Sanofi-Aventis v. Pfizer Inc. (Fed. Cir. 2013)

by McDonnell Boehnen Hulbert & Berghoff LLP
Contact

Sanofi-AventisLast week, in Sanofi-Aventis v. Pfizer Inc., the Federal Circuit affirmed an award of priority to Pfizer by the Board of Patent Appeals and Interferences in an interference involving the cDNA for the human interleukin-13 receptor binding chain (IL-13bc).  In particular, the appeal concerned the Board's decision with respect to the following count:

Count 3.  The isolated protein of 6,268,480 claim 4;

OR

The isolated polynucleotide of 5,710,023 claim 1, selection (b) (an isolated polynucleotide comprising a nucleotide sequence of SEQ ID NO:3 from nucleotide 103 to nucleotide 1242).

PfizerAs the Federal Circuit noted, the parties disagreed as to the dispositive question in the interference, with Pfizer arguing that the question was "who first had in hand the actual isolated DNA of the count and appreciated its IL-13bc function," and Sanofi arguing that the question was "the date each party first knew the complete sequence" of nucleotides 103 to 1242 (i.e., the protein encoding portion of IL-13bc).  In the interference, Sanofi was awarded the benefit of its December 6, 1995 priority date, and Pfizer presented evidence that by October 16, 1995, it had isolated a clone for human IL-13bc from a human cDNA library.  While the sequencing of that human IL-13bc clone was completed by November 15, 1995, eight possible errors were subsequently identified in the 1143-nucleotide sequence, yielding an amino acid sequence that was correct at 379 of 380 residues.  Although the Board concluded that Pfizer did not have a corrected sequence until February 7, 1996, it nevertheless determined that Pfizer had established conception of the subject matter of the count when it selected, isolated, and obtained the desired IL-13bc full-length polynucleotide and verified that it was the desired product, regardless of whether the fully correct sequencing of the polynucleotide was complete.

On appeal, Sanofi argued that by awarding priority to Pfizer, the Board had erred as a matter of law.  In particular, Sanofi argued that Pfizer cannot be credited with conception before December 6, 1995 (Sanofi's date) because Pfizer's sequence analysis was in error as to eight nucleotides.  In other words, Sanofi contended that until Pfizer had correctly analyzed the polynucleotide, neither conception nor reduction to practice could occur, because Federal Circuit precedent requires the full and correct nucleotide sequence to establish conception and reduction to practice.  In support of its argument, Sanofi pointed to Amgen Inc. v Chugai Pharmaceutical Co., 927 F.2d 1200 (Fed. Cir. 1991), Fiers v. Revel, 984 F.2d 1164 (Fed. Cir. 1993), and Burroughs Wellcome Co. v. Barr Laboratories, Inc., 40 F.3d 1223 (Fed. Cir. 1994).

In affirming the Board's award of priority to Pfizer, the Federal Circuit indicated that Amgen did not support Sanofi's argument that Pfizer did not, as a matter of law, have a complete conception until Pfizer had the full correct nucleotide sequence.  Instead, "[t]he court in Amgen held that when 'an inventor is unable to envision the detailed constitution of a gene' there may nonetheless be conception and reduction to practice of the gene when the inventor is in possession of the gene and a method for its preparation, i.e. 'after the gene has been isolated,' accompanied by knowledge of 'other characteristics sufficient to distinguish it from other genes.'"  In this case, "[t]he Pfizer activity meets these criteria."  With respect to Fiers, which Sanofi argued established a per se rule that conception of an isolated DNA requires the full and correct nucleotide sequence, the Federal Circuit noted that "[t]he Board distinguished Fiers and Amgen as holding that conception and reduction to practice did not occur until the gene was isolated, for in those cases neither structure nor definitive properties had been established for the isolated gene," and indicated that "Amgen and Fiers did not hold, as Sanofi asserts, that conception requires the complete and correct sequencing of the isolated DNA; the court instead referred to 'whatever characteristics sufficiently distinguish it.'"  With respect to Sanofi's citation of Burroughs Wellcome, the Court stated that this case "did not change these requirements, in holding that conception requires that the claimed DNA is possessed as a physical embodiment," adding that "[k]nowledge of the specific nucleotide sequence was not required in Burroughs Wellcome."

The Federal Circuit explained that its "[p]recedent illustrates a variety of circumstances in which this requirement was met although the complete nucleotide sequence was not known," citing Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956 (Fed. Cir. 2002) (upholding claims for DNA probes that were made available by deposit in a public depository although the nucleotide sequence had not been determined); University of New Mexico v. Knight, 321 F.3d 1111 (Fed. Cir. 2003) (explaining that "a chemical structure is simply a means of describing a compound; it is not the invention itself"); and In re Wallach, 378 F.3d 1330 (Fed. Cir. 2004) (finding that the inventors were in possession of a protein that was described by a partial amino acid sequence in addition to other characteristics sufficient to identify it).  Stating that "[w]hen the subject matter is a DNA segment, conception requires possession and appreciation of the DNA segment that is claimed," the Federal Circuit concluded that "the Board correctly based conception and reduction to practice on the possession of the isolated DNA segment that was shown to have the desired properties."  The Court therefore concluded that the Board had applied the correct law, and affirmed the Board's award of priority to Pfizer.

Sanofi-Aventis v. Pfizer Inc. (Fed. Cir. 2013)
Panel: Circuit Judges Newman and Lourie and District Judge Davis, sitting by designation
Opinion by Circuit Judge Newman

 

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.

© McDonnell Boehnen Hulbert & Berghoff LLP | Attorney Advertising

Written by:

McDonnell Boehnen Hulbert & Berghoff LLP
Contact
more
less

McDonnell Boehnen Hulbert & Berghoff 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.