United States District Court, D. Delaware
FERRING PHARMACEUTICALS INC. and FERRING INTERNATIONAL CENTER S.A., Plaintiffs;
PAR PHARMACEUTICAL, INC., Defendant.
W. Bourke, Esq., WOMBLE CARLYLE SANDRIDGE & RICE, LLP,
Wilmington, DE; Dana K. Severance, Esq., WOMBLE CARLYLE
SANDRIDGE & RICE, LLP, Wilmington, DE; Daniel M. Attaway,
Esq., WOMBLE CARLYLE SANDRIDGE & RICE, LLP, Wilmington,
DE; John W. Cox, Esq., WOMBLE CARLYLE SANDRIDGE & RICE,
LLP, Atlanta, GA. Attorneys for Plaintiffs
J. Fineman, Esq., RICHARDS, LAYTON & FINGER, PA,
Wilmington, DE; Katharine C. Lester, Esq., RICHARDS, LAYTON
& FINGER, PA, Wilmington, DE; Richard J. Berman, Esq.,
ARENT FOX LLP, Washington, DC; Janine A. Carlan, Esq., ARENT
FOX LLP, Washington, DC; Taniel Anderson, Esq., ARENT FOX
LLP, Washington, DC; Ahmed Abdel-Rahman, Esq., ARENT FOX LLP,
Washington, DC. Attorneys for Defendant
AMENDED TRIAL OPINION
ANDREWS, U.S. DISTRICT JUDGE
brought this patent infringement action against Par
Pharmaceutical, Inc. on February 20, 2015. (D.I. 1).
Defendant filed an Abbreviated New Drug Application
("ANDA"), seeking to engage in the commercial
manufacture, use, and sale of a generic version of
Ferring's Prepopik product. (D.I. 170-1 at 3,
¶¶9-10). Plaintiffs allege that Defendant's
submission of this ANDA infringes U.S. Patent Nos. 8, 450,
338 ("the '338 patent") and 8, 481, 083
("the '083 patent"). (D.I. 170 at 3, ¶l)
product at issue in this case is a treatment used as
preparation for colonoscopy. (D.I. 170-1 at 2, ¶8).
Plaintiffs' Prepopik product is comprised of sodium
picosulfate, magnesium oxide, and citric acid. (Id.
at 2, ¶5). The Court held a bench trial on November 8-9,
2016. (D.I. 178, 179) ("Tr."). Prior to trial,
Defendants dismissed all invalidity defenses with prejudice.
(D.I. 165). Therefore, the only issue addressed at trial was
whether Defendant's proposed ANDA product and process
infringe the '338 and '083 patents.
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 banc), aff'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. This second
step is a question of fact. 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 of law." Bayer AG v. Elan
Pharm. Research Corp., 212 F.3d 1241, 1247 (Fed. Cir.
2000). The patent owner has the burden of proving
infringement by a preponderance of the evidence. See
Smith Kline Diagnostics, Inc. v. Helena Labs. Corp., 859
F.2d 878, 889 (Fed. Cir. 1988).
INFRINGEMENT OF THE '083 AND '338 PATENTS
assert claims 1, 4-12, and 17-18 of the '338 patent and
claims 1 and 7-11 of the '083 patent. The parties agree
that if Defendant's ANDA product meets all limitations of
claim 1 of the '338 patent and if the process by which it
makes its ANDA product meets all limitations of claim 8 of
the '338 patent, then all limitations of the asserted
dependent claims of the '338 patent are met. (D.I. 170-1
at 6-7, ¶¶34-35). Independent claim 1 is a
composition claim and reads as follows:
composition comprising sodium picosulphate coated granules
having a spray-coated layer of sodium picosulphate coating a
potassium bicarbonate core.
patent, claim 1). Claim 8 is a process claim and reads as
8. A process for the preparation of a composition according
to claim 1 wherein said process comprises steps of:
(a) spray coating a solution of sodium picosulfate on to
potassium bicarbonate; and
(b) drying the sodium picosulfate and potassium bicarbonate
thereby obtaining sodium picosulphate coated granules,
Wherein the sodium picosulfate coated granules have a layer
of sodium picosulfate coating a potassium bicarbonate core.
('338 patent, claim 8). Independent claim 7 is identical
to claim 8, with the exception of the preamble, which in
claim 7 reads, "A composition prepared by a process
comprising the steps of."
is no dispute that Defendant's ANDA product is a
composition comprising sodium picosulfate and potassium
bicarbonate. (D.I. 170-1 at 6, ¶¶29, 31). There is
also no dispute that Defendant's ANDA product contains
granules. (Id. at 6, ¶32).
parties also agree that if Defendant's ANDA product meets
all limitations of claim 1 of the '083 patent, then all
limitations of the asserted claims of the '083 patent are
met. (Id. at 7, ...