PTAB

IPR2017-01879

Sanofi-Aventis U.S. LLC v. Immunex Corporation

Log In

1. Case Identification

2. Patent Overview

  • Title: Anti-Interleukin-4 Receptor Antibodies
  • Brief Description: The ’487 patent is directed to antibodies that block the human interleukin-4 receptor (hIL-4R) to inhibit signaling induced by both interleukin-4 (IL-4) and interleukin-13 (IL-13), which are involved in allergic disorders. The patent claims a broad, functionally-defined genus of isolated human antibodies, where the claimed antibodies are defined not by their structure, but by their ability to compete for binding to hIL-4R with a specific "reference antibody" (mAb 12B5).

3. Grounds for Unpatentability

Ground 1: Claims 1-14 and 16-17 are anticipated under 35 U.S.C. § 102(e) by the ’132 Publication.

  • Prior Art Relied Upon: Pluenneke (Application # 2002/0002132), referred to throughout the petition as the "'132 Publication".
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that the ’487 patent is anticipated by the Patent Owner's own prior art. During prosecution of the application leading to the ’487 patent, the Patent Owner expressly disclaimed priority to its three earliest applications, including the application that published as the '132 Publication. Because the '132 Publication has a different inventive entity and an earlier filing date (February 15, 2001) than the ’487 patent’s claimed priority date (May 1, 2001), it qualifies as prior art under §102(e).
    • Petitioner contended that the '132 Publication discloses an antibody, mAb 6-2, which is also one of the six antibodies described in the ’487 patent’s own specification. Petitioner asserted that this prior-art mAb 6-2 anticipates the challenged claims because it inherently possesses all the claimed functional properties. The '132 Publication explicitly describes mAb 6-2 as an isolated, blocking human antibody that inhibits IL-4 and IL-13 activity. The central limitation—competing with the reference antibody mAb 12B5—was argued to be an inherent property of mAb 6-2. Petitioner supported this with new experimental evidence (the Zurawski Declaration) showing that mAb 6-2 strongly competes with mAb 12B5.
    • Dependent claims 2-14 and 16-17 were argued to be anticipated for the same reasons, as the '132 Publication and supporting declaration allegedly show that mAb 6-2 also meets the further functional limitations, including specific binding affinities (claims 8-10), antibody forms (claims 11-14), and suitability for pharmaceutical compositions and kits (claims 16-17).
    • Key Aspects: The anticipation argument is built on the Patent Owner's express priority disclaimer, which converted its own earlier disclosure into citable prior art against its later, broader claims. The argument hinges on proving inherency for a functional claim limitation ("competes with...") using newly generated experimental evidence.

4. Key Claim Construction Positions

  • "human" (Claim 1): Petitioner argued that the broadest reasonable interpretation (BRI) of "human" is "partially or fully human." This position was based on the '487 patent's specification, which states that "[a]ntibodies of the invention include... partially human (preferably fully human) monoclonal antibodies." Petitioner contended this construction is necessary because construing the term to mean only "fully human" would improperly exclude disclosed embodiments, such as chimeric antibodies.
  • "antibody" (Claim 1): Petitioner argued that "antibody" should be given its broad BRI, encompassing "whole antibodies and antigen binding fragments thereof," as defined in the '487 patent's specification and supported by the scope of dependent claims 11-15. This construction was presented to counter any attempt by the Patent Owner to narrow the claims to avoid the prior art disclosure of mAb 6-2.

5. Key Technical Contentions (Beyond Claim Construction)

  • Inherency Proven by Experimental Evidence: The petition's central technical contention was that the mAb 6-2 antibody disclosed in the '132 Publication inherently competes with the '487 patent's reference antibody, mAb 12B5. Petitioner asserted that even though the '132 Publication does not explicitly state this competitive relationship, it is a necessary property of the disclosed mAb 6-2. To prove this inherency, Petitioner relied on experimental data from the Zurawski Declaration, which detailed competition assays showing that mAb 6-2 and mAb 12B5 inhibit each other's binding to hIL-4R by over 90%. Petitioner argued that under established legal precedent, such later-developed experimental evidence is proper to establish what was inherent in a prior art reference.

6. Arguments Regarding Discretionary Denial

  • Not Cumulative with a Related IPR: Petitioner argued that this inter partes review (IPR) should not be discretionarily denied as cumulative of a related proceeding (IPR2017-01129). The earlier IPR challenged the '487 patent's validity based on a different reference (Stevens) and a different theory—that the '487 patent was not entitled to its claimed priority date. This petition, in contrast, presents an alternative challenge that assumes the '487 patent is entitled to its priority date but is anticipated by the Patent Owner's own disclaimed prior art (the '132 Publication). Petitioner also stated that this ground could not have been raised earlier, as the experimental testing required to prove inherency was only recently completed.

7. Relief Requested

  • Petitioner requested institution of an inter partes review and cancellation of claims 1-14 and 16-17 of Patent 8,679,487 as unpatentable.