Pfizer Inc. et. al v. Teva Pharmaceuticals USA, Inc. et al. (Fed Cir)

by Robins Kaplan LLP

Case Name: Pfizer Inc. et. al v. Teva Pharmaceuticals USA, Inc. et al., Civ. Nos. 2012-1576, 2012-1601, 2012-1602, 2012-1603, 2012-1604, 2012-1605, 2012-1607, 2014 U.S. App. LEXIS 2242 (Fed. Cir. February 6, 2014) (Circuit Judges Rader, Prost and Moore presiding; Opinion by Prost) (Appeal from D. Del., Sleet, J.) (Affirming construction of the term “4-amino-3-(2-methylpropyl) butanoic acid,” judgment of non-infringement based on that construction and validity of the patents.)

Drug Product and Patent(s)-in-Suit: Lyrica® (pregabalin); U.S. Pat. No. 6,197,819 (“the ’819 patent”) and U.S. Reissue Patent No. 41,920 (“RE ’920 patent”)

Nature of the Case and Issue(s) Presented: Appellants challenged the district court’s claim construction of “4-amino-3-(2-methylpropyl) butanoic acid” and its finding that the patent was valid. The district court construed “4-amino-3-(2-methylpropyl) butanoic acid” to mean “the chemical compound 4-amino-3-(2-methylpropyl) butanoic acid” without limitation as to the stereochemical form.” Appellants argued that the district court erred in this construction by not limiting it only to the racemic mixture. Appellants stated that the specification, prosecution history, and applicant declarations supported a narrower construction. The Court rejected Appellants arguments because the plain language supports the broader reading and, while the specification only reported results of the racemate, there was no clear disavowal of claim scope. Appellant also challenged the district court’s findings that the patent was enabled, contained adequate written description and was nonobvious.  Appellant argued that the patent was not enabled since it did not disclose how to prepare every conceivable mixture of 4-amino-3-(2-methylpropyl) butanoic acid. The Court rejected this argument finding that methods for preparing or isolating enantiomers were well known in the art. Appellant also argued that the claims lacked written description support because the inventors failed to sufficiently describe the separating the racemate into its enantiomers. The Court rejected this argument affirming the district court’s finding that there was adequate disclosure, since the patent disclosed the structure of the compound, in vitro and in vivo data for the compound, and described a method of synthesizing the compound. The patentee was not required to reduce the practice every species of a genus claim. Finally, Appellant challenged the district court determination that the patent was not obvious. Appellants argued that the district court erred in failing to find (1) that the prior art taught that 3-isopropylGABA and other homologues had anticonvulsant activity; (2) that one of ordinary skill in the art would have expected 4-amino-3-(2-methylpropyl) butanoic acid to have anticonvulsant activity due to structural similarity to 2-isopropylGABA; and (3) gabapentin, another 3-alkylGABA compound would have provided motivation to try other alkyl substitutes at GABA’s 3-position.  The Court rejected Appellants arguments stating that Appellants obviousness evidence was too sparse.

Why Appellees Prevailed:  Appellee prevailed on infringement because the Court found no clear disavowal of claim scope regarding 4-amino-3-(2-methylpropyl) butanoic acid. The Court affirmed the claim construction because while the specification only discussed the racemate, there was no disavowal of other enantiomers. With respect to Appellants’ lack of enablement and written description arguments, the Court’s decision rested on the finding that one of ordinary skill in the art would understand how to separate enantiomers and the patentee is not required to disclose each and every permutation of the claims. Finally, on obviousness, Appellants failed to put forth sufficient evidence. To invalidate a compound patent, the court must identify a lead compound and find that the prior art would teach one of ordinary skill in the art to make “specific molecular modifications” to the lead compound with a reasonable expectation of success. According to the Court, Appellants did not adequately identify a lead compound and that the record only contains scant evidence that either gabapentin or 3-isopropylGABA would have been selected as a lead compound. Appellants also failed to identify teachings that would lead one of ordinary skill in the art to make “specific molecular modifications.” The prior art references disclosed trillions of compounds without calling out specific alkyl groups or singling out the isobutyl group. Furthermore, the prior art precluded any finding of a reasonable expectation of success since anticonvulsant drug discovery at the time of filing was “complicated,” “unpredictable” and “largely conducted through trial and error.”


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.