India: Pharma Companies Extend Patent Life With Slight Modifications

Last Updated: 3 January 2019
Article by Deepika Sharma


Pharmaceutical industry is one of the most potential industry which has huge profit margins. Extensive growth and knowledge is required with frequent changes for better technology and results. Starting from early to the final stage there are gigantic chances of the product's to face success or failure. Apart from these challenges, a large amount is invested to launch product in the market. In this entire process starting from drug designing to manufacturing, IPR plays an vital role. Intellectual Property Rights today are the most strategic and powerful asset of all large and Multinational Companies throughout the world, providing continued global market, economic dominance and profitability. Multinational companies decide mergers and acquisitions on the basis of Intellectual Property Assets. All companies irrespective of their size get their technology Patented/Registered which makes their assets safe for trading license, joint R&D/Production ventures, recognized globally.

Extension of Patent Life by Making Modification in Drugs

Pharmaceutical companies are playing smart by making slight modifications to their existing drugs in order to extend a patent life span which has resulted in calls for the government to not recognize process methods for patenting, and allowing only molecular patents.

Pfizer's Caduet  is perfect example, It is a pill used for treatment of heart disease. Caduet is a simple combination of the blood pressure drug amlodipine besylate (marketed as Norvasc) and the cholesterol drug atorvastatin calcium (better known is Lipitor). Pfizer developed both Norvasc and Lipitor, with Lipitor holding the post of top selling pharmaceutical in the world for several years. Pfizer's patent on Norvasc and Lipitor expired in 2007and 2011, respectively, but due to Pfizer's existing patent on the molecules, no other manufacturers could produce a combination medication containing the molecules. Caduet conveniently entered the market in 2004.

  Another example is Prilosec, when the patent for Prilosec was near expiry, AstraZeneca in order to maintain the monopoly of the blockbuster drug Prilosec launched Nexium which was the same drug with minor changes in design and colour

Pharmaceutical R&D is an expensive and time consuming process which may take 8-10 years to complete. Companies are well aware of the time consumed in review and approval process by regulatory bodies before a new drug gets approval for marketing. So in order to recoup the considerable time and resources invested in the drug development and approval process the pharmaceutical companies depend on exclusivity provisions granted by the regulatory bodies.

There are many official and unofficial methods to extend term of a patent beyond 20 years wherein,

Official methods include provisions by some regulatory bodies such as Data exclusivity, Orphan drug exclusivity, Paediatric exclusivity and the 180-day exclusivity (Hatch Waxman Act, U.S. Food and Drug Administration), Supplementary protection certificate (European Medical Agency), whereas

Unofficial methods include altering or reformulate the existing compound to obtain a new patent by utilising polymorphism, creating combinations, stereo-selective/chiral switches, conversion to NDDS, OTC switching, authorised generics, etc. This article aims at highlighting the strategies used by Pharma giants to extend the term of their patent portfolio in order to maintain their monopoly for extended periods and the regulatory provisions in different countries to check these practices.

However, the Pharmaceutical Association of Malaysia (PhAMA) is arguing with government that modifications do make a difference because different salts carry different pharmacological properties which put forth different effects on patients. Moreover, different salts are patented alone as each carry different properties altogether.

As per PhAMA, nobody is able to predict which salt form is able to provide the desired therapeutic effects and both innovative and generic pharmaceutical companies do file their own patents which are further granted on the basis of novelty, inventive steps and industrial applicability.

After discovering a compound and registering it as a patent, a drug company has 20 years of protection for the patent where it will then carry out pre-clinical trials, and Phases 1 to 3 clinical trials, all which may take 10 to 12 years. After the trials, the company submits the results for product registration and the authority will evaluate the document.

Usage of Patented Technology in Pharma Industry

Pharmaceutical companies are usually at high-risk as once a drug has been successfully created, it is susceptible to being copied by third party through reverse engineering as pharmaceutical compounds can be easily imitated once they have been discovered hence, patent protects the rights of inventor and invention. It third party voids their rights, they are bound to undergo Legal consequences.

Chin says that a strong IP regime is critical for Malaysia to boost its competitiveness, especially to attract foreign direct investment while at the same time encourage technological advancement and innovation.


Since drug development carries unknown risks and extensive research and development which consumes several years. For example, a pharmaceutical company spends some years time getting Federal Drug Administration (FDA) approval for a drug. This means that when the drug comes up in the market, the patent could be good for only a few more years.

Some have considered whether it would be sensible to allow a solid 15 years of patent life after the drug has been cleared by the FDA. However, this is a complicated solution. Presently, drug companies already try to extend the patent life of their drugs as much as they can.

Most of the countries provide a 20-year exclusivity for a patented drug, so that innovator firm remits to undue practices such as evergreening in order to recover heavy costs incurred by them. These practices have become too aggressive with passing time.

Cooperative firms state to understand the pain of people and work for humanity, however are not in any way humanitarian in their approach, even though they pose to be, their sole motive is to hold their monopoly in the market and increase number of patents in their patent portfolios. To check this practice some countries have included certain provisions in their patent laws to extend the overall life of the patent so as to recover some of the time lost during regulatory processes, but in turn innovators firms have found loopholes in laws and even started exploiting these official provisions.







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

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

Similar Articles
Relevancy Powered by MondaqAI
Krishna & Saurastri Associates
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Krishna & Saurastri Associates
Related Articles
Up-coming Events Search
Font Size:
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 (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

To Use 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.


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.


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