Bioverativ Inc. et al v. CSL Behring LLC et al
Filing
266
MEMORANDUM OPINION. Signed by Judge Richard G. Andrews on 3/5/2020. (nms)
Case 1:17-cv-00914-RGA-SRF Document 266 Filed 03/05/20 Page 1 of 8 PageID #: 15716
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
BIO VERA TIV INC., BIO VERATIV
THERAPEUTICS INC. , and BIO VERA TIV
U.S . LLC,
Plaintiffs,
Civil Action No. 17-914-RGA
V.
CSL BEHRING LLC, CSL BEHRING
GMBH, and CSL BEHRING LENGNAU
AG,
Defendants.
MEMORANDUM OPINION
Thomas C. Grimm and Stephen J. Kraftschik, MORRIS , NICHOLS , ARSHT & TUNNELL LLP,
Wilmington, DE; Paul H. Berghoff, Alison J. Baldwin, James C. Gumina, Sarah E. Fendrick,
James L. Lovsin, Nicole E. Grimm, Nathaniel P. Chongsiriwatana, and Daniel F. Gelwicks,
MCDONNELL BOEHNEN HULBERT & BERGHOFF LLP, Chicago, IL, Attorneys for
Plaintiffs.
Frederick L. Cottrell, III and Christine D. Haynes, RICHARDS , LAYTON & FINGER, P.A. ,
Wilmington, DE; Lisa J. Pirozzolo, Kevin S. Prussia, Emily Whelan, and Kelli J. Powell,
WILMER CUTLER PICKERING HALE AND DORR, Boston, MA, Attorneys for Defendants.
March ~
2020
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ANDREWS, ~
~~
:
Before me are five motions submitted by Bioverativ and CSL Behring. This
memorandum opinion will address Defendants' Motion for Summary Judgment oflnvalidity of
All Asserted Patent Claims. (D .I. 210). I have reviewed the parties' briefing and related papers.
(D.I. 217,227, 237). I heard oral argument on February 21, 2020. After full consideration of the
briefing, the motion is resolved as follows.
I.
BACKGROUND
Plaintiffs Bioverativ Inc. , Bioverativ Therapeutics Inc. , and Bioverativ U.S . LLC filed
this lawsuit against Defendants CSL Behring LLC, CSL Behring GmbH, and CSL Behring
Lengau AG on July 7, 2017, asserting infringement of U.S. Patent Nos. 9,670,475 ("the ' 475
patent"), 9,623,091 ("the '091 patent"), and 9,629,903 ("the ' 903 patent") (collectively, "the
Asserted Patents"). (D .I. 1). Defendants move for summary judgment of insufficient written
description and/or lack of enablement under 3 5 U.S. C. § 112 of claims 1, 14, 17-19, and 29 of
U.S . Patent No. 9,670,475; claims 1 and 22 of U.S. Patent No. 9,629,903; and claims 1 and 24 of
U.S. Patent No. 9,623 ,091.
Hemophilia B is a bleeding disorder that results from a deficiency of FIX protein that is
necessary for blood clotting. (Ex. 1, '4 75 patent at 1:62-65). Hemophilia B is treated by
administering replacement FIX "on demand" to stop active bleeding or "prophylactically" to
prevent bleeding before it occurs. (Id. at 1:65-2:1 , 12:66-13:3). The asserted claims are directed
to regimens for controlling bleeding and preventing spontaneous bleeding in patients with
hemophilia B by administering FIX fusion proteins comprising an Fe or albumin polypeptide.
(Ex. 1, '475 patent at Claim 1, 14, 17-19, 29; Ex. 2, ' 903 patent at Claims 1, 22; Ex. 3, '091
patent at Claims 1, 24).
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Plaintiffs ' Alprolix and Defendants ' accused product Idelvion are both extended half-life
FIX products approved by the United States Food and Drug Administration for on-demand
treatment and prophylaxis. (Ex. 26, Alprolix Label at 1; Ex. 27, Idelvion Label at 1). Alprolix is
a recombinant fusion protein in which FIX is fused to an Fe domain of a human immunoglobulin
antibody . (Ex. 26, Alprolix Label at 13). Idelvion is a recombinant fusion protein in which FIX is
fused to another protein, human serum albumin, via a linker that is cleaved by the same enzyme
that activates FIX in the coagulation process. (Ex. 27, Idelvion Label at 4).
The Asserted Patents share a common specification and claim priority to a provisional
application filed on July 9, 2010. (Ex. 1, '475 patent; Ex. 2, '903 patent; Ex. 3, ' 091 patent). For
the purposes of the enablement and written description analysis, I will consider the '475 patent
and its specification to be representative of all of the patents-in-suit.
II.
LEGALSTANDARD
"The 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)). When 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).
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III.
DISCUSSION
Defendants ask the court for summary judgment of invalidity for lack of written
description and no enablement. (D.I. 217 at 1). Plaintiffs assert that genuine issues of material
fact preclude summary judgment. (D.I. 227 at 2). I agree with Plaintiffs. Because I find that the
same issues of material fact preclude summary judgment on the basis of both written description
and enablement, I will discuss them together.
Defendants assert that summary judgment of invalidity for lack of written description
should be entered for the patents in suit because Plaintiffs' patents do not contain adequate
written description for the claimed methods of using the vast number of chimeric FIX
polypeptides that the inventors never made or tested. (D.I. 217 at 8) . Plaintiffs assert that the
written description requirement is fulfilled because the asserted claims are sufficiently described
by the specification, particularly when viewed with the knowledge of a person of skill in the art.
(D.I. 227 at 2).
The written description requirement contained in 35 U.S.C. § 112, 1 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. In c. , v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir.
2010) (en bane) (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
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description by clear and convincing evidence." Vasudevan Software, Inc. v. MicroStrategy, Inc.,
782 F.3d 671 , 682 (Fed. Cir. 2015).
With respect to the enablement requirement, Defendants argue that Plaintiffs ' patents do
not enable a skilled artisan to make and use the full scope of the claimed methods without undue
experimentation. (D.I. 217 at 13). Plaintiffs contend that a skilled artisan would not require
undue experimentation in order to practice Plaintiffs ' claims over their full scope because the
dosing information is stated in the claims, along with how to make and use the chimeric FIX
polypeptides, which are comprised of components well-characterized in the prior art. (D.I. 227 at
12).
The enablement requirement, considered a separate and distinct requirement contained in
35 U.S.C. § 112, , 1, 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.
In re Wands, 858 F.2d 731 , 737 (Fed. Cir. 1988). "A party must prove invalidity for lack of
enablement by clear and convincing evidence." Vasudevan, 782 F.3d at 684.
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The asserted claims cover methods of treating hemophilia B "with a vast genus of
chimeric FIX polypeptides," according to Defendants, "including a class of FIX-albumin
polypeptides for which the specification contains no working examples or information." (D.I.
217 at 14). Defendants argue that the written description is insufficient due to the sheer breadth
of the claims, which they contend include "at least millions" of chimeric FIX polypeptides. (Id. ;
citing Ex. 4, Camire Dep. at 90 :12-91:8; Ex. 12, Pierce Dep. at 218:14-219:10). Defendants
assert that the claims lack written description because a skilled artisan "could not predict whether
a chimeric FIX polypeptide meeting the structural limitations would meet the functional
limitations of the claims based on the amino acid sequence." (D.I. 217 at 6). Defendants contend
that the asserted claims are not limited to the administration of FIX polypeptides "consisting of'
only an FcRn binding partner, but instead use the open-ended term "comprising." (D.I. 237 at 2).
Therefore, the asserted claims encompass chimeric proteins that could include "not only variants
of each component part (i. e., FIX, Fe, and albumin) in a multitude of configurations, but also an
unlimited number of additional components." (Id.). As such, a skilled artisan could not envision
the claimed genus with reference to the structural features alone. (Id. at 4).
Plaintiffs assert that Defendants' written description argument fails to consider a skilled
artisan' s knowledge of the prior art. (D.I. 227 at 3). Information that is well known in the art
need not be described in detail in the specification. Ajinomoto Co. v. ITC, 932 F.3d 1342, 1359
(Fed. Cir. 2019) ("a patentee may rely on information that is well-known in the art for purposes
of meeting the written description requirement, because the specification is viewed from the
perspective of [a skilled artisan]. ") (cleaned up) . According to Plaintiffs, a skilled artisan would
have been aware of the representative species of chimeric FIX-albumin fusions and could
"immediately visualize the members of the genus as containing FIX and albumin or Fe and
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variants thereof." (D.I. 227. at 4, 8). Plaintiffs point to the Schulte and Metzner scientific
publications I to establish prior art supporting that a skilled artisan would have been aware of the
FIX-albumin constructs taught therein. (Id. at 3).
Plaintiffs also argue that the enablement requirement is satisfied because, after
accounting for the required biological functionality, a skilled artisan would not have to make and
test chimeric polypeptides meeting the structural limitations of the asserted claims to determine
the scope of the genus because the scope is already limited only to those species with functional
FIX, Fe, and albumin components. (Id. at 9, 19). To fall within the scope of the recited genus,
Plaintiffs argue that a chimeric FIX polypeptide must not only comprise FIX and either albumin
or Fe but must also be biologically functional. (Id. at 10). Plaintiffs state that the claim
constructions require that the chimeric FIX polypeptides comprise (1) FIX functional in its
normal role in coagulation and (2) albumin or Fe able to be bound by and transported by FcRn.
(Id. at 8, citing D.I. 122).
The written description requirement demands that persons of ordinary skill in the art be
able to recognize that the inventor invented what is claimed. See Ariad Pharm., 598 F.3d at
1351. Here, there is a genuine dispute as to the scope of the genus described in the claims and
whether a skilled artisan could envision the claimed genus with reference to its structural features
alone. See, e.g., D.I. 237 at 2-4. The parties meaningfully disagree about whether a skilled artisan
could determine whether certain chimeric FIX polypeptides would meet the functional
limitations of the asserted claims such that the inventor' s possession over the claimed subject
matter would be clear. See id. at 4, 8-9; D.I. 227 at 17-18.
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Schulte is incorporated by reference into the specification. Metzner is cited in Schulte.
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Similar to their arguments for sufficient written description, Plaintiffs attempt to satisfy
the enablement requirement of § 112 largely in reliance on their assessment of a skilled artisan's
knowledge of the prior art. See, e.g., D.I. 227 at 14, 16.
A specification that requires a skilled artisan to "engage in an iterative, trial-and-error
process to practice the claimed invention" does not provide an enabling disclosure. Idenix
Pharms. LLC v. Gilead Scis., Inc. , 941 F.3d 1149, 1161 (Fed. Cir. 2019). With regards to the
presence of absence of working examples and the amount of direction or guidance presented to
one skilled in the art, Plaintiffs assert that because all of the species within the recited genus of
chimeric FIX polypeptides share key structural similarities, the asserted claims are fully
supported by "relatively few representative examples or formulas ." (D.I. 227 at 5-6). Plaintiffs
suggest that undue experimentation is not necessary here where, "Based on the substantial
information in the prior art, a POSA would have had reasonable confidence that any embodiment
falling within the scope of the claims could be made and used according to the teachings of the
specification." (Id. at 16). However, there remains a genuine dispute of material fact as to the
nature of the alleged invention and the scope of the claims, specifically, the size of the genus of
claimed chimeric FIX polypeptides.
Therefore, I will deny Defendants' motion for summary judgment of lack of written
description and for lack of enablement.
IV.
CONCLUSION
For the reasons discussed above, I will deny Defendants' motion. An accompanying
order will be entered.
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