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Extending Patent Protection for Medicinal Products in Russia

posted 8 years ago

Whether it is possible to extend a standard maximum term for patent protection (i.e., 20 years from the filing date of the patent application) in respect of pharmaceuticals under the Russian law is one of the most frequently asked questions by our clients from all around the globe.

In Russia, the possibility to extend the patent term in order to compensate a patentee for the loss of effective protection arising out of the time taken to obtain regulatory approval for a medicinal product which is protected by a patent is provided for by Art. 1362(2) of the Russian Civil Code.

Pursuant to the abovementioned Article, such an extension is available for patentee, upon an application filed with the Russian Patent and Trademark Office (Rospatent), in a situation where the patent in question protects a medicinal product that needs regulatory approval to be sold in Russia (i.e., marketing authorization), but the first authorization to place the product as a medicinal product on the Russian market has been granted more than five (5) years from the date on which the application for the said patent was lodged with Rospatent.

The term of the patent may be extended for a period equal to the period of time which elapsed between the date on which the application for the patent in question was filed with Rospatent and the date of the first authorization to place the corresponding medicinal product on the Russian market reduced by a period of five years. The extension of the patent term shall never exceed a period of five years.

An application for patent term extension must be lodged during the term of validity of the patent in question within (i) six months from the date on which the first the first authorization to place the corresponding medicinal product on the Russian market was granted; or (ii) six months from the date of grant of the patent, whichever expires the later.

Where the application for a patent term extension and the medicinal product to which it relates meet the conditions set out in Art. 1362(2) of the Russian Civil Code, a Supplementary Patent is granted. Such Supplementary Patent shall contain only those claims which relates to the product covered by the corresponding marketing authorization.

Formal requirements applicable to the application for patent term extension, and other procedural provisions regarding extension of the patent term are set out in the corresponding Administrative Regulations adopted by the Order of the Ministry of Economic Development of the Russian Federation No. 810 dated 3 November 2015 (as amended).

It is important to emphasize that although the procedure for extension of the patent term under Russian law has many features similar to the EU system of supplementary protection certificates (SPC) for medicinal products, there are also some rather significant differences.

For example, while under European legislation, i.e., Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products, a SPC may be granted to the holder of the patent protecting either the active ingredient or combination of active ingredients of a medicinal product, or a process to obtain the same, or an application of the same.

In contrast, according to Art. 1362(2) of the Russian Civil Code and current Russian judicial practice (see Resolution of the Federal Arbitrazh Court for the Moscow District on case No. KA-40/8324-04 dated September 22, 2004) extension of the patent term is only available to the holders of the patents protecting the medicinal products as such.

Another example is the absence in the Russian law of any provisions intended to use extension of the patent term as an incentive for obtaining marketing authorisations for paediatric use similar to those contained in Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use.

Pavel Pustilnikov

IPT Group

 

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