Hard to Reverse Adverse PTAB Rulings Under Substantial Evidence Standard

by McDermott Will & Emery
Contact

McDermott Will & Emery

Over a vigorous dissent, the US Court of Appeals for the Federal Circuit affirmed a Patent Trial and Appeal Board (PTAB or Board) decision affirming rejection of all pending claims of a patent as being obvious, as supported by substantial evidence notwithstanding a showing of commercial success. In re: Efthymiopoulos, Case No. 16-1003 (Fed. Cir., Oct. 18, 2016) (Prost, CJ) (Newman, J, dissenting).

The patent application at issue related to methods of treating or preventing influenza by administering the drug zanamivir by oral inhalation. The Examiner, affirmed by the PTAB, rejected all pending claims as obvious, primarily over two prior art references: Von Itzstein II in view of Von Itzstein I.

The Federal Circuit agreed with the PTAB’s conclusion that the pending claims were obvious as supported by substantial evidence. In doing so, the majority opinion noted that Von Itzstein I disclosed the intranasal use of zanamivir to treat and prevent influenza, and that Von Itzstein II disclosed different administration methods, including “inhalation,” for an adjacent homologue of zanamivir to achieve the same result of treating or preventing influenza. Although Von Itzstein II did not teach oral inhalation specifically, the Federal Circuit agreed with the Examiner and PTAB’s conclusion that Von Itzstein II’s disclosure of administration through “inhalation” included oral inhalation. As to secondary considerations of non-obviousness, the Federal Circuit found that the PTAB, after thoroughly considering an expert’s declaration, properly concluded that the claimed method would not necessarily yield an unexpected result.

Judge Newman dissented, stating that zanamivir was a known drug for treatment of influenza administered by nasal inhalation. She disagreed with the majority’s holding that the discovery of effective treatment by oral inhalation was obvious even though it was “not obvious to experts, and not suggested in the prior art.” Judge Newman noted that there was extensive discussion in Von Itzstein II directed to all known forms of oral administration of the product that spanned several pages, but that it lacked any mention or suggestion of oral inhalation. She voiced her concern that it “cannot be ‘obvious to try’ the only form of oral administration that is absent from the Von Itzstein [II] recitations.” Rather, the omission of oral inhalation from this list of “all the ‘known options’ for this drug makes conspicuously clear that oral inhalation was not an ‘identified predictable solution.’” Judge Newman concluded that there was not substantial evidence to support the PTAB’s ruling of obviousness.

 

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.

© McDermott Will & Emery | Attorney Advertising

Written by:

McDermott Will & Emery
Contact
more
less

McDermott Will & Emery 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.