Kazakhstan: Legalmax Law Firm And Kassilgov & Partners Successfully Defended In Court The Rights Of The Original Medicine Manufacturer Applying The "Data Exclusivity" Institute

Last Updated: 3 May 2019
Article by Zhanna Abylkhanova

Problem description

One of the current problems the pharmaceutical companies (right holders and original medicine manufacturers) face in the Kazakhstan market is a violation of their rights by individual generic drug manufacturers expressed in using by them the confidential data from the original medicine registration dossier in order to obtain marketing authorization for their own generic drugs.

This issue is particularly relevant for pharmaceutical industry leaders, manufacturers of new medicines, which have no patent protection in Kazakhstan or have the expired patents.

Our lawyers have represented in courts of first, appeal and cassation levels, a leading American biotechnology company ("Plaintiff") focused on development and sale of medicines for cancer and inflammatory diseases, on the issues of the Plaintiff's right defense through applying the legislative novel (amendments to the legislation were made as a part of Kazakhstan accession to the WTO) - the data exclusivity institute. Our previous article "Data Exclusivity Institute in Kazakhstan and Its Influence on Activity of Pharmaceutical Companies" demonstrates in more detail the specifics of the legal regulation of the data exclusivity.

The essence of the dispute was as follows: in 2016 the Plaintiff registered in Kazakhstan the original medicine with Azacytidine as an active substance, and imported and marketed it in the country. However, in 2017, the Indian generic company ("Defendant") obtained in Kazakhstan a Registration Certificate for a generic drug ("generic") with the international non-proprietary name "Azacytidine" and introduced it into a stream of commerce along with the original medicine. Since according to the Plaintiff that due to the rules on data exclusivity, registration of a generic for original medicine during the data exclusivity six-year period is illegal, in September 2017, the Plaintiff filed a claim to the Specialized Interdistrict Economic Court of Almaty, to:

  1. Recognize the generic registration in the Republic of Kazakhstan as illegal;
  2. Recognize the opinion of the Center for Expertise with regard to generic as illegal;
  3. Bind upon the Pharmacy Committee to revoke the Registration Certificate for generic.

The co-defendants in the case were Defendant, the Center for Expertise and the Pharmacy Committee. The litigation lasted a year and a half and was resolved in March 2019.

Findings of the courts of first and appeal levels

In the previous publication we indicated that Article 71 (cl.19) of the Code of the Republic of Kazakhstan "On People's Health and Health System (The RK Code on Health) provides for a six-year period of data exclusivity in Kazakhstan from the original medicine registration date. It should be noted that the Plaintiff does not have a patent for the active substance, therefore, in this case, the violation of data exclusivity period for the original medicine was the only ground for legal action. The Plaintiff's position was based on the following interpretation of the rules on "data exclusivity" as applied to the dispute in question: examination and registration of a generic without consent from the Original Medicine Registration Certificate Holder for six years from the date of the original medicine registration are illegal, since the procedures for examination and registration of the generic inevitably involve the commercial use of confidential information contained in the original medicine registration dossier.

For the lack of judicial practice on a similar issue, the case was not easy, and the Plaintiff lost this case in the courts of first and appeal levels. The refusal to satisfy the claim was motivated by the following:

  1. The original medicine registration application does not contain a data exclusivity mark;
  2. The Plaintiff does not possess a patent or copyright certificate for the medicine;
  3. The Plaintiff did not provide evidence confirming the disclosure and commercial use of confidential information in the process of generic registration;
  4. The Plaintiff failed to prove that the examination of the generic and its registration without the Plaintiff's consent prior to expiration of the data exclusivity six-year period means a violation of Article 71 (cl.17) of the RK Code on Health.

Disagreeing with the rulings issued by the local courts, which were based on the misinterpretation of the rules on "data exclusivity", the Plaintiff filed a petition to the Supreme Court of the Republic of Kazakhstan to review the court acts under cassation procedure.

Findings of the Supreme Court and retrial

The Supreme Court of the Republic of Kazakhstan annulled the judicial order issued by the court of appeals and sent back the case for review to a differently constituted court of appeals. The highest court found that the local court had come to the wrong conclusions due to misinterpretation of the rule on the data exclusivity period (Article 71 (cl.19) of the RK Code on Health), and the fact of generic registration under the original medicine during the data exclusivity period is a violation of the Plaintiff's rights. As a result of the retrial, the Plaintiff's claims were satisfied in full.

Key findings of the court in the case:

  1. Neither the legislation of the Republic of Kazakhstan, nor rules contained in international treaties, provide for the requirement to have a data exclusivity mark in the medicine registration application;
  2. Information about the medicine filed for the state registration is confidential;
  3. Article 71 (cl.19 and cl. 20) of the RK Code on Health is intended to protect the original medicine registration certificate holders from direct or indirect use for commercial purposes of information provided by them for registration of a medicine without their consent by other persons for registration of other medicines;
  4. Due to the peculiarities of the generic examination procedure, which includes the comparative studies with the original medicine (aimed at extrapolation for the generic of the results of non-clinical trials and clinical studies conducted on the original referenced medicine), as well as examination of the package leaflet of a generic for compliance with the package leaflet of original medicine, it is impossible to register a generic without the commercial use of confidential information on the original medicine that is subjected to protection from use if no consent obtained from the applicant;
  5. The medicine data exclusivity is an independent way to protect the data in the original medicine registration dossier, and can be used independently of other methods for exclusive right protection (including cases when the patent is absent);
  6. Generic examination for the original medicine and generic registration without the Plaintiff's consent during the data exclusivity period is a violation of the Plaintiff's rights, since the generic examination and registration process inevitably includes the commercial use of confidential information from the state registration application, examination materials, as well as the original medicine registration dossier.

Thus, the strategy developed by lawyers contributed to creating a judicial precedent according to which the generic drug registration for six years after the original medicine registration is illegal if the applicant does not have consent received from the Original Medicine Registration Certificate Holder to use the data from the original medicine registration dossier.

Importance for business

The application of the data exclusivity principle allows the holder of patent for original medicine, which expires in the near future, to obtain an additional protection period, e.g. in cases where a medicine is filed for registration at the end of patent protection (due to lengthy clinical trials, marketing policy, etc.) or for any other reasons.
After registration of the original medicine when the patent is expired or even in the absence of patent, the registration dossier data is still subjected to protection, therefore, during the six-year protection period from unfair commercial use, no one other than the person providing secret information and test data on the original medicine shall, without the express consent of the person providing such secret information and test data, refer, directly or indirectly, to such data supporting an application for generic access to the market in Kazakhstan. During this six-year period, any subsequent generic registration application should not be accepted, unless the applicant provides the consent from the Original Medicine Registration Certificate Holder to use the original medicine data; and generics registered without such consent must be removed from the market until the elimination of violations.
We hope that the successful resolution of this dispute in favor of the Plaintiff will lay the foundation for a positive law enforcement practice that meets international standards, principles and rules of international law. This will create the conditions for more effective protection and enforcement of pharmaceutical companies' intellectual property rights in Kazakhstan, which will undoubtedly have an effect on the investment attractiveness of Kazakhstan.

The Client's interests in the courts were represented by Zhanna Abylkhanova, Partner, Legalmax Law Firm and Ravil Kassilgov, Managing Partner, Kassilgov & Partners

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
Zhanna Abylkhanova
 
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”

Related Topics
 
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