India: Section 3(D): Hurdle Or Advantage To The Pharmaceutical Sector- An Indian Perspective


Section 3(d) first appeared in the Indian Patents Act 1970 under Section 3 "What are not inventions". Indian companies began manufacturing bulk drugs only after early 1970s. As a result India quickly became a major supplier of cheap drugs to a number of developing and under developed countries; however, absence of product patent production in pharmaceuticals discouraged innovation. Major phase in development of India's patent system happened after India joined World Trade Organization (WTO) in 1995. Trade related aspects of Intellectual Property Rights (TRIPS) agreement was signed on 1st January 1995 which is one of the important provision of WTO Agreement. In order to become TRIPS compliant, India needed to revise its patent law to provide product patent protection for pharmaceuticals. The Indian Parliament redesigned (amendment) section 3(d) in 2005 that not only complied with TRIPS but also did not negatively impact public health. The main aim of the proposed amendment of Patents (Amendment) Act of 2005 is to prohibit the ever-greening of drug patents and allow patents on variants of only those chemical compounds that show significant enhancement in therapeutic efficacy. The following article deals with Section 3(d) and its implications with regards to generic pharmaceutical industry as well as the innovators thereby providing a clear picture of its interpretation.


Section 3(d) what are not inventions. - The following are not inventions within the meaning of this Act,-the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.

Explanation – For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy."

Apart from passing the criteria of novelty, inventive step and industrial applicability, an invention has to clear the patent eligibility test in the form of efficacy along with other patentability test23.

Section 3(d)

Patent eligibility to a new use or new form of known molecules is denied, unless they contribute to higher therapeutic efficacy over the previous form.

Derivative of existing substance is considered to be identical to the existing substance except for significance difference in properties in consonance with efficacy


The term 'Efficacy' is of prime importance under Section 3(d) of the Indian Patents Act. However, the term efficacy is not much elaborated in the said Act. The Madras High Court had observed in context to 'efficacy' of pharmaceutical product as the effectiveness of a newly discovered drug in relieving from disease and production of a desired effect on the patient body. The applicant filing patent application for a novel drug has to bring out the difference between his patent application and already granted patent on the grounds of therapeutic effect. To prove the 'therapeutic efficacy' to the patent examiner is a challenging task for a patent applicant as most of the applications are filed by pharmaceutical industry at initial stage of drug discovery. It is possible for the applicant to gather required information regarding the therapeutic efficacy of the drug only at later development stage after having sufficient clinical trials.

India is not considered TRIPS compliant as Section 3(d) is found to be violating on two grounds24 1. Section 3(d) does not provide patent protection for incremental innovation. TRIPS state there is a need to define incremental innovation.2. TRIPS allows WTO members to be more liberal in providing patent rights over the TRIPS criteria, but not make them more stringent. However, Section 3(d) seems to lack standard protection for all categories that is mandated by TRIPS.

Pharmaceutical research is generally done in incremental steps with lesser "breakthrough" moments. An invention which is a result of regular exploitation such as enhanced bioavailability, shelf life, heat stability, reduced side-effects, compatibility, safety etc. can represent a significant innovation in itself.

In pharmaceutical sector, often minor modifications are patented leading to ever-greening of patents. The explanation provided for section 3(d) under Indian Patents Act says that various salt forms, esters, isomers etc are similar in configuration, which in turn is likely to exhibit equivalent function. A newly developed drug is patentable only if it gives better performance which must be proven experimentally. Section 3(d) promotes subsequent expansion of existing chemical substance, compounds, technologies, processes and products which are helpful in fulfilling the health requirement of the public and balance public goods with exclusivity provided by the patent rights. The need of the hour is clear cut definition of "efficacy" which can solve the issues surrounding Section 3(d) such as misapplication, arbitrariness and legal uncertainties. Such a step forward could bring an amicable solution to India's patent regime and TRIPS.

With regards to Public health, India provides quality drugs with reasonable cost not only to the Indian market but also to many countries. Patentability criteria due to section 3(d) ensures that Indian Patent regime gives protection only to creditable and deserving inventions and not to some frivolous innovations.



Glivec (imatinib mesylate), produced by the pharmaceutical company Novartis, is prescribed in the case of Chronic Myeloid Leukemia, one of the most common blood cancers in eastern countries. After more than a decade of legal battles surrounding its patentability, the Supreme Court of India gave its final decision on April 1st of 2013 rejecting patent application for 'Glivec' on the grounds of Section 3(d) that aims to restrict ever-greening' and patenting of new use or new form of existing pharmaceutical substance without any noticeable increase in efficacy. Unfortunately, "neither the Indian patent statute nor its implementing rules define 'efficacy'", and there are no available guidelines for companies like Novartis seeking second-generation patents (i.e., extended patents on modifications of previous products) .This is a landmark case because it represents critical issues related to intellectual property protection and access to medicines, which will impact how multinational pharmaceutical companies conduct business in India in the future, as well as India's role as the "Pharmacy of the Developing World".


Roche sued Cipla in early 2008 for infringement of their Patent IN '774, claiming [6, 7-bis (2- methoxyethoxy) quinazolin-4-yl]- (3-ethynylphenyl) amine hydrochloride' also known as 'Erlotinib Hydrochloride'. No interim relief granted to Roche in the early stages of the suit and the main matter was decided after the trial vide an order dated 7th September 2012.

Justice Manmohan Singh gave the judgment in favor of cipla stating that Cipla did not infringe Roche's Indian patent IN'774 as the Cipla's generic drug – Erlocip is the polymeric form B which is different from Roche's patented drug (Tarceva) which is a mixture of polymorph A&B.. Roche later filed IN'507 application in India for the polymeric form B which was rejected under section 3(d) since it did not show increases efficacy in comparison to the drug IN'774 patent which was for a mixture of polymorph A & B.


Abraxene is an injectible formulation of protein bound particles (paclitaxel) primarily used in the treatment of breast cancer, lung cancer and pancreatic cancer. On 29th June 2009 a patent Application titled 'Composition and method for delivery of pharmacological agents' bearing application No: 2899/DELNP/2005 was filed in India by Abraxis Biosciences claiming priority from a US patent application filed on the 9th of December, 2002.

NATCO filed a pre-grant opposition on several grounds including lack of novelty as the claimed drug was a combination of new form of a known substance Paclitaxel and anti-SPARC antibody. The applicant had mentioned in the complete specification that by his invention the associated side-effects of said composition are reduced and enhancing transportation of claimed composition. However, the specification neither indicated any enhance effect of paclitaxel nor demonstrated any significance of such properties with regard to 'therapeutic efficacy' in view of the known substance.

Therefore, in absence of any therapeutic efficacy of the composition as claimed, the said application was rejected under section 3(d) of the Patents Act, 1970. It paved way for generic companies to launch affordable versions in the domestic market.


From the above, it is evident Indian Patent regime do not foster incremental innovation. Section 3(d) can be used as an effective tool in restraining incremental inventions and prevent ever-greening of patents which was the case of pharmaceutical patents granted before amendment of Section 3(d) in 2005. Ever-greening of patents results in high drug prices in the market due to monopolizing which may directly impact the affordability of the majority of the Indian population. On the other hand, to balance and promote the innovation of the healthcare sector which is largely dependent on patent system, it is a good approach to use resources efficiently to research on blockbuster drugs that enhance bioavailability, shelf life, heat stability, reduced side-effects, compatibility, safety etc. in the areas of concern in the developing countries. Such efficacious drugs will promote the R&D sector as well as expand its market providing cost effective treatment and accessibility to the majority of affected population.







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