United States District Court, D. Delaware
D. Smith II, Michael J. Flynn, MORRIS, NICHOLS, ARSHT &
TUNNELL LLP, Wilmington, DE; Bradford J. Badke, Sona De,
Ching-Lee Fukuda, Caroline Bercier, Julie L. Hsia, SIDLEY
AUSTIN LLP, New York, NY; Kevin O'Brien, Sue Wang,
Saurabh Prabhakar, SIDLEY AUSTIN LLP, San Francisco, CA; Gwen
Hochman Stewart, Grace L.W. St. Vincent, SIDLEY AUSTIN LLP,
Chicago, IL. Attorneys for Plaintiff.
Frederick L. Cottrell, III, Kelly E. Farnan, Nicole K. Pedi,
RICHARDS, LAYTON & FINGER, P.A., Wilmington, DE; Edgar H.
Haug, Angus Chen, Porter F. Fleming, Richard F. Kurz, Erika
V. Selli, HAUG PARTNERS LLP, New York, NY. Attorneys for
ANDREWS, U.S. DISTRICT JUDGE
before the Court are Defendants' motion for summary
judgment (D.I. 246) and Plaintiffs motion for partial summary
judgment (D.I. 237). I have reviewed the parties'
briefing. (D.I. 238, 247, 265, 268, 276, 281).
asserts claims 1-9 of U.S. Patent No. 9, 364, 520 ("the
'520 patent"). (D.I. 1; D.I. 268 at 2). The '520
patent is directed to forms of factor VIII, "a protein
necessary for normal blood clotting in response to
injury." (D.I. 99 at 1). The patent claims factor VIII
conjugates not found in nature, made up of recombinant factor
VIII and one or more biocompatible polymers chemically bonded
to factor VIII at the protein region known as the
"B-domain." (Id. at 1, 3).
claimed factor VIII conjugates are formed through a process
called pegylation, which is the conjugation of recombinant
factor VIII with polyethylene glycol ("PEG"), a
biocompatible polymer. (Id. at 5). The '520
patent has two independent claims (1 and 9):
1. An isolated polypeptide conjugate comprising a functional
factor VIII polypeptide and one or more biocompatible
polymers, wherein the functional factor VIII polypeptide
comprises the amino acid sequence of SEQ ID NO: 4 or an
allelic variant thereof and has a B-domain, and further
wherein the biocompatible polymer comprises polyalkylene
oxide and is covalently attached to the functional factor
VIII polypeptide at the B-domain.
9. A pharmaceutical composition comprising (1) a
therapeutically effective amount of a monopegylated
polypeptide conjugate, wherein the monopegylated polypeptide
conjugate comprises a functional factor VIII polypeptide and
one polyethylene glycol polymer, the functional factor VIII
polypeptide comprises the amino acid sequence of SEQ ID NO: 4
or an allelic variant thereof and has a B-domain, and the
polyethylene glycol is covalently attached to the functional
factor VIII polypeptide at the B-domain; and (2) a
pharmaceutically acceptable adjuvant.
Claims 2-8 depend from claim 1.
accused product is Adynovate, a pegylated factor VIII used to
treat hemophilia A. (D.I. 28 ¶ 25; D.I. 247 at 1).
Hemophilia A is a congenital bleeding disorder caused by
deficient or defective factor VIII. ('520 patent at
1:25-32). The FDA approved the Adynovate Biologies License
Application ("BLA") on November 13, 2015. (D.I. 28
move for summary judgment on all asserted claims for
noninfringement, and invalidity as not enabled. (D.I. 246).
Plaintiff moves for summary judgment on Defendants'
invalidity defenses of anticipation, obviousness, and lack of
utility. (D.I. 237).
patent is infringed when a person "without authority
makes, uses, offers to sell, or sells any patented invention,
within the United States ... during the term of the patent...
." 35 U.S.C. § 271(a). A two-step analysis is
employed in making an infringement determination. See
Markman v. Westview Instruments, Inc., 52 F.3d 967, 976
(Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370
(1996). First, the court must construe the asserted claims to
ascertain their meaning and scope. See Id. The trier
of fact must then compare the properly construed claims with
the accused infringing product. See Id. at 976. This
second step is a question of fact. See Bai v. L & L
Wings, Inc., 160 F.3d 1350, 1353 (Fed. Cir. 1998).
infringement of a claim exists when every limitation recited
in the claim is found in the accused device." Kahn
v. Gen. Motors Corp., 135 F.3d 1472, 1477 (Fed. Cir.
1998). "If any claim limitation is absent from the
accused device, there is no literal infringement as a matter
of law." Bayer AG v. Elan Pharm. Research
Corp., 212 F.3d 1241, 1247 (Fed. Cir. 2000). If an
accused product does not infringe an independent claim, it
also does not infringe any claim depending thereon. See
Wahpeton Canvas Co. v. Frontier, Inc., 870 F.2d 1546,
1553 (Fed. Cir. 1989). However, "[o]ne may infringe an
independent claim and not infringe a claim dependent on that
claim." Monsanto Co. v. Syngenta Seeds, Inc.,
503 F.3d 1352, 1359 (Fed. Cir. 2007) (internal quotations
omitted). A product that does not literally infringe a patent
claim may still infringe under the doctrine of equivalents if
the differences between an individual limitation of the
claimed invention and an element of the accused product are
insubstantial. See Warner-Jenkinson Co. v. Hilton Davis
Chem. Co., 520 U.S. 17, 24 (1997). The patent owner has
the burden of proving infringement and must meet its burden
by a preponderance of the evidence. See SmithKline
Diagnostics, Inc. v. Helena Lab. Corp., 859 F.2d 878,
889 (Fed. Cir. 1988) (citations omitted).
accused infringer moves for summary judgment of
non-infringement, such relief may be granted only if at least
one limitation of the claim in question does not read on an
element of the accused product, either literally or under the
doctrine of equivalents. See Chimie v. PPG Indus.,
Inc., 402 F.3d 1371, 1376 (Fed. Cir. 2005); see also
TechSearch, L.L.C. v. Intel Corp., 286 F.3d 1360, 1369
(Fed. Cir. 2002) ("Summary judgment of noninfringement
is . . . appropriate where the patent owner's proof is
deficient in meeting an essential part of the legal standard
for infringement, because such failure will render all other
facts immaterial."). Thus, summary judgment of
noninfringement can only be granted if, after viewing the
facts in the light most favorable to the non-movant, there is
no genuine issue as to whether the accused product is covered
by the claims (as construed by the court). See Pitney
Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1304
(Fed. Cir. 1999).
patent claim is invalid as anticipated under 35 U.S.C. §
102 if "within the four corners of a single, prior art
document. . . every element of the claimed invention [is
described], either expressly or inherently, such that a
person of ordinary skill in the art could practice the
invention without undue experimentation." Callaway
Golf Co. v. Acushnet Co., 576 F.3d 1331, 1346 (Fed. Cir.
2009). As with infringement, the court construes the claims
and compares them against the prior art. See Enzo
Biochem, Inc. v. Applera Corp., 599 F.3d 1325, 1332
(Fed. Cir. 2010). Anticipation "may be decided on
summary judgment if the record reveals no genuine dispute of
material fact." Encyclopaedia Britannica, Inc. v.
Alpine Elecs. of Am., Inc., 609 F.3d 1345, 1349 (Fed.
claim is invalid as obvious under 35 U.S.C. § 103
"if the differences between the claimed invention and
the prior art are such that the claimed invention as a whole
would have been obvious before the effective filing date of
the claimed invention to a person having ordinary skill in
the art to which the claimed invention pertains." 35
U.S.C. § 103; see also KSR Int'l Co. v. Teleflex
Inc., 550 U.S. 398, 406-07 (2007). "Under §
103, the scope and content of the prior art are to be
determined; differences between the prior art and the claims
at issue are to be ascertained; and the level of ordinary
skill in the pertinent art resolved. Against this background,
the obviousness or nonobviousness of the subject matter is
determined." KSR, 550 U.S. at 406 (citation and
quotation marks omitted).
is required to consider secondary considerations, or
objective indicia of nonobviousness, before reaching an
obviousness determination, as a "check against hindsight
bias." See In re Cyclobenzaprine Hydrochloride
Extended-Release Capsule Patent Litig., 676 F.3d 1063,
1078-79 (Fed. Cir. 2012). "Such secondary considerations
as commercial success, long felt but unsolved needs, failure
of others, etc., might be utilized to give light to the
circumstances surrounding the origin of the subject matter
sought to be patented." Graham v. John Deere Co. of
Kansas City, 383 U.S. 1, 17-18 (1966). Where "the
content of the prior art, the scope of the patent claim, and
the level of ordinary skill in the art are not in material
dispute, and the obviousness of the claim is apparent in
light of these factors, summary judgment is
appropriate." KSR, 550 U.S. at 427.
enablement requirement, considered a separate and distinct
requirement contained in paragraph one of 35 U.S.C. §
112, assesses whether "one skilled in the art, after
reading the specification, could practice the claimed
invention without undue experimentation." Si trick
v. Dreamworks, LLC, 516 F.3d 993, 999 (Fed. Cir. 2008).
Because the enablement inquiry takes into account what is
known to one skilled in the art, the Federal Circuit has
"repeatedly explained that a patent applicant does not
need to include in the specification that which is already
known to and available to one of ordinary skill in the
art." Koito Mfg. Co. v. Turn-Key-Tech, LLC, 381
F.3d 1142, 1156 (Fed. Cir. 2004). "Enablement is a legal
question based on underlying factual determinations."
Vasudevan Software, Inc. v. MicroStrategy, Inc., 782
F.3d 671, 684 (Fed. Cir. 2015). Factors considered in
assessing the enablement requirement include:
(1) the quantity of experimentation necessary, (2) the amount
of direction or guidance presented, (3) the presence or
absence of working examples, (4) the nature of the invention,
(5) the state of the prior art, (6) the relative skill of
those in the art, (7) the predictability or unpredictability
of the art, and (8) the breadth of the claims.
In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).
DEFENDANTS' MOTION FOR SUMMARY JUDGMENT
move for summary judgment on all asserted claims for
noninfringement, and invalidity as not enabled. (D.I. 247).