India: Finding Escape Routes: Can Your Invention Avoid Or Overcome Section 3 (i ) Of Indian Patents Act : "Method Of Treatment"

Last Updated: 18 April 2017
Article by Preeti Tyagi

Most of the inventions relating to medical device or an implant face the litmus test –"method of treatment" objection during prosecution by Indian Patent Office. More specifically, if the invention is claiming a method which directly or indirectly makes a reference to a medical condition, it becomes difficult to convince the Examiner. However, there are some successful strategies which can be adopted to avoid such situation or to handle the situation in a better way.

Section 3 defines what not inventions within the meaning of the act are and sub section (i) reads as follows:

Section 3(i): "any process for the medicinal surgical curative, prophylactic diagnostic, therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products."

Strategy to handle objection under section 3 (i):-

How to claim method in inventions relating to medical device:-

  1. In the method claims, the terms such as "diagnose an individual", "obtaining test sample from the individual" and " indication that the individual is susceptible to a disease" should be avoided.
  2. Rewording the claim language, for example, in patent application 870/MUM/2007 to receive favourable Controller's decision (Feb 28, 2017), the term "performing" was deleted, a "means for surveying" was replaced by "a surveying coherence optical tomography system for surveying", "means for monitoring and controlling" was replaced by "a surveying controller and an ablating controller acting in a feedback loop for monitoring and controlling". This case has been granted Indian Patent 280777.
  3. Specifying the process to be "in-vitro‟ in claim of the invention. To overcome objection under sections 3(i) in patent application 861/CHE/2007 which was involving isolation of MSCs by negative selection using specific antibody combination viz. Gly-A and CD31, claims have been amended to specify the process to be "in-vitro‟. Specification has been amended to indicate that no embryo or fetus was used or destroyed in the instant application" to overcome objection under section 3(b) - relating to "unethical" invention. Controller's favourable decision came on Feb 6, 2017. This case has been granted Indian Patent 279948.
  4. Method claims in a digital Medical imaging device - Indian Patent 280533 is relating to a system for providing interactive computer aided detection of abnormalities captured in medical images. When the Controller cannot be convinced by Agent's arguments to overcome objection under section 3 (i) on method claims, the agent has made method claim dependent on system claim as " a method of acquiring a medical image, carried out without medication aided by system of claim 1".
  5. Another good example is patent application 5458/DELNP/2006 which is granted as Indian Patent 279332 on January 27, 2017. The examiner has objected to system and method claim relating to sustain release of therapeutically effective amount of the steroid dispersed within biodegradable polymer matrix which is placed in an ocular site or region of an eye under section 3(i). However, the applicant argued that problem to be solved can be seen in the provision of a steroid intraocular implant, having a sustain release of a therapeutically effective amount of steroid from the implant for a time greater than two months. The method claim was presented as "method of making biodegradable intra-ocular implant, comprising the steps of extruding a mixture of steroid & biodegradable polymer to form a biodegradable material that releases drug at a rate effective to sustain release of therapeutically effective amount of the steroid dispersed within biodegradable polymer matrix which is placed in an ocular site or region of an eye".
  6. In the inventions relating to genetic material in a medical device and method, it is advisable that applicant amend claims to recite only the variant form of the known natural sequences, having new substitutions (less than 100 % identity with existing data). BLAST search result for the claimed sequences can be submitted to demonstrate that the claimed sequences are a variant form of the known natural sequences having new substitutions. Claimed specific fragments can be identified by their respective SEQ ID No. Also, source of each of the claimed sequences provided in specification. Accession number of the wild type sequence as well as claimed sequence SEQ ID can be provided. These steps help in convincing the examiner during prosecution of the application.
  7. Directing the invention and method purely for cosmetic purposes. It has been given in recent draft Manual of Patent Practice and Procedure that "application of substances to the body for purely cosmetic purposes is not therapy".

Facing rejection:-

An interesting example is 3321/DELNP/2007 - relating to method for determining if an pancreas isolated from a member of species will be a source of therapeutically useful islets which has been objected under section 3 (i).

In this application, it has been argued that the claimed process does not involve isolation of pancreas and method is carried out on sample, which is isolated pancreas include ischemia time which is defined as the time between initiation of exsanguinations and placement of the pancreas in cold preservative. However, the Controller objected that claims fall within the scope of such clause of section 3(i) of the Patents Act, 1970 as the treatment given to animal during isolation of organ affect the quality of organ as potential donor of islets, such method of treatment of animal increasing the economic value of its organ as donor are not allowable. Further, the Controller has objected that claims fall within the scope of such clause of section 3(b) of the Patents Act, 1970 (relating to morality/ ethical) because pancreas organ has been collected from animal, which were stunned electrically and sample is collected in a manner that Cold ischemia times ranged from 15-20 minutes. Treatment of animal such as electrocution of animals cause very hardship to animal and cause serious prejudice to life to animal and further it is related to trade/commerce in the field of organ trade, and it is against morality. In addition, the Controller has objected that claims fall within the scope of such clause of section 3(k) of the Patents Act, 1970 (relating to Computer/ algorithm) as it is related to evaluation of pancreas biopsies for its suitability for islet isolation by assessing five variables and in each case a score of either +1 or -1 has been assigned to the variable. If more than 15 minutes transpire, a score of -1 was assessed. Thus, present invention is related to scoring method for determining the yield of islets in the isolated pancreas which is a mathematical method, a kind of algorithm for assessing five variables as numerical value has been given as score for phenotypic expression of characteristic of Pancreas biopsies, hence not allowable. This application was rejected under section 3(i), 3(b) and 3(k) of Indian Patents Act.

Most referred decision of the Board of Appeal of the European Patent Office

  1. G 1104 (OJ 2006 334}, has been mostly referred by the agents during prosecution. In G 0001/04 it was stated that an important contribution to diagnoses performed by physicians in private practice and in hospitals was the determination of medical laboratory parameters. Most of these parameters were concentrations of molecules or cells in a body liquid (e.g. blood or urine) and normally determined invitro. The sample (e.g. body fluid) was mixed with the reagents in a reaction vessel, and the detectable change was evaluated by the instrument which belonged to the system. Inventions relating to such in-vitro determination of medical laboratory parameters could in most cases be protected by product claims. But where method claims were appropriate, such methods should neither be excluded from patentability under Article 52(4} EPC, since none of the method steps was carried out on the body. Only if direct interaction with the body made a real difference whether the object of the invention was achieved, should a diagnostic method be regarded as falling within the exclusion under Article 52(4) EPC. Moreover, for the exclusion to operate, the entirety of the diagnostic method had to be practiced on the body. Thus, it is clearly established by the European Patent Office that diagnostic treatment methods performed on the human body are excluded from patentability, however in-vitro assay methods or in-vitro diagnostic methods that is performed on tissue or fluids permanently removed from the body are not excluded from patentability.

    Comparing Article 52(4) EPC provision and Section 3(i) of Indian Patents Act.

    In most of the cases, Indian examiners are allowing method claims where "in-vitro" is specified.

    However, there is no clear distinction of in-vitro or in-vivo diagnostic method in the clause (i) of section 3 of Patents Act, 1970. It is very clearly expressed in the EPC provision on the method practiced on the body of human or animal are only not patentable whereas the provision of clause (i) of section 3 of Patents Act, 1970 states that "any process for the .....diagnostic of human beings...." is not patentable. Therefore, it is strongly advised that along with method claims, system or device claim should be present in patent application. In some cases, technical features of "deleted matter of method claims" have been incorporated as dependent claims on a system.
  2. Decision of Technical Board of Appeal in T383/03 in Europe, in General Hospital Corporation also relied upon by Virulite where the invention related to a method of hair removal from skin region by applying short bursts of light of a selected wavelength to the skin.

    The Board at paragraph 4.1 has held the following:-

    "While the underlying cause of excess hair may be malignancy or endocrinologic diseases, excess hair itself is not harmful and its removal does not treat the underlying cause of unwanted hair, nor is it relevant to the physical health of the treated person, the treatment merely results in an aesthetic improvement of the appearance of the person. The claims are directed to a "cosmetic method" in order to emphasise that the purpose of the claimed method is to improve the aesthetic appearance of the person treated rather than to cure the underlying malady."

    In Virulite, the following two steps were laid down for determining whether a method is a method of treatment or not:-

    1. Whether there is non-insignificant intentional physical intervention
    2. Whether the treatment is suitable or potentially suitable for maintaining or restoring health, the physical integrity, or the physical well being of human beings or animals
    If the response to both the questions is in the affirmative, said method is method of treatment. However, if even one of response is in negative, said method falls outside the exclusion.

Position at Indian Patent Office:

It has been given in recent draft Manual of Indian Patent Practice and Procedure that application of substances to the body for purely cosmetic purposes is not therapy. Therefore, such claims do not fall under section 3(i) of Indian Patents Act.

Conclusion: Inventions relating to medical device or an implant and claiming a method also can avoid objection under section 3 (i) –"method of treatment" during prosecution at Indian Patent Office. There are some successful strategies which can be adopted to avoid such situation or to handle the situation in a better way.

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.

Preeti Tyagi
Similar Articles
Relevancy Powered by MondaqAI
Chadha & Chadha IP
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Chadha & Chadha IP
Related Articles
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
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of

To Use you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

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