Kazakhstan: Patent Linkage System And Its Relevance For Generic Drugs Registration In Uzbekistan And Kazakhstan

Last Updated: 8 August 2016
Article by Mukhammadali Makhmudov

This articles addresses issues related to the protection of the rights of brand-name drug patent holders in connection with generic drugs registration by other manufacturers.

The way drugs have to make from a laboratory to a pharmacy is known to be very long and, in addition to research activities, involves certain legal procedures such as obtaining patents, registering brands as intellectual property and drug registration with special healthcare and certification bodies.

Fast-growing economies and large population make CIS countries, such as Uzbekistan and Kazakhstan, high-potential emerging markets both for pharmaceutical giants and smaller drug manufacturers.

Most drugs marketed in these countries are either brand-name or generic (i.e. identical to the original formulations).

Having reviewed our efforts in the sphere of patent protection in the pharmaceutical industry over the last years, we conclude that there is a need for certain improvements to the existing laws to protect the rights of holders of patents to brand-name drugs and to create good faith competition among generics manufacturers.

Our understanding of the pressing issues and possible solutions suggested in this article are based on many months of work of an Almaty (Kazakhstan) based task force consisting of Legalmax specialists, representatives of the leading global pharmaceutical companies, our colleagues from international law firms, and patent attorneys. Officials from the Ministry of Justice and the Ministry of Healthcare and Social Development as well as other stakeholders also contributed to the discussion.

The approach to streamlining the marketing of brand-name drugs and generics boils down to the necessity of harmonizing administrative regulations in the area of drugs registration and approval and laws governing registration and protection of intellectual property rights, including, without limitation, patents which are typically hold by developers of innovator drugs.

The term "innovator (brand-name) drugs" means original drugs first developed/manufactured and protected under valid patents, including, without limitation, entitled to legal protection in a certain country. A "generic drug" is, in turn, a non-patented drug identical to the original brand-name one due to the use of the same active pharmaceutical ingredient for which the term of legal protection has expired.

The lack of legal tools and legal provisions prohibiting registration and market launch of generics during the term of the patent for invention containing the same active ingredient is the source of most legal disputes and, therefore, leads to the infringement of patent holders' rights in relation to original drugs and formulations used in them.

As a result of legal loopholes in this area, generics are approved for market launch during the term of the validity of patents for active ingredients used in such generics which, in most cases, creates grounds for patent disputes.

Many of the above problems can be avoided and the interests of patent holders and those of the generics manufacturers may be balanced if healthcare authorities and generics manufacturers are under obligation to take certain actions aimed at excluding the possibility of entering into the national register of pharmaceuticals or medical goods for as long as the patent for their active ingredient remains valid.

This recommendation is not news and has been implemented on a global scale in the form of the Patent Linkage system that has proven itself as one of the most efficient tools in the area of protection of lawful patent holders' rights.

Patent Linkage principles have been built into the laws of most developed countries, and their implementation in the laws of Kazakhstan and Uzbekistan is a pressing issue for the professional business community and end consumers of pharmaceuticals.

The importance and necessity of this system are due primarily to the fact that it offers protection to inventions made by national and foreign research centers thus promoting their innovative efforts and research in the area of improving existing and creating new drugs. Secondly, guarantees of foreign patent holders' rights protection and observance will lure the most advanced treatments and disease prevention methods into the consumer market.

Patent Linkage may be made a part of national legislation through introduction of simple yet efficient instruments to control and prevent the infringement of valid patents:

  1. All drug registration applications filed by interested companies shall be published in specialized bulletins or on the official website of the Ministry of Healthcare or its divisions; thus, the brand-name drug patent holders and manufacturers will be able to identify by themselves any potential infringements of their intellectual property rights.
  2. The patent holders must be entitled to file a request with the registration authorities (based on information obtained from the above open sources) to suspend registration subject to the provision of reasonable and sufficient evidence that the patent holder's rights may be infringed if the generic is registered and allowed into the market.
  3. In addition to declaring that no third party rights are infringed, the person applying for generic registration shall support such declaration with documents obtained from the national patent authorities (Kazpatent and Intellectual Property Agency of the Republic of Uzbekistan) through the official procedure of obtaining information about patent search of the key components of drugs to be registered, and their manufacture and use procedure.
  4. The application for generic drug registration shall, in a manner excluding any double interpretation or ambiguity, specify whether there is any legal impairment to the drug components. In particular, one of the below conclusions must be made in the application:

    • the drug to be registered does not contain any inventions or any other patented objects that are under legal protection in the country; or
    • the drug to be registered contains elements of an invention with valid legal protection, the expiry date of the patent to be specified.

If the generic to be registered contains any patented components, its registration is to be suspended until the patent expires, or until a respective court decision comes into effect if the applicant files a court complaint in connection with the patent holder's actions.

The proposed way of Patent Linkage introduction into the national legal system will undoubtedly involve further work; however, we believe that using it will allow us in the nearest future to materially reduce the possibility of patent holders' right infringement, to strike the right balance among interests of all pharmaceutical market participants, and to create conditions for good faith competitive environment.

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
 
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