United States District Court, D. Delaware
B. Blumenfeld, Esquire and Derek J. Fahnestock, Esquire of
Morris, Nichols, Arsht & Tunnell LLP, Wilmington,
Delaware. Counsel for Plaintiffs. Of Counsel: Nicolas
Barzoukas, Esquire, Joshua Davis, Esquire, Kevin E. Cadwell,
Esquire, and Lisa M. Thomas, Esquire of Reed Smith LLP.
Shea Gaza, Esquire, Robert M. Vrana, Esquire, and Samantha G.
Wilson, Esquire of Young Conaway Stargatt & Taylor, LLP,
Wilmington, Delaware. Counsel for Defendant. Of Counsel:
Constance S. Huttner, Esquire, Michael H. Imbacuan, Esquire,
Stephanie J. Kamerow, Esquire, Caroline Sun, Esquire of Budd
ROBINSON District Judge
action arises out of the filing of Abbreviated New Drug
Application ("ANDA") No. 207989 by defendant Amneal
Pharmaceuticals LLC ("Amneal") seeking to produce
and market a generic mometasone furoate nasal spray. (D.I.
56) On March 20, 2015, plaintiff Merck Sharp & Dohme
Corp. ("Merck") brought this action alleging
infringement of U.S. Patent No. 6,127,353 ("the '353
patent"). (D.I. 1) Merck filed an amended complaint
on September 4, 2015, which Amneal answered on September 18,
2015. (D.I. 56; D.I. 59) The court held a Markman
hearing on July 31, 2015 and issued a claim construction
order on September 3, 2015, construing certain disputed
limitations. (D.I. 107) The court held a final pretrial
conference on June 7, 2016, and a two-day bench trial on June
21 and 22, 2016 on the infringement issue. The parties have
since completed post-trial briefing. The 30-month stay of FDA
final approval on Amneal's ANDA expires on August 4,
2017. (D.I. 142, ex. 1 at ¶46) The court has
jurisdiction over this matter pursuant to 28 U.S.C.
§§ 1331, 1338(a), and 1400(b). Having considered
the documentary evidence and testimony, the court makes the
following findings of fact and conclusions of law pursuant to
Federal Rule of Civil Procedure 52(a).
FINDINGS OF FACT AND CONCLUSIONS OF LAW
Technology at Issue
Development of MFM
mometasone furoate ("MFA") was first synthesized
and patented by a Merck chemist, Dr. Elliot Shapiro, in the
early 1980s. (D.I. 163 at 4) After MFA was discovered, its
unique physical properties that prevented it from dissolving
in water or known pharmaceutically acceptable compounds kept
it on the "backbumer" for further research.
(Id.) Years later, scientists found that MFA
dissolved in a new pharmaceutical solvent and developed MFA
for the treatment of psoriasis, a skin condition.
late 1980s, a formulator at Merck, Dr. Yuen, led a project
seeking to develop mometasone furoate for nasal applications.
As a result of this project, mometasone furoate monohydrate
("MFM") was developed. MFM has the chemical name,
monohydrate and the following chemical structure:
163 at 46; '353 patent)
MFM are polymorphs. MFM differs from MFA in that every
molecule of MFM is associated with a molecule of water,
whereas no water is present in the crystal lattice structure
of MFA. The difference between the molecular structures of
MFM and MFA causes changes to the solid structure of the two
crystalline forms. (D.I. 163 at 5; PTX18)
Development of Nasonex
discovering MFM, Dr. Yuen determined that using MFM as a
suspension in water with other excipients provided a stable
formulation. (D.I. 163 at 6) The formation was further
developed and ultimately was approved as Nasonex. The
formulation is protected by the '353 patent.
is indicated for the treatment of perennial allergenic
rhinitis, seasonal allergic rhinitis, nasal polyps, and
congestion associated with the nasal symptoms of allergic
rhinitis (D.I. 142, ex. 1 at ¶ 26) The product insert
for Nasonex states: "[Nasonex] Nasal Spray 50 meg is a
corticosteroid demonstrating potent antiinflammatory
properties." (Id. at ¶ 35) It further
states: "The precise mechanism of corticosteroid action
on allergic rhinitis is not known. Corticosteroids have been
shown to have a wide range of effects on multiple cell types
. . . and mediators . . . involved in inflammation."
(Id.) Nasonex contains MFM as its active
pharmaceutical ingredient ("API"). (Id. at
The '353 patent
'353 patent, titled "Mometasone furoate monohydrate,
process for making same and pharmaceutical
compositions," issued on October 3, 2000. (JTX 1) Merck
alleges infringement of independent claims 1 and 6 and
dependent claims 9-12. (D.I. 142, ex. 1 at ¶ 15) The
patent claims MFM, a process for preparing MFM by
crystallization from a saturated aqueous water miscible
organic solution, and aqueous stable pharmaceutical
compositions of MFM. ('353 patent, 1:31-48) Independent
claim 1 recites "9a,21
and independent claim 6 recites "[a] pharmaceutical
composition comprising mometasone furoate monohydrate in a
carrier consisting essentially of water."
The accused ANDA product
ANDA product is a generic mometasone furoate nasal spray, 50
meg, using MFA as the active pharmaceutical ingredient.
Amneal's ANDA product has a proposed shelf-life of two
years. Merck does not allege that the pre-formulation active
pharmaceutical ingredient used in Amneal's ANDA product
contains MFM or otherwise infringes the '353 patent.
(D.I. 142, ex. 1 at ¶¶ 43-47; D.I. 163 at 3; PTX
patent is infringed when a person "without authority
makes, uses or sells any patented invention, within the
United States . . . during the term of the patent." 35
U.S.C. § 271(a). To prove direct infringement, the
patentee must establish that one or more claims of the patent
read on the accused device literally or under the doctrine of
equivalents. See Advanced Cardiovascular Sys., Inc. v.
Scimed Life Sys., Inc., 261 F.3d 1329, 1336 (Fed. Cir.
2001). 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),
aff'd, 517 U.S. 370 (1996). First, the court must
construe the asserted claims to ascertain their meaning and
scope, a question of law. See Id. at 976-77; see
also Teva Pharms. USA, Inc. v. Sandoz, Inc., __ U.S. __,
135 S. Ct. 831, 837 (2015). The trier of fact must then
compare the properly construed claims with the accused
infringing product. See Markman, 52 F.3d at 976.
This second step is a question of fact. Spectrum Pharm.,
Inc. v. Sandoz Inc., 802 F.3d 1326, 1337 (Fed. Cir.
2015) (citing Bai v. L & L Wings, Inc., 160 F.3d
1350, 1353 (Fed. Cir. 1998)). "Direct infringement
requires a party to perform each and every step or element of
a claimed method or product." Exergen Corp. v.
Wal-Mart Stores, Inc., 575 F.3d 1312, 1320 (Fed. Cir.
2009) (quoting BMC Res., Inc. v. Paymentech, LP.,
498 F.3d 1373, 1378 (Fed. Cir. 2007)). "If any claim
limitation is absent. . ., 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). If
an accused product does not infringe an independent claim, it
also does not infringe any claim depending thereon.
Ferring B.V. v. Watson Labs., Inc.-Florida, 764 F.3d
1401, 1411 (Fed. Cir. 2014) (citing Wahpeton Canvas Co.,
Inc. v. Frontier, Inc., 870 F.2d 1546, 1552 (Fed. Cir.
1989) ("One who does not infringe an independent claim
cannot infringe a claim dependent on (and thus containing all
the limitations of) that claim.")). 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)
(quoting Wahpeton Canvas, 870 F.2d at 1552)
(internal quotations omitted). The patent owner has the
burden of proving literal infringement by a preponderance of
the evidence. Octane Fitness, LLC v. ICON Health &
Fitness, Inc., __ U.S. __, 134 S. Ct. 1749, 1758 (2014).
question for infringement is whether Amneal's ANDA
product (an aqueous suspension made with prior art MFA)
contains any patented MFM during the product's two-year
produced samples of Batch Nos. BB-ST-13003A (manufactured
October 28, 2013), 13005A (manufactured November 22, 2013),
and 13006A (manufactured December 9, 2013) (collectively
"the Exhibit Batches") and samples of Batch No.
RD-3965-162 ("the R&D Batch") to
Merck. (JTX 8-10, 14-16) The samples were
packaged in nasal spray bottles, Amneal's finished
product form. (D.I. 176 at 55:17-23, 110:23-111:5) Amneal
produced samples from Batch No. RD-3965-157 ("the
Commercial Batch"), after which Amneal changed its
manufacturing process. The court ruled that evidence of MFM
in such samples could not be used to show
infringement. (D.I. 89, 98, 154) Amneal produced samples
of another commercial-sized batch, Batch No. BB-ST-16001
("Batch 16001") in glass bottles. (D.I. 130; D.I.
176 at 110:20-111:5; JTX 5, 13) The samples produced were
drawn after manufacture on January 11, 2016 ("Batch
16001 Day 1"). Three days later, on January 14, 2016,
the batch was mixed and a certain portion was removed and
packaged in nasal spray bottles ("Batch 16001 A").
The next day, the batch was mixed, samples were drawn
("Batch 16001 Day 4"), and the remainder was
packaged in nasal spray bottles ("Batch
16001A"). (JTX 11-12) Amneal stipulated that the
Batch 16001 Day 1 samples produced to Merck are
representative of its ANDA product. (D.I. 130)