India: Section 3(d) of The Patents Act, 1970 (As Amended): A Deeming Provision!

Last Updated: 24 July 2017
Article by Dinesh Kumar Sharma

Ambiguous and inconsistent standards regarding interpretation of Section 3(d) of the Patents Act, 1970, as amended by the Patents (Amendment) Act, 2005, a provision peculiar to Indian law, has remained a key issue in India. The constitutional validity of Section 3(d) of the Patents Act, 1970, (as amended) came under judicial scrutiny before the Division Bench (DB) of the Hon'ble High Court of Madras (MHC) in Novartis AG & Anr. vs. Union of India & Ors. [(2007) 4 MLJ 1153]

One of the core issues before the DB of the MHC for consideration was whether amended Section could be held to be violative of Article 14 of the Constitution of India on the ground of vagueness, arbitrariness and conferring un-canalised powers on the Statutory Authority.

Does Section 3(d) Engraft a Deeming Fiction?

Novartis submitted that the Explanation added to the amended section creates a deeming fiction to the effect that all salts, esters, etc., etc., if derived from a known substance, then, such derivatives are also considered to be the same substance, unless the derivatives are shown to differ significantly in properties with regard to efficacy. Novartis argued that all derivatives need not necessarily be the same substance and therefore the deeming fiction created by the Explanation is bereft of any guidelines and is bad in law. It was strenuously argued that there must be some guidance or guideline in the Act itself as to when a derivative shall be held to be differing significantly in properties with regard to efficacy. Novartis argued that both the amended Section as well as the Explanation to the amended Section must prescribe in clear terms for the Authority constituted under the Act, the guidelines to decide in what circumstances it can be held that the discovery of a new form of a known substance had resulted in the enhancement of the known efficacy of that substance and when the derivatives are found to differ significantly in properties with regard to efficacy.

Ruling of DB of MHC

After going through the entire records in the light of the arguments advanced by the parties, reading the Parliamentary debates on Patents (Amendment) Ordinance, 2004 (Ordinance No.  7/2004) and bearing in mind the object which the Amending Act wanted to achieve namely, to prevent evergreening; to provide easy access to the citizens of this country to life saving drugs and to discharge their Constitutional obligation of providing good health care to its citizens, the DB found that the Explanation creates a deeming fiction that derivatives of a known substance are deemed to be the same substance unless they differ significantly in properties with regard to efficacy.

The Court observed that it is accordingly clear from the amended Section and the Explanation that in the pharmacology field, if a discovery is made from a known substance, a duty is cast upon the patent applicant to show that the discovery had resulted in the enhancement of a known efficacy of that substance and in deciding whether to grant a Patent or not on such new discovery, the Explanation creates a deeming fiction that all derivatives of a known substance would be deemed to be the same substance unless it differ significantly in properties with regard to efficacy. The Court opined that due to the advanced technology in all fields of science, it is possible to show by giving necessary comparative details based on such science that the discovery of a new form of a known substance had resulted in the enhancement of the known efficacy of the original substance and the derivative so derived will not be the same substance, since the properties of the derivatives differ significantly with regard to efficacy. While observing so, the Court also referred to, inter alia, a judgment of the Hon'ble Supreme Court in M/s. J. K. Cotton Spinning and Weaving Mills Ltd. Vs. Union of India (AIR 1988 SC 191) wherein the Apex Court observed, inter alia, that "the Legislature is quite competent to enact a deeming provision for the purpose of assuming the existence of a fact which does not really exist."

Accordingly, the Court rejected Novartis' argument that the amended Section must be held to be bad in law since for want of guidelines it gives scope to the Statutory Authority to exercise its power arbitrarily, as it found that there are in- built materials in the amended Section and the Explanation itself, which would control / guide the discretion to be exercised by the Statutory Authority. The Court also found that the amended Section does not suffer from the vice of vagueness, ambiguity and arbitrariness. Consequently, the Court held that the amended Section is not in violation of Article 14 of the Constitution of India and accordingly dismissed the Writ Petitions filed by Novartis. 

Import of Section 3(d) on the Determination of Infringement of Patent

In the recently decided high profile case of F Hoffmann-La Roche Ltd. v Cipla Ltd [RFA(OS) 92/2012 & RFA (OS) 103/2012] arising out of the judgment dated September 7, 2012 passed by the Single Judge (SJ) of the Delhi High Court (DHC), the DB of the DHC comprising Hon'ble Mr. Justice Pradeep Nandrajog and Hon'ble Ms. Justice Mukta Gupta was faced with a crucial issue as to whether manufacture of polymorph B of the compound Erlotinib Hydrochloride (for which product claims in Plaintiff OSI Pharmaceuticals, Inc.'s patent application IN/PCT/2002/00507/DEL were rejected by the Indian Patent Office) by Cipla Ltd. infringes the suit patent IN196774 allegedly disclosing polymorph A+B of Erlotinib Hydrochloride.

Cipla's defence to the charge of infringement was essentially based on a claim that while the patent sought to be enforced was for Polymorphs A+B, the product actually under manufacture by both Roche and Cipla was Polymorph B which ought to be assumed to be in the public domain and hence its activities are non-infringing in nature.

Cipla argued that the very filing of a separate patent application was indicative of the fact that Polymorph B of Erlotinib Hydrochloride was a separate invention. Cipla urged that Polymorph B was neither disclosed, enabled nor claimed in the suit patent in any jurisdiction and hence something which came into being later cannot be argued as being retrospectively covered in an earlier patent. It was argued further that Section 3(d) is a deeming provision in a legal sense, but in a technical sense it cannot be presumed that once the patent/patent application for a new form of a known substance is rejected / abandoned then said new form is covered under a prior patent relating to that substance.

Interestingly, there were several indian patent infringement cases including Merck Sharp And Dohme Corporation And Anr. Vs. Glenmark Pharmaceuticals that witnessed a trend where the respective Defendants took the similar argument of defence to the charge of infringement as Cipla took in F Hoffmann-La Roche Ltd.

Ruling of DB of DHC

At the outset, the DB discussed the legal position concerning construction of claims. The DB referred to a number of decisions including the recent decision of the DB of the DHC in Merck Sharp And Dohme Corporation And Anr. Vs. Glenmark Pharmaceuticals [FAO (OS) No.190/2013] (arising out of SJ's Order dated April 5, 2013 dismissing Merck's application for grant of an interim injunction) wherein the DB comprising Justice Ravindra Bhat and Justice Najwi Wajiri held that claim construction to determine the coverage in the suit patent has to be determined objectively on its own terms with regard to the words used by the inventor and the context of the invention in terms of the knowledge existing in the industry. Subsequent abandonment of an application cannot remove what is patented earlier nor can it include something that was excluded earlier and that a patent is construed by the terms used by the inventor and not the inventor's subjective intent as to what was meant to be covered. Merely because an inventor applies for a latter patent that is already objectively included in a prior patent, but which inventor subjectively feels needs a separate patent application, doesn't mean it is to be taken at face value and therefore neither Section 3(d) nor abandonment of subsequent patent application can be used to read into terms of prior application, which has to be construed on its own terms.

The DB found itself unable to agree with Cipla's arguments on the import of rejection of patent application for polymorph B. The DB observed that the purpose of the qualification threshold laid down by Section 3(d) as to what subject matter would qualify as the 'same' or 'known' substance and what would qualify as a 'new' substance is that when something is the same/known substance, then the derivatives of such a substance as enumerated in the Explanation to Section 3(d) would be covered under the same protection that exists for the known substance. The DB specifically observed, inter alia:

"....What Section 3(d) certainly does NOT do, is doubly penalize the innovator, which appears to be the argument advanced by learned senior counsel for Cipla. If the argument is to be taken to its logical conclusion, it would mean that a rejection of a polymorphic version of Roche's existing patented molecule (i.e. the 'known substance' in this case) on the anvil of Section 3(d) would also result in effectively permitting all manufacturers of the said polymorph from being deemed non-infringers under Section 48. That is in fact not the import of Section 3(d) nor the legislative intent behind the provision.

73. We understand Section 3(d) as a positive provision that in fact recognizes incremental innovation while cautioning that the incremental steps may sometimes be so little that the resultant product is no different from the original. The inherent assumption in this is that an infringement of the resultant product would therefore be an infringement of the original i.e. the known substance and by no stretch of imagination can Section 3(d) be interpreted as constituting a defence to infringement."

Accordingly, the DB held that the rejection of the patent application for Polymorph B by the Indian Patent Office leads to a direct conclusion that there was a lack of sufficient matter to suggest that Polymorph B qualified as a 'new product' for consideration under Section 2(1)(j) for patentability and should therefore be regarded for all practical purposes as the allegedly old product itself i.e. Polymorphs A+B. The DB further held that as interestingly Cipla's argument would shoot down the polymorph because of Section 3(d) and also attempts to shoot down the main compound, because of the polymorph's rejection, it cannot be done.

The DB finally held that claim 1 of the suit patent is a sufficiently broad claim that is clearly not limited to any polymorphic version of Erlotinib Hydrochloride, but to Erlotinib Hydrochloride itself and this compound may exist in several polymorphic forms, but any and all such forms will be subsumed within this patent and therefore as Cipla's Erlocip is admittedly one particular polymorphic form of the Erlotinib Hydrochloride compound (Polymorph B), it will clearly infringe the suit patent.

Interestingly, it bears recalling that the SJ of the DHC in the same case had not accepted the Plaintiffs' "deeming fiction" argument. The Plaintiffs while relying upon the Patent Office's Order dated December 15, 2008 rejecting the product claims in the application IN/PCT/2002/00507/DEL argued that there is a deeming fiction in law to treat the suit patent compound and Polymorphic version B as the same substance. The SJ, however, had observed that upon the mere reading of the provision Section 3(d) as well as the Explanation appended thereto, it cannot be said that the provisions use the words "deeming" or "deemed to be", rather the wording used is "considered". The SJ had opined that that there is only a limited scope of consideration which is enacted in the form of Explanation till the time the efficacy differences are shown and not the blanket fiction of law which has been enacted. The SJ had further opined that even if the fiction is engrafted under Section 3(d) to treat the Polymorphic version as a same substance, the said treatment has been accorded by the law only for the purposes of applicability of Section 3(d). The said limited fiction nowhere states and can be construed to mean that for all other reasons too including for the purposes of determining the infringement of the patent, the said Polymorphic version B shall be deemed to the same substance.

Implications of DB's Ruling in F. Hoffmann-La Roche Ltd. (Supra) and Need for Greater Clarity

The DB's ruling that the rejection of the patent application for Polymorph B leads to a direct conclusion that there was a lack of sufficient matter to suggest that Polymorph B qualified as a 'new product' for consideration under Section 2(1)(j) for patentability and should therefore be regarded for all practical purposes as the old product itself i.e. Polymorphs A+B appears to mean that salts, esters, etc. would be deemed to be covered by the suit patent and thus any manufacture of these will infringe the original patented product or in other words that the coverage of a patent can be wider than the disclosure made therein.

Some concerns and issues appear to arise in view of the DB's ruling in F. Hoffmann-La Roche Ltd. including particularly regarding the purported dichotomy between coverage and disclosure in a patent which was in fact ruled out by the Hon'ble Supreme Court (SC) in Novartis AG Vs. Union of India [2013 (5) SCALE 12] by specifically holding, inter alia:

"139. The dichotomy that is sought to be drawn between coverage or claim on the one hand and disclosure or enablement or teaching in a patent on the other hand, seems to strike at the very root of the rationale of the law of patent. Under the scheme of patent, a monopoly is granted to a private individual in exchange of the invention being made public so that, at the end of the patent term, the invention may belong to the people at large who may be benefited by it. To say that the coverage in a patent might go much beyond the disclosure thus seem to negate the fundamental rule underlying the grant of patents.......we would like to say that in this country the law of patent, after the introduction of product patent for all kinds of substances in the patent regime, is in its infancy. We certainly do not wish the law of patent in this country to develop on lines where there may be a vast gap between the coverage and the disclosure under the patent; where the scope of the patent is determined not on the intrinsic worth of the invention but by the artful drafting of its claims by skilful lawyers, and where patents are traded as a commodity not for production and marketing of the patented products but to search for someone who may be sued for infringement of the patent."

Some of the apparent concerns and issues that still appear to remain unaddressed or unresolved include - Whether the views taken by the DB in F. Hoffmann-La Roche Ltd. are in conformity with the observations made by the Apex Court in Novartis (Supra)? - For instance, whether DB's view that the purpose of Section 3(d) is to encourage incremental innovation in pharmaceuticals have the same meaning and import as the SC's view in Novartis (Supra) that Section 3(d) does not bar patent protection for all incremental inventions of chemical and pharmaceutical substances; whether claim construction is dependent on the scope of Section 3(d) vis-ŕ-vis the purported improvement to basic patent?; Whether the rejection of the patent application for the derivative like polymorph would ipso facto make the derivative (polymorph) subsumed in the suit patent?; whether interpretation of Section 3(d) which leads to a conclusion that the product being excluded is actually being granted a patent, is contrary to the legislative intent?; and whether Section 3(d) can be utilized as a tool to enhance the ambit of a patent to cover even those forms for which patent applications have either been rejected by the Patent Office or abandoned by the patentee itself?

A Lost Opportunity

Roche vs. Cipla long-standing battle eventually, as expected, reached the SC as Cipla preferred Special Leave Petitions [SLP (C) No. 1677-78 of 2016] against the DB's ruling in F. Hoffmann-La Roche Ltd. (Supra). The SC was finally considering the various questions of law and issues including issues such as the true scope and import of Section 3(d) in the civil appeal. However, in a surprising development, after a series of legal proceedings, the parties have finally settled their disputes. On May 30, 2017, the SJ of the DHC disposed of the suit as well as the counter-claim in terms of the compromise arrived at between the parties and accordingly passed a decree. Finally, on Cipla's request, the SC on June 22, 2017 dismissed the civil appeals as unconditionally withdrawn and accordingly allowed Cipla's application for withdrawal of the appeals.

This development possibly means a lost opportunity to evolve patent jurisprudence further. It is now hoped that the day will come soon when a fitting case involving interpretation of Section 3(d) will reach the SC, allowing jurisprudence on the subject to be revisited and statutory provisions to be interpreted in a manner suited to the true intent behind their promulgation, thereby providing much-needed clarity and the legal certainty on the issues involved.

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
Check to state you have read and
agree to our Terms and Conditions

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.

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 by clicking here .

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.


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.