Shire Dev. LLC v. Watson Pharms., Inc.

by Robins Kaplan LLP

Case Name: Shire Dev. LLC v. Watson Pharms., Inc., No. 2013-1409, 2014 U.S. App. LEXIS 5719 (Fed. Cir. Mar. 28, 2014) (Circuit Judges Rader, Prost, and Hughes presiding; Opinion by Hughes, J.) (appeal S.D. Fla., Middlebrooks, J.)

Drug Product and Patent(s)-in-Suit: Lialda® (mesalamine); U.S. Patent No. 6,773,720 (“the ’720 patent”)

Nature of the Case and Issue(s) Presented: 5-aminosalicylic acid, also known as mesalazine or mesalamine, must be formulated so that it can transit the digestive system intact before reaching its target—the large intestine. In order to achieve this objective, mesalamine is formulated into a tablet having hydrophilic properties in its outer layer and a lipophilic layer mixed with the active ingredient in its inner layer. The ’720 patent teaches an inner lipophilic matrix and an outer hydrophilic matrix to address the limitations of the prior art systems.  Shire owns the ’720 patent, and sued Watson for patent infringement after Watson submitted an ANDA seeking FDA approval to manufacture and sell a generic version of Lialda.

The district court construed several disputed claim terms, including “inner lipophilic matrix” and “outer hydrophilic matrix.” After trial, the district court found that Watson’s ANDA product infringed claims 1 and 3 of the ’720 patent, that the claims were not invalid under 35 U.S.C. § 112, ¶ 1, and that Shire was entitled to injunctive relief. The district court found that the mesalamine in Watson’s ANDA product was dispersed in both the lipophilic and hydrophilic matrices because the mesalamine was present in both the granules and the spaces outside the granules. Watson appealed the issues of claim construction, infringement, and invalidity. The Federal Circuit reversed the district court’s claim constructions with regard to the terms “inner lipophilic matrix” and “outer hydrophilic matrix” and also reversed the lower court’s finding of infringement.

Why Watson Prevailed:  The Federal Circuit took issue with the district court’s claim construction. The district court construed the term “inner lipophilic matrix” to mean “a matrix including at least one lipophilic excipient, where the matrix is located within one or more substances,” and the term “outer hydrophilic matrix” to mean “a matrix of at least one hydrophilic excipient, where the matrix is located outside the inner lipophilic matrix.” In doing so, the district court rejected Watson’s argument that the inner matrix and outer matrix must be separate and distinct. The district court acknowledged that the applicants described their matrices as separate to distinguish over the prior art references, but found that nowhere in the prosecution history, claims, or specification did the term “separate and distinct” appear. The Federal Circuit determined that the district court correctly found no prosecution disclaimer because the statements in the prosecution history were not unambiguous disavowals. During prosecution, Shire carefully characterized the prior art as not having separate matrices, but never actually stated that the claimed invention does have separate matrices.

The Federal Circuit concluded that the logical reading of the claim requires separation between the matrices because the matrices are defined by mutually exclusive spatial characteristics—one inner, one outer—and mutually exclusive compositional characteristics—one hydrophilic, one lipophilic. The Federal Circuit found further support that the separation was required based upon the fact that, during prosecution, the applicants added claim limitations citing Markush groups that identified specific hydrophilic and lipophilic components.

Under the construction adopted by the district court, a single mixed matrix with both hydrophilic and lipophilic components could contain both an inner lipophilic matrix and an outer hydrophilic matrix. Indeed, the Federal Circuit concluded, any arbitrarily selected volume in a single mixed matrix could potentially satisfy the district court’s construction of “inner lipophilic matrix” because that volume would necessarily contain “at least one lipophilic excipient” and it would be “inside” the surrounding volume.  Similarly, under the district court’s construction, that same arbitrarily selected volume would constitute an “outer hydrophilic matrix” because it would contain “at least one hydrophilic excipient” and would be “outside” the inner lipophilic matrix. This construction could not be correct, because the claims at issue required two matrices with a defined spatial relationship between them.


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.