Bayer Healthcare LLC v. Baxalta Incorporated et al
Filing
319
MEMORANDUM OPINION. Signed by Judge Richard G. Andrews on 12/21/2018. (crb)
IN THE UNITED STATES DISTRJCT COURT
FOR THE DISTRJCT OF DELAWARE
BAYER HEALTHCARE LLC,
Plaintiff,
V.
No. 16-cv-1122-RGA
BAXAL TA INC. , BAXALTA US INC., and
NEKTAR THERAPEUTICS,
Defendants.
MEMORANDUM OPINION
Rodger 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, RJCHARDS, 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 Defendants.
December
21_,2018
Presently 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).
I.
BACKGROUND
Plaintiff asserts claims 1- 9 ofU.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).
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). 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.
2
The accused product is Adynovate, a pegylated factor VIII used to treat hemophilia A.
(D.I. 28 ,r 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 Biologics
License Application ("BLA") on November 13, 2015. (D.I. 28
,r 25).
Defendants 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).
II.
LEGAL STANDARD
A. Infringement
A 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 bane), ajf'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).
"Literal 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
oflaw." 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.
3
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 WarnerJenkinson 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).
When an 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).
B. Invalidity
1. Anticipation
4
A 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. ofAm. , Inc., 609 F.3d 1345, 1349
(Fed. Cir. 2010).
2. Obviousness
A patent 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).
A court 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 Cy clobenzaprine Hydrochloride Extended-Release Capsule Patent Litig. , 676
F.3d 1063, 1078-79 (Fed. Cir. 2012). "Such secondary considerations as commercial success,
5
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.
3. Enablement
The 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." Sitrick 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.
Inre Wands, 858 F.2d 731 , 737 (Fed. Cir. 1988).
III.
DEFENDANTS' MOTION FOR SUMMARY JUDGMENT
Defendants move for summary judgment on all asserted claims for noninfringement, and
invalidity as not enabled. (D.I. 247).
6
A. Noninfringement
1. Claims 1-8
Defendants argue that no genuine issue of infringement exists for claim 1, and its
dependent claims 2-8, because Adynovate is made by random conjugation and thus fails to meet
the limitation of "an isolated polypeptide conjugate." I have construed "an isolated polypeptide
conjugate" as "a polypeptide conjugate where conjugation was not random." (D.I. 195 at 4).
First, Defendants argue that Plaintiff disclaimed Adynovate in the prosecution history.
Defendants point to Plaintiffs response to a Patent Office rejection of claim 1 as anticipated by
Bossard (U.S. App. Pub. No. 2004/0235734, granted as U.S. Patent No. 7,199,223):
Bossard's purification does not teach Appellant's isolated conjugates. Claim
[1] recites isolated conjugates having B-domain conjugation. Thus, the
conjugate is separate from conjugates that do not have a polyalkylene oxide
attached at the B-domain. Much of the Patent Officer's prior arguments relied
upon possible conjugation at amines or carboxy sites, which are present not
only in the B-domain but in other domains. Any conjugation with these
reactive groups is random and does not ensure that attachment occurs at the Bdomain.
(D.I. 247 at 5, 8-9; D.I. 248, ex. 4 at BAYER000l 716). Defendants focus on the phrase "[a]ny
conjugation with these reactive groups is random," wherein "these reactive groups" are "amines
or carboxy sites." The phrase allegedly shows that Plaintiff "unconditionally defined 'random'
in the context of the '520 patent to be 'any' conjugation with amines." (D.I. 247 at 8). 1 It is
undisputed that Adynovate has conjugations with amines. (D.I. 248, ex. 5 at 38:12-15).
1
Defendants also argue, "The '520 patent defines conjugation with amines is [sic] random: '[r]andom
modification of FVIII by targeting primary amines (N-terminus and lysines) with large polymers ... has
been attempted .... "' (D.I. 247 at 8 (quoting '520 patent at 3:50-52)). The quoted language, when read
in full, clearly describes "random modification" that existed in the prior art. '520 patent at 3:50-61. The
specification does not state, as Defendants suggest, that any modification targeting amines is a "random
modification." See id.
7
Therefore, Defendants argue that Adynovate relies on random conjugation and cannot meet my
construction of "an isolated polypeptide conjugate." (Id.) .
I rejected Defendants' arguments during claim construction. Addressing the same
passage from the prosecution history, I stated:
Defendants argue that Plaintiffs statements constitute clear and unmistakable
disclaimer of conjugation at amines and carboxy sites. I disagree. Plaintiff
stated that conjugation at amines and carboxy sites cannot ensure PEGylation
at the B-domain-not that conjugation cannot occur at amines and carboxy
sites.
(D.I. 195 at 16). Defendants take the phrase, "[a]ny conjugation with [amines] is random," out
of context. When the entire passage is read together, it is clear that " [a]ny conjugation" refers to
the conjugations allegedly disclosed by Bossard. In other words, Bossard may have taught
conjugations at various sites on factor VIII, such as amines or carboxy sites, but Plaintiff argued
that the conjugations were not targeted to particular sites. Therefore, Plaintiff described " [a]ny
conjugation" in Bossard as random. It does not follow, however, that Plaintiff defined all
conjugations with amines or carboxy sites as random. Defendants have failed to provide any
evidence to the contrary. The fact that Adynovate may have conjugations with amines does not
necessarily mean that Adynovate is the product of random conjugation.
Second, Defendants argue that Adynovate is made by random conjugation as defined by
Plaintiffs expert, Dr. Ploegh. (D.I. 247 at 10- 11). Dr. Ploegh stated, "Random PEGylation
allows for PEG attachment without regard to location. That is, the PEG reagent may attach at
any available site ofreaction throughout the protein." (D.I. 248, ex. 2 ,r 37). Dr. Ploegh also
agreed that the Adynovate manufacturing process, as described in one study, allowed PEG to
attach at any of the 55 identified available sites throughout factor VIII, some of which are
8
outside the B-domain. 2 (Id., ex. 5 at 70:3-19). Defendants thus argue that there is no genuine
dispute as to whether Adynovate is made by random conjugation.
I do not think the fact that some pegylation occurs outside the B-domain is sufficient to
show that Adynovate is made by random conjugation. I determined during claim construction
that non-random conjugation does not require total homogeneity. Defendants argued that
Plaintiff disclaimed all heterogenous conjugation by adding the term "an isolated polypeptide
conjugate." I disagreed because although the prosecution history "disparage[s] products with a
high degree of heterogeneity," it "do[es] not expressly distinguish all prior art products with even
the slightest degree of heterogeneity." (D.I. 195 at 6 & n.1). I believe the same analysis applies
regardless of whether the heterogeneity is among factor VIII conjugates in a product, or within
each individual factor VIII conjugate. (See '520 patent at 8:21-30).
Dr. Ploegh opines extensively on the controlled nature of the Adynovate manufacturing
process, such that pegylation is concentrated in the B-domain. (D.I. 248, ex. 2 ,r,r 51-93).
Plaintiff further identifies "thousands of pages" of the Adynovate BLA that allegedly show its
"controlled" and "targeted" process that results in full-length factor VIII "predominantly" and
"preferentially" pegylated at the B-domain. (D.I. 268 at 5-8, 15). Thus, I believe there is a
genuine dispute of fact as to whether Adynovate is manufactured by non-random conjugation.
Third, Defendants argue that Adynovate is randomly conjugated because it does not
separate conjugates that are pegylated at the B-domain from those that are pegylated elsewhere.
Defendants argue that this separation is required by the term "isolated" in "an isolated
2
Plaintiff points out that Dr. Ploegh also testified that 40 of the 55 sites are inside the B-domain. (D.I.
268 at 17).
9
polypeptide conjugate." (D.I. 247 at 12-13). Defendants again rely on Plaintiff's response to
the Patent Office rejection of claim 1 as anticipated by Bossard:
[T]he purification discussed in [Bossard] would not separate conjugates with
B-domain attachment from those without B-domain attachment. Instead,
[Bossard] discusses separating conjugates based on the number of PEG
molecules attached, not the positions where they are attached .... Accordingly,
the Patent Office has not shown where Bossard teaches isolation of conjugates
having B-domain polyalkylene attachment from conjugates that do not.
(D.I. 248, ex. 4 at BA YER000l 716).
Defendants are rearguing claim construction. I have construed "an isolated polypeptide
conjugate" as "a polypeptide conjugate where conjugation was not random." "[I]solated" is not
a separate limitation. If Adynovate practices "a polypeptide conjugate where conjugation was
not random," it will necessarily practice an "isolated" polypeptide conjugate. 3
For the foregoing reasons, Defendants' motion for summary judgment of
noninfringement of claims 1-8 is DENIED.
2. Claim 9
To the extent that Defendants argue noninfringement of claim 9 for the same reasons as
claims 1-8, their motion is DENIED. (D.I. 247 at 13).
Defendants' remaining arguments relate to the "monopegylated" limitation in claim 9unlike claim 1, claim 9 requires a "monopegylated polypeptide conjugate." I construed
"monopegylated polypeptide conjugate" as its plain and ordinary meaning, "a polypeptide with
one polyethylene glycol polymer (PEG) attached." (D.I. 195 at 16). Defendants argue that
Plaintiff has not offered any evidence to show that Adynovate contains monpegylated
3
As a matter of claim construction, I do not believe Plaintiffs response to the Patent Office shows that
claim 1 specifically requires separating B-domain conjugates from other conjugates. Rather, I think
Plaintiff merely argued that Bossard does not teach any targeted pegylation, either by initially targeting
the B-domain, or by later separating out B-domain pegylated conjugates.
10
conjugates, let alone that the monopegylated conjugates are (i) present in a "therapeutically
effective amount," (ii) have one PEG attached, (iii) at the B-domain of a factor VIII polypeptide,
which (iv) has the entire B-domain, and (v) retains functional activity. (D.I. 247 at 13-14).
Essentially, Defendants argue that Plaintiff fails to address (1) presence in a "therapeutically
effective amount," and (2) structure-a factor VIII with one PEG attached at the complete Bdomain.
Regarding therapeutic effectiveness,4 Plaintiff argues that Adynovate meets the claim
limitation because "its activity is comparable" to Advate, Baxalta' s preceding factor VIII
product, which is therapeutically effective. (D.I. 268 at 18). 5 Defendants argue that summary
judgment is warranted because Plaintiff relies on insufficient evidence. (D.I. 247 at 14-15).
Specifically, Defendants assert that therapeutic effectiveness can only be determined by
"quantitative evidence" such as "extensive research to characterize the amount of
[monopegylated polypeptide conjugates] in Adynovate® and test[ing] them for their efficacy in
treating hemophilia, such as in a clinical trial." (Id. at 15). Defendants do not argue, however,
that as a matter of law, Plaintiff may not prove infringement by indirect evidence. I do not think
Plaintiff is limited to such "quantitative evidence." I believe whether Plaintiff can meet its
burden of showing that Adynovate is therapeutically effective through comparison with Advate
depends on factual questions. For example, are there material differences between Adynovate
and Advate? What is the significance of the testing done on each?
4
I assume, for purposes for summary judgment, that if the factor VIII conjugate is present in a
"therapeutically effective amount," the factor VIII retains functional activity. Neither party provides
substantive arguments specific to retaining functional activity. (D.I. 247 at 16; D.I. 268 at 17-19; D.I.
281 at 9).
5
Adynovate is "built on" Advate, but with modifications to extend its circulating half-life. (D.I. 1, ex. C).
11
Regarding structure, Plaintiffs experts opine that B-domain monopegylated conjugates
are "necessarily present" in Adynovate based on the manufacturing process. (D.1. 268 at 17-18).
For example, one expert described the type of branched PEG used to manufacture Adynovate as
"umbrella-like," which can block other PEGs from reacting, resulting in monopegylated
conjugates. (DJ. 269, ex. M ,r,r 44--45). The expert further opined that a laboratory analysis of
Adynovate shows it contains B-domain monopegylated factor VIII. (Id.
,r 39).
Plaintiffs
experts also opined that Adynovate uses full length factor VIII, which includes a complete Bdomain. (D.1. 268 at 18). Likewise, Defendants' BLA refers to Advate, allegedly an
unpegylated form of the same factor VIII used to make Adynovate, as a "full length human
rFVIII [factor VIII] with a complete B-domain." (D.1. 268 at 18; D.I. 269, ex. A at
BAXADYNO0000542). I do not think Plaintiffs arguments are mere ipse dixit. I believe there
is a genuine dispute o_ fact over whether Adynovate meets the structural limitations of claim 9.
f
For the foregoing reasons, Defendants' motion for summary judgment of
noninfringement of claim 9 is DENIED.
B. Enablement
Defendants argue that claims 1-9 are invalid as not enabled because the '520 patent fails
to teach a person of ordinary skill in the art how to practice the claimed invention using amineconjugation. (D.1. 247 at 16). Defendants argue that the '520 patent is not only silent as to how
to conjugate PEG at amines but teaches away from it. (Id. at 17). Defendants again rely on
Plaintiffs statement to the Patent Office that "[a]ny conjugation" in Bossard "is random" to
argue that all conjugations with amines are random and thus taught against. (Jd.). 6
6
In addition, Defendants again assert that the '520 patent defines conjugation with amines as random
based on a clause of a sentence in the specification. (D.I. 24 7 at 17). The specification, read in context,
does not support Defendants' argument. See supra note I.
12
This is the same argument I rejected during claim construction and discussed in detail
with respect to noninfringement. See supra III.A. I. Just as the statement does not show that
Plaintiff disclaimed conjugation at amines, it also does not show that the '520 patent teaches
against conjugation at amines. (See D.I. 195 at 15-16). Therefore, I find no evidence that the
'520 patent teaches away from amine conjugation generally.
The fact that the specification does not teach how to conduct amine conjugation is by
itself insufficient to show lack of enablement. "A patent need not disclose what is well known in
the art." In re Wands, 858 F.3d at 735. The priority date of the '520 patent is in 2005. (D.I. 268
at 10). "The enablement requirement is satisfied when one skilled in the art, after reading the
specification, could practice the claimed invention without undue experimentation." Sitrick, 516
F.3d at 999. Plaintiff's experts have opined, based on the '520 patent specification and prior art,
that skilled artisans in 2005 "knew how to take advantage of reaction chemistries and protein
properties to control and select conditions for localized amine pegylation in order to practice the
'520 patent." (D.I. 268 at 19). For example, one expert relied on pre-2005 literature to identify
specific properties that affect the "location and rate of reaction between amino-reactive PEG and
amino acid residues in Factor VIII," such as "side-chain pKa, exposed surface area (ESA),
polarity and hydrophobicity." (D.I. 269, ex. 0
,r,r 40-44).
Defendants argue that Plaintiff's expert testimony is inappropriate, because "an expert's
opinion on the ultimate legal issue must be supported by something more than a conclusory
statement." In re Buchner, 929 F.2d 660, 661 (Fed. Cir. 1991). 7 Although Plaintiff's experts do
7
Defendants appear to blend several issues together. (D.I. 281 at 10). The fact that an expert must
provide more than a conclusory statement does not affect the general rule that a patent need not disclose
information well known in the art. In re Buchner, 929 F .2d at 661. If information is not well known in
the art, "the application itself must contain this information; it is not sufficient to provide it only through
an expert's declaration." Id.
13
opine on the ultimate legal issue of enablement, those opinions are based on their specific
findings about the state of the art in 2005. (See, e.g. D.I. 269, ex. 0
,r,r 40-44).
I believe that is
sufficient to show a genuine dispute of fact as to whether amine conjugation was well-known in
the art at the time, or more generally, whether one skilled in the art could have practiced amine
conjugation in the claimed invention without "undue experimentation."
For the foregoing reasons, Defendants' motion for summary judgment of invalidity of
claims 1-9 for lack of enablement is DENIED.
IV.
PLAINTIFF'S MOTION FOR PARTIAL SUMMARY JUDGMENT
Plaintiff moves for summary judgment on three of Defendants' invalidity defenses-(1) §
102 anticipation by Bossard, (2) § 103 obviousness based on Bossard, and (3) lack of§ 101
utility.
A. Anticipation
Plaintiff argues that Bossard does not anticipate any of the ' 520 patent claims for three
independent reasons.
First, Plaintiff argues that Bossard' s pegylation process was disclaimed during
prosecution of the '520 patent, and "[w]here particular subject matter of a prior art reference was
disclaimed during prosecution of a patent, that prior art subject matter falls outside the scope of
the patent claims, and therefore cannot constitute disclosure of the distinguished claim elements
for purposes of showing anticipation." (D.I. 238 at 8). Plaintiff cites to Ekchian v. Home Depot,
Inc. , which states, " [S]ince, by distinguishing the claimed invention over the prior art, an
applicant is indicating what the claims do not cover, he is by implication surrendering such
protection." 104 F.3d 1299, 1304 (Fed. Cir. 1997) (discussing prosecution history estoppel).
Under Plaintiffs theory, because it disclaimed Bossard' s random pegylation process during
14
prosecution, the claims do not cover random pegylation, and thus, Bossard cannot anticipate the
claims.
I do not think Ekchian supports Plaintiffs argument-the court merely described the
concept of disclaimer. Plaintiff argues, far beyond disclaimer, that because the claims do not
cover the disclaimed subject matter in the prior art, the prior art does not disclose the claimed
subject matter. This logic is flawed. I held during claim construction that Plaintiff disclaimed
any "polypeptide conjugate where conjugation was random" based on Plaintiffs response to the
Patent Office rejection over Bossard. (D.I. 195 at 7). I did not make any rulings on what
Bossard did or did not disclose. The relevant question for anticipation is whether Bossard
disclosed, in addition to all the other claim limitations, a non-random pegylation process. The
fact that Plaintiff characterized Bossard as only disclosing random pegylation during prosecution
does not mean that, as a matter of law, Bossard only disclosed random pegylation. Therefore,
Plaintiff has failed to show a lack of genuine dispute over whether Bossard discloses non-random
pegylation as claimed by the '520 patent.
Second, Plaintiff argues that no reasonable jury could conclude that the Patent Office
erred in issuing the '520 patent over Bossard, because Defendants' invalidity expert, Dr.
Zalipsky, merely repeats arguments rejected during prosecution. (D.I. 238 at 9-12). Whether
Dr. Zalipsky presented new evidence not seen by the Patent Office, although disputed, is not
dispositive. The fact, if true, that the Patent Office previously addressed the same arguments
related to the same prior art is insufficient to meet Plaintiffs burden on summary judgment. The
Federal Circuit recently held:
[A] reexamination confirming patentability of a patent claim alone is not
determinative of whether a genuine issue of fact precludes summary judgment
of no invalidity. Surviving a reexamination does not warrant ipso facto
summary judgment that a patent is not invalid. Holding otherwise would
15
improperly give complete deference and preclusive effect to the PTO ' s
patentability determination, foreclosing challenges to patent validity in district
court based on the same prior art.
Exmark Mfg Co. Inc. v. Briggs & Stratton Power Prod. Grp., LLC, 879 F.3d 1332, 1341 (Fed.
Cir. 2018). Likewise, granting a patent claim over prior art objections does not by itself warrant
summary judgment of no anticipation. Plaintiff has a presumption of validity under 35 U.S.C. §
282. "The presumption of validity, however, is just that- a presumption- which can be
overcome by the patent challenger who meets its high burden of proving the factual elements of
invalidity by clear and convincing evidence." Id. Plaintiff has not shown that, given Dr.
Zalipsky' s testimony, no reasonable jury could find the ' 520 patent invalid as anticipated by
Bossard.
Third, Plaintiff argues that Dr. Zalipsky' s anticipation theories are legally flawed because
they relied on references beyond the four comers of Bossard. (D.I. 238 at 11- 12). In addition to
Bossard, Dr. Zalipsky relied on three prior art references and several of Plaintiffs internal
documents. (D.I. 266, ex. 4 (ex. B ,r,r 101-12)).
Anticipation, as compared to obviousness, requires a single prior art reference to disclose
every claim limitation. Callaway Golf, 576 F.3d at 1346. " [A]nticipation by inherent disclosure
is appropriate only when the reference discloses prior art that must necessarily include the
unstated limitation." Monsanto Tech. LLC v. E. I DuPont de Nemours & Co., 878 F.3d 1336,
1343 (Fed. Cir. 2018). "Whether a claim limitation is inherent in a prior art reference is a
question of fact. " Telemac Cellular Corp. v. Topp Telecom, Inc., 247 F.3d 1316, 1328 (Fed. Cir.
2011). "[R]ecourse to extrinsic evidence is proper to determine whether a feature, while not
explicitly discussed, is necessarily present in a reference. The evidence must make clear that the
16
missing feature is necessarily present, and that it would be so recognized by persons of ordinary
skill in the relevant art." Id. (citations omitted).
Defendants argue that Dr. Zalipksy relied on the extrinsic documents only to support
what is "necessarily present" in Bossard. (D.I. 265 at 9). For anticipation of claim 1, Dr.
Zalipsky relied on three prior art references to opine, "A POSA would understand, based on the
prior art, that the B-domain is surface-exposed and flexible." (D.I. 266, ex. 4 (ex. B ,r 103)). He
also relied on Plaintiffs internal documents to opine, "A POSA would know that the B-domain
of non-mutated, factor VIII contains four cysteines, and that the non-mutated, B-domain deleted
form of factor VIII contains nineteen cysteines, 16 of which form disulfides and the remaining
three of which are buried and not accessible for PEGylation." (Id.
,r 102).
For anticipation of
both claims 1 and 9, he relied on Plaintiffs internal documents to opine, "Bossard inherently
discloses functionally active conjugates PEGylated at the B-domain." (Id.
,r,r 103-04).
Plaintiff argues that Dr. Zali psky' s analyses reach beyond the bounds of inherent
anticipation because he fails to connect the extrinsic documents to Bossard-specifically, by
showing that the documents address factor VIII conjugates made using the Bossard processes.
(D.I. 238 at 12; D.I. 276 at 4-5). I disagree with Plaintiffs framing of the issue. I do not think
what is "necessarily present" in Bossard must be tied to the disclosed conjugation processes. For
example, the fact, if true, that "the B-domain is surface-exposed and flexible" or that "the Bdomain of non-mutated, factor VIII contains four cysteines," remains true regardless of whether
the Bossard processes are used. The focus for inherent anticipation is whether a person of
ordinary skill in the art, given Bossard, would agree that those elements are "necessarily present"
in the reference. I believe that is a disputed question of fact.
17
For the foregoing reasons, Plaintiffs motion for summary judgment of no anticipation by
Bossard is DENIED.
B. Obviousness
Plaintiff argues that Dr. Zalipksy' s obviousness opinions based on Bossard fail as a
matter of law because they do not account for every claim limitation, namely, "functional factor
VIII." (D.I. 238 at 13).
Defendants identify several instances where Dr. Zalipsky opined that Bossard discloses
functionally active factor VIII. (D.I. 265 at 12- 13). As discussed above, Dr. Zalipsky opined,
"Bossard inherently discloses functionally active conjugates PEGylated at the B-domain." (Id.
,r,r 103- 04).
He also stated:
Bossard describes the activity for PEGylated conjugates using stable linkages
(i.e., amine bonds). The disclosed activity ranges from 2-100% in incremental
amounts and explains that the stable conjugate "will possess at least some
degree of bioactivity." Bossard also explains how to assay for bioactivity.
(D.I. 266, ex. 4 (ex. C ,r 76) (citations omitted)). Plaintiff argues that Dr. Zalipsky' s testimony
should be disregarded as conclusory. Plaintiff further argues that Dr. Zalipsky' s citations to
Bossard are insufficient because Bossard is not directed to B-domain pegylation, and Dr.
Zalipsky fails to explain "what such 'bioactivity' or ' activity' represents, or how this reference to
levels as low as 2% supposedly relates to the functional requirements of the ' 520 patent." (D.I.
276 at 6).
Plaintiff has not met its burden of showing that no reasonable jury could find the ' 520
patent obvious based on Bossard. Obviousness requires resolving several factual issues,
including the scope and content of the prior art. KSR, 550 U.S. at 406. I do not think Dr.
Zalipsky' s opinions are so conclusory that they fail to raise a genuine dispute as to the scope and
content of Bossard, specifically, as to whether Bossard discloses "functional factor VIII."
18
For the foregoing reasons, Plaintiffs motion for summary judgment of no obviousness
based on Bossard is DENIED.
C. Utility
To meet the § 101 utility requirement, a patentee must show both "substantial" and
"specific" utility. In re Fisher, 421 F.3d 1365, 1371 (Fed. Cir. 2005). Substantial utility, also
referred to as "practical" or "real world" utility, is met when "the claimed invention has a
significant and presently available benefit to the public." Id. Specific utility is met when "the
claimed invention can be used to provide a well-defined and particular benefit to the public." Id.
That is, "an application must disclose a use which is not so vague as to be meaningless." Id.
Defendants argue that the '520 patent lacks substantial utility because it fails to
accomplish its disclosed objective of extending the half-life of factor VIII conjugates. (D.I. 265
at 15-20). The '520 patent states that its objectives include "to provide a biocompatible
polymer-conjugated functional FVIII polypeptide having improved pharmacokinetic
characteristics [e.g., improved half-life] and therapeutic characteristics." '520 patent at 5:7-10.
Defendants do not appear to dispute that the claimed invention, a pegylated factor VIII, is a
blood coagulant. (See D.I. 265 at 14-17). Instead, Defendants assert that the claimed invention
must have a utility that offers a benefit beyond what existed in the prior art. (Id.) . They argue
that "unless the [claimed] modification leads to an improvement (e.g. , improved half-life, in the
context of the '520 patent), there is no benefit to merely retaining the activity that Factor VIII
had before modification." (D.I. 265 at 14). Specifically, Defendants argue that under Fujikawa
v. Wattanasin , 93 F.3d 1559 (Fed. Cir. 1996), Plaintiff cannot claim the benefits associated with
factor VIII or pegylated factor VIII, generally, because "[Plaintiff] did not discover Factor VIII,
19
nor PEGylated Factor VIII, nor that either Factor VIII or PEGylated Factor VIII may cause
coagulation." (D.I. 265 at 16).
Defendants misstate the law in several ways.
First, it is well-accepted that "[a] claimed invention need not accomplish all objectives
stated in the specification." Raytheon Co. v. Roper Corp., 724 F.2d 951, 958 (Fed. Cir. 1983).
The invention need only meet "at least one stated objective." Id. It is clear, from the plain
language of the specification, that one objective of the claimed invention is to provide
"functional" factor VIII polypeptides, such that they "substantially retain their coagulant
activity." '520 patent at 5:7-10, 8:15-21. There is no legal basis, for purposes of utility, to
specifically require that the claimed invention improve half-life as well.
Second, Defendants blur§ 101 utility with§ 103 nonobviousness. Unlike
nonobviousness, utility is not a comparative standard-it does not require a certain level of
usefulness relative to that which exists in the prior art. See In re Fisher, 421 F.3d at 1381-82
(Rader, J., dissenting) ("The utility requirement .. . lacks any standard for assessing the state of
the prior art and the contributions of the claimed advance. The proper tool for assessing
sufficient contribution to the useful arts is the obviousness requirement of 35 U.S.C. § 103."). A
patentee need only show substantial and specific utility. Id. at 1371. There is no requirement
that the "benefit to the public" be different or greater than that of prior inventions.
Third, Defendants misread Fujikawa. The court in Fujikawa held, "[A] patent may not
be granted to an invention unless substantial or practical utility for the invention has been
discovered and disclosed." 93 F.3d at 1563 (emphasis added). The relevant question is not
whether Plaintiff discovered a substantial utility for pegylated factor VIII generally, but whether
Plaintiff discovered a substantial utility for the claimed invention, a specific type of pegylated
20
factor VIII. Defendants assume that to do so, Plaintiff may not rely on the known utility of
pegylated factor VIII as shown by the prior art. (D.I. 265 at 16). I do not think Fujikawa
supports Defendants' argument. In fact, the court implied that a patentee should look to
analogous compounds in the prior art to establish substantial utility. See Fujikawa, 93 F.3d at
1564 ("It may be difficult to predict, however, whether a novel compound will exhibit
pharmacological activity, even when the behavior of analogous compounds is known to those
skilled in the art.").
It seems that the court in Fujikawa was primarily concerned with ensuring that a claimed
pharmaceutical compound is adequately linked to some substantial utility. That substantial
utility is met by showing any pharmacological activity. Fujikawa, 93 F.3d at 1564. Defendants
do not dispute that the claimed invention helps coagulate blood, a pharmacological activity. (See
D.I. 265 at 14-17). Therefore, I do not think there is any genuine dispute of material fact as to
whether the claimed invention meets§ 101 utility. 8
For the foregoing reasons, Plaintiffs motion for summary judgment on utility is
GRANTED.
V.
CONCLUSION
A separate order will be entered.
8
The parties do not explicitly address specific utility, but to the extent it is disputed, I find specific utility
is met. Defendants cannot reasonably argue that the claimed invention does not provide a "well-defined
and particular benefit to the public" by helping to coagulate blood and treat hemophilia A.
21
Disclaimer: Justia Dockets & Filings provides public litigation records from the federal appellate and district courts. These filings and docket sheets should not be considered findings of fact or liability, nor do they necessarily reflect the view of Justia.
Why Is My Information Online?