United States District Court, D. Delaware
KYOWA HAKKA BIO, CO., LTD, BIOKYOWA, INC., KYOWA HAKKA BIO U.S. HOLDINGS, INC., and KYOWA HAKKO U.S.A., INC., Plaintiffs,
AJINOMOTO CO., INC., AJINOMOTO ANIMAL NUTRITION GROUP, INC., AJINOMOTO NORTH AMERICA, INC. AJINOMOTO HEARTLAND, INC. and AJINOMOTO WINDSOR, INC., Defendants.
Kyowa Hakko Bio Co., Ltd, BioKyowa, Inc., Kyowa Hakko Bio
U.S. Holdings, Inc., and Kyowa Hakko U.S.A., Inc.
(collectively, “Plaintiffs”) allege infringement
of their U.S. Patent No. RE 45, 723, entitled “Process
for Producing Amino Acids” by Defendants Ajinomoto Co.,
Inc., Ajinomoto Animal Nutrition Group, Inc., Ajinomoto North
America, Inc., Ajinomoto Heartland, Inc., and Ajinomoto
Windsor, Inc. (collectively, “Defendants”).
Presently before me is Defendants' Motion to Dismiss the
Complaint. For the following reasons, the Motion will be
FACTUAL ALLEGATIONS IN THE COMPLAINT
Kyowa Hakko Bio, Co., Ltd. (“KHB”) and BioKyowa
(“BioKyowa”) are biochemical companies that
provide amino acids and other high value-added functional
materials for inclusion in pharmaceutical, medical treatment,
healthcare, dietary supplement, and cosmetic products.
Plaintiff Kyowa Hakko U.S.A., Inc. (“KHU”)
markets and sells the products of KHB and BioKyowa in the
United States. BioKyowa and KHU are wholly owned subsidiaries
of Plaintiff Kyowa Hakko Bio U.S. Holdings, Inc.
(“KHH”). In turn, KHH is a wholly owned
subsidiary of KHB. (Id. ¶¶ 8, 9, 11.)
Ajinomoto Heartland, Inc. (“AH”) principally
imports, manufactures, and sells animal nutrition products
under the general direction of Defendants Ajinomoto Co., Ltd.
(“AJ”) and Ajinomoto Animal Nutrition Group, Inc.
(“AANG”). Defendant Ajinomoto North America, Inc.
(“ANA”) is a wholly owned subsidiary of AJ and
principally imports, manufactures, and sells cosmetic, human
food, human nutritional, or pharmaceutical product
applications under the general direction and control of AJ.
Defendant Anjinomoto Windsor, Inc. (“AW”)
principally imports, manufactures, and sells food products.
Defendants are all members of the Ajinomoto Group and are
controlled and managed by AJ. (Id. ¶¶
patent-in-suit, U.S. Patent No. RE 45, 723 (the
“‘723 patent”) was issued by the United
States Patent and Trademark Office on October 6, 2015.
Plaintiff Kyowa Hakka Bio Co., Ltd. (“KHB”) is
the owner, by valid assignment of the entire right, title,
and interest in and to the ‘723 patent. KHB has
authorized BioKwoya, Inc. (“BioKwoya”) and KHU to
use the inventions claimed in the ‘723 patent.
(Id. ¶¶ 42-43, 46-47.)
one of the ‘723 patent (as amended during reissue
proceedings) sets forth a process for making amino acids, as
1. A process for producing an amino acid, which comprises:
[a] culturing a microorganism having an ability to produce
the amino acid in a medium,
[b] adding crystals of the amino acid having an average
particle size of 7 to 50 μm to the medium at some time
after the amino acid concentration in the medium reaches the
saturation solubility and before crystals of the amino acid
deposit in the medium so that the concentration of the
crystals of the amino acid becomes 0.5 g/l or more,
[c] culturing the microorganism having the ability to produce
the amino acid in the medium, [d] allowing the crystals of
the amino acid to grow to crystals of the amino acid having
an average particle size of 30 μm or more and accumulate
in the medium, and [e] recovering the crystals of the amino
acid from the culture by separating the microorganism
producing the amino acid and the accumulated crystals of the
amino acid based on the difference in particle size or
specific gravity between them.
(Id. ¶ 48.)
is the same as claim 1 except that, in claim 1, the
“adding crystals” step [b] concludes “so
that the concentration of the crystals of the amino acid
becomes 0.5 g/l or more, ” while, in claim 2, the
“adding crystals” step [b] concludes “so
that the total surface area of the crystals of the amino acid
in the medium becomes 0.02 m2/1 or more.” (Id.
¶ 49.) Steps [b] - [e] of Claims 1 and 2 define a
particular type of Direct Crystal Precipitation
(“DCP”) process. (Id. ¶ 50.)
Infringement Allegations and Procedural
filed their patent infringement suit on March 23, 2017. The
Amended Complaint alleges that Defendants, acting as a single
business enterprise, are liable for various acts of
infringement through the sale of the “Accused Products,
” which are defined as
the amino acids L-glutamine, L-glutamic acid, L-tryptophan,
and L-valine, and monosodium glutamate (which is a sodium
salt of L-glutamic acid) and other products incorporating one
of those amino acids, which (a) were offered for sale, sold,
made or used in the United States by one or more of the
Defendants or entities under the control of a Defendant, and
(b) . . . were made using a method as claimed or in
equivalent to any of claims 1, 2, 7, and 8 of the ‘723
patent, either in the United States, or outside the United
States and imported into the United States.
(Id. ¶ 2.) The Amended Complaint sets forth
claims of direct infringement, vicarious infringement,
inducement of infringement, and infringement by importing or
selling the Accused Product into the United States.
(Id. ¶¶ 64-67.)
moved to dismiss the Amended Complaint on August 21, 2017.
Plaintiffs filed a response on September 5, 2017, Defendants
submitted a reply brief on October 11, 2017, and Plaintiffs
filed a notice of subsequent authority on October 31, 2017.
STANDARD OF REVIEW
Federal Rule of Civil Procedure 12(b)(6), a defendant bears
the burden of demonstrating that the plaintiff has not stated
a claim upon which relief can be granted. Fed.R.Civ.P.
12(b)(6); see also Hedges v. United States, 404 F.3d
744, 750 (3d Cir. 2005). The United States Supreme Court has
recognized that “a plaintiff's obligation to
provide the ‘grounds' of his ‘entitle[ment]
to relief' requires more than labels and
conclusions.” Bell Atl. Corp. v. Twombly, 550
U.S. 544, 555 (2007) (quotations omitted).
“[T]hreadbare recitals of the elements of a cause of
action, supported by mere conclusory statements, do not
suffice” and “only a complaint that states a
plausible claim for relief survives a motion to
dismiss.” Ashcroft v. Iqbal, 556 U.S. 662, 678
(2009). “A claim has facial plausibility when the
plaintiff pleads factual content that allows the court to
draw the reasonable inference that the defendant is liable
for the misconduct alleged.” Id. A complaint
does not show an entitlement to relief when the well-pleaded
facts do not permit the court to infer more than the mere
possibility of misconduct. Id.
United States Court of Appeals for the Third Circuit has
detailed a three-step process to determine whether a
complaint meets the pleadings standard. Bistrian v.
Levi, 696 F.3d 352 (3d Cir. 2014). First, the court
outlines the elements a plaintiff must plead to state a claim
for relief. Id. at 365. Next, the court must
“peel away those allegations that are no more than
conclusions and thus not entitled to the assumption of
truth.” Id. Finally, the court “look[s]
for well-pled factual allegations, assume[s] their veracity,
and then ‘determine[s] whether they plausibly give rise
to an entitlement to relief.'” Id.
(quoting Iqbal, 556 U.S. at 679). The last step is
“a context-specific task that requires the reviewing
court to draw on its judicial experience and common
sense.” Id. (quoting Iqbal, 556 U.S.
the sufficiency of complaints involving claims of direct
infringement were previously analyzed under Federal Rule of
Civil Procedure 84 and the Appendix of Forms, those rules
were abrogated effective December 1, 2015. Raindance
Techs., Inc. v. 10x Genomics, Inc., No. 15-150, 2016 WL
927143, at *2 (D. Del. Mar. 4, 2016). It is now well
established that both direct and indirect infringement claims
are subject to the Twombly/Iqbal standard.
IP Commc'n Solutions, LLC v. Viber Media (USA)
Inc., No. 16-134, 2017 WL 1312942, at *2 (D. Del. Apr.
5, 2017); RAH Color Techs. LLC v. Ricoh USA Inc.,
194 F.Supp.3d 346, 350-51 (E.D. Pa. 2016).
Infringement Under the Doctrine of
first move to dismiss Plaintiffs' cause of action for
direct infringement. Upon review, I find that the Amended
Complaint adequately states a claim upon which relief may be
direct infringement of a patent occurs when a party, without
authority, “makes, uses, offers to sell, or sells any
patented invention, within the United States. . . .” 35
U.S.C. § 271(a). A patentee may prove direct
infringement under § 271(a) either by (1) demonstrating
specific instances of direct infringement; or (2) showing
that an accused device necessarily infringes on the patent.
ACCO Brands, Inc. v. ABA Locks Mfrs. Co., 501 F.3d
1307, 1313 (Fed. Cir. 2007).
order to plead a cause of action for direct infringement of a
method claim, the complaint must allege that the accused
infringer “perform[ed] all the steps of the claimed
method, either personally or through another acting under his
direction or control.” Courtesy Prods, LLC v.
Hamilton Beach Brands, Inc., 73 F.Supp.3d 435, 439 (D.
Del. 2014). In other words “[d]irect infringement
requires a single party to perform every step of a claimed
method.” Forest Labs. Holdings Ltd. v. Mylan,
Inc., 206 F.Supp.3d 957, 973 (D. Del. 2016).
literal infringement is not present, however, a Plaintiff may
prove direct infringement via the doctrine of equivalents,
i.e., where the accused product is the substantial
equivalent of the patented invention. See
Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S.
17, 24 (1997). “Application of the doctrine of
equivalents may allow a patentee to recover for infringement
even though the accused device falls outside of the literal
scope of the claims, but only where the differences between
the innovation and the accused products are
insubstantial.” Highland Tank & Mfg. Co. v. PS
Int'l, Inc., 742 F.Supp.2d 722, 728 (W.D. Pa. 2010).
determine whether an accused device infringes under the
doctrine of equivalents, a court examines the differences
between the claimed invention and the accused device.
Dawn Equip. Co. v. Kentucky Farms, Inc., 140 F.3d
1009, 1015-16 (Fed. Cir. 1998). This inquiry generally
involves determining whether “the element of the
accused device at issue performs substantially the same
function in substantially the same way, to achieve
substantially the same result, as the limitation at issue in
the claim.” Id. at 1016 (describing the
“function/way/result” inquiry). Each element
contained in a patent claim is deemed material to defining
the scope of patented invention. Thus, the doctrine of
equivalents must be applied to individual elements of claim,
not to the invention as a whole. Warner-Jenkinson,
520 U.S. at 29.
Amended Complaint here sets forth a direct infringement claim
by alleging that:
65. Upon information and belief, the process used by ANA to
produce glutamic acid at its plant in Eddyville, Iowa
includes steps literally corresponding to each of steps [a]
and [c]-[e] of claims 1 and 2 of the ‘723 patent . . .
66. Upon information and belief, the process used by ANA to
produce glutamic acid at its plant in Eddyville, Iowa
includes a step literally corresponding to or the equivalent
of adding seed crystals of glutamic acid to cause
precipitation of glutamic acid crystals as ...