Obviousness Only Requires Reasonable Expectation of Success of One Compound Encompassed by Broad Genus Claims

by McDermott Will & Emery

Addressing the issue of showing a reasonable expectation of success when making obviousness combinations in the context of broad genus claims, the U.S. Court of Appeals for the Federal Circuit reversed a district court’s ruling that the asserted patents were non-obvious, finding that the district court erred by limiting the analysis to one compound covered by the broad claim.   Allergan, Inc. v. Apotex Inc., Case Nos. 13-1245; -1246; -1247; -1249 (Fed. Cir., June 10, 2014) (Prost, C.J.) (Chen, J. dissenting-in-part).

The plaintiff-appellee Allergan has FDA approval to sell Latisse®, an ophthalmic solution used to treat eyelash hair loss by stimulating growth of the eyelashes.  The defendants-appellants are generic drug manufacturers who filed Abbreviated New Drug Applications (ANDAs) seeking FDA approval to market generic versions of Allergan’s Latisse.  Allergan sued defendants for infringement of two patents covering its hair-promoting product.  After the district court found that the defendants infringed the patents and that the patents were not invalid, the generic drug makers appealed.

The Federal Circuit reversed the district court’s obviousness ruling.  The active ingredient in Latisse is bimatoprost, which is a synthetic prostaglandin-F (PGF” analog.  For one of the asserted patents, which claims methods of treating hair loss through administration of a compound selected from the recited genus of PGF analogs, the Federal Circuit found that the claims were invalid in view of a combination of prior art references, one of which disclosed using compounds from a broad class of PGF analogs to promote hair growth.

The district court had concluded that the claims were not obvious based in part on findings that there was no reasonable expectation of success or motivation to use the claimed compounds disclosed in the prior art references to treat hair loss, and also based on evidence of unexpected results achieved with bimatoprost.  These factual findings by the district court were in large part based on evidence that one variant disclosed in the prior art reference would have resulted in a person of ordinary skill in the art not having a reasonable expectation of success of promoting hair growth with that compound.  The Federal Circuit disagreed.

In reaching its decision, the Federal Circuit did not overturn any of the district court’s factual findings, but instead explained that failure to consider the appropriate scope of the patent’s claimed invention in evaluating the reasonable expectation of success and secondary considerations constitutes a legal error that is reviewed without deference.

The patent covered a broad genus of compounds, including but not limited to the variant disclosed in the prior art reference that the district court relied on.  The Federal Circuit stated that the district court failed to make a finding on how the one variant necessarily applied to the reasonable expectation of success for the full scope of the patent’s claimed invention.  Accordingly, the Federal Circuit stated that the district court’s findings were not relevant to the patent’s actual claimed invention.

Furthermore, to establish that the evidence of unexpected results was commensurate in scope with the claims, the district court “needed to have found that other embodiments falling within the claim will behave in the ‘same manner.’” In the absence of such evidence, the district court had not made any factual finding “that would diminish the more probative facts supporting a person of ordinary skill’s substantial reasonable expectation of success and motivation to use PGF analogs” to treat hair loss as claimed in the patent.

Written by:

McDermott Will & Emery

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):

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.


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.