Patenting pharmaceuticals in Russia – what to know

“Pharmaceutical patent applications constitute a large portion of all patent applications filed in Russia,” says Linda Norrgård, a European Patent Attorney at Papula-Nevinpat.

The Russian approach to assessing the inventive step of a patent application differs from that of the European Patent Office (EPO). Whereas the EPO applies the so-called problem-solution approach – with strict rules on how prior art documents can be combined in the assessment of inventive step – the approach in Russia is to focus more on the technical effect brought about by the defining features of the invention.

“We often hear clients filing patents in Russia wanting to use arguments and make amendments similar to those they’ve used in Europe,” says patent attorney Linda Norrgård. “Sometimes this may be possible, but in many cases you need to follow a different line of argumentation to be persuasive for the Russian patent office and its examiners.”

Tighter rules around compounds

At least the following pharmaceutical subject matter are considered patentable in Russia:

• Compounds used as active agents in medication
• Pharmaceutical compositions comprising at least one active agent
• Methods for dosing medication
• Methods for preparing a compound or composition and/or using it in treatment
• New uses of a known product

When filing applications to protect compounds, some examples are usually required and need to be included with the patent application. Other experimental data can typically be provided later, during the examination procedure.

Russia has recently been tightening its patent rules and practices around the prosecution of pharmaceutical patent applications, including those for compounds.

“The rules have become stricter in terms of providing experimental data and demonstrating the technical effect of compounds,” says Norrgård. “Without these, it can be very difficult to obtain broad claims. This applies to new combinations of known compounds too.”

Antibody patents require extra data

In addition to demonstrating novelty, the inventive step and industrial applicability, claims involving an antibody need to include its name, biological function in intended use, and its amino-acid sequence. Experimental data is important too.

“Better protection is usually achieved if several antibody claims are included, even if amino-acid sequences are only partially disclosed,” says Norrgård. “Also worth noting is that use claims are generally more valuable than method-of-treatment claims.”

Dealing with patent-term extensions

As in Europe, patent-term extensions are available in Russia for medicine, pesticide and agrochemical inventions. The maximum extension period is five years.

“For a pharmaceutical patent to be extended in Russia, it must disclose the active agent of the marketed product,” says Norrgård. “Then the patent can be extended more than once, and more than one patent can be extended on the basis of the same marketing authorization.”

The term for filing a patent-extension request in Russia is six months from either the first marketing authorization issue date or the patent grant date – whichever expires later. Current regulations require the submission of a revised set of claims together with the extension request.

See here the webinar recordal on the topic.