Federal Circuit Vacates Infringement of Braintree SUPREP Patent

by Foley & Lardner LLP
Contact

In a divided opinion issued in Braintree Labs., Inc. v. Novel Labs., Inc., the Federal Circuit reversed the district court on one of two challenged claim construction issues and vacated the district court’s finding of infringement to remand for further factual findings. When no judge agrees with the basis of the decision and neither party is satisfied with the outcome, what can we learn from this case?

The Patent at Issue

The patent at issue was Braintree’s U.S. 6,946,149, which is listed in the Orange Book for its SUPREP® Bowel Prep Kit for preparing patients for colonoscopies. Reexamined claim 15 was treated as representative:

A composition for inducing purgation of the colon of a patient, the composition comprising from about 100 mL to about 500 mL of an aqueous hypertonic solution comprising an effective amount of Na2SO4, an effective amount of MgSO4, and an effective amount of K2SO4, wherein the composition does not produce any clinically significant electrolyte shifts and does not include phosphate.

According to the Federal Circuit decision, “Braintree sells SUPREP® in a kit containing two six-ounce bottles of concentrated solution, along with a dilution cup.” To use the product, “[a] patient must dilute each of the two six-ounce bottles with ten ounces of water to form two sixteen-ounce solutions,” each of which has a volume of 473 mL. Thus, Braintree’s theory of infringement (and basis for listing the patent in the Orange Book for SUPREP®) is that one bottle of the two-bottle kit falls within the scope of the claims. The Federal Circuit decision refers to this as the “one bottle” theory of infringement.

The ANDA Litigation

Novel filed an ANDA seeking approval to market a generic version of SUPREP®, and making a paragraph IV certification against the ‘149 patent. In the ensuing ANDA litigation, the district court construed the claims, granted summary judgment of infringement, and upheld the validity of the patent after a bench trial.

The claim construction issues challenged on appeal related to the meaning of “purgation” and the meaning of “clinically significant electrolyte shifts.” While not treated as an independent claim construction issue, the impact of the term “a patient” in the preamble also was important to the infringement issue.

The Federal Circuit Decision

The Federal Circuit decision was authored by Judge Prost. Judge Dyk wrote an opinion concurring-in-part, dissenting-in-part, and concurring in the result, while Judge Moore wrote a dissenting opinion. The judges appear to agree on the claim construction issues, but disagree on infringement and/or the “patient” issue.

“Purgation”

As noted by the Federal Circuit, “[t]he district court construed ‘purgation’ to mean ‘an evacuation of a copious amount of stool from the bowels after oral administration of the solution.’” Novel argued that “purgation” should mean the type of complete “cleansing” required to permit visualization of the colon for a colonoscopy. The Federal Circuit disagreed, focusing on the plain language of the claims and interpreting “inducing purgation” as meaning “inducing diarrhea.”

“clinically significant electrolyte shifts”

As noted by the Federal Circuit, the district court construed “‘clinically significant electrolyte shifts’” to be ‘alterations in blood chemistry that are both outside the normal upper or lower limits of their range and accompanied by or manifested as other untoward effects.’” The Federal Circuit reversed that claim construction, because the specification expressly defined the term as meaning “alterations in blood chemistry that are outside the normal upper or lower limits of their range or other untoward effects.”

Infringement

The Federal Circuit decision vacates the district court’s summary judgment of infringement. Judge Dyk concurred in that result, but believes that Novel established non-infringement as a matter of law because he disagrees with the “one bottle” theory of infringement. In contrast, Judge Moore dissents because she disagrees with Judge Prost’s treatment of the “a patient” language.

The district court considered infringement from two perspectives:

  • does one bottle of SUPREP® induce purgation
  • does one bottle of SUPREP® avoid producing clinically significant electrolyte shifts

Judge Prost affirmed the district court’s decision that one bottle of SUPREP® induces purgation, even though two bottles are required to prepare a patient for a colonoscopy. Judge Dyk disagrees with the “one bottle” theory of infringement because it is inconsistent with the product at issue in the ANDA. That is, because Novel’s ANDA sought approval of a two-bottle product wherein the patient is administered a total volume of 946 mL, it could not infringe a claim reciting “a composition with a volume or 100-500 mL for inducing purgation and a method of using the same.”

Judge Prost vacated the district court’s summary judgment of infringement because there was a genuine issue of material fact as to whether SUPREP® avoids producing clinically significant electrolyte shifts in a patient population. While the district court interpreted the “clinically significant electrolyte shifts” clause in conjunction with the “a patient” referenced in the preamble as requiring that “at least one patient” not experience those effects, Judge Prost interpreted the claim as requiring that “a patient population” not experience those effects. Judge Moore disagrees with the collective view of the side effects clause, and finds that the specification indicates that “clinical significance is measured in an individual patient.” Thus, she would have found the product to infringe even if only one patient out of 100 does not experience clinically significant electrolyte shift.

Non-Infringement in the ANDA Context

In the ANDA context, non-infringement is found if making, using, or selling the proposed generic product for use in accordance with the approved labeling does not infringe the Orange Book listed patent(s). In many cases, generic companies may be able to design around the patents in such a way that the generic product is somewhat different from the approved brand name product. In this case, however, Novel’s proposed product appears to be identical to SUPREP®. Thus, a finding that Novel’s ANDA does not infringe the patent would indicate that the Orange Book listed patent does not, in fact, cover the approved product and so should not have been listed in the Orange Book.

View This Blog

 

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.

© Foley & Lardner LLP | Attorney Advertising

Written by:

Foley & Lardner LLP
Contact
more
less

Foley & Lardner 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.
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.
Feedback? Tell us what you think of the new jdsupra.com!