India: A Glimpse Of Recent Developments In Patent Arena

Last Updated: 10 June 2014
Article by PSA


The US Trade Representative 301 Report found that Indian IP regime favors the native and therefore, the chances of US downgrading India in this report was most likely.1 However, the Indian government refused to participate in US unilateral investigation while defending its IP regime. Essentially, India is compliant with its commitments under TRIPS and has used flexibilities which are available to WTO members and that is entirely within the limit and commitments made by India under TRIPS and WTO agreements. India is also gradually aligning its IP regime to the global regime. In the domain of patents, India became a contracting state to the Patent Cooperation Treaty ("PCT") on December 7, 1998 and this heralded an era of regulatory and procedural changes. Now, the Indian Patent Office ("IPO") enjoys the privileges enjoyed by the patent offices of other developed nations. The recent unprecedented decision of granting compulsory license for manufacturing patented drugs by Indian patent authorities have also evoked mixed responses and, turned the attention of other countries to the patent law developments in India.

The present bulletin will discuss the various changes carried out to the IPO by WIPO followed by the streamlining of the procedural aspects of patent registrations in view of the newly acquired status by IPO and, also, the concept and recent grant of compulsory license.

1. Upgradation of IPO

From October 15, 2013, the IPO has started functioning as an International Searching Authority ("ISA") and International Preliminary Examining Authority ("IPEA") under the PCT.2 This was the outcome of the agreement3 entered into between IPO and the International Bureau of WIPO on September 25, 2013,4 which, in turn, was the postscript to IPO's recognition as ISA & IPEA in 2007. As a result of this recognition as ISA/IPEA by WIPO, IPO will now be entitled to conduct international searches and international preliminary examinations and issue preliminary examination reports. These international search reports and preliminary examination reports issued by IPO will aid the applicants in ascertaining the most relevant prior art (all information that is publically available) in the field of the applicant's patent as well as in formulating a preliminary opinion as to whether their inventions appear to be novel, involve an inventive step and capable of industrial application, the three criteria recognized for valid patent registrations.5 Availing these search services of IPO will cost INR 10,000 (around USD 167)6 for companies and INR 2500 (around USD 42) for individuals.

2. Amendments to the Patent rules

The Patent Rules, 2003 that regulate the procedural aspects of patent registrations and other allied matters with respect to patents in India has undergone two significant amendments in the recent past.

2.1. The Patent (Amendment) Rules, 2013

The Patent (Amendment) Rules, 20137, first among the two recent amendments, came into force on October 15, 2013. These amended rules are primarily aimed at streamlining the various procedures in line with IPO's agreement with the International Bureau of WIPO. As per the amended rules, the IPO, Delhi office will be the designated office for ISA and IPEA. In variance with the old rule where the applications were bound to be processed by the patent office of initial filing, the amended rules empowers the Controller to transfer patent applications between the various patent offices in India. The rules prescribe a period of three months or in case of priority, nine months from the date of priority, whichever expires first for the preparation of international search report ("ISR"). Similarly, rules set period of twenty eight months from the priority date or six months from the start of International Preliminary Examination or six months from the date of receipt of the translation by the examination authority for establishing the IPER by the examining authority. Copies of ISR, written opinion and IPER shall be transmitted to International Bureau as well as to the applicant. A tabulated fee structure for international applications for various requirements under the treaty also forms part as fifth schedule of the new rule.

2.2. The Patent (Amendment) Rules, 2014

The changes brought in by the subsequent amendment to the Patent Rules with effect from February 28, 20148 are as summed up below:

i. Fee structure has been revised for patent application filing and other processes before the IPOs. The Rules also provide for a deduction of 10% for e-filing of application with IPO as opposed to physical filing.

ii. The amendment rules brought into picture a third category of applicant, "small entity", as defined under Section 7(1)(a) & 7(1)(b) of the Micro, Small and Medium Enterprises Development Act, 2006 i.e. enterprises engaged in manufacture or production of goods whose investments in plant and machinery are within INR 100,000,000 (approximately USD 16,66,666) or which are into providing/rendering of services with an investment cap of INR 50,000,000 (approximately USD 8,33,333) in equipments. A fee structure falling between that for a natural persons and larger entities is stipulated for these small entity applicants. In the eventuality of full/part conversion of the applicant entity from small to larger one, the rules mandate the payment of additional fee calculated as the difference between the fee structure for small entities and the larger entities. It is further clarified that the highest fee category as applicable among the joint owners will be considered for fee calculation in the case of joint applications.

iii. Two forms, Form 7(A) towards filing of "Representation Opposing Grant of Patent" (without any accompanying fee) and Form-28 which should be part of every new application, are newly introduced by the amendment.

3. Compulsory Licensing and Patent law

Compulsory licenses are generally defined as "authorizations permitting a third party to make, use, or sell a patented invention without the patent owner's consent."9 The compulsory licenses are generally granted with a view to help the needy people to buy the life saving drugs at an affordable price. Since compulsory licenses limits the monopoly rights conferred to the patent holders there have always been controversies associated with its implementation. As per the Indian Patent Act, 1970 ("Act"), the applicant should first make an attempt to get voluntary license from the patentee itself to manufacture the patented drug. Only if the applicant is not able to procure the same within the prescribed period of 6 months, the applicant can file an application before the Controller General of Patents for providing compulsory license to manufacture the said patented drug. As per section 84 of the Act, for the compulsory license of patented invention, the interested party can apply to the controller after the expiry of three years from the date of grant of such patent based on the following reasons: (i) reasonable requirements of public have not been satisfied; or (ii) patented invention is not available with the public; or (iii) patented invention is not worked in the territory of India.

3.1 Cases of recent Compulsory License Grants

India's first compulsory license was granted to Natco Pharma Ltd ("Natco") for manufacturing Bayer Corporation's ("Bayer") patented drug Nexaver used in the treatment of liver and kidney cancer. Nexavar is a life-enhancing drug as it would extend the life span of the patients suffering from kidney or liver cancer. Bayer launched Nexavar in the year 2006 and obtained patent protection on March 3, 2008. Bayer sold the drug at an approximate cost of INR 280,000 (approximately USD 4,666) per month. Natco, an Indian pharmaceutical company, applied to Bayer for a voluntary license to manufacture and sell the drug but since then Bayer had continued to reject Natco's proposal. Aggrieved by this rejection, Natco filed an application for the grant of a compulsory license with the IPO and the Controller General of Patents ("CGP") after considering all the three aforementioned grounds for grant of compulsory licenses, decided in favor of Natco. CGP has permitted Natco to manufacture the patented drug based on its assurance to sell the drug at a price of INR 8,800, which is only 3% of the Bayer's cost. Further, a lot of conditions have been imposed on Natco including payment of a royalty of 6% of net sales to Bayer, manufacturing of the drug at its own manufacturing facility, selling the drug within Indian Territory and supply of the same to at least 600 patients per year free of cost. Aggrieved by the decision, Bayer appealed before the Intellectual Property Appellate Board ("IPAB") against the CGP's decision alleging that the grant of compulsory license was illegal and untenable under law. However, IPAB dismissed the appeal stating that granting compulsory license to Natco is valid under law and revoking the same would jeopardize the interest of the public who are in need of the drug.10 Thus, eventually the CGP's order granting compulsory license to Natco was upheld.

In an another interesting case between BDR Pharmaceuticals Ltd ("BDR Pharma") and Bristol Myers Squibb Pharmaceuticals Ltd ("BMS Pharma"), CGP rejected the application filed by BDR Pharma for compulsory license of anti cancer drug Dasatinib, a patented drug of BMS Pharma citing that the applicant has failed to make out a prima facie case for an order under section 87 of the Act. BMS Pharma was selling the drug at a price of INR 2761 (USD 6) per tablet whereas BDR Pharma proposed to the sell the generic version of the drug for INR 135 (USD 2.25) per tablet. As mentioned earlier, an applicant in order to obtain a compulsory license must have made the necessary efforts to procure a voluntary license from the patent holder and only in the event of the failure of such attempts that the applicant can file an application for compulsory license within 6 months of the initial request. Likewise, BDR Pharma had sent a request to BMS Pharma to issue voluntary license for the manufacture of its anticancer patented drug Dasatinib, but BMS Pharma responded by raising numerous questions to BDR Pharma such as whether BDR Pharma posses necessary wherewithal for the manufacture of good quality patented drugs. BDR Pharma did not reply to the queries raised by BMS Pharma, but chosen to file an application for compulsory license with the CGP. CGP in his order held that BDR Pharma by failing to reply to the queries raised by BMS Pharma had not fulfilled the conditional steps required for obtaining compulsory license and, thus rejected the application. It was also pointed out that the BDR Pharma must have negotiated with BMS Pharma for at least 6 months for obtaining voluntary license and, therefore BDR Pharma failed to prove the existence of a prima facie case for the grant of compulsory license.

Though the grant of compulsory license was welcomed by a section of the society, the pharmaceutical companies were not happy by the decision as they are of the opinion that it would undermine the innovative steps undertaken by them and further discourages the investment in the research and development of new medicines. As a result, the invention of new drugs and related business opportunity would be adversely affected and, therefore, the foreign multinational companies wanted US Trade Representative to classify India as Priority Foreign Country in its Special 301 report in order to pressurize India into change its stand in grant of compulsory licenses as per section 84 of the Act. However, US has elected to place India in Priority Watch List Country instead of Priority Country hoping that the recently constituted government will provide a more conducive IP environment to US traders.


The promotion of IPO into ISA and IPEA is a milestone in the history of IPO but there are several concerns such as the sufficiency and competency of the IPO workforce, existence of some procedural grey areas etc. still bother the stakeholders. Further, the intention of the lawmakers in the promulgation of the above amended rules is to disseminate and systemize the procedural aspects with regard to IPO's functioning as ISA and IPEA. The discounted fee for e-filing, a step in the direction of paperless patent office, is laudable. But this noble intent of the policy makers can face hitches unless the e-filing platform of the IPO is efficiently maintained without any technical glitch. These developments in Patent arena have placed India in an advantageous position to compete with the developed countries. Though the grant of compulsory license is criticized by the developed countries and its traders, India should not succumb to their pressure as it is imperative for a developing country like India, where a substantial population is below the poverty line, to grant compulsory license as it would make the expensive life saving drugs available to the needy patients. So, there is a need to bridge the gap between business profits and providing access to medicines to the poor.


1 Annual report prepared by the office of United States Trade Representative as per United States Trade Act, 1974 consisting list of countries whose IPR regime is adverse to United States and its traders.

2 PCT is an international patent law treaty, concluded in 1970 which presently has 148 member countries in its fold and facilitates a unified procedure for filing patent applications to the states which are parties to this treaty.

3 This agreement of IPO with the International Bureau of WIPO will be prevailing until 2017.

4 Full text of the agreement can be accessed at (as visited on May 29, 2014).

5 Article 33(1) of PCT accessible at (as visited on May 29, 2014).

6 Approximately 1USD = INR 60.

7 Accessible at (as visited on May 29, 2014).

8 Available at (as visited on May 29, 2014).

9 F.M. SCHERER & JAYASHREE WATAL, POST-TRIPS options for access to patented medicines in developing countries 13 (Common on Macroeconomics & Health, Working Paper No. WG4:1, 2001, available at (as visited on May 29, 2014).

10 OA 35/2012 - Intellectual Property Appellate Board.

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