India: Non-Obviousness/Inventive-Step –The Essential Requirement For Biotechnology Patent Prosecution


Patent protection plays a crucial role on which the biotechnology industry's tremendous investment in research and development as well as its growth rests. The biotechnological inventions majorly includes products and/or processes of gene engineering technologies, methods of isolation of micro-organisms from culture medium, methods of mutation, cultures, mutants, transformants, plasmids, processes for making monoclonal antibodies, etc.,1 Often, the focus is laid on controversial issues surrounding biotechnology patenting such as criteria for patenting plants and animals, the patenting of gene sequences and related morality issues. Contrary to the aforesaid issues, majority of biotechnology patent applications will be decided on serious issues of patent system such as novelty, inventive step and industrial application as well as the sufficiency of disclosure and support of the description to the claims.

Obviousness, or lack of inventive development, is a ground for rejecting a claim during patent prosecution or for invalidating the claim in patent infringement litigation. An invention is unpatentable because the differences between the claim and the prior art should have been obvious at the time of invention to a person of ordinary skill in the realm of that art.


Section 2(1)(ja) : "inventive step" means a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art.

Inventive step is defined as the step that makes an invention new and unique. However, there is always a never-ending debate on what exactly comprises an inventive step.

Consider the case of an isolated purified form of a protein which is not obvious if it is otherwise identical to the naturally occurring protein that is already known. The courts resorted to the traditional approach of comparing what is claimed with the prior art. In another example, if a protein is already known, but what is claimed in an invention is a gene and the gene has been isolated and purified. Such a gene clears novelty but it is difficult to assess the obviousness/inventivestep owing to the fact that a particular gene having a particular nucleotide sequence exists in principle but whether it would be obvious to one skilled in the art to identify and isolate the aforesaid gene is another hurdle.

It was held in In re Bell case that "it may be true that knowing the structure of the protein, one can use the genetic code to hypothesize possible structures for the corresponding gene and that one has the potential for obtaining that gene"2, nevertheless the degeneracy of the genetic code is such that there are more than 1036 different possible nucleotide sequences in a gene that might code for a protein. Therefore, unless there is something in prior art that would suggest a researcher a particular gene in question, isolation and purification of nucleotide sequences are not obvious and may be patented as opposed to the mere hypothesis of existence of numerous nucleotide sequences that might possible encode the particular protein. Though the process for looking for the right nucleotide sequence might be known, it is not obvious to choose the right sequence from the entire human genome.

The draft guidelines issued by the Indian Patent Office, mandates to the examiner to design a comprehensive search strategy by combining various search parameters including key words, IPC, sequences etc and thorough search should be carried out in patent as well as non patent literature. The following are some of the illustrative examples mentioned in the aforesaid guidelines for assessing non-obviousness/inventive criteria of biotechnology based inventions.


It is noteworthy to analyze few examples in order to establish non-obviousness of biotechnological inventions through prior art.

Let us consider the claim of an invention as follows as an example:

"An isolated DNA sequence encoding a mature human IL-3 protein having a proline residue at position 8 of the mature polypeptide, said protein processing bone proliferation-inducing activity in a human bone marrow proliferation assay. It was mentioned that the difference with prior art is that the claimed compound at position 8, there was a proline moiety whereas in the prior art compound in the same position there was a serine molecule. When analyzed by the Controller it was found that the single variation in the amino acid sequence does not normally change the activity and function of the protein unless such change is in a critical region of the protein. Since the Applicant could not provide any evidence that the protein coded by the claimed DNA was different from that of the prior art in its chemical properties inventive step was not acknowledged.


Let us consider the claim of an invention as follows as an example,

"An improved process for the production of galactooligosaccharides (GOS) of high yield and purity comprising the steps of: (i) isolating Bullera singularis and Saccharomyces sp. (ii) immobilizing the B. Singularis and Saccharomyces sp; (iii) hydrolysis of lactose by the immobilized microbial cells, said reaction being carried out until galactose content being at least 65 % and (iv) optionally concentrating the galactooligosaccharides solution. "

The prior art document D1 disclosed a process for the production of galactic-oligosaccharides from lactose using immobilized B.Singularis cells. D2 disclosed the use of Saccharomyces sp. for the production of galactooligosaccharides from lactose. It further disclosed that Saccharomyces sp. uses lactose as a carbon source & approximately it removes 92% of glucose from the GOS mixture by fermentation without losing the GOS content. It was analyzed by the Controller that since it is evident from D2 that Saccharomyces sp. consume glucose, one of ordinary person skilled in the art would be motivated to use Saccharomyces sp. in combination with B. singularis to solve the problem of separation of saccharides and also, reducing the competitive inhibition of beta-galactosidase enzyme by glucose, which leading to high yield & purity of GOS. Thus, the claimed subject-matter lacks inventive step.


It was mentioned in the guidelines that if the claimed invention relates to a polynucleotide/polypeptide having mutation(s) in a known sequence of polynucleotide/ polypeptide, which does not result in an unexpected property whatsoever, then the claimed subject-matter lacks inventive step.

In another invention it was claimed for "Pro-insulin having a C-peptide encompassing only two amino acids selected from Arg-Lys, Lys-Lys and Lys-Arg*". It is known that Human Pro-insulin is comprised of three chains, A, B and C, in the insulin the two chains are combined eliminating the third chain, i.e. the C–chain consisting of thirty amino acids). Further the Prior art discloses natural Pro-insulin having 30 amino acids C-peptide, Pro-insulin with C-peptide as short as two amino acids (Arg-Arg)

It was held by the Controller that the claim was prima facie obvious. Though the applicant argued that the yield of claimed Pro-insulin having a C-peptide expressed in yeast is 1.6 to 2.0 mmol/l whereas the yield of the prior art Pro-insulin with a C-chain of Arg- Arg is only 1.0 mmol/l such a difference in change did not constitute 'unexpected property' and hence, the subject-matter was held to be obvious.

In another example of an invention, it was claimed for 'A recombinant DNA sequence of SEQ ID NO: X encoding human interferon α2 polypeptide'. It is known from prior art the existence of a nucleic acid sequence of SEQ ID NO: X1 encoding human interferon α1 polypeptide. After thorough analysis it was held by the controller that although the claimed human interferon α2 is structurally close to the prior art's human interferon α1, the alleged invention was non-obvious as the claimed human interferon is thirty times more potent in its antiviral activity than its prior art analogue.


From the above analyzed examples, two things are obvious,

  • that Indian Patent office deals with a great number of patent applications in order to determine whether or not an inventive step exists or not.
  • that there are number of different factors involved in deciding whether or not an invention is obvious.

The amount of clarity we achieve in this issue plays a vital role in determining whether a patent application will proceed to grant or whether a patent application will be rejected or a patent in suit will be declared invalid.


1. Guidelines For Examination of Biotechnology Applications For Patent, Office of The Controller General of Patents, Designs and Trade Marks, March 2013; available from   ,


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.

Similar Articles
Relevancy Powered by MondaqAI
Intepat IP Services Pvt Ltd
S.S. Rana & Co. Advocates
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Intepat IP Services Pvt Ltd
S.S. Rana & Co. Advocates
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