India: Kit of parts Claims: Indian position

Last Updated: 10 August 2018
Article by DPS Parmar

We normally come across many types of patent claims. A patent kit type claims refers to a claim where the inventor wants to patent the selling of two or more products together in a 'kit' to be combined at the time of use only. Such kits normally come with instruction for use by the end user. These types of claims are useful in any type of business but they are found commonly in biotech, paint and coating industry products. More particularly, in combination therapy cases the invention lies in the finding the enhanced therapeutic benefit of using the combination in a particular manner. In such cases the therapeutic benefits is derived from the synergistic or inter working relationship between the active ingredients in the body. In Indian context common hurdle for patenting combination therapy is Section 3(e), which specifically bars patentability of "a substance obtained by mere admixture" and any process for its preparation. Combination vaccines therapy invariably invite objection from IPO under this clause. However, the existing IPO practice allows a composition therapy claims comprising of known therapeutic components provided that it exhibits synergism. What amounts to synergy in a combination therapy claims lacks a clear statutory definition leaving IPO controllers with lot of discretion to decide patentability issues on a case to case basis.

Combination meaning

Combination drugs are moving fast in the acceptance of particular therapy in the modern medicine. It is likely to move further and further in the direction of combined therapies where special products with flexible methods of administering would be required. If the combination of the two components has been justly acknowledged as inventive in the specification there should no bar to provide the patent protection to such combinations. So long as such a preparation is envisaged as a narrow physical combination of the components or simply a union of mixture just to differentiate the claimed product from a state of the art which may include the a medical kit, collection or package containing the two agents in separate but adjacent form for their known independent applications in medicine, it could be afforded patent protect. This principle has been followed in various patent jurisdictions to climb the hurdle of novelty. Another hurdle that such claims must cross is the requirement of representing a functional unity in the combination.

Kit of Parts claims

Kit-of-parts claims basically relate to a combination product which provides the two actives ingredients together in a package ready for co-administration. As a kit-of-parts of claim it is not essential to establish a true combination in view of the physical separation of the individual components. The mere loose association of known components does not in itself turn them into a functional unity. In a kit type of claims where combination of component is envisaged, a direct interaction between the components is a precondition for the purposive use (cf. e.g. lock and key, match and striking surface, two-component adhesive). Even if components in the claimed combination do not enter into such a direct interaction with each other, the indication of purpose for the combined therapy may re-establish the unity of the product as a functional amalgamation of its two components, if it represents a genuine restriction to the specified application.

Compositions and admixtures : kit type claims

Section 3(e) of the Patents Act 1970 as amended put a bar on patenting the substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance. When we talk about composition in pharmaceutical terms such a composition is characterized as a product (substance). Since composition is not defined in the act we may take its dictionary meaning. According to the Oxford English Dictionary composition refers to "A condition consisting in a combination or union of several things; a combination, aggregate or mixture". According to Le Robert, Dictionnaire Alphabétique et Analogique de la Langue Française "composition" may also have the meaning of "combinaison" - especially in chemistry - or in general terms "assemblage". The combined products intended under section 3(e) for therapeutic, surgical or diagnostic methods also include compositions in which the components are presented side by side and can therefore be applied simultaneously, separately or at intervals to one and the same human or animal body. Since the components referred in section 3(e) cannot attain the advantageous effect according to the invention independently of each other, the joint effect justifies the unity of the combined product. If the applicant is able to justify and substantiate the better or synergistic effect as a result of the limitation by the indication of purpose of the area of protection of the claim under the conditions he would be in a position to remain outside the provision of section 3(e). Even in cases where the components are presented side-by-side and not as a union, subject-matter of kit type claim would fulfill these conditions. Section 3(e) refers to the cases in which substances or compositions already belong to the state of the art. This kind of 'kit type claims' permits particular types of known products to be claimed. However, the IPO is not consistent in taking the view that such claims in accordance with section 3(e) cannot be denied to the applicant even if the product as such is new to some extent when compared with mere admixtures. One must understand that this category of claims can serve as a fall-back position and protects, for example, against the consequences of incidental previous publications of the product even in any other field.

Position in US: Cytostatic therapy case

In this typical kit claim case the applicant claimed kits useful for cytostatic therapy where a combination of oxazaphosporin with sodium salt of 2- mercaptoethane sulphonic acid for simultaneous or sequential use is recommended for relieving pain associated with injecting oxazaphosporin cytostatic agent. It is known that cyclohexylamine salt or a lysine salt cytostatic when injected in a vein gives a severe long-lasting pain. Apparently this pain is due to a specific reaction of the cystostaic agent with sensitive nerve-ending or pain receptors. In US4770870A it was disclosed that "The pain is not the result of a inflammatory tissue reaction. It occurs even with no histologically detectable tissue damage. Surprisingly this pain is prevented by the use, e.g. simultaneously of the compound of formula II, for example 2-mercapto-ethanesulfonic acid in the form of sodium salt or N-acetyl cysteine."    Based on this disclosure the patent was granted to such cytostatic therapy.

Reasons for Rejection of Combination claims in EPO [Cytostatic therapy]

When similar application was filed in EPO [Patent application number 78 101 583.9, it was refused by decision of the Examining Division of the European Patent Office. The patentability of the subject-matter of claims 6 to 10 was acknowledged in the decision, but claims 1 to 5 directed to uses of substances in cytostatic therapy were considered not patentable. Claims 1 was worded as follows:

1. Use of pharmacologically acceptable salts of a mercapto- alkane-sulphonic acid with the general formula HS-alk-SO3H, where alk is a straight-chain or branched alkyl residue with 2 to 6 carbon atoms, in cytostatic therapy with alkylation agents.

This combination therapy claim was initially rejected by EPO examiner on the ground that each component of the preparation was known and their respective pharmaceutical effects were also known. The applicant filed appeal in the EPO board.

Grounds for the appeal [Cytostatic therapy]

  1. The applicant submitted that this invention is of great importance for chemotherapy with oxazaphosphorin cytostatic agents, used frequently in the treatment of cancer. Treatment of patients with such cytostatic agents leads to severe damage to the kidney, urinary passages and bladder, so that as a rule the therapy has to be interrupted or completely terminated.
  2. The Applicant contended that the impugned invention is based on the finding that this damage does not occur when sodium 2-mercapto-ethane-sulphonate is also administered. The detoxicating function of this salt on the oxazaphosphoring metabolites can be observed, for example, when both components, are administrated simultaneously, but it is also beneficial to use these components separately or at intervals.
  3. The claimed product may therefore also contain the kit of the two active ingredients in ampoules for the intravenous injection. In view of this comprehensive, new and indisputably inventive teaching, adequate protection must be claimed for all these variants, at least in the form of product protection."

Reasons for allowing combination claims by EPO Board of appeal

The appeal was heard by the Board of appeal EPO and the Board allowed such combination. The Board observed that although first-mentioned component of the product was known, and the second component was also a known as mucolytic agent but as per the documentary prior art available to the board, the two active ingredients had never been used together for a new joint effect and were unknown as a composition. The active ingredients according to the Board observation are administered preferably at the same time (cf. page 5, lines 14 and 15 of the application) according to the invention do not therefore represent a mere aggregate of known agents, but a new combination with the surprising, valuable property that the severe side-effects to be expected when administering the cytostatic agents are absent as a result of the detoxicating effect of the sodium 2-mercapto-ethane-sulphonate.

The Board further observed that such a preparation would have to be envisaged as a narrow physical combination of the components, i.e. a union of mixture, to differentiate the product from a state of the art which includes the possibility of a medical kit, collection or package containing the two agents in separate but adjacent form for their known independent applications in medicine.

The Board also made it clear that the active ingredients which were administered preferably at the same time according to the invention did not therefore, represent a mere aggregate of known agents, but a new combination with the surprising, valuable property that the severe side-effects to be expected when administering the cytostatic agents were absent as a result of the detoxifying effect of the sodium 2-mercapto-ethane-sulphonate.

Synergism in Indian Context

In the cases where composition of known substances is claimed as a combination kit, the applicant is expected to substantiate it with existence of synergistic results or unexpected /surprising results. Indian patent office practice varies from Controller to Controller. For example the patent 256057 was granted for administering to a patient Calcitonin (anti osteoporosis) followed by Glucocorticoid (anti-inflammatory) for a "Pharmaceutical composition comprising a calcitonin and a pharmaceutically acceptable carrier". This patent was allowed after the applicant amended the claims to a synergistic composition of Calicitonin and Glucorticoid where the two components come into contact with each other only in human body. Even the method claim for preparing the composition by bringing the two compounds into contact with each other at a locus was allowed. But in similar case where composition of combination claim such as " A composition for use in long-term treatment of fibromyalgia and its symptoms in a patient suffering from fibromyalgia comprising milnacipran, or a pharmaceutically acceptable salt thereof, and a second active compound administered adjunctively with the milnacipran "  was denied for the reason that applicant failed disclose or substantiate through examples the synergistic effect  claimed in the reply arguments.[ Cypress Bioscience, Inc. application  3183/DELNP/2008]. It was refused under section 3(e). It seems that one of the principal reasons for refusal of second case was the non-disclosure of the synergistic effect in the specification. However, it does give a hope to patent a new uses for existing medicines provided that they are claimed as synergistic combinations supported by the disclosure of data in the specification.

Need for indication of purpose in a claim

Most of the kit type claims give the preamble as to the purpose of the invention. The applicant is not duty bound to indicate purpose in the claims but such an indication of purpose in claims is technically meaningful if the skilled person is thereby made aware of further, not expressly specified or yet to be specified characteristics of the product, or of additional conditions for a process, which are necessary for the intended use or operability (e.g. a particular selection, quality or inter-relation of the various components). In other words the indication of purpose with physical relevance of the invention to the indication of purpose would provide meaningfulness and clarity to the claim. By contrast, indications for therapeutic use under section 3(e) are necessarily significant and may under certain conditions even provide grounds for the novelty of a known product, without requiring any additional identifiable or verifiable physical characteristics. But cautiously such conditions should restrict the subject-matter appropriately, so that already known applications of the subject-matter are excluded from the claim.


Protection for the combined product as a collection of essential components with a corresponding indication and with reference to joint use, moreover, in the therapeutic field also exceptionally justified by the fact that certain active substances do not necessarily bring about their joint effect at the same time or directly. For example when a combination is taken orally, one component may be absorbed in the stomach, whereas another merely passes into the intestine. The kit-of-parts of the essential components of the combination does not therefore need to appear in molecular or microscopic dimensions according to the inventive teaching. It would not be justified if such advantageous therapeutic combinations for solving the longstanding problem were not included in the patent protection. Modern medicine may move further and further in the direction of combined therapies which require special products with flexible methods of administering. Be aware that the individual components of the combined product in the kit type claims are themselves known for some therapeutic applications. Therefore, these claims, by expressly including the separate presentation of those components, are indeed to be regarded as limited to the joint use of the combined products, so that the individual applications according to the state of the art are excluded. The indication of purpose provided for in section 3 (e) for such products serves this objective, so long as its formulation complies with the other requirements of section such as synergistic effect/ surprising results.

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
Related Topics
Related Articles
Up-coming Events Search
Font Size:
Mondaq on Twitter
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please 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