United States District Court, D. Delaware
D. Smith II, Michael J. Flynn, MORRIS, NICHOLS, ARSHT &
TUNNELL LLP, Wilmington, DE; Bradford J. Badke (argued), Sona
De (argued), Caroline Bercier, SIDLEY AUSTIN LLP, New York
NY; Sue Wang, Kevin O'Brien, SIDLEY AUSTIN LLP, San
Francisco, CA; Grace L.W. St. Vincent, SIDLEY AUSTIN LLP,
Chicago, IL. Attorneys for Plaintiff.
Frederick L. Cottrell, III, Kelly E. Farnan, Jason J.
Rawnsley, RICHARDS, LAYTON & FINGER, P.A., Wilmington,
DE; Edgar H. Haug (argued), Angus Chen (argued), Porter F.
Fleming, Sandra Kuzmich, Richard F. Kurz, Erika Selli,
Michelle E. Irwin, HAUG PARTNERS LLP, New York, NY. Attorneys
ANDREWS, U.S. DISTRICT JUDGE.
before the Court is the issue of claim construction of
multiple terms in U.S. Patent No. 9, 364, 520 ("the
'520 patent"). The Court has considered the
Parties' Joint Claim Construction Brief. (D.I. 99). The
Court heard oral argument on February 28, 2018. (D.I. 108
("Tr.")). The parties submitted supplemental
briefing at the Court's request. (D.I. 109, 111).
patent-in-suit is directed to forms of factor VIII, "a
protein necessary for normal blood clotting in response to
injury." (D.I. 99 at 1). The '520 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). The 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). PEGylation occurs at "one of numerous amino acid
sites across" factor VIII. (Id. at 6).
is a bedrock principle of patent law that the claims of a
patent define the invention to which the patentee is entitled
the right to exclude." Phillips v. AWHCorp.,
415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc) (internal
quotation marks omitted). '"[T]here is no magic
formula or catechism for conducting claim construction.'
Instead, the court is free to attach the appropriate weight
to appropriate sources 'in light of the statutes and
policies that inform patent law."' SoftView LLC
v. Apple Inc., 2013 WL 4758195, at * 1 (D. Del. Sept. 4,
2013) (quoting Phillips, 415 F.3d at 1324)
(alteration in original). When construing patent claims, a
court considers the literal language of the claim, the patent
specification, and the prosecution history. Markman v.
Westview Instruments, Inc., 52 F.3d 967, 977-80 (Fed.
Cir. 1995) (en banc), aff'd, 517 U.S. 370
(1996). Of these sources, "the specification is always
highly relevant to the claim construction analysis. Usually,
it is dispositive; it is the single best guide to the meaning
of a disputed term." Phillips, 415 F.3d at 1315
(internal quotation marks omitted).
words of a claim are generally given their ordinary and
customary meaning. . . . [Which is] the meaning that the term
would have to a person of ordinary skill in the art in
question at the time of the invention, i.e., as of the
effective filing date of the patent application."
Id. at 1312-13 (citations and internal quotation
marks omitted). "[T]he ordinary meaning of a claim term
is its meaning to [an] ordinary artisan after reading the
entire patent." Id. at 1321 (internal quotation
marks omitted). "In some cases, the ordinary meaning of
claim language as understood by a person of skill in the art
may be readily apparent even to lay judges, and claim
construction in such cases involves little more than the
application of the widely accepted meaning of commonly
understood words." Id. at 1314.
court relies solely upon the intrinsic evidence-the patent
claims, the specification, and the prosecution history-the
court's construction is a determination of law. See
Teva Pharm. USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831,
841 (2015). The court may also make factual findings based
upon consideration of extrinsic evidence, which
"consists of all evidence external to the patent and
prosecution history, including expert and inventor testimony,
dictionaries, and learned treatises." Phillips,
415 F.3d at 1317-19. Extrinsic evidence may assist the court
in understanding the underlying technology, the meaning of
terms to one skilled in the art, and how the invention works.
Id. Extrinsic evidence, however, is less reliable
and less useful in claim construction than the patent and its
prosecution history. Id.
claim construction is persuasive, not because it follows a
certain rule, but because it defines terms in the context of
the whole patent." Renishaw PLC v. Marposs Societa
'per Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998).
It follows that "a claim interpretation that would
exclude the inventor's device is rarely the correct
interpretation." Osram GMBH v. Int'l Trade
Comm'n, 505 F.3d 1351, 1358 (Fed. Cir. 2007)
TERMS FOR CONSTRUCTION
claims 1 and 9 of the '520 patent contain all disputed
limitations, and are representative. (Id. at 1,
3-4). They read as follows:
1. An isolated polypeptide conjugate comprising
a functional factor VIII polypeptide and one or more
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
wherein the monopegylated polypeptide conjugate comprises a
functional factor VIII polypeptide and one polyethylene
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.
patent, claims 1, 9) (disputed terms italicized).
"an isolated polypeptide conjugate" (claim
Plaintiff s proposed construction:
preamble is not limiting.
extent the preamble is limiting, plain and ordinary meaning:
"recombinant polypeptide conjugate"
Defendants 'proposed construction:
polypeptide conjugate that is not heterogeneous and in which
essentially all the molecules have polyalkylene oxide
attached at the B-domain"
polypeptide conjugate where conjugation was not random"
"[A]n isolated polypeptide conjugate" appears in
the preamble of claim 1. The parties dispute whether the
preamble is limiting. (D.I. 99 at 12).
general, a preamble limits the invention if it recites
essential structure or steps, or if it is 'necessary to
give life, meaning, and vitality' to the claim."
Catalina Marketing Int'l, Inc. v. Coolsavings.com,
Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (citing
Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d
1298, 1305 (Fed. Cir. 1999)). "No litmus test defines
when a preamble limits claim scope." Catalina,
289 F.3d at 808. However, the Federal Circuit has identified
"[s]ome guideposts" for determining when a preamble
does limit claim scope. Id. For example, a preamble
might limit claim scope when "Jepson claiming" is
used; when there is "dependence on a particular disputed
preamble phase for antecedent basis"; "when the
preamble is essential to understand limitations or terms in
the claim body"; "when reciting additional
structure or steps underscored as important by the
specification"; and when the preamble contains
"statements of intended use or asserted benefits . . .,
but only if the applicant clearly and unmistakably relied on
those uses or benefits to distinguish prior art."
Id. at 808-09.
make two arguments that the preamble is limiting. First,
Defendants argue that Plaintiff made "an isolated
polypeptide conjugate" an "essential element"
of the claims by amending the preamble during prosecution,
and by disparaging "heterogeneous" conjugates in
the specification. (D.I. 99 at 16-17). Second, Defendants
argue that Plaintiff made a disclaimer by relying on the
preamble to distinguish the claimed conjugate over the prior
art during prosecution. (Mat 18, 32).
Defendants' first argument, Plaintiff added the term
"an isolated conjugate" in a claim amendment during
prosecution, and relied on three paragraphs from the
specification as support. (D.I. 63-1 at p. 515-16).
Defendants argue that the paragraphs show "that the
claimed conjugate was 'isolated' by having one amino
acid available for conjugation, applying the three-step
site-directed conjugation method, and yielding a conjugate
that was not heterogeneous." (D.I. 99 at 17). However,
as Plaintiff notes, this amendment occurred not in response
to an art rejection, but during a claim election to proceed
with product claims, rather than method claims. (Id.
at 24 (citing D.I. 62-6 at p. 38)). Furthermore, I agree with
Plaintiff that the cited "enabling passages do not
invoke the preamble term 'isolated polypeptide
conjugate' to distinguish the prior art, much ...