduced into amended claims. For example, aryl can be specified in a claim as 'C6-C12aryl' or 'phenyl or naphtyl' only if features such as 'C6- C12aryl' or 'phenyl or naphtyl' were indicated in the original disclosure or claims.