Prometheus Labs., Inc. v. Roxane Labs., Inc. (D.N.J.)

by Robins Kaplan LLP

Case Name: Prometheus Labs, Inc. v. Roxane Labs, Inc., Case Nos. 11-230 (FSH), 11-1241 (FSH), Unpublished (D.N.J. May 21, 2014) (Hochberg, J.)

Drug Product and Patent(s)-in-Suit: Lotronex® (alosetron hydrochloride); U.S. Pat. No. 6,284,770 (“the ’770 patent”)

Nature of the Case and Issue(s) Presented:  Lotronex was initially launched in 2000, but was subsequently removed from the market in light of serious side effects attributed to the drug. It was re-launched in 2002 with a new label. At the time, the ’770 patent was listed in the Orange Book along with U.S. Patent No. 5,360,800 (“the ’800 patent”). In 2005, the ’770 patent was de-listed from the Orange Book. In 2007, Prometheus acquired the Lotronex franchise and initiated a reexamination of the ’770 patent. The USPTO issued the reexamination certificate in 2010. Prometheus re-listed the ’770 patent in the Orange Book.

In December 2010, Roxane submitted its ANDA with a paragraph IV certification to the FDA, and Prometheus filed suit against Roxanne and its API manufacturer. Prometheus asserted three method claims against defendants. The method claims are directed to treating a diarrhea-predominant female irritable bowel syndrome (IBS-D) patient by assessing whether the patient has experienced symptoms for at least six months and administering an effective amount of alosetron. The court identified the following invalidity issues for trial: (i) obviousness; (ii) obviousness-type double patenting; (iii) lack of written description; and (iv) lack of patentable subject matter. After trial, the court issued its findings of fact and conclusions of law finding that the ’770 patent was invalid as obvious and invalid for obviousness-type double patenting in light of the claims of the ’800 patent. The court also found that the patent contained adequate written description and did not lack patentable subject matter.

Why Roxane Prevailed:  The court found the asserted claims obvious because all of the elements were disclosed in the prior art. The prior art disclosed using alosetron to treat IBS, which would include women with IBS-D who had symptoms for more than six months. One reference disclosed that alosetron slowed colonic transit and alleviated pain. The side effects of alosetron were known and a gastroenterologist would be cautious in administering the drug, therefore the six-month symptom duration would have been a substantially expected result. It would have also been obvious to assess patients for at least moderate pain and administer alosetron to treat moderate pain. The court also found that treating female patients as opposed to male patients fails to impart novelty because, first, the prior art would have included women patients, and, second, the patent-in-suit does not affirmatively claim the exclusion of men. The claims do not contain a negative limitation and the Court refused to import one.

The court also found the ’770 patent invalid for obviousness-type double patenting in light of the claims in the ’800 patent. While the ‘800 patent was listed in the Orange Book, it was never considered by the Patent Examiner during the prosecution or the reexamination of the ’770 patent. The court determined that any elements added by the ’770 patent were simply obvious variants of the ’800 patent which every good doctor would execute. The differences between the ’770 patent and the ’800 patent are the relevant population, or object of the method claims, rather than the method itself.

The dispute concerning the written description requirement centered on whether the ’770 patent demonstrated that the inventors possessed “assessing” whether a patient had IBS-D (rather than simply IBS symptoms) for six months or more. Plaintiffs argued that since the reported clinical trials only included patients with diarrhea-predominant IBS or alternating constipation/diarrhea, one of ordinary skill would read this passage as requiring IBS-D symptoms. The parties’ experts disagreed. The court noted that having mixed symptoms (constipated and diarrhea) included in the population muddies the situation. Nonetheless, defendants failed to provide clear and convincing evidence that the description was inadequate.

Finally, the court rejected defendants’ argument that the asserted claim covered unpatentable subject matter. Defendants argued since the claim included assessing whether the patient had symptoms for six months, it was attempted to cover a law of nature. The court was not persuaded because routine activities or mental steps alone would not render the asserted claim unpatentable subject matter.

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.