During the week of February 11, the Patent Trial and Appeal Board (“the Board”) issued several decisions in TC 1600, including two final written decisions in inter partes reviews (“IPR”).  Summaries of the final written decisions follow.

Sanofi-Aventis U.S. LLC, Genzyme Corp., and Regeneron Pharmaceuticals (collectively referred to as “Sanofi”) v. Immunex Corp. (“Immunex”), IPR2017-01879 (Final Written Decision Entered February 14, 2019).

In its petition, Sanofi challenged claims 1-14, 16, and 17 of U.S. Patent No. 8,679,487 (“the ’487 patent”), which is directed to compositions and methods for treating medical conditions induced by interleukin-4 (“IL-4”) by administering an IL-4 antagonist.

Independent claim 1 is representative and recites:

An isolated human antibody that competes with a reference antibody for binding to human IL-4 interleukin-4 (IL-4) receptor, wherein the light chain of said reference antibody comprises the amino acid sequence of SEQ ID NO:10 and the heavy chain of said reference antibody comprises the amino acid sequence of SEQ ID NO:12.

Sanofi challenged the claims on one ground of anticipation under 35 U.S.C. § 102(e) by U.S. Patent Application Publication No. 2002/0002132 (“the ’132 publication”).  Although the ’132 publication is in the same family as the challenged ’487 patent, a continuation-in-part, Immunex expressly disclaimed priority to the ’132 publication during prosecution of the ’487 patent.  Immunex further argued that the ’132 publication was not work “by another,” as required to qualify as prior art under § 102(e) and did not enable one of skill in the art to make the claimed antibody.

As rebuttal evidence that the portions of the ’132 publication relied upon by Sanofi represented solely the work of the ’487 patent inventors, Immunex submitted inventor and corroborating witness declarations along with contemporaneous meeting minutes prepared after monthly group meetings.  The Board considered the rebuttal evidence and found that Immunex had satisfied its burden of production to show the ’132 publication does not constitute prior art under § 102(e).  The Board then determined that Sanofi failed to establish that Immunex’s evidence was conclusory and lacked credible corroboration by contemporaneous documentary evidence.

As such, the Board concluded that Sanofi did not demonstrate by preponderance of the evidence that claims 1-14, 16, and 17 of the ’487 patent were unpatentable.

Sanofi-Aventis U.S. LLC, Genzyme Corp., and Regeneron Pharmaceuticals (collectively referred to as “Sanofi”) v. Immunex Corporation (“Immunex”), IPR2017-01884 (Final Written Decision Entered February 14, 2019).

In its petition, Sanofi challenged claims 1-17 U.S. Patent No. 8,679,487 (“the ’487 patent”).  The disclosure of the ’487 patent is summarized above.

During claim construction, Immunex argued the term “human antibody” should be limited to “fully human antibodies.”  The Board rejected this construction and held that the broadest reasonable interpretation of “human antibody” consistent with the specification included partially human antibodies, e.g. humanized antibodies.  In support of its construction, the Board cited several references in the specification to the antibodies of the invention that included both partially and fully human monoclonal antibodies.  The Board rejected Immunex’s contention that in one of these instances a reference to “the antibodies” being partially or completely human referred only to the specific IL-4R antibodies recited earlier in the paragraph, stating that it was improper to construe the sentence in a way that contradicted the specification as a whole.  The Board also pointed to several instances where the specification clarified that certain human antibodies were fully human, noting that the specification would not need to state this if all human antibodies were necessarily fully human.  The Board rejected Immunex’s argument that amendments made during prosecution supported its proffered construction because the cited prosecution history was “equivocal, at best” and there was no “clear and unmistakable” disclaimer, particularly in view of Immunex’s failure to correct the Examiner’s consistent characterization of the claims as drawn to an “isolated antibody…that is a human antibody…wherein the antibody is humanized.” The Board also found that expert testimony offered by Immunex on claim construction was not persuasive because “[t]he specification is ‘the single best guide to the meaning of a disputed term,’ and ‘[u]sually, it is dispositive,’” and that the district court judge’s differing claim construction in a parallel proceeding was not controlling in the IPR proceeding “based on the broader applicable case law here.”

The claims were challenged on two grounds of obviousness under 35 U.S.C. § 103 (pre-AIA).  The cited references taught use of a murine anti-human-IL-4 antibody (referred to as “MAb230”) and that non-human antibodies could be humanized.  In view of the cited references, the Board held that one of skill in the art would have been motivated to humanize mouse antibodies for use in treating allergic disorders and that it would have been obvious to modify the cited references to arrive at the claimed invention.  Immunex attempted to establish that Sanofi improperly relied on hindsight to present an oversimplified view of the art and ignored the wide range of potential strategies to alter IL-4 signaling.  However, the Board was not persuaded by Immunex’s argument that potential side effects would have deterred one of skill in the art from developing a way to overcome those side effects and further held that Immunex failed to demonstrate the cited references taught away from humanizing the claimed antibody.

In response to Immunex’s “no reasonable expectation of success” argument, the Board relied on several of Immunex’s statements during prosecution of a related application, which the Board found consistent with the cited references in teaching that one of skill in the art would have believed a humanized antibody may have therapeutic potential.  The Board further noted that Immunex did not separately present any secondary considerations to rebut a finding of a prima facie case of obviousness.

As such, the Board concluded that Sanofi demonstrated by a preponderance of the evidence that claims 1-17 of the ’487 patent were unpatentable.