India: CRISPR Case

Last Updated: 11 June 2019
Article by Dias Michelle Jerry

Regents of the University of California, University of Vienna, Emmanuelle Charpentier, (Appellants) (UC)v. Broad Institute, Inc., Massachusetts Institute of Technology, President and Fellows of Harvard College, (Respondents) (Broad)

This case was decided on 10th September 2018 in the United States Court of Appeal for the Federal Circuit ("FC"). It is an Appeal from the United States Patent and Trademark Office, Patent Trial and Appeal Board.

Facts: CRISPR is an acronym for "Clustered Regularly Interspaced Short Palindromic Repeats." CRISPR is a family of DNA sequences that are used in genetic engineering to edit or alter gene functions of prokaryotes and eukaryotes. There are three components to a CRISPR-Cas9 system. 1. crRNA, 2. tracrRNA and 3. Cas9 protein.

In August 2012, an article ("Jinek 2012") was published by UC researchers which demonstrated the use of isolated elements of the CRISPR-Cas9 system in vitro non-cellular experimental environment. Within a year in February 2013, Broad researchers published an article describing the use of CRISPR-Cas9 in a human cell line. Both parties sought patent protection for their work. Jinek 2012 article did not report the results of experiments using CRISPR-Cas9 in a eukaryotic cell nor did theyrefer to a particular cell type or environment. They used naked nuclear material and Cas9 protein for their experiment. The Broad article on the other hand specifically mentiond the use of eukaryotic cell in their claims.

The UC instituted a suit against Broad for obviousness, and Broad moved to terminate the suit, arguing its claims are patentably distinct from UC's claims.There is no reasonable expectation that the CRISPR-Cas9 system would work successfully in a eukaryotic cell by a person of ordinary skill in the art. The Board (PTAB) determined there was no interference-in-fact because, given the differences between eukaryotic and prokaryotic systems, a person of ordinary skill in the art would not have had a reasonable expectation of success in applying the CRISPR-Cas9 system in eukaryotes. PTAB determined, therefore, that UC's claims to the use of CRISPR-Cas9 did not render obvious Broad's claims to its use in eukaryotes. UC appeals.

Issue: Whether there was interference-in-fact (obviousness) between UC's patent, and the claims of patent owned by the Broad.

Held: There is no interference-in-fact.

Explanation: US follows the first to invent system if there arises a dispute between two patents having similar subject matter. To determine obviousness, the Supreme Court has laid own four tests in the case ofGraham v. John Deere Co., 383 U.S. 1, 17–18 (1966)(1) the scope and content of the prior art; (2) the differences between the claims and the prior art;(3) the level of ordinary skill in the art; and(4) objective considerations of non-obviousness—are questions of fact to be reviewed for substantial evidence.To determine obviousness, it is required that a person of ordinary skill in the art would been couraged to combine or modify the instructions in the prior art and would have had a reasonable expectation of success in doing so. This case had to be decided on substantial evidence standard.

  1. Reasonable Expectation of Success: For obviousness,a rigid test was adopted by the Board that looked for specific instructions in the prior art while ignoring that a person of ordinary skill in the art would use his creativity and inferences to come to a conclusion.
    Response by FC: Only specific instructions in the art would have given one of ordinary skill in the art a reasonable expectation of success.There were failures demonstrated in using Cas9 which indicated the lack of a reasonable expectation of success.
  2. Simultaneous invention: It can be compelling and strong objective of evidence for obviousness because CRISPR-Cas9 was applied within months of UC's publication.
    Response by FC: Evidence of simultaneous invention cannot alone show obviousness, otherwise any claims involved in a conflict would be unpatentable for obviousness.

In addition to this there was also a testimony given by UC's expert Dr Dana Carroll recognizing issues that could arise in attempting to apply the CRISPR-Cas9 system in eukaryotic cells. That CRISPR-Cas9 might be degraded by nucleases in eukaryotic cells. The DNA of eukaryotes is in the form of chromatin coiled around proteins called histones. Targeting the site becomes difficult and even after it does recognise, DNA-RNA hybrid stability is seen as foreign in a normal cell.The efficacy of gene editing through base pairing remains unpromisingly low. Only attempts to apply the system in eukaryotes by conducting experiments will address these concerns.

FC thus decided that, PTAB had performed a thorough analysis of the factual evidence,considered statements by experts for both parties, past failures and successes of using CRISPR-Cas9 in the field, evidence of simultaneous invention, and the extent to which the claims provided specific instructions for applying the CRISPR-Cas9 technology in a new environment. It was concluded that there was no reasonable expectation of success and substantial evidence supports the Board's finding. The Board made no default in its determination that there is no interference-in-fact. The decision of the Board was affirmed by FC.

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