Shire LLC v. Amneal Pharms., LLC (D.N.J.)

by Robins Kaplan LLP
Contact

Case Name: Shire LLC v. Amneal Pharms., LLC, Case No. 11-3781 (SRC), 2014 U.S. Dist. LEXIS 85369 (D.N.J. June 23, 2014) (Chesler, J.)

Drug Product and Patent(s)-in-Suit: Vyvanse® (lisdexamfetamine dimesylate); U.S. Patent Nos. 7,105,486 (“the ’486 patent); 7,659,253 (“the ’253 patent); 7,659,254 (“the ’254 patent”); 7,671,031 (“the ’031 patent”); 7,678,770 (“the ’770 patent); 7,662,787 (“the ’787 patent”); 7,662,788 (“the ’788 patent”); 7,713,936 (“the ’936 patent”); 7,671,030 (“the ’030 patent”); 7,674,774 (“the ’774 patent”); 7,687,467 (“the ’467 patent”); 7,723,305 (“the ’305 patent”); 7,718,619 (“the ’619 patent”); and 7,678,771 (“the ’771 patent”)

Nature of the Case and Issue(s) Presented:  The defendants include generic ANDA applicants (the “generic defendants”) and the API manufacturer, Johnson Matthey, Inc. and Johnson Matthey Pharmaceutical Materials (collectively “JM”). Six summary judgment motions were filed with the court concerning a smaller subset of 400 claims and 18 patents-in-suit: (i) generic defendants’ motion for partial summary judgment of anticipation for claims 1, 2, and 5 of the ’787 patent; (ii) generic defendants’ motion for partial summary judgment of non-infringement; (iii) generic defendants’ motion for partial summary judgment of invalidity under 35 U.S.C. §101; (iv) generic defendants’ motion for partial summary judgment of no willful infringement; (v) JM’s motion for partial summary judgment of no indirect infringement; and (vi) plaintiffs’ motion for summary judgment that the asserted claims of the ’630, ’787, ’253, and ’486 patents are infringed and not invalid. The court granted the motions in part and denied the motions-in-part.

Why Plaintiffs Prevailed:  The court determined that the defendants infringed at least four of the 18 patents-in-suit; namely, the ’630, ’787, ’253, and ’486 patents. Plaintiffs asserted compound claims for the ’630, ’787, and ’253 patents. The parties did not dispute that generic defendants directly infringe the compound claims if the patents were valid. However, the court determined that JM did not directly infringe those compound patents because the safe harbor provision 35 U.S.C. §271(e)(1) exempts its activity from infringement. The asserted claim of the ‘486 patent was a method claim. The court found that the generic defendants induced infringement of the method claim because plaintiffs pointed to sufficient evidence in the generic defendants’ proposed ANDA label. The generic defendants did not address plaintiffs’ evidence in its opposition brief.  The court also found that JM induced infringement of the ’486 patent. Defendants argued that Plaintiffs failed to address the specific intent or knowledge requirement of inducing infringement. The court determined that plaintiffs offered sufficient evidence and that defendants failed to point to any record evidence that raised any genuine issue of fact.

The court also determined that the ’630, ’787, ’253, and ’486 patents were valid. Defendants argued that the compound patents were anticipated by an Australian patent application, despite not explicitly disclosing the compound lisdexamfetamine dimesylate. Rather, defendants pointed to a passage that listed a variety of amino acid amides and salts. Defendants argued that the phrase “and the like” at the end of that passage limited the class of potential compounds to 20 or fewer. The court determined that this genus could not anticipate the species since defendants did not point to any evidence that one of ordinary skill would understand the genus recited in the passage would include the claimed compound. The court also rejected defendants’ argument that, based on Wm. Wrigley, Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356 (Fed. Cir. 2012), multiple disclosures in the same reference may be combined to be an anticipatory disclosure. Defendants argued that the Australian application disclosed protected lisdexamfetamine and how to deprotect the compound. As an initial matter, the court disagreed with the defendants’ application of Wrigley. Moreover, combining formula ingredients as in Wrigley is not analogous to combining a compound with a technique.

The court also rejected defendants’ obviousness argument that the court was not required to apply a lead compound obviousness inquiry, but rather should focus on the rationale for modifications and a reasonable expectation of success. The court rejected this approach because defendants could not show that lisdexamfetamine or its salts were known in the art. The court found that defendants did not identify a lead compound and that its obviousness argument was an “obvious to try” theory. The court also found that defendants never explained how the disclosed amino acids in the Australian patent application were a finite number of predictable solutions. With respect to the method claim of the ’486 patent, the court determined that defendants failed to provide any evidence except conclusory statements by its own experts. Thus, the court found that the ’486 patent was not invalid.

The court also denied defendants’ motion that claims 1, 2, and 5 of the ’787 patent are invalid as anticipated. After the defendants filed their motion, the parties stipulated to dismissal of the claims, thereby depriving the court of jurisdiction.

Defendants also moved for summary judgment of no direct or indirect infringement of the method claims of the ’486, ’253, ’254, ’031, ’770, ’788, ’936, ’030, ’774, ’467, ’305, ’619, and ’771 patents. Plaintiffs asserted that the complaint did not include any direct infringement claim. But defendants disagreed. The court dismissed any direct infringement claims with prejudice. With respect to inducement, defendants argued that their proposed labels do not: (i) require administration with food; (ii) require the use of various rating scales; and (ii) relate to abuse resistance. The court agreed with defendants, since the proposed labeling: (i) indicated that the drug may be taken with or without food; (ii) did not instruct the use of rating scales; and (iii) did not indicate that abuse resistance was an FDA-approved use.

The court also rejected defendants’ motion under 35 U.S.C. §101. Defendants argued that the claims were unpatentable since they included pharmacokinetic properties. The court rejected this argument because the claims were composition claims, not method claims, and thus, were not claiming processes that apply a law of nature.

The court also found that defendants did not willfully infringe the patents. This is a typical Hatch-Waxman case and plaintiffs could not point to any evidence of misconduct to justify an exceptional case.

Finally, the court rejected JM’s argument that it did not indirectly infringed the patents-in-suit. The court found that plaintiffs’ theory legally viable. Plaintiffs assert that JM induced infringement by inducing the filing of an ANDA as the applicant’s manufacturer/supplier.

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
Contact
more
less

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):
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.