Amgen Inc. v. Amneal Pharmaceuticals et al

Filing 300

MEMORANDUM re #294 . Signed by Judge Mitchell S. Goldberg on 2/27/18. (gvw)

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE

AMGEN INC.,
Plaintiff,
v.
AUROBINDO PHARMA LTD., et al.,
Defendants.

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Civ. No. 16-853-GMS
CONSOLIDATED

MEMORANDUM
Pending before me are several evidentiary issues raised by the parties in connection with
a patent infringement trial commencing on March 5, 2018. (D.I. 294-1, Ex. 8 & Ex. 8.1). I will
address two of these evidentiary issues below.
I.

CLAIM CONSTRUCTION
In the Proposed Joint Pretrial Order, Plaintiff Amgen, Inc. (“Amgen”) argues that the

Markush groups in the binder and disintegrant limitations should be “open sets.”

(D.I. 294-1,

Ex. 8 at ¶ 2(b)). Amgen also urges that Defendants should be precluded from raising any claim
construction issues, and that the time to raise this issue was at the Markman hearing. Id. at ¶ 2.
Conversely, Defendants urge that the Markush groups are “closed.” (D.I. 294-1, Ex. 7.1 at p.
318-19, ¶¶ 32-33).
Claim construction is a “fluid process,” Cadence Pharma., Inc. v. Innopharma Licensing
LLC, 2016 WL 3661751, at *3 n.2 (D. Del. July 8, 2016), and that process is “not final until
judgment is entered,” Eaton Corp. v. Parker-Hannifin Corp., 292 F. Supp. 2d 555, 572 n.2 (D.

Del. 2003). Until then, “[t]he court may re-construe the claims if it finds the original claim
construction to be in error based upon a more developed record,” and/or “may add claim
constructions for terms that become disputed through the course of trial.” Eaton Corp., 292 F.
Supp. 2d at 572 n.2.
Here, the claim construction issues Defendants now raise appear to have developed after
the Markman hearing. Because these issues will substantially effect how the parties present their
theories of infringement or non-infringement at trial, I will resolve this dispute now.
Independent claims 1 and 20 of United States Patent No. 9,375,405 (“the ’405 patent”)
contain three Markush groups defining the list of excipients permitted for use as diluents,
binders, and disintegrants. (D.I. 294-1, Ex. 7.1 at p. 36, ¶ 21).
Claim 1 states:
(1)

A pharmaceutical composition comprising:

(a)
from about 10% to about 40% by weight of cinacalcet HCl in an
amount of from about 20 mg to about 100 mg;
(b)
from about 45% to about 85% by weight of a diluent selected from
the group consisting of microcrystalline cellulose, starch, dicalcium phosphate,
lactose, sorbitol, mannitol, sucrose, methyl dextrins, and mixtures thereof;
(c)
from about 1% to about 5% by weight of at least one binder
selected from the group consisting of povidone, hydroxypropyl methylcellulose,
hydroxypropyl cellulose, sodium carboxymethylcellulose, and mixtures thereof;
and
(d)
from about 1% to 10% by weight of at least one disintegrant
selected from the group consisting of crospovidine (sic), sodium starch glycolate,
croscarmellose sodium, and mixtures thereof, wherein the percentage by weight is
relative to the total weight of the composition, and wherein the composition is for
the treatment of at least one of hyperparathyroidism, hyperphosphonia,
hypercalcemia, and elevated calcium phosphorus product.
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(D.I. 294-1, Ex. 7 at 4).
A Markush group “lists alternative species or elements that can be selected as part of the
claimed invention.” Multilayer Stretch Cling Film Holdings, Inc. v. Berry Plastics Corp., 831
F.3d 1350, 1357 (Fed. Cir. 2016). It is typically expressed in the form: “a member selected from
the group consisting of A, B and C.” Abbott Labs. V. Baxter Pharm. Prods., Inc., 334 F.3d 1274,
1280 (Fed. Cir. 2003). “The members of the Markush group (A, B, and C in the example above)
ordinarily must belong to a recognized physical or chemical class or to an art-recognized class.”
Manual of Patent Examining Procedure § 803.02. By claiming a Markush group, a patentee “has
indicated that, for the purpose of claim validity, the members of the claimed group are
functionally equivalent.” Ecolochem, Inc. v. S. Cal. Edison Co., 1996 WL 297601, at *2 (Fed.
Cir. June 5, 1996); see also In re Driscoll, 562 F.2d 1245, 1249 (CCPA 1977) (“It is generally
understood that ... the members of the Markush group ... are alternatively usable for the purposes
of the invention.”).
As noted above, the parties dispute whether the Markush groups for the binder and
disintegrant elements in the ’405 patent are closed. (D.I. 294-1, Ex. 8 at ¶ 2(b)). Amgen argues
that, even if the Markush groups are closed, it may still rely on the doctrine of equivalents to
demonstrate infringement of the binder and disintegrant elements. (D.I. 298).
A. The Markush Groups Are Closed
“Use of the transitional phrase ‘consisting of’ to set off a patent claim element creates a
very strong presumption that that claim element is ‘closed’ and therefore ‘excludes any elements,
steps, or ingredients not specified in the claim.’” Multilayer, 831 F.3d at 1358 (quoting AFG
Indus., Inc. v. Cardinal IG Co., 239 F.3d 1239, 1245 (Fed. Cir. 2001) (internal brackets omitted).
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Shire Dev., LLC v. Watson Pharma., Inc., 848 F.3d 981, 986 (Fed. Cir. 2017) (quoting
Multilayer, 831 F.3d at 1359) (“consisting of” or “ consists of” creates a very strong presumption
that the claim is closed).

“Overcoming this presumption requires ‘the specification and

prosecution history’ to ‘unmistakably manifest an alternative meaning,’ such as when the
patentee acts as its own lexicographer.” Watson, 848 F.3d at 984 (quoting Multilayer, 831 F.3d
at 1359).
Amgen argues that the Markush groups for the binder and disintegrant elements are open,
because the preamble to claims 1 and 20 use the term “comprising.” (See D.I. 294-1, Ex. 7 at p.
226 (stating “[a] pharmaceutical composition comprising”); D.I. 298 at 2). The transitional term
“‘comprising’ can create a presumption that the recited elements are only a part of the device,
[and] that the claim does not exclude additional, unrecited elements.” Multilayer, 831 F.3d at
1358 (quoting Crystal Semiconductor Corp. v. TriTech Microelectronics Int’l, Inc., 246 F.3d
1336, 1348 (Fed. Cir. 2001)). Thus, I must determine the effect of the presumably open-ended
term “comprising” in the preamble in conjunction with the presumably closed Markush groups in
the body of the claim.1

1

Several cases cited by Amgen do not address claims containing both the term
“comprising” and a Markush group. See, e.g., Mannesmann Demag Corp. v. Engineered Metal
Prods. Co., 793 F.2d 1279, 1282 (Fed. Cir. 1986); In re Crish, 393 F.3d 1253 (Fed. Cir. 2004).
Mannesmann and Crish affirmed the basic proposition that, with the term “comprising,” a
defendant does not defeat infringement by showing that its composition contains additional
unrecited elements. Mannesmann, 793 F.2d at 1282; Crish, 393 F.3d at 1257. But the additional
unrecited elements in those cases were not alternatively used for the purposes of the Markush
group members. For example, in Mannesman, the additional unrecited elements—the “slagstopping and backbone bars”—were not alternative species of the recited claim element—the
cooling pipe coil. 793 F.2d at 1282.
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The Federal Circuit recently addressed this issue in Multilayer, 831 F.3d 1350. There,
the patent claimed a Markush group for resins, stating in relevant part:
A multi-layer, thermoplastic stretch wrap film containing seven separately
identifiable polymeric layers, comprising:
….
(b) five identifiable inner layers, with each layer being selected from the group
consisting of linear low density polyethylene [“LLDPE”], very low density
polyethylene [“VLPDE”], ultra low density polyethylene [“ULDPE”], and
metallocene-catalyzed linear low density polyethylene [“mLLDPE”] resins;
said resins are homopolymers, copolymers, or terpolymers, of ethylene and C3
to C20 alpha-olefins;
Id. at 1353. “The district court construed element (b) as closed to unrecited resins—i.e., types of
resin other than LLDPE, VLDPE, ULDPE, and mLLDPE.” Id. at 1358. Before evaluating
whether the plaintiff had overcome the “very strong presumption” that the Markush groups were
closed, the court explained what a closed Markush group meant. “[I]f a patent claim recites ‘a
member selected from the group consisting of A, B, and C,’ the ‘member’ is presumed to be
closed to alternative ingredients D, E, and F.” Id. The court explained, that to construe the
Markush group “as open not only to the four recited resins but also to any other polyolefin resin
conceivably suitable for use in a stretchable plastic cling film … would render the ’055 patent’s
Markush language—‘each layer being selected from the group consisting of’—equivalent to the
phrase ‘each layer comprising one or more of.’” Id.
The claim terms in Multilayer,—i.e., use of “comprising” in the preamble and a Markush
group with the transitional phrase “consisting of”—are similar to the claim terms before me.
And, I am, of course, bound by Federal Circuit precedent. Accordingly, there is a very strong
presumption that the binder and disintegrant elements in the ’405 patent are closed to unrecited

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binders and disintegrants unless Amgen points to sufficient evidence to overcome this
presumption.
In Multilayer, plaintiff pointed to the specification of the ’055 patent as evidence of “an
unmistakable intent to open the Markush group of element (b) to unrecited resins.” Id. at 1359.
Several passages of the specification, including three dependent claims and two of the three
embodiments, described inner layers with unrecited resins.

Id. at 1359-60.

The court

nevertheless concluded that “the specification of the ’055 patent, including its dependent claims,
[was] insufficient to overcome the very strong presumption, created by the patent’s use of the
transitional phrase ‘consisting of,’ that the Markush group of element (b) is closed to resins other
than the four recited.” Id. at 1360-61.
Here, Amgen is unable to point to anything, other than the use of “comprising” in the
preamble, to support its argument that the Markush groups for the binder and disintegrant
elements are open to unrecited elements. Considering that the evidence in Multilayer, which
specifically described the use of unrecited resins, was not enough to overcome the presumption,
what Amgen offers in comparison cannot be enough, particularly when Multilayer similarly used
“comprising” in the preamble. Accordingly, I conclude that Amgen has not overcome the very
strong presumption that the Markush groups for the binder and disintegrant elements are closed
to unrecited binders and disintegrants.
In reaching the above conclusion, I have considered that, when examining similar
language, the court in Maxma v. ConocoPhillips, Inc., 2005 WL 1690611 (E.D. Tex. July 19,
2005), took a different tack. In Maxma, a Texas district court addressed a Markush group for
carrier liquid. The claim stated in relevant part:
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In a fuel additive for a hydrocarbon fuel, the composition comprising:
(a) at least 90 wt. % of a carrier liquid selected from the group consisting of a
hydrocarbon fraction in the kerosene boiling range having a flash point of at
least 100 F. and an auto-ignition temperature of at least 400 F., a C1–C3
monohydric, dihydric, or polyhydric aliphatic alcohol, and mixtures thereof;
Id. at *4. Based on the open-ended “comprising” in the preamble, the court concluded that “the
presence of the recited composition will infringe the claim, even if other structures or ingredients
are also present.” Id. at *5. Thus, the plaintiffs had to “prove the presence of one of the
members of the [Markush] group” for carrier liquid. Id. But “the [additional] presence of some
unlisted ingredient in the accused product that otherwise meets the court’s definition of a carrier
liquid” would not defeat infringement. Id. In other words, the court rejected defendant’s
argument that the closed Markush group meant the “accused composition may include only one
of the recited carrier fluids.” Id. Under the rules laid out in Maxma, if the claim recited “a
member selected from a group consisting of A, B, and C,” then a defendant’s composition met
the claim limitation if it included member “A” as well as unlisted member “D.” As a result,
Maxma is not consistent with the rules of construction outlined in Multilayer. More importantly,
Maxma pre-dates Multilayer and, therefore, did not apply the “very strong presumption” that
Markush groups are closed. Multilayer, 831 F.3d at 1358; see also Watson, 848 F.3d at 986
(referring to the presumption as “exceptionally strong”). Given the above, I decline to follow
Maxma on this particular issue.
Finally, I note that there are only a few instances where defendants use as binders or
disintegrants both a recited member and unrecited alternative. There are a greater number of
instances where defendants use only an unrecited alternative, and Amgen has cited no case
showing that even an “open” Markush group would allow it to prove that Defendants’
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composition meets the Markush group limitation based on unrecited alternatives only. Indeed,
even in Maxma, the court was clear that plaintiff could not discharge its burden by
“establish[ing] [only] the presence of a substance meeting the court’s definition of ‘carrier
liquid’ that is not within the group of listed alternatives.” Id.; see also Bristol-Myers Squibb Co.
v. Mylan Pharms. Inc., 2013 U.S. Dist. LEXIS 188207, at *23 (D. Del. Oct. 17, 2013) (allowing
the x-ray powder diffraction pattern to include additional 2θ values, but requiring that the x-ray
powder diffraction pattern include at least six of the eleven 2θ values, as required by the
Markush group language).
B. The Doctrine of Equivalents
Amgen also argues that even if the Markush groups are closed, it may still prove
infringement under the doctrine of equivalents. “[T]he [claim] drafter’s choice of the phrase
‘consisting of’ does not foreclose infringement under the doctrine of equivalents.” Vehicular
Techs. v. Titan Wheel Int’l, 212 F.3d 1377, 1383 (Fed. Cir. 2000). Thus, it appears that a
patentee may still rely on the doctrine of equivalents to prove infringement of an element
containing a closed Markush group. See, e.g., Intervet Inc. v. Merial Ltd., 617 F.3d 1282, 1286,
1290-1292 (Fed. Cir. 2010) (holding that a district court “erred in…barring the doctrine of
equivalents from its infringement analysis” of a claim covering “[a] vector comprising an
isolated DNA molecule comprising a sequence selected from the group consisting of ORFs 1 to
13 of porcine circovirus type II”); E.I. Du Pont de NeMours & Co. v. Heraeus Precious Metals
N. Am. Conshohocken LLC, 2013 WL 2659533, at *3 (D. Or. June 7, 2013) (rejecting an
argument that plaintiff was “foreclosed” from arguing that any compound not listed in a claimed
Markush group was an equivalent).
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Given the above, Amgen is not precluded from relying on the doctrine of equivalents to
prove that a defendant infringed the binder or disintegrant elements, even though the Markush
group for those elements are closed.2
II.

LATE IDENTIFIED WITNESS
In the parties’ Proposed Joint Pretrial Order, defendant Dr. Reddy’s Laboratories
(“DRL”) identified Movva Snehalatha (“Snehalatha”) as a potential witness that “may be called
at trial.” (D.I. 293-1, Ex. 4.1). Amgen argues that DRL should either be precluded from calling
Snehalatha as witness, because DRL failed to timely identify her or, be ordered to produce
Snehalatha for a deposition in advance of trial. (D.I. 294-1, Ex. 8 at ¶ 1(d)).
Fed. R. Civ. P. 26(a)(1) provides that, early in the case, a party must disclose “the name
... of each individual likely to have discoverable information—along with the subjects of that
information—that the disclosing party may use to support its claims or defenses.” Fed. R. Civ.
P. 26(a)(3) provides that a party must “promptly” disclose the name of a witness it may present
at trial other than solely for impeachment. Finally, Fed. R. Civ. P. 26(e) states that a party must
supplement its disclosures in a “timely manner.” If a party fails to timely identify a witness as
required by Fed. R. Civ. P. 26(a) or (e), “the party is not allowed to use that … witness to supply
evidence … at a trial, unless the failure was substantially justified or is harmless.” Fed. R. Civ.
P. 37(c)(1). It is left to the trial court’s discretion to determine whether a party provides

2

The court is aware that Defendants plan to present several arguments as to why Amgen
cannot invoke the doctrine of equivalents, including prosecution history estoppel. Nothing herein
should be construed as precluding or prejudging those arguments.
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substantial justification for their delay or if the delay is harmless. M. Eagles Tool Warehouse,
Inc. v. Fisher Tooling Co., 2007 WL 979854, at *12 n. 12 (D.N.J. Mar. 30, 2007). In exercising
its discretion, the court should consider: “(1) the prejudice or surprise in fact to the opposing
party, (2) the ability of the party to cure the prejudice, (3) the extent of disruption of the orderly
and efficient trial of the case, and (4) the bad faith or willfulness of the non-compliance.”
Stambler v. RSA Sec., Inc., 212 F.R.D. 470, 471 (D. Del. 2003) (quoting Greate Bay Hotel &
Casino v. Tose, 34 F.3d 1227, 1236 (3d Cir. 1994)).
As no testimony has been taken, I do not yet have the necessary context of Snehalatha’s
testimony. Nor do I know when Snethalatha was first identified as a witness, or why she was not
identified earlier. That said, and in order to avoid further conflict on this issue, Snehalatha shall
be produced for deposition before to March 5, 2018. See Impax Labs. Inc. v. Lannett Holdings
Inc., 2016 WL 9240617, at *1 (D. Del. Aug. 24, 2016) (allowing late-identified witness to testify
at trial where opposing party was amenable to a pre-trial deposition as a remedy).
III.

CONCLUSION
An order consistent with this memorandum will be entered.

/s/ Mitchell S. Goldberg
Dated: February 27, 2018

____________________________________
MITCHELL S. GOLDBERG, J.

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