In Russia, a patent issuing on an invention has a term of 20 years from its filing date. However, the term of a patent relating to a medicine, pesticide or agrochemical substance requiring a market authorization from the Ministry of Health (MOH) may be extended if such approval is delayed for a period of more than five years from the filing date of the application. The maximum amount of extension available is five years (which is granted if approval is delayed for more than 10 years from the filing date of the application).
Medicine, pesticide and agrochemical substances are defined in the Patent Term Extension (PTE) regulations and these definitions correspond to the definitions set forth in the laws “On Circulation of Medicines” and “On safe Circulation of Pesticides and Agrochemicals.” Specifically, these definitions are as follows:
1. Medicines – a substance or a combination thereof that comes into contact with a human or animal organism that penetrate into the organs and tissues of the human or animal organism and are used for the prophylaxis, diagnosis (except for a substance or the combination thereof which do not come into contact with a human or animal organism), treatment of disease, and rehabilitation for maintaining, preventing or terminating pregnancy and which are obtained from blood plasma, organs, tissues of a human or animal organism, plants, minerals or by synthetic methods using biological techniques. Thus, pharmaceutical substances and drugs are considered to be medicines.
2. Pesticides – chemical or biological substances used to control pests and plant diseases, weeds, pests of stored agricultural products, household pests and external parasites of animals, as well as to regulate the growth of plants, the pre-harvest removal of leaves (defoliants) and the pre-harvest drying of plants (desiccants).
3. Agrochemicals – fertilizers, chemical ameliorants and feed additives intended for plant nutrition, regulation of soil fertility and the feeding of animals. This term does not apply to peat used for other purposes.
According to the PTE regulations, an invention relates to a medicine, pesticide or agrochemical if:
1. The claims characterize the invention as a compound or a group of compounds represented by a general structural formula and the specification discloses the possibility of using the compounds or group of compounds as an active ingredient of a medicine, pesticide or agrochemical; or
2. The claims characterize the invention as a medicine, pesticide or agrochemical composition.
There is no limitation on the number of patents for which a request for PTE can be filed provided that each of the patents for which such a request is filed contains at least one independent claim (and optionally, one or more corresponding dependent claims) that contain all features of the approved medicine, pesticide or agrochemical product. In practice, a PTE is granted for patents containing product claims (namely, to a compound or a group of compounds united by a general chemical structure; for example, Markush claims), pharmaceutical composition or formulation claims, EPC 2000 claims and “use”-type claims (such as Swiss and German type claims). For each patent to be extended, the period of extension is calculated from the filing date of the application until the date of receipt of the first market approval minus five years.
A patentee (or his patent attorney) must file a request for patent term extension prior to the expiration of the patent term and before the expiration of six months after receipt of the market approval or the date of the issuance of the patent, whichever occurs later. The MOH posts notices of approval on its website and will also mail a certificate of approval to the patentee or his representative. It is imperative that patentees closely monitor the website of the MOH for a notice of approval for a product pending approval. Specifically, there have been reports of delays between the date of issuance of the certificate of approval and receipt of the certificate by the patentee (Such delays are being reported even though under Russia’s regulations the MOH is required to issue the certificate of approval within five days of approval). In some instances, the patentee has received its certificate six months after receiving approval.
The following documents must be submitted when filing a request for PTE in the Russian Federal Service for Intellectual Property (ROSPATENT):
1. A notarized copy of the first market approval issued by the MOH;
2. A list of claims from each patent for which a PTE is sought which cover the medicine, pesticide or agrochemical;
3. Documents and patentee’s comments that prove that the chemical formulation of the medicine, pesticide or agrochemical for which the first market approval has been granted and the patented compound/composition are identical (There is no specified list of documents accepted by ROSPATENT in establishing such identity; however, examples of some documents that can be submitted include, a medicine pharmacopoeia, extracts from the registration dossier, the package insert, extracts from the Medical Guides such as the Merck Index, etc.); and
4. An original Power of Attorney signed by the patentee.
There is no obligation for the patentee to include the calculation for the PTE when filing the request as ROSPATENT is required to calculate the length of the extension itself. However, it is recommended that the patentee include the calculation when filing its PTE request in order to avoid errors from ROSPATENT in making the calculation.
If ROSPATENT denies a patentee’s application for PTE, a patentee can file a lawsuit against ROSPATENT within three months of the date of refusal of the PTE request. Such a lawsuit can be filed with the Russian Intellectual Property (IP) Court. In the event the IP Court also denies the application for PTE, its decision can be appealed at the Presidium of the IP Court and then to the Supreme Commercial Court
This post was written by Tatiana Lyu and Vladislav Ugryumov of Gowlings and Lisa Mueller.