India: Role Of IPR In Forming Legal Strategies For Pharma Industry

Last Updated: 16 October 2015
Article by Pranav K. Mysore, Ravi Bhola and Shivakumar R

Pharmaceutical industry currently has an evolving IPR strategy requiring a better focus and approach in the coming era. This article chalks out the evolving role of IPR in framing legal strategies for pharmaceutical industry.

In the era of globalisation, there is a constant technological race especially in the field of pharmaceuticals to develop new/improvised drugs. Due to this, pharmaceutical companies are making huge investments on R&D and hence, it is imperative to protect the Intellectual Property (IP) associated therein and obtain returns by its commercialisation. Accordingly, it is no surprise that IP, particularly patents have become important in framing legal strategies for pharmaceutical companies, right from the commencement of research till the expiry of patents. Frequently, pharmaceutical companies strategise on procuring and enforcing their patents, however, such strategies are not focused on how to maintain their patents when challenged for validity. On the other hand, economic liberalisation has seeded a competitive market pressurising the competitors to come out with generic or biosimilar versions for which suitable strategies have to be formulated1.

The exclusive monopolistic rights over an invention granted to pharmaceutical companies under the existing Indian Patent Regime are affected by issues such as restrictions during procurement of patents, lack of presumption of validity, use of patents under "Bolar Provision" and so on.

Restrictions for procurement of patents come by way of issues relating to patentable inventions, lack of enablement and pre-grant opposition by third parties. It is pertinent to mention here that the recently proposed guidelines by Indian Patent Office for examining pharmaceutical applications recommend enablement for all the groups claimed under "Markush Structure". The guideline with respect to enablement for all the groups under "Markush Structure" is unique in the sense that other jurisdictions accept enablement for some of the groups while Indian Patent Office suggests enablement for all the groups. Though these guidelines have not come into force and there may be a debate on this aspect, it is still better to consider these guidelines while drafting the application.

In addition to lack of enablement, it is seen that presently most patent applications in the field of pharmaceuticals do not comply with requirements of "enhanced therapeutic efficacy" under section 3(d) of Indian Patents Act, 1970. Often, while filing application for patent on an invention, enhanced efficacy data is misconstrued as the activity data of the compound so claimed. Per contra, enhanced efficacy data would mean a comparative data demonstrating enhanced efficacy of the compound so claimed over closest known compounds. Such misinterpretation has resulted in rejection of several patent applications in India. Although other countries do not have such an express provision, they do conduct examination and raise objections under inventiveness as it is sometimes raised under section 3(d). Lack of enhanced efficacy data not only affects the patents from being granted by the patent offices, but also allows third party to file pre-grant opposition. Such rigorous process during prosecution and a right given to third party to oppose grant puts evergreening of patents under scrutiny.

Even if a third party loses out on filing a pre-grant opposition, options to invalidate a granted patent are available by way of post-grant opposition or revocation of patent. Yet again, these provisions act as a check on evergreening of patents amongst other legislative framework. On the other hand, patentee can institute infringement action against the infringer to protect and safeguard the interest in the patent, thus preventing anyone from practicing patentee's invention for commercial gains.

During proceedings such as opposition, revocation or infringement, the strategy lies in providing appropriate information that would support and strengthen the stand taken by concerned parties. For example: A patent is said to be infringed on the grounds that the patentee has monopoly over a particular compound A. The patentee identified that a third party is infringing the patent by selling salt Y of the compound A. It was found during proceedings that the patentee had filed another application for salt Y of the compound A which was abandoned later. The defendant argued that it is imperative from these facts that the plaintiff (patentee) themselves considered compound A and salt Y of compound A to be different from one another. Such being the case, the patent covering compound A cannot be said to be infringed by the defendants product - salt Y of compound A, even though the patent claims relate to pharmaceutically acceptable salts of compound A. The Hon'ble Delhi High Court held that the plaintiff ought to have shown the defendant's product remained equivalent to compound A to establish prima facie case of infringement2. The decision was appealed and the order is yet to be passed in this case. It appears that the case would have been in favour of the patentee if the activity of the compound A and its salt form Y was shown as equivalent. Even though such proof could be furnished at the appeal stage, the issue could have been resolved in the preliminary stage itself if it was proved. Another important factor to be considered based on this case is to decide on the need for filing independent patent applications for related subject-matter as such filings have a bearing on the parent application at a later date. One probable option that pharmaceutical companies can consider in such situation is to file a divisional application/patent of addition depending on case to case basis rather than filing an independent application for related subject-matter.

Having said the above, there are certain provisions in the law which allow third party to use patent granted to the patentee. One such provision relates to compulsory licensing, wherein any person interested may request for issuance of an involuntary licence to practice a granted patent, subject to certain conditions - meeting reasonable requirement of public such as accessibility and affordability, in addition to working of the patented invention in India. IPAB has held that the term "Worked" has a flexible meaning based on the specific facts3 . If the working of the invention is not feasible, the onus lies with the patentee to prove as to how the working was not feasible without merely making a statement to this extent.

Another provision under which a patent can be used by third party is "Bolar Provision" which is present in legislative framework of many countries. Bolar Provision is a specific enablement towards using the patent without authorisation of the patentee for the purpose of research, development and to obtain approval from regulatory authority. India has added one extra element to this Bolar Provision which enables a person to even sell the patented product. The legislative intent incorporating this element to the existing known Bolar Provision should not be misinterpreted to state that any person can sell/manufacture the drug on a commercial scale. It has to be interpreted in a manner which is necessary for procuring approvals from various quarters of the Government.

Hence, Indian Bolar Provision has to be interpreted to state that any person can use/manufacture/sell /import the patented drug solely for the purpose of research and development and for the purpose of procuring regulatory approvals. Any misuse of this provision would be construed as infringement and necessary action can be instituted by the patentee.

Generally, the regulations in obtaining approval under Bolar Provision or after the expiry of the patent is simpler for generic drugs compared to biosimilars owing to the differences in the process by which the patented drug and biosimilars are produced. Thus, it is necessary to furnish clinical trial data for biosimilar versions while seeking approval from a regulatory authority. Though the regulatory aspect is not binding on Indian Patent Provisions for approving a patented drug, pharmaceutical companies are bound by such provisions for not selling the approved drug for commercial purposes until the expiry of the patent owing to the issues of infringement. In conclusion, framing right legal strategies based on the provisions available within the Indian legal framework would help pharmaceutical companies in addressing issues relating to procurement, enforcement and commercialisation of patents. Such strategies would lessen the challenges even if one cannot avoid the issues completely.



2) Merck v/s Glenmark – CS (OS) 586/2013 –Delhi High Court – order dated 05-04-2013.

3) Bayer vs. NATCO – OA/35/2012/PT/MUM – IPAB – order dated 04/03/20138)

Originally published in Pharma Bio World - June 2014

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.

In association with
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:
  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.
  • Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.
    If you do not want us to provide your name and email address you may opt out by clicking here
    If you do not wish to receive any future announcements of products and services offered by Mondaq you may opt out by clicking here

    Terms & Conditions and Privacy Statement (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

    Use of

    You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). 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 & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


    Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd 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 or performance of information available from this server.

    The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


    Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

    • To allow you to personalize the Mondaq websites you are visiting.
    • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
    • To produce demographic feedback for our information providers who provide information free for your use.

    Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

    Information Collection and Use

    We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

    We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to with “no disclosure” in the subject heading

    Mondaq News Alerts

    In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


    A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

    Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

    Log Files

    We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


    This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

    Surveys & Contests

    From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


    If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


    From time to time Mondaq may send you emails promoting Mondaq services including new services. You may opt out of receiving such emails by clicking below.

    *** If you do not wish to receive any future announcements of services offered by Mondaq you may opt out by clicking here .


    This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to

    Correcting/Updating Personal Information

    If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to

    Notification of Changes

    If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

    How to contact Mondaq

    You can contact us with comments or queries at

    If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at and we will use commercially reasonable efforts to determine and correct the problem promptly.

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