Russian Federation: Pharmaceutical Inventions And Patent Term Extension Procedure

Last Updated: 1 May 2019
Article by Elena Nazina

Most Read Contributor in Russian Federation, July 2019

Once the Patent Law entered into effect in 1991, it became possible in Russia to get a national patent directed at pharmaceutical inventions, such as:

  • a compound or a group of compounds of general formula (Markush formula);
  • a pharmaceutical composition;
  • a biotech product;
  • a preparation process;
  • a new use of a known product;
  • a method for treatment;
  • prophylaxis; and
  • diagnostics.

When the Eurasian Patent Convention entered into effect in 1995, it became possible to get a Eurasian patent on those same pharmaceutical inventions.

Characterisation of inventions

Nevertheless, until quite recently, Russian patent legislation contained no special restrictions regarding the selection features for characterisation for any of the listed inventions.

For example, a 'second medical use' invention could be characterised in the claims using the following subject matters:

  • a pharmaceutical composition for intended use, comprising product X;
  • a medicine for intended use, which is product X;
  • use of product X for intended use;
  • use of product X for manufacturing a medicine for intended use; and
  • a method for the treatment of disease Y, comprising administration of product X.

Any of the above could include additional characteristics, including:

  • the physical properties of the pharmaceutical composition (eg, solubility and composition release profile, among others);
  • indication of the specific dosage form of composition;
  • product amount defined by a dosage or dosage range; and
  • a regime of product administration.

Moreover, all features characterising the invention in an independent claim have been considered when assessing novelty and inventive step. As a result, a pharmaceutical composition or medicine is distinguishable from known products by only its new intended use and could therefore be recognised and patented.

For the first time, the Eurasian Patent Organisation has introduced a limitation on the features applicable for the characterisation of pharmaceutical compositions.

In June 2012 amended rules for the preparation, filing and consideration of Eurasian applications with the Eurasian Patent Office entered into force, including Item 2.5.4.4 stating that: "to characterise a composition it is not legal to use as the features thereof the characteristics, which do not direct to the composition (for example, conditions and regimes of use of this composition in some process, method), quantitative parameter (measured or calculated), characterising one or more properties of the compositions if said parameter is used as the only feature characterising composition in the independent claim (for example, parameter of the strength of lamination, resistance to crack under stress, pharmacokinetics profile, etc.); technical result achieved when composition is used. Use of features directed to a method for treatment or prophylaxis of a disease (for example indication of doses, conditions or regimes of use of the composition or the drugs comprising said composition) is not allowed for characterization of the composition."

In practice, the Eurasian Patent Office has not allowed claims directed to a composition or medicine where the only distinctive feature was intended use.

Further, if features such as dosage of the active agent and its administration regime should be used for the characterisation of the invention, the only possible subject matter for protection of such invention through a Eurasian patent is a method for treatment.

Until June 2016, Russian patent legislation contained no such restrictions.

New rules for the preparation, filing and consideration of applications for inventions entered into force in Russia in July 2016. Item 70 of the rules stipulates that the provisions for novelty of the invention assessment contain the following: "the invention, the only distinctive feature of which is the intended use, can be recognised as novel if said intended use is the result of some product characteristics, which distinguish it from the known product. If the new intended use is merely the result of some intrinsic properties of the claimed product, which properties have not been known before, the claimed product is not recognised to be novel. In this case, the Applicant has the right to characterise this invention as 'use of the product for (new intended use)'."

The introduction of limitation means a ban on the protection of second medical use inventions using product claim formats such as 'pharmaceutical composition' and 'medicine'. The acceptable claims formats for the protection of second medical use inventions are 'use' and 'method for treatment'. 'Use' claims are preferable form a rights enforcement perspective.

On 1 October 2018 the rules and requirements for patent application documents were added with a stipulation limiting the features which could be used for the characterisation of compositions. Item 39 of the requirements stipulates that the features used for the characterisation of inventions directed at compositions and pharmaceutical compositions, among others, was added with Subitem 3 comprising the following feature limitations: "To characterise a composition it is prohibited to use as the features thereof the characteristics, which are not directed at composition (for example, conditions and regimes of use of this composition in some process, method), quantitative parameter (measured or calculated) characterising one or more properties of the composition if said parameter is used as the only feature characterising composition in the independent claim (for example, parameter of the strength of lamination, resistance to crack under stress, pharmacokinetics profile, etc.); technical result achieved when composition use. Use of features directed to a method for treatment or prophylaxis of a disease (for example, indication of doses, conditions or regimes of use of the composition or the drugs comprising said composition) is not allowed for characterisation of the composition."

Assessment of novelty and level of invention

Items 70 and 76 of the rules were added with a note stipulating that the features indicated in Subitem 3 of Item 39 of the requirements did not take into account assessment of novelty and level of invention.

Therefore, in accordance with the Russian patent legislation in force since October 2018, only products with either a new structure or a new qualitative or/and quantitative makeup can be recognised as meeting the novelty requirement and, if there is a new unexpected technical result, as having inventive level. The new provisions apply only to the national applications filed or entered in the national phase after the new provisions entered into force.

Scope of protection and experimental support

Both Rospatent and the Eurasian Patent Office define in practice the possible scope of invention protection on the basis of experimental supporting data presented in the patent application specification. Neither the Russian nor Eurasian patent legislation requires experimental support of the implementation of invention, claimed intended use or achievement of the claimed technical result for each specific embodiment of the invention characterised in the claims by the features defined by the general concepts.

However, recently Rospatent's position in respect of the scope of the experimental support of the implementation of the invention, the claimed intended use of the invention and the achievement of the claimed technical result by the claimed invention has become increasingly strict.

In the past, in order to support the possibility of the preparation of the salts of claimed new compounds, it has been sufficient to include in the specification of the patent application a general description of the salts and the process for their preparation. Today, experimental examples of the preparation and isolation of the particular salts for some compounds and the physicochemical characteristics thereof which prove actual preparation of said salts must be submitted.

The same approach is applied by Rospatent to inventions directed at pharmaceutical compositions. In the past, general disclosure of possible auxiliary ingredients of the compositions and possible unit dosage forms of the compositions were sufficient to meet disclosure requirements. Today, submission of at least some particular examples, including complete qualitative and quantitative makeup of the composition and its dosage form, are required.

Rospatent's requirements for experimental support of realisation of the intended therapeutic use of an invention directed at novel compounds, second medical use and methods for treatment and prophylaxis of the disease have also become very strict. It is no longer sufficient to submit in vitro data proving some biological activity of the product and some documents disclosing the interconnection between said biological activity and claimed therapeutic use. Only in vivo data on the relevant animal models will be considered by Rospatent as sufficient support of the claimed therapeutic use. If more than one therapeutic use is claimed, the mentioned experimental data should be submitted for each use.

Nevertheless, it is still acceptable to use some general definitions for features characterising the claimed invention in both national and Eurasian applications, even if the experimental data is submitted only in respect of certain particular embodiments of the invention.

However, Rospatent tends to restrict the scope of the original claims to bring it as close as possible to the scope of experimentally supported embodiments of the inventions.

The scope of protection of such inventions as a selection invention and a synergetic composition is strictly restricted to the particular compounds and compositions for which the claimed technical result is supported by the experimental data. Namely, for the new compound claimed as the selective invention, new qualitative or quantitative properties unknown for the known group of compounds covering this individual compound should be proved.

Data supporting synergetic effect for all combinations of the active agents should be submitted for the invention directed at the synergetic composition. If the composition is characterised by the range of the ratios of the agents, experimental data supporting synergetic effect within the entire range should be submitted.

To date, both Rospatent and the Eurasian Patent Office have accepted additional experimental data supporting the original scope of laimed inventions submitted by applicants during the prosecution of the application.

In accordance with the recent amendments to the Russian patent legislation, only technical results clearly defined in the specification of the patent application will be taken into account when the level of invention is established.

If the technical result has not been defined in the original documents of the patent application, the applicant is not allowed to declare the new technical result or submit the additional data supporting said new technical result to prove the inventive level of the claimed invention. The previous patent legislation contained no such limitations.

Due to the recently introduced limitations, it is imperative that the applicant be careful when drafting the specification and claims of the patent application to be filed/entered in Russia. The original application materials should clearly define the technical result for the claimed inventions, as well as sufficient scope of experimental data supporting the implementation of the invention, realisation of intended use of the claimed invention and achievement of the claimed technical result.

Patent term extension procedure

The term extension procedure for patents directed at medicine, pesticides and agrochemicals was considerably revised in 2015.

The patent term extension procedure was first introduced in Russia in 2003. In accordance with Russian legislation, which regulated patent term extension procedure until 2015, a patent directed at a medicine, pesticide or agrochemical was extended in respect of the claims covering the product as such (eg, a compound, composition or combination) in the whole scope. In order for the patent to be recognised as the subject for the patent term extension procedure a provision must be met; namely, the marketed product or active agent used in the marketed product must be covered by the scope of the granted patent claims. No specific disclosure of the marketed product or the active agent in the granted claims or the patent specification was required.

In October 2014 amendments were made to Article 1363 (2), Part IV of the Civil Code, which entered into force on 1 January 2019. The amendments introduced the procedure of grant of a supplementary patent restricted to the marketed product.

New patent term extension regulations were put into force on 8 January 2016. The term for filing the patent term extension request has not been changed and is six months from either the first marketing authorisation issue date or patent grant date, which ever expires the later.

Calculating the possible patent term extension also remains the same: the time between the application filing date and the first marketing authorisation issue date less five years. Until now only the first marketing authorisation issued in Russia serves as grounds for a patent term extension for both Russian and Eurasian patents in the Russian territory. The main difference in the new patent term extension procedure is the issue of the supplementary patent with the restricted scope of protection. In accordance with the new patent term extension regulations, the revised set of claims for the supplementary patent should be submitted by the patentee along with the patent term extension request.

Correction of the claims for the supplementary patent should be performed on the basis of the features contained in the granted claims. It is still unclear whether it is possible to use the features disclosed only in the patent specification to specify the general features of the granted claims to bring the scope of the claim into conformity with the characteristics of the marketed product.

In respect of patents directed at the group of compounds defined by a general structure, as of January 2019 Rospatent requires not only an indication of the specific radicals' meaning in the structure corresponding to those of the active agent of the marketed product but also the position of substitution for said radicals in the structure.

Introducing a new patent term extension procedure has limited the number of eligible patents, since only patents actually disclosing the compound corresponding to the active agent of the marketed product can now be extended. The only general definition which remains regarding supplementary patents is 'pharmaceutically acceptable salts'.

If the patent is directed to a composition characterised by the components amounts range, the patentee is allowed to specify the quality of each component by the specific meaning given in the marketing authorisation, even if these specific meanings were not disclosed in the original specification.

The new patent term extension procedure allows for a patent term extension to be applied for the same patent more than once. It is also still possible to extend more than one patent on the basis of the same marketing authorisation.

In general, the new patent term extension procedure for Russian patents has become much more complicated due to the necessity of bringing granted claims into conformity with the scope covering only the marketed product in the absence of any recommendations in the patent term extension regulations regarding how to do it and due to Rospatent's constantly changing approach to this procedure.

The introduction of these latest amendments to Russia's patent legislation clearly demonstrates that the current trends in patent protection of pharmaceutical inventions in Russia are limiting the scope of the protection of the inventions to keep it close to the experimentally supported embodiments of the invention, preventing protection of inventions directed at products characterised by features which are intrinsic properties of the product unknown from the prior art, limiting the possibility to obtain an additional term of validity for pharmaceutical patents.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
Similar Articles
Relevancy Powered by MondaqAI
 
Some comments from our readers…
“The articles are extremely timely and highly applicable”
“I often find critical information not available elsewhere”
“As in-house counsel, Mondaq’s service is of great value”

Practice Guides
by Mondaq Advice Centres
Relevancy Powered by MondaqAI
Canada
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
 
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions