Allergan, Inc. v. Sandoz Inc.

by Robins Kaplan LLP

Case Name: Allergan, Inc. v. Sandoz Inc., Case No. 11-cv-441, Dkt. No. 136 (E.D. Tex. Jan. 13, 2014) (Schneider, J.)

Drug Product and Patent(s)-in-Suit:  Lumigan® (bimatoprost); U.S. Patents Nos. 7,851,504 (“the ’504 patent”), 8,278,353 (“the ’353 patent”), 8,299,118 (“the ’118 patent”), 8,309,605 (“the ’605 patent”), and 8,339,479 (“the ’479 patent”)

Nature of the Case and Issue(s) Presented:  Allergan asserted patent infringement claims against various defendants for attempting to make and market generic versions of Lumigan. Some defendants argued that their ANDA products would not infringe the patents in suit because those defendants stated in their ANDA that the product’s pH range during its shelf life is 6.8–7.2. The asserted claims of the ’502, ’497, and ’605 patents all require a pH of “about 7.3.”

Defendants also argued that the asserted claims were invalid as obvious in view of the prior art. Allergan, on the other hand, asserted that the prior art taught away from the claimed invention of using 0.01% bimatoprost with 200 ppm benzalkonium chloride. Finally, Allergan argued that that it was entitled to a permanent injunction because it would suffer irreparable harm if defendants were allowed to enter the market with their proposed ANDA products.

The court reached the following conclusions: (i) defendants’ proposed generic drug products infringed Allergan’s patents; (ii) Allergan’s patents are not invalid and are enforceable; and (iii) Allergan was entitled to a permanent injunction preventing defendants from introducing generic versions of Lumigan until the expiration of Allergan’s patents.

Why Allergan Prevailed: The asserted claims were not invalid, because the prior art did not teach the claimed invention. Ophthalmic formulation is a very unpredictable art. The referenced prior art did not suggest that there was a finite number of predictable solutions. Indeed, some of the asserted prior art taught away from the claimed invention. The court found considerable differences between the prior art and the claimed invention. The court further rejected defendants’ argument that it would have been obvious to one of skill to try the claimed invention because of the numerous possibilities available, skepticism in the prior art, and the unpredictability in the art.

Next, the court found that the defendants’ proposed ANDA products infringed the patents in suit. As for some of defendants’ arguments concerning the pH limitation, the court found that pH levels around 7.0 were infringing both literally and under the doctrine of equivalents. The court rejected defendants’ argument that prosecution history estoppel applied because the amendments made during prosecution only tangentially related to the pH limitation.

Finally, the court granted a permanent injunction in favor of Allergan because the irreparable harm to Allergan outweighed the competition in the market that will result should the proposed ANDA products enter the market. The court also reasoned that patent protection was a greater public interest than entry of generics into the market place. 

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.

© Robins Kaplan LLP | Attorney Advertising

Written by:

Robins Kaplan LLP

Robins Kaplan 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):

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 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:

- 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.