United States District Court, D. Delaware
AMGEN INC., AMGEN MANUFACTURING, LTD, and AMGEN USA INC., Plaintiffs;
SANOFI, SANOFI-AVENTIS U.S. LLC, AVENTISUB LLC, f/d/b/a AVENTIS PHARMACEUTICALS INC., and REGENERON PHARMACEUTICALS, INC., Defendants.
Melanie K. Sharp, James L. Higgins, and Michelle M.
Ovanesian, YOUNG CONAWAY STARGATT & TAYLOR, LLP,
Wilmington, DE; William G. Gaede III, MCDERMOTT WILL &
EMERY LLP, Menlo Park, CA; Sarah C. Columbia and K. Nicole
Clouse, MCDERMOTT WILL & EMERY LLP, Boston, MA; Rebecca
Harker Duttry, MCDERMOTT WILL & EMERY LLP, Washington,
D.C.; Christopher B. Mead, LONDON & MEAD, Washington,
D.C.; Keith R. Hummel, David N. Greenwald, Lauren A.
Moskowitz, Geoffrey G. Hu, and Sharonmoyee Goswami, CRAVATH,
SWAINE & MOORE LLP, New York, NY; Lauren Martin, QUINN
EMANUEL URQUHART & SULLIVAN, LLP, Boston, MA, attorneys
E. Wilks and Scott B. Czerwonka, WILKS, LUKOFF &
BRACEGIRDLE, LLC, Wilmington, DE; Matthew M. Wolf, ARNOLD
& PORTER KAYE SCHOLER LLP, Washington, D.C.; David K.
Barr and Daniel L. Reisner, ARNOLD & PORTER KAYE SCHOLER
LLP, New York, NY; John Josef Molenda and Vishal Chandra
Gupta, STEPOE & JOHNSON LLP, New York, NY; Paul D.
Clement and George W. Hicks, Jr., KIRKLAND & ELLIS LLP,
Washington, D.C., attorneys for Defendants.
ANDREWS, U.S. DISTRICT JUDGE.
pending before the Court are Plaintiffs' Motion for
Partial Summary Judgment (D.I. 634), Defendants'
Cross-Motion for Summary Judgment on Estoppel (D.I. 673), and
Defendants' Motion for Summary Judgment on Invalidity.
(D.I. 630). The Parties have fully briefed the issues. (D.I.
631, D.I. 635, D.I. 674, D.I. 678, D.I. 691, D.I. 693). For
the following reasons, Plaintiffs' Motion for Partial
Summary Judgment and Defendants' Motion for Summary
Judgment on Invalidity are DENIED. Defendants'
Cross-Motion is GRANTED.
Amgen, Inc., Amgen Manufacturing Limited, and Amgen USA Inc.
(collectively "Plaintiffs") filed suit against
Defendants Sanofi, Sanofi-Aventis U.S. LLC, Aventisub LLC,
and Regeneron Pharmaceuticals, Inc. (collectively
"Defendants") on October 17, 2014. (D.I. 1).
Plaintiffs assert that Defendants' manufacture and sale
of Praluent, a drug that treats patients with high levels of
low density lipoprotein cholesterol, infringes claims of U.S.
Patent Nos. 8, 829, 165 ("the '165 patent") and
8, 859, 741 ("the '741 patent") (collectively,
the "Amgen patents"). (D.I. 1). The parties
stipulated to infringement of certain claims on February 22,
2016. (D.I. 235). During trial, the Court issued two Rule
50(a) rulings. The Court determined that as a matter of law,
the patent claims were non-obvious and Plaintiffs had failed
to meet the burden of showing that Defendants'
infringement was willful. (D.I. 345 at 5:2-3; D.I. 302). The
case was submitted to the jury on the remaining issues:
written description and enablement of the patent claims. The
trial resulted in a judgment for Plaintiffs that the patents
are not invalid. (D.I. 304). After trial, Defendants moved
for renewed judgment as a matter of law on patent validity
and for a new trial. (D.I. 331, 332). Plaintiffs moved for a
permanent injunction. (D.I. 336). The Court denied
Defendants' post-trial motions and entered final judgment
in favor of Plaintiffs under Rule 54(b) on January 3, 2017.
(D.I. 390, 391). The Court granted Plaintiffs' motion for
a permanent injunction on January 5, 2017. (D.I. 392).
appealed. (D.I. 402). The Federal Circuit determined that the
Court had erred in precluding post-priority date evidence
relevant to written description and enablement, and had
improperly instructed the jury on written description.
Amgen Inc. v. Sanofi, 872 F.3d 1367, 1371 (Fed. Cir.
2017). The Federal Circuit remanded for a new trial on
written description and enablement. Id.
parties now move for summary judgment. Defendants move for
summary judgment that the asserted patents are "invalid
on written description and enablement grounds." (D.I.
631 at 6; D.I. 630). Plaintiffs move for partial summary
judgment to "estop Defendants from arguing that
Amgen's selected claims lack written description and
enablement." (D.I. 635 at 8; D.I. 634). Defendants
cross-move for summary judgment on estoppel. (D.I. 673).
court shall grant summary judgment if the movant shows that
there is no genuine dispute as to any material fact and the
movant is entitled to judgment as a matter of law."
Fed.R.Civ.P. 56(a). The moving party has the initial burden
of proving the absence of a genuinely disputed material fact
relative to the claims in question. Celotex Corp. v.
Catrett, 477 U.S. 317, 330 (1986). Material facts are
those "that could affect the outcome" of the
proceeding, and "a dispute about a material fact is
'genuine' if the evidence is sufficient to permit a
reasonable jury to return a verdict for the nonmoving
party." Lamont v. New Jersey, 637 F.3d 177, 181
(3d Cir. 2011) (quoting Anderson v. Liberty Lobby,
Inc., 477 U.S. 242, 248 (1986)). The burden on the
moving party may be discharged by pointing out to the
district court that there is an absence of evidence
supporting the non-moving party's case. Celotex,
477 U.S. at 323.
burden then shifts to the non-movant to demonstrate the
existence of a genuine issue for trial. Matsushita Elec.
Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586-87
(1986); Williams v. Borough of West Chester, Pa.,
891 F.2d 458, 460-61 (3d Cir. 1989). A non-moving party
asserting that a fact is genuinely disputed must support such
an assertion by: "(A) citing to particular parts of
materials in the record, including depositions, documents,
electronically stored information, affidavits or
declarations, stipulations ..., admissions, interrogatory
answers, or other materials; or (B) showing that the
materials cited [by the opposing party] do not establish the
absence ... of a genuine dispute ...." Fed.R.Civ.P.
determining whether a genuine issue of material fact exists,
the court must view the evidence in the light most favorable
to the non-moving party and draw all reasonable inferences in
that party's favor. Scott v. Harris, 550 U.S.
372, 380 (2007); Wishkin v. Potter, 476 F.3d 180,
184 (3d Cir. 2007). A dispute is "genuine" only if
the evidence is such that a reasonable jury could return a
verdict for the non-moving party. Anderson, 477 U.S.
at 247-49. If the non-moving party fails to make a sufficient
showing on an essential element of its case with respect to
which it has the burden of proof, the moving party is
entitled to judgment as a matter of law. See Celotex
Corp., 477 U.S. at 322.
Defendants' Motion for Summary Judgment of
ask the Court for summary judgment of invalidity for lack of
written description and no enablement. (D.I. 630). Plaintiffs
assert that genuine disputes of material fact preclude
summary judgment. (D.I. 678 at 5). I agree with Plaintiffs.
written description requirement contained in 35 U.S.C. §
112, ¶ 1 requires that the specification "clearly
allow persons of ordinary skill in the art to recognize that
the inventor invented what is claimed." Ariad
Pharm., Inc., v. Eli Lilly & Co., 598 F.3d 1336,
1351 (Fed. Cir. 2010) (en banc) (cleaned up). "In other
words, the test for sufficiency is whether the disclosure of
the application relied upon reasonably conveys to those
skilled in the art that the inventor had possession of the
claimed subject matter as of the filing date."
Id. The written description inquiry is a question of
fact. See Id. Although it is a question of fact,
"[c]ompliance with the written description
requirement... is amenable to summary judgment in cases where
no reasonable fact finder could return a verdict for the
non-moving party." PowerOasis, Inc. v. T-Mobile USA,
Inc., 522 F.3d 1299, 1307 (Fed. Cir. 2008). "A
party must prove invalidity for lack of written description
by clear and convincing evidence." Vasudevan
Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 682
(Fed. Cir. 2015).
assert that no disputes of material fact exist and that the
patent is invalid for lack of written description. (D.I. 631
at 14). Plaintiffs argue that there are genuine disputes of
material facts under both the common structural features test
and representative species test. (D.I. 678 at 6-7). I agree
with Plaintiffs that genuine issues of material fact preclude
summary judgment on the written description defense.
the parties dispute whether the specification discloses a
common structural feature of the claimed antibodies. (D.I.
631 at 15-17; D.I. 678 at 9-11). Defendants argue that the
Federal Circuit's opinion in Amgen stands for
the proposition that an antibody cannot be described by its
function-binding to an antigen. (D.I. 631 at 16-17). However,
in Amgen, the Federal Circuit recognized that it is
"hotly disputed [whether] knowledge of the chemical
structure of an antigen gives the required kind of
structure-identifying information about the corresponding
antibodies." 872 F.3d at 1378. The parties' experts
continue to dispute whether the function of binding
correlates to the structure of the antibody. (D.I. 631 at
16-17; D.I. 678 at 10-11). ...