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.

In association with
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:
  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.
  • Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.
    If you do not want us to provide your name and email address you may opt out by clicking here
    If you do not wish to receive any future announcements of products and services offered by Mondaq you may opt out by clicking here

    Terms & Conditions and Privacy Statement (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

    Use of

    You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


    Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

    The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


    Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

    • To allow you to personalize the Mondaq websites you are visiting.
    • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
    • To produce demographic feedback for our information providers who provide information free for your use.

    Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

    Information Collection and Use

    We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

    We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to with “no disclosure” in the subject heading

    Mondaq News Alerts

    In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


    A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

    Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

    Log Files

    We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


    This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

    Surveys & Contests

    From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


    If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


    From time to time Mondaq may send you emails promoting Mondaq services including new services. You may opt out of receiving such emails by clicking below.

    *** If you do not wish to receive any future announcements of services offered by Mondaq you may opt out by clicking here .


    This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to

    Correcting/Updating Personal Information

    If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to

    Notification of Changes

    If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

    How to contact Mondaq

    You can contact us with comments or queries at

    If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at and we will use commercially reasonable efforts to determine and correct the problem promptly.

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