Boehringer Ingelheim v. Mylan Pharmaceuticals Inc. ( 2020 )

Case: 19-1172 Document: 82 Page: 1 Filed: 03/16/2020
NOTE: This disposition is nonprecedential.
United States Court of Appeals
for the Federal Circuit
______________________
BOEHRINGER INGELHEIM PHARMACEUTICALS
INC., BOEHRINGER INGELHEIM
INTERNATIONAL GMBH, BOEHRINGER
INGELHEIM CORPORATION, BOEHRINGER
INGELHEIM PHARMA GMBH & CO. KG,
Plaintiffs-Appellants
v.
MYLAN PHARMACEUTICALS INC., MYLAN INC.,
MYLAN LABORATORIES LIMITED, AUROBINDO
PHARMA LIMITED, AUROBINDO PHARMA USA,
INC.,
Defendants-Appellees
______________________
2019-1172
______________________
Appeal from the United States District Court for the
District of New Jersey in Nos. 3:15-cv-05982-PGS-TJB,
3:16-cv-00851-PGS-TJB, 3:16-cv-00852-PGS-TJB, 3:16-cv-
01727-PGS-TJB, 3:16-cv-02394-PGS-TJB, Senior Judge
Peter G. Sheridan.
______________________
Decided: March 16, 2020
______________________
Case: 19-1172 Document: 82 Page: 2 Filed: 03/16/2020
2 BOEHRINGER INGELHEIM v. MYLAN PHARMACEUTICALS INC.
LEORA BEN-AMI, Kirkland & Ellis LLP, New York, NY,
argued for plaintiffs-appellants. Also represented by MIRA
ATANASSOVA MULVANEY, JEANNA WACKER; LIZA M. WALSH,
Walsh Pizzi O'Reilly Falanga LLP, Newark, NJ.
DEEPRO MUKERJEE, Katten Muchin Rosenman LLP,
New York, NY, argued for all defendants-appellees. De-
fendants-appellees Mylan Pharmaceuticals Inc., Mylan
Inc., Mylan Laboratories Limited also represented by
LANCE SODERSTROM; JOSEPH JANUSZ, Charlotte, NC;
HOWARD ROBERT RUBIN, RAJESH RAM SRINIVASAN, ERIC
THOMAS WERLINGER, Washington, DC; CHRISTOPHER L.
MCARDLE, THOMAS J. PARKER, Alston & Bird LLP, New
York, NY.
JEFFREY STEPHEN WARD, Green, Griffith & Borg-Breen
LLP, Middleton, WI, for defendants-appellees Aurobindo
Pharma Limited, Aurobindo Pharma USA, Inc. Also rep-
resented by WENDY M. WARD; PAIGE STRADLEY, Merchant
& Gould P.C., Minneapolis, MN.
______________________
Before DYK, MOORE, and HUGHES, Circuit Judges.
MOORE, Circuit Judge.
Appellants Boehringer Ingelheim Pharmaceuticals,
Inc., Boehringer Ingelheim International GmbH,
Boehringer Ingelheim Corporation, and Boehringer Ingel-
heim Pharma GmgH & Co. KG (collectively, Boehringer)
sued Mylan Pharmaceuticals Inc., Mylan Inc., Mylan La-
boratories, Ltd., Aurobindo Pharma Limited and Auro-
bindo Pharma USA, Inc. (collectively, Appellees) for
infringement of U.S. Patent Nos. 8,853,156, 9,173,859 and
8,673,927, which relate to the treatment of type 2 diabetes
mellitus with DPP-IV inhibitors such as linagliptin. Ap-
pellees moved for partial judgment on the pleadings under
Federal Rule of Civil Procedure 12(c) alleging that claims
10-17, 24 and 25 of the ’156 patent are directed to ineligible
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BOEHRINGER INGELHEIM v. MYLAN PHARMACEUTICALS INC. 3
subject matter under 35 U.S.C. § 101. The district court
granted Appellees’ motion, holding the claims patent ineli-
gible under the two-step framework of Alice Corporation
Pty. Ltd. v. CLS Bank International. 573 U.S. 208, 217
(2014).
A bench trial ensued on the ’859 and ’927 patents. The
district court held that claims 1, 14, 15, 20, and 21 of the
’859 patent and claims 7, 9, 15, 17, 19, 25, and 26 of the
’927 patent are invalid for obviousness-type double patent-
ing in light of the claims of U.S. Patent No. 8,178,541, and
invalid as obvious in view of U.S. Patent Application Pub-
lication No. 2004/0097510. Boehringer appealed. We have
jurisdiction under 28 U.S.C. § 1295(a)(1).
For the reasons discussed below, we reverse the district
court’s judgment that claims 10–17, 24 and 25 of the ’156
patent are directed to ineligible subject matter under 35
U.S.C. § 101 and remand for further proceedings. We af-
firm the district court’s judgment that the asserted claims
of the ’859 and ’927 patents are invalid for obviousness and
obviousness-type double patenting.
DISCUSSION
I
The district court granted Appellees’ motion for judg-
ment on the pleadings under Federal Rule of Civil Proce-
dure 12(c) holding claims 10–17, 24 and 25 of the ’156
patent ineligible under § 101. The district court held that
the claims are directed to an “abstract idea,” namely “the
act of administering the DPP-IV inhibitor to the targeted
patient population.” J.A. 108–09. The district court fur-
ther determined that the claims fail to recite an inventive
concept. 1
1The district court determined that “the additional fea-
tures recited in claim 1 do not amount to ‘significantly
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4 BOEHRINGER INGELHEIM v. MYLAN PHARMACEUTICALS INC.
We review a district court’s Rule 12(c) dismissal for
judgment on the pleadings under the law of the regional
circuit. Amdocs (Isr.) Ltd. v. Openet Telecom, Inc., 841 F.3d
1288, 1293 (Fed. Cir. 2016). The Third Circuit reviews a
grant of judgment on the pleadings de novo. Hanover Ins.
Co. v. Urban Outfitters, Inc., 806 F.3d 761, 764 (3d Cir.
2015). In doing so, the Third Circuit views “the facts pre-
sented in the pleadings and the inferences to be drawn
therefrom in the light most favorable to the nonmoving
party.” Id. (internal quotations omitted). Eligibility under
§ 101 is a question of law based on underlying facts that,
ultimately, we review de novo. SAP Am., Inc. v. InvestPic,
LLC, 898 F.3d 1161, 1166 (Fed. Cir. 2018).
In determining patent eligibility under § 101 “we first
determine whether the claims at issue are ‘directed to’ a
patent ineligible concept.” Natural Alternatives Int’l, Inc.
v. Creative Compounds, LLC, 918 F.3d 1338, 1342 (Fed.
Cir. 2019) (quoting Alice Corp., 573 U.S. at 218). “As the
Supreme Court has cautioned, we must be careful in this
analysis as ‘too broad an interpretation of this exclusionary
principle could eviscerate patent law. For all inventions at
more,’ which transform the abstract idea of administering
the DPP-IV inhibitor to a patent eligible subject matter.”
J.A. 111. As to claim 10, it declared that the additional
features are “well-understood, routine, and conventional
features that do not transform the abstract idea recited in
claim 1 into a patent eligible subject matter.” J.A. 114.
Similarly, “the additional features recited in claims 11–17
do not add ‘significantly more’ to the abstract idea of claim
1” such that “claims 11–17 do not render claim 1 patent
eligible under § 101.” J.A. 115. Finally, as to claims 24 and
25, their additional features “do not add significantly more
to the abstract idea of administering a DPP-IV inhibitor
such that they transform the abstract idea into patent eli-
gible subject matter.” J.A. 116.
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BOEHRINGER INGELHEIM v. MYLAN PHARMACEUTICALS INC. 5
some level embody, use, reflect, rest upon, or apply laws of
nature, natural phenomena, or abstract ideas.’” Id. at 1342
(quoting Mayo Collaborative Servs. v. Prometheus Labs.,
Inc., 566 U.S. 66, 71 (2012)); id. at 1345 (“The fact that the
human body responds to the treatment through biochemi-
cal processes does not convert the claim into an ineligible
one.”). We conclude claims 10–17, 24 and 25 of the ’156
patent are directed to patent eligible subject matter.
The ’156 patent relates to the treatment and/or preven-
tion of metabolic diseases such as type 2 diabetes mellitus
with DPP-IV inhibitors such as linagliptin “in patients for
whom normal metformin therapy is not appropriate.” ’156
patent at 1:5–11. Type 2 diabetes may be associated with
complications such as renal impairment or failure. Id. at
1:17–21. Because metformin is largely eliminated by the
kidneys, “it is contraindicated in patients with renal dis-
ease or renal impairment.” Id. at 1:62–65. The specifica-
tion indicates that “it has now surprisingly been found that
DPP-4 inhibitors as defined herein have surprising and
particularly advantageous properties, which make them
particularly suitable for treating and/or preventing . . .
metabolic diseases, particularly diabetes . . . in patients for
whom metformin therapy is inappropriate due to intolera-
bility or contraindication against metformin . . . .” Id. at
9:30–39. It further explains, for example, that “[t]he DPP-
4 inhibitor is substantially or mainly excreted via the liver
. . . .” Id. at 13:45–46.
Claims 1 and 10 of the ’156 patent recite:
1. A method of treating and/or preventing meta-
bolic diseases in a patient for whom metformin
therapy is inappropriate due to at least one contra-
indication against metformin comprising orally ad-
ministering to the patient a DPP-IV inhibitor
wherein the contraindication is selected from the
group consisting of: renal disease, renal impair-
ment or renal dysfunction, unstable or acute
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6 BOEHRINGER INGELHEIM v. MYLAN PHARMACEUTICALS INC.
congestive heart failure, acute or chronic metabolic
acidosis, and hereditary galactose intolerance.
10. The method according to claim 1 wherein the
metabolic disorder is type 2 diabetes mellitus and
wherein the contraindication is renal disease, renal
impairment or renal dysfunction, and wherein said
DPP-4 inhibitor is used for said patient in the same
dose as for a patient with normal renal function.
Boehringer argues that the claims are directed to a
“method of treating a specific disease ([type 2 diabetes
mellitus]) for specific patients (with renal impairment) us-
ing a specific compound (linagliptin) at specific doses (same
dose in patients with renal impairment as in patients with
normal renal function) to achieve a specific outcome.” Ap-
pellants’ Br. 38. Appellees argue that the claims are di-
rected to the natural law that “certain DPP-IV inhibitors
(including linagliptin) are metabolized by the liver rather
than the kidney.” Appellees’ Br. 38; see also id. at 43.
We hold that, consistent with this court’s decision in
Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuti-
cals International Ltd., 887 F.3d 1117 (Fed. Cir. 2018), the
claims are directed to a particular method of treatment un-
der step one and are therefore patent eligible. The claims
in Vanda involved a method of treating patients with schiz-
ophrenia that first required performing a genetic test to de-
termine if a patient was a CYP2D6 poor metabolizer. Id.
at 1121. Based on the results of that test, a particular dose
of iloperidone was selected and internally administered.
Id. As a result, the risk of QTc prolongation, a dangerous
side effect, was decreased. Id. at 1121 & n.2. We held that
the claims were not directed to a natural relationship be-
tween iloperidone, CYP2D6 metabolism, and QTc prolon-
gation. Id. at 1134. While we acknowledged that the
inventors had recognized the underlying relationships, we
explained that those were not what was claimed. Id. at
1135. Instead, the claims were directed to a patent-eligible
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BOEHRINGER INGELHEIM v. MYLAN PHARMACEUTICALS INC. 7
method of using iloperidone to treat schizophrenia, “a spe-
cific method of treatment for specific patients using a spe-
cific compound at specific doses to achieve a specific
outcome.” Id. at 1136; see also Mayo, 566 U.S. at 87 (dis-
tinguishing the Mayo claim from “a typical patent on a new
drug or a new way of using an existing drug,” because the
Mayo claim did not “confine [its] reach to particular appli-
cations” of the natural laws relied upon).
The claims of the ’156 patent are likewise directed to a
method of treating type 2 diabetes mellitus using a DPP-
IV inhibitor, such as linagliptin. 2 That “certain DPP-IV in-
hibitors (including linagliptin) are metabolized by the liver
rather than the kidney,” Appellees’ Br. 38, “does not make
the claim ‘directed to’ that natural ability.” Rapid Litiga-
tion Mgmt. Ltd. v. CellzDirect, Inc., 827 F.3d 1042, 1049
(Fed. Cir. 2016) (stating that the “natural ability of the sub-
ject matter to undergo the process does not make the claim
‘directed to’ that natural ability”).
Because we hold that the claims are directed to a
method of treatment at step one, we conclude the claims
are patent eligible and need not reach step two. We do not,
of course, at this stage address the issues of obviousness
and obviousness-type double patenting with respect to
these claims. Accordingly, we reverse the district court’s
grant of judgment on the pleadings and remand to the dis-
trict court for further proceedings.
II
The district court held claims 1, 14, 15, 20, and 21 of
the ’859 patent and claims 7, 9, 15, 17, 19, 25, and 26 of the
’927 patent (collectively, the claims at issue) invalid for ob-
viousness-type double patenting and invalid as obvious in
2 We recognize that the district court made its decision
in 2016 without the benefit of our decision in Vanda and
its progeny, which dictate the conclusion we reach today.
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8 BOEHRINGER INGELHEIM v. MYLAN PHARMACEUTICALS INC.
view of the prior art. On appeal from a bench trial, we re-
view a district court’s conclusions of law de novo and its
findings of fact for clear error. Braintree Labs., Inc. v.
Novel Labs., Inc., 749 F.3d 1349, 1358 (Fed. Cir. 2014). “A
factual finding is clearly erroneous when, despite some
supporting evidence, we are left with a definite and firm
conviction that the district court was in error.” Alcon Re-
search Ltd. v. Barr Labs., Inc., 745 F.3d 1180, 1186 (Fed.
Cir. 2014) (citing Alza Corp. v. Mylan Labs., Inc., 464 F.3d
1286, 1289 (Fed. Cir. 2006)). “Where there are two permis-
sible views of the evidence, the factfinder’s choice between
them cannot be clearly erroneous.” Anderson v. City of Bes-
semer City, 470 U.S. 564, 574 (1985) (citing United States
v. Yellow Cab Co., 338 U.S. 338, 342 (1949)). Obviousness
is a question of law based on underlying facts, including
the scope and content of the prior art. Kinetic Concepts,
Inc. v. Smith & Nephew, Inc., 688 F.3d 1342, 1360 (Fed.
Cir. 2012). “As with statutory obviousness under 35 U.S.C.
§ 103, obviousness-type double patenting is an issue of law
premised on underlying factual inquiries.” Eli Lilly and
Co. v. Teva Parenteral Meds., Inc., 689 F.3d 1368, 1376
(Fed. Cir. 2012).
The claims at issue relate to the treatment of type 2
diabetes mellitus with linagliptin in 2.5 or 5 mg doses. As
to the ’859 patent, claim 14 is illustrative:
14. An oral tablet formulation comprising 1-[(4-me-
thyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-
1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xanthine in an
amount of 2.5 mg or 5 mg optionally in combination
with metformin, and a pharmaceutically accepta-
ble carrier or diluent.
As to the ’927 patent, claim 7, which depends from
claim 1, is illustrative:
1. A method of treating type II diabetes mellitus
comprising administering to a patient in need
thereof a pharmaceutically effective oral amount of
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1-[(4-methyl-quinazolin-2-yl)-methyl]-3-methyl-7-
(2-butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xan-
thine, and a pharmaceutically effective amount of
metformin, which is from 300 mg to 1000 mg once
or twice a day, or delayed-release metformin in a
dose of 500 mg to 1000 mg once or twice a day or
500 mg to 2000 mg once a day.
7. The method according to claim 1, wherein the 1-
[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-
butyn-1-yl)-8-(3-(R)-amino-piperidin-1-yl)-xan-
thine is administered in an oral dosage of 2.5 mg or
5 mg.
The district court held that the claims at issue are in-
valid for obviousness-type double patenting in light of the
claims of Boehringer’s earlier-expiring ’541 patent. It also
held that the claims would have been obvious in light of the
’510 publication (the priority application with the same
specification as the ’541 patent). Boehringer argues that
both of these conclusions depend on the district court’s de-
termination that the claimed dosages would have been ob-
vious. The district court determined that because “the
claimed invention’s doses of linagliptin in 2.5 mg and 5 mg
fall within the ’510 publication[’]s disclosed range of 1–100
mg,” there is a presumption of obviousness. See J.A. 164
(citing Tyco Healthcare Grp. LP v. Mutual Pharm. Co., 642
F.3d 1370, 1372–73 (Fed. Cir. 2011). The district court al-
ternatively found that a person of ordinary skill in the art
would have obtained the claimed dosages through routine
experimentation. Because we conclude that the district
court’s alternative finding is not clearly erroneous, we need
not decide whether the district court’s presumption deter-
mination was correct.
In view of the evidence presented, the district court did
not clearly err in determining that a skilled artisan would
“have a reasonable expectation of arriving at the claimed
2.5 mg and 5 mg dosages” through routine
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10 BOEHRINGER INGELHEIM v. MYLAN PHARMACEUTICALS INC.
experimentation. J.A. 154; see also J.A. 164. For example,
Dr. Grass testified that dose ranging studies are “con-
ducted starting with a low dose, and sequentially moving
through increasing doses.” J.A. 147 (quoting J.A. 1037 at
720:6–9, id. at 720:10–721:10; see also J.A. 1158 at 1060:2–
5 (Dr. Lam agreeing that “a person of ordinary skill in the
art would understand the general guidelines that were is-
sued by the FDA would include . . . dose-ranging studies”);
J.A. 1259 at 1356:7–10 (Dr. Accili agreeing that dose-rang-
ing studies are required for FDA approval). Dr. Grass fur-
ther testified that linagliptin has a low IC50 value disclosed
in the ’510 publication indicating that it has a high potency.
J.A. 1045 at 752:19–753:6 (“Using the ’510 which we spoke
about earlier, one would recognize that linagliptin is dis-
closed in the ’510; it’s a compound that’s shown to have . . .
the lowest IC50 value or the greatest potency; there’s a pre-
ferred dose range of 1 to 100 milligrams; and there’s a pre-
ferred list of compounds in which linagliptin is a member;
one would be guided through that information of looking at
the lowest end of the dose range for the most potent com-
pound . . . .”). Additionally, one of the inventors of the ’859
and ’927 patents, Dr. Dugi, testified that “[r]egulators ex-
pect you to define the lowest maximum therapeutic dose,”
which may have the benefits of: (1) being a smaller, easier
to swallow tablet; (2) being easier to formulate in combina-
tion pills; (3) having a lower risk of drug to drug interac-
tions; and (4) reducing the risk of side effects. J.A. 1286 at
1464:11–17; J.A. 1289 at 1476:4–1477:16; J.A. 152–53. Fi-
nally, we see no clear error in the district court’s secondary
consideration analysis.
Accordingly, we affirm the district court’s decision
holding the asserted claims of the ’859 and ’927 patents in-
valid for obviousness and obviousness-type double patent-
ing.
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BOEHRINGER INGELHEIM v. MYLAN PHARMACEUTICALS INC. 11
CONCLUSION
REVERSED-IN-PART, AFFIRMED-IN-PART, AND
REMANDED
COSTS
Each party shall bear its own costs.