PTAB Terminates Interference Involving Revolutionary Gene Modification Technology

by Akin Gump Strauss Hauer & Feld LLP
Contact

Akin Gump Strauss Hauer & Feld LLP

On February 15, 2017, the Patent Trial and Appeal Board (PTAB) terminated a patent interference between the Broad Institute and the University of California, finding the parties’ respective claims to CRISPR-Cas9 systems and methods patentably distinct and therefore not interfering.

CRISPR-Cas9

CRISPR, or clustered regularly interspaced short palindromic repeats, are segments of prokaryotic DNA that combine with small clusters of cas genes (CRISPR-associated system) to form a system capable of alternating the genetic sequence of an organism. In nature, CRISPR-Cas systems protect bacteria against infection by viruses–they are not known to occur naturally in eukaryotes, such as plants and animals. However, one CRISPR-Cas9 system, the CRISPR-Cas9 system, is currently being put to use as a tool to modify specific DNA sequences in the genomes of other organisms, including plants and animals. The system functions by linking a DNA-cutting enzyme to a specific site on a target gene, thereby achieving specific, targeted manipulation of DNA. As a result, the CRISPR-Cas9 system may be used to edit, delete, or repair specific gene sequences. As one example, scientists are using the CRISPR-Cas9 system to create animal models of human diseases. Although research remains in the relatively early stages, potential applications for the CRISPR-Cas9 system run from basic scientific research to clinical applications for humans.

The Interference

On April 13, 2015, the Regents of the University of California, University of Vienna and Emmanuelle Charpentier (collectively, UC) suggested an interference between its patent application and multiple patents issued to Broad Institute, Inc., Massachusetts Institute of Technology, and President and Fellows of Harvard College (collectively, “Broad”). On February 11, 2016, the PTAB declared an interference to determine whether Broad’s and UC’s claims were directed to patentably indistinct subject matter under 35 U.S.C. § 102(g). By way of background, an interference-in-fact does not exist if the claims of either party are patentably distinct. To determine whether an interference-in-fact exists, the PTAB uses a two-way test that considers whether each party’s claims are obvious or anticipated by the other party’s claims. Thus, an interference-in-fact could not exist in this case if UC’s claims, when treated as prior art, fail to anticipate or render obvious Broad’s claims or if Broad’s claims, when treated as prior art, fail to anticipate or render obvious UC’s claims.  

In declaring the interference, the PTAB identified claims of both Broad and UC directed to CRISPR-Cas9 systems and methods. Broad’s involved claims differed from UC’s in one notable respect. All of the Broad claims were limited to methods of systems being used in eukaryotic cells, whereas none of UC’s involved claims were limited to any particular environment.

During the motions phase of the interference, Broad filed a motion arguing that no interference-in-fact existed between the parties’ claims because a skilled artisan would not have reasonably expected the CRISPR-Cas9 systems described in its claims to work based on the broader disclosures of CRISPR-Cas9 systems in the UC claims. In particular, Broad cited to statements from inventors of the UC patents expressing doubts as to whether the CRISPR-Cas9 system would function in eukaryotes. UC responded that its inventors’ statements were merely noting that confirmatory results had not been reported. UC added that its inventors and the prior art established an expectation of success because they predicted the potential to exploit the CRISPR-Cas9 system for RNA-programmable editing.

In its decision on the motion, the PTAB agreed with Broad and held that a person of ordinary skill in the art would have a reasonable expectation of success that the CRISPR-Cas9 system would work in eukaryotes based on UC’s claims alone or in view of the prior art. The PTAB noted that, although the prior art gave a reason to try CRISPR-Cas9 systems in eukaryotic cells, there was no way to discern any expectation that it would work before the results to the actual studies were known. The PTAB also rejected UC’s argument that, because many independent research groups were able to use the CRISPR-Cas9 systems after the UC inventors published their work, those skilled in the art possessed a reasonable expectation of success. Specifically, the PTAB concluded that “[w]e are not persuaded that a scientist’s ‘belief’ in the success of his or her own experiments is necessarily a reasonable expectation of success that indicates obviousness. Were this true, the requirement for a reasonable expectation of success or predictability in the context of subject matter that would have been obvious to try would be rendered meaningless.” The PTAB then turned to the specific disclosures in the prior art and examined whether those disclosures provided instructions relevant to the use of the CRISPR-Cas9 system such that one skilled in the art would reasonably expect that it would work in eukaryotic cells. Upon review of the prior art, the PTAB determined that failures demonstrated in other systems indicated the opposite. Thus, the PTAB held that UC’s claims, if treated as prior art to Broad’s claims, would not anticipate or render Broad’s claims obvious, and that, as a result, there is no interference-in-fact between Broad’s claims and UC’s claims.

Based on its finding of no interference-in-fact, the PTAB terminated the interference without entering judgment against either party’s claims. UC may now appeal the PTAB’s decision to the Federal Circuit.              

Broad Institute Inc. et al. v. the Regents of the University of California, Interference No. 106,048 (PTAB Feb. 15, 2017) (Paper No. 893).

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Akin Gump Strauss Hauer & Feld LLP | Attorney Advertising

Written by:

Akin Gump Strauss Hauer & Feld LLP
Contact
more
less

Akin Gump Strauss Hauer & Feld LLP on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
Privacy Policy (Updated: October 8, 2015):
hide

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.

Security

JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at info@jdsupra.com. In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at: info@jdsupra.com.

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.