ELI LILLY AND COMPANY v. DR. REDDY'S LABORATORIES, LTD. et al
Filing
241
FINDINGS OF FACT AND CONCLUSIONS OF LAW FOLLOWING FEBRUARY 1, 2018 BENCH TRIAL -Based upon the foregoing findings of fact and conclusions of law, the Court concludes that Lilly has shown by a preponderance of the evidence that the asserted claims of the '209 Patent would be infringed by Dr. Reddy's product under the doctrine of equivalents based upon inducement and contributory infringement. The Court finds that Dr. Reddy's product indirectly infringes the asserted claims of the & #039;209 Patent, and finds in favor of Eli Lilly And Company and against Dr. Reddy's Laboratories, Inc. and Dr. Reddy's Laboratories, Ltd. Final judgment shall issue separate from this Entry. (See Entry.) Signed by Judge Tanya Walton Pratt on 6/22/2018.(NAD)
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF INDIANA
INDIANAPOLIS DIVISION
ELI LILLY AND COMPANY,
Plaintiff,
v.
DR. REDDY’S LABORATORIES, LTD., and
DR. REDDY’S LABORATORIES, INC.,
Defendants.
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) Case No. 1:16-cv-00308-TWP-MPB
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FINDINGS OF FACT AND CONCLUSIONS OF LAW
FOLLOWING FEBRUARY 1, 2018 BENCH TRIAL
This matter was before the Court for a bench trial beginning on February 1, 2018 and
concluding on February 2, 2018, on the issue of infringement of U.S. Patent No. 7,772,209 (the
“‘209 Patent”). This is a Hatch-Waxman patent infringement action brought by Eli Lilly and
Company (“Lilly”), the owner of the ‘209 Patent, against Defendants Dr. Reddy’s Laboratories,
Inc. and Dr. Reddy’s Laboratories, Ltd. (collectively, “Dr. Reddy’s”) arising out of Dr. Reddy’s
filing of New Drug Application No. 208297 (the “NDA”) with the Food and Drug Administration
(“FDA”) seeking approval to market the product described therein. The ‘209 Patent describes a
method of administering a chemotherapy drug, pemetrexed disodium (“pemetrexed”), with
vitamins, which is marketed by Lilly under the trade name ALITMA®. Lilly is asserting that Dr.
Reddy’s drug product, which uses pemetrexed ditromethamine, infringes the ‘209 Patent. Dr.
Reddy’s contends that its product is not a generic drug, rather, its product uses a different chemical.
Particularly at issue is claim 12. The Court previously constructed claim 12 to refer to a liquid
administration of pemetrexed disodium. (Filing No. 199 at 9.) Having heard testimony and
considered the exhibits and arguments of the parties, the Court makes the following findings of
fact and conclusions of law pursuant to Federal Rule of Civil Procedure 52.
I. FINDINGS OF FACT
Lilly is a corporation organized and existing under the laws of the State of Indiana, having
its corporate offices and principal place of business at Lilly Corporate Center, Indianapolis, Indiana
46285. Lilly sells pemetrexed in the United States under the trademark ALIMTA® for treatment
of patients with malignant pleural mesothelioma, or for the initial treatment of locally advanced or
metastatic nonsquamous non-small cell lung cancer, and other forms of lung cancer. ALIMTA®
is covered under U.S. Patent No. 5,344,932, which is owned by The Trustees of Princeton
University and licensed exclusively to Lilly.
Dr. Reddy’s Ltd. is a drug manufacturer with a principal executive office at Hyderabad,
Telangana 500 034, India, and Dr. Reddy’s Inc. is a corporation organized and existing under the
laws of the State of New Jersey. Dr. Reddy’s is in the business of manufacturing, marketing, and
selling both generic and non-generic drug products. In December 2015, Dr. Reddy’s notified Lilly
that it had submitted to the FDA New Drug Application No. 208297, a product that will be
marketed as competing products to ALIMTA®
Dr. Clet Niyikiza (“Dr. Niyikiza”), the inventor of the ‘209 Patent, is a mathematician that
was employed by Lilly in the 1990s to help with the clinical development of cancer compounds.
In early 1997, Dr. Niyikiza performed a series of statistical analyses, known as multivariate
analyses, on more than 60 variables in patients participating in pemetrexed clinical trials in efforts
to better understand which patients were likely to develop the sporadic toxicities observed with
pemetrexed. The problem the invention solves is toxicity in patients receiving chemotherapeutic
treatment with pemetrexed. In particular, the ‘209 Patent provides for a method that mitigates the
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toxicity associated with pemetrexed treatment, using the vitamin pretreatment regimen of vitamin
B12 and folic acid. (Filing No. 231 at 35.)
The primary focus of this infringement trial is on whether Dr. Reddy’s label, specifically
the use of pemetrexed ditromethamine product described therein, infringes the ‘209 Patent, which
uses pemetrexed disodium, under the doctrine of equivalents. The ‘209 Patent covers the method
of administration of ALIMTA®, requiring that physicians co-administer the drug with folic acid
and vitamin B12 to reduce the incidence of patient toxicity caused by ALIMTA®. Claim 12 of the
‘209 Patent describes an improved method for administering pemetrexed disodium, comprising
“a) administration of between 3500 µg and about 1000 µg of folic acid prior to the first
administration of pemetrexed disodium; b) administration of about 500 µg to about 1500 µg of
vitamin B12, prior to the first administration of pemetrexed disodium; and c) administration of
pemetrexed disodium.” (Filing No. 1-1 at 9).
The parties disagree on the relevance of any chemical differences between pemetrexed
disodium and pemetrexed ditromethamine, nevertheless both Lilly’s and Dr. Reddy’s experts, Dr.
Bruce A. Chabner, M.D., (“Dr. Chabner”), Rodolfo Pinal (“Dr. Pinal”), and George Gokel (“Dr.
Gokel”), agreed on what the differences were between the two chemical compounds. Sodium is
an inorganic metallic salt, and tromethamine is an organic, nonmetallic salt. (Filing No. 231 at
181.) Tromethamine weighs more than sodium. Id. Because tromethamine can raise pH, it can
be used as buffer; however, sodium may not be used as a buffer because it cannot be used as a pH
adjuster. Id. at 158. Additionally, it is undisputed that pemetrexed disodium is more hygroscopic
and absorbs more than twice the amount of water than pemetrexed ditromethamine. Id. at 173.
As noted in the Court’s claim construction finding, regardless if pemetrexed disodium or
pemetrexed ditromethamine is administered to the patient, the patient receives an intravenous
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solution of pemetrexed in treating the patient’s cancer. The evidence presented at trial
demonstrates that the person who solves the problems to which the claims are addressed requires
a medical oncologist.
II. CONCLUSIONS OF LAW
A.
Prosecution History Estoppel
In the Court’s amended Final Pretrial Entry, the Court permitted the parties, at trial, to
supplement the summary judgment record on the issue of prosecution history estoppel. (Filing
No. 216 at 4.) In its Entry on Motion for Summary Judgment of Noninfringement, the Court found
Lilly was not barred, as a matter of law under prosecution history estoppel, from asserting the
doctrine of equivalents. (Filing No. 199 at 15.) (“Lilly has met its burden of showing that it did
not surrender the equivalent in question because the choice of pemetrexed salt is tangential to the
reasons for the amendment and summary judgment is precluded on this issue.”)
As in the summary judgment briefing, Dr. Reddy’s continues to collapse the foreseeability
exception with the tangential exception, on which the Court relied in holding in Lilly’s favor.
Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 733 (2002). Dr. Reddy’s
focuses on the unexplained reason that Lilly limited the ‘209 Patent to pemetrexed disodium, in
essentially arguing that Lilly could have drafted a better claim. (“[A]” patentee cannot argue in
litigation that a narrowing amendment in prosecution was excessive, and that the patentee could
have avoided the prior art (and gained allowance) with a less severe amendment that would have
literally embraced the accused equivalent.” (Filing No. 234 at 6).) In any event, Lilly has explained
the reason for the narrowing amendment: it was narrowed to overcome a rejection in view of
Arsenyan, a prior art article about a different antifolate, methotrexate. (Filing No. 235 at 35.) The
Court agrees with Lilly that at trial Dr. Reddy’s expert, Dr. Gokel, did nothing to dispute or add to
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the summary judgment record as to the prosecution history evidence from which tangentiality is
analyzed. (Filing No. 232 at 42.) Accordingly, the Court again concludes that Lilly’s rationale
for limiting its claim to pemetrexed disodium (to avoid a rejection based on the prior art Arsenyan)
is tangential to the accused equivalent—pemetrexed ditromethamine. The Court directs the parties
to Filing No. 199 for a more detailed analysis regarding the Court’s holding that Lilly has rebutted
the presumption that prosecution history estoppel applies.
B.
Disclosure-Dedication Rule
Another issue, extensively briefed by the parties on summary judgment, was the disclosure-
dedication doctrine. Again, the trial record and the summary judgment record contain significant
overlap as to this issue. Because Lilly did not move for summary judgment on this issue, it was
not decided on summary judgment, rather it was fleshed out by expert testimony at the trial. The
disclosure-dedication rule bars a doctrine of equivalents claim when a patentee discloses but does
not claim subject matter. Johnson & Johnston Associates, Inc. v. R.E. Service Co., Inc., 285 F.3d
1046, 1054 (Fed. Cir. 2002).
As noted in the Court’s Entry on Motion for Summary Judgment of Noninfringement, it is
undisputed that the ‘209 Patent’s specification did not expressly disclose pemetrexed
ditromethamine. Rather, Dr. Reddy’s bases its disclosure-dedication argument on the fact that the
‘209 Patent referenced U.S. Patent No. 4,997,838 to Akimoto and that from Akimoto the
hypothetical person of skill in the art (“POSA”) could find pemetrexed ditromethamine disclosed
among the alternatives disclosed in Akimoto. (Filing No. 234 at 25-26.) Generic references in a
written specification do not necessarily dedicate all members of a particular genus to the public.
SanDisk Corp. v. Kingston Technology Co., Inc., 695 F.3d 1348, 1363 (Fed. Cir. 2012).
Rather, the ‘disclosure must be of such specificity that one of ordinary skill in the
art could identify the subject matter that had been disclosed and not claimed.’
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Additionally, in Pfizer Inc. v. Teva Pharmaceuticals, USA, Inc., 429 F.3d 1364
(Fed. Cir. 2005), this court further clarified that ‘before unclaimed subject matter
is deemed to have been dedicated to the public, that unclaimed subject matter must
have been identified by the patentee as an alternative to a claim limitation.’
Id. (citations omitted). Although the ‘209 Patent did not expressly incorporate Akimoto by
reference, it cited that preferred examples of antifolates can be found in the derivatives described
by Akimoto. (Filing No. 1-1 at 5.) Because this issue hinged on what a POSA would recognize
as unclaimed subject matter disclosed in the ‘209 Patent specification and if Akimoto’s disclosures
in combination would disclose pemetrexed ditromethamine, it left a factual dispute for trial.
At trial, Dr. Pinal testified that Akimoto included pemetrexed and any “pharmaceutically
acceptable salt thereof.” (Filing No. 231 at 249.) From this concession, Dr. Reddy’s argues that
pharmaceutically accepted salts would include substituted ammonium salts of which tromethamine
is one of a few FDA-approved substituted ammonium salts. (Filing No. 234 at 24.) Thus, Dr.
Reddy’s contends that a POSA would have recognized pemetrexed in combination with
tromethamine as an alternative to pemetrexed disodium. (Filing No. 234 at 26-27.) Lilly responds
that while Dr. Pinal testified that pemetrexed is within the genus covered by Akimoto, Dr. Pinal
also testified that Akimoto disclosed a genus of thousands of antifolates. (Filing No. 231 at 227.)
Further, tromethamine is not specifically disclosed in any referenced patent nor is the compound
pemetrexed ditromethamine. (Filing No. 238 at 16-17.) Because Akimoto was not expressly
incorporated, as required, in the ‘209 Patent, and in any event Akimoto does not specifically
disclose pemetrexed ditromethamine as an alternative to pemetrexed disodium, the disclosurededication rule does not bar Lilly’s doctrine of equivalents claim. At most, the reference to
Akimoto and what was contained therein amounts to a generic reference which does not dedicate
all members of a particular genus to the public.
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C.
Doctrine of Equivalents
Lilly asserts, and the Court agrees, that healthcare providers using the proposed Dr.
Reddy’s product will directly infringe under the doctrine of equivalents, and that Dr. Reddy’s is
liable as an indirect infringer under 35 U.S.C. §§ 271(b) and (c).
As an initial matter, the relevant POSA must be defined for a doctrine of equivalents
analysis. “What constitutes equivalency must be determined against the context of the patent, the
prior art, and the particular circumstances of the case.” Warner-Jenkinson Co. v. Hilton Davis
Chem. Co., 520 U.S. 17, 24 (1997) (citation omitted). Thus, a POSA becomes an important factor
as to “whether persons reasonably skilled in the art would have known of the interchangeability of
an ingredient not contained in the patent with one that was.” Id. Dr. Reddy’s contends that the
POSA should be the type of person who solves the problems to which the claims are addressed
such as Dr. Niyikiza, the inventor of the patent. 1 (Filing No. 234 at 28, 30.) (“The POSA could be
trained as a chemist, biochemist, pharmaceutical scientist, physician, or molecular biologist. The
POSA, even if he is a physician, should have a strong background in chemistry and biochemistry,
understand the folate pathways and metabolism, and have a solid grasp of acid-base.”) Dr. Reddy’s
proposed POSA would examine the doctrine of equivalents from the perspective of the chemical
and biochemical properties between pemetrexed disodium and pemetrexed ditromethamine.
(Filing No. 234 at 30.) Lilly responds that the ‘209 Patent makes clear, from the plain language
of the claims and testimony from the inventor, Dr. Niyikiza, that the POSA is directed to a medical
oncologist. (Filing No. 235 at 13.) Lilly’s proposed POSA would perform a doctrine of
equivalents analysis focusing on the medical treatment aspects of the claims. (Filing No. 238 at
19.) This Court has “previously defined the POSA as ‘a medical doctor who specializes in
Dr. Niyikiza is a statistician, with a Ph.D. in mathematics and statistics, not a chemist, biochemist, pharmaceutical
scientist, physician, or molecular biologist. (Filing No. 238 at 21.)
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oncology or a medical doctor with extensive experience in the areas of nutritional sciences
involving vitamin deficiencies [,who] collaborated with medical oncologists who have knowledge
and experience in the treatment of cancer through the use of antifolates.’” Eli Lilly and Company
v. Teva Parenteral Meds., Inc., 1:10-cv-1376-TWP-MPB, 2012 WL 2358102, at *4 (S.D. Ind.
June 20, 2012), ECF 115 at 8. Essentially, the point of contention between the proposed POSAs
advanced by the parties is whether the POSA is a chemist or an oncologist.
Dr. Reddy’s POSA definition is defeated by the plain language of the ‘209 Patent as the
invention explicitly identifies it as “a method of reducing the toxicity associated with the
administration of an antifolate to a mammal. . .” (Filing No. 1-1 at 5). Lilly is correct that the
relevant POSA who works to mitigate the toxicities of chemotherapy would be an oncologist,
particularly an oncologist with extensive experience in the areas of nutritional sciences involving
vitamin deficiencies as confirmed by Dr. Chabner. Thus, equivalency is examined from an
oncologist POSA. The relevant POSA is critical (and dispositive) to resolving the doctrine of
equivalents analysis in the context of the claims as to whether the POSA would focus on the
different salt forms of pemetrexed disodium and pemetrexed ditromethamine as being substantial
differences, or instead would focus on the pemetrexed treatment that the patient receives.
The United States Supreme Court has set out two frameworks for evaluating equivalence—
the function, way, result test (whether the accused product performs ‘substantially the same
function in substantially the same way to obtain the same result’), and the insubstantial differences
test (whether the accused product or process is substantially different from what is patented).
Mylan Institutional LLC v. Aurobindo Pharma Ltd., 857 F.3d 858, 866–67 (Fed. Cir. 2017) (“Thus,
the Court seemingly blessed two equivalents tests, leaving to the lower courts in future cases the
choice of which to apply.”) (quoting Graver Tank & Mfg. Co. v. Linde Air Prod. Co., 339 U.S.
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605, 608 (1950). Additionally, the Federal Circuit, relying on Graver, noted that the insubstantial
differences test may be more appropriate in chemical arts cases. Id. (“The Supreme Court was
surely correct in stating that non-mechanical cases may not be well-suited to consideration under
the FWR test.”) Because equivalence in this case is based on chemical properties, the Court
determines that the insubstantial differences test is the more appropriate framework for evaluating
equivalence.
“Under the doctrine of equivalents, a claim limitation not literally met may be satisfied by
an element of the accused product if the differences between the two are ‘insubstantial’ to one of
ordinary skill in the art.” Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320
F.3d 1339, 1351 (Fed. Cir. 2003). “The doctrine of equivalents allows the patentee to claim those
insubstantial alterations that were not captured in drafting the original patent claim but which could
be created through trivial changes.” Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535
U.S. 722, 733 (2002). As noted previously, the relevant POSA, in this case, is a medical
oncologist. Dr. Chabner testified that the invention claimed in the ‘209 Patent relates to “using
pretreatment B12 and folic acid to mitigate the toxicity of pemetrexed when it’s given to a patient
with cancer.” (Filing No. 231 at 70.) Additionally, Dr. Chabner testified that the pemetrexed
disodium could not exert an anti-cancer effect in solid form, thus the POSA would understand that
pemetrexed disodium is administered by first putting it into solution and then intravenously
administering the solution to the patient for an anti-cancer effect. Id. at 72.
Under the relevant context that the claim relates to medical treatment, pemetrexed
ditromethamine treats the patient’s cancer in exactly the same way as pemetrexed disodium. It is
undisputed that when both pemetrexed disodium and pemetrexed ditromethamine are placed in
solution, that both compounds dissociate completely in solution resulting in free pemetrexed and
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therapeutically irrelevant counterions. Id. at 208-09. In fact, in aqueous solution, the two products
will be identical. (Filing No. 231 at 212.) Recognizing these similarities, Dr. Reddy’s relied on
Lilly’s clinical trials of pemetrexed disodium, in demonstrating the safety and efficacy of its
product, when it told the FDA that the salt form does not matter when it comes to treating the
patient to support approval of its NDA product. (Filing No. 231 at 80-81.) It is undisputed that
the products are bioequivalent; however, the parties disagree on whether there is patent
equivalence in the context of the claimed method. (Filing No. 234 at 42-43; Filing No. 238 at 24.)
“[W]hen a commercial product meets all of the claim limitations, then a comparison to that product
may support a finding of infringement.” Adams Respiratory Therapeutics, Inc. v. Perrigo Co.,
616 F.3d 1283, 1289 (Fed. Cir. 2010).
The differences in the chemical properties between pemetrexed disodium and pemetrexed
ditromethamine with regards to solubility, stability, pH, and buffering capacity are irrelevant in
the context of the claimed method including this Court’s claim construction. (Filing No. 234 at
42.) Additionally, the theoretical phenomenon of the difference of salting out between the two
products is irrelevant, as ALIMTA®’s label “requires the solution to be clear prior to
administration and specifically instructs physicians not to administer it if any particulate matter is
observed.” (Filing No. 235 at 22-23.) To be sure, the evidence shows that tromethamine differs
from sodium with regards to the chemical properties as alleged by Dr. Reddy’s. Lilly does not
dispute that there are differences when the products are in solid form, instead Lilly argues that the
differences are insubstantial. (Filing No. 231 at 80.) The Court agrees. The differences are
irrelevant in the context of the claimed method which is a liquid administration of pemetrexed
sodium. What is in fact ultimately administered to the patient is injectable pemetrexed ions that
enter the patient’s cells. (Filing No. 231 at 79-80.) The products are identical in liquid form as
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pemetrexed is the active moiety in both Dr. Reddy’s and Lilly’s products dissolved in solution.
(See Filing No. 232 at 124-25; Filing No. 235 at 18.) Furthermore, Dr. Reddy’s incorrectly relies
on a chemist POSA in posing nonequivalence, who would not administer the drugs to a patient as
the ‘209 Patent is a claimed method of treatment.
Accordingly, Lilly has shown by a
preponderance of the evidence that Dr. Reddy’s product is equivalent to Lilly’s product.
D.
Inducement and Contribution to Infringement of ‘209 Patent
A party can be held liable for indirect infringement by actively inducing or contributing to
direct infringement by others. 35 U.S.C. § 271(b), (c). Direct infringement occurs when one party
makes, uses, offers to sell, sells, or imports each element of a patented invention. 35 U.S.C. §
271(a). Because Dr. Reddy’s does not provide care to patients, the direct infringement is attributed
to the healthcare providers.
“Inducement requires that the alleged infringer knowingly induced infringement and
possessed a specific intent to encourage another’s infringement.” AstraZeneca LP v. Apotex, Inc.,
633 F.3d 1042, 1056 (Fed. Cir. 2010). Courts have inferred intent to induce infringement based
on the contents of labels. Id. (holding circumstantial evidence may suffice to prove specific intent
to induce infringement). Similarly, labels may also form the basis to infer intent under contributory
infringement when they instruct users to perform a patented method. See Eli Lilly & Co. v. Actavis
Elizabeth LLC, 435 F. App’x 917, 926 (Fed. Cir. 2011).
Relying on Commil USA, LLC v. Cisco Sys., Inc., 135 S. Ct. 1920, 1928 (2015), Dr.
Reddy’s contends that Lilly cannot prove Dr. Reddy’s specifically intended to infringe because
specific intent requires proof that Dr. Reddy’s knew the acts were infringing. (Filing No. 234 at
44.) As evidence that Dr. Reddy’s did not know its product would infringe the ‘209 Patent, Dr.
Reddy’s offers that it selected tromethamine, in good-faith belief, to avoid infringing the ‘209
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Patent. Id. at 45. As Lilly correctly points out, Dr. Reddy’s ignores how specific intent can be
shown in the Hatch-Waxman context, particularly how specific intent can be inferred from an
accused product’s labeling. AstraZeneca LP v. Apotex, Inc. considered similar facts where
Apotex’s product development team testified that it “never intended to instruct or encourage either
physicians or patients to use its generic drug once-daily.” Id. However, AstraZeneca held “[t]he
pertinent question is whether the proposed label instructs users to perform the patented method. If
so, the proposed label may provide evidence of Apotex’s affirmative intent to induce
infringement.” Id. at 1060. Specific intent and liability for inducement are established if “the
product labeling that Defendants seek would inevitably lead some physicians to infringe.” Eli Lilly
and Company v. Teva Parenteral Meds., Inc., 845 F.3d 1357, 1368-69 (Fed. Cir. 2017); Takeda
Pharms. USA, Inc. v. West-Ward Pharm. Corp., 758 F.3d 625, 631 (Fed. Cir. 2015). Dr. Reddy’s
has provided no defense to the infringing pretreatment regimen portion of its label that this Court
has already found induced infringement in another case with label instructions substantively
identical to those in Dr. Reddy’s Label. Eli Lilly and Company v. Teva Parenteral Meds., Inc.,
No.1:10-cv-1376-TWP-MPB, 126 F.Supp.3d 1037 (S.D. Ind. Aug. 25, 2015).
As noted previously, administration of pemetrexed ditromethamine according to Dr.
Reddy’s label infringes Lilly’s product under the doctrine of equivalents. In a Hatch-Waxman
case such as this, infringement “is focused on the product that is likely to be sold following FDA
approval,” including the relevant knowledge of the parties at the time the product is sold. See
Abbott Laboratories v. TorPharm, Inc., 300 F.3d 1367, 1373 (Fed. Cir. 2002) (“This determination
is based on consideration of all the relevant evidence, including the ANDA filing, other materials
submitted by the accused infringer to the FDA, and other evidence provided by the parties.”). “We
have long held that the sale of a product specifically labeled for use in a patented method
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constitutes inducement to infringe that patent, and usually is also contributory infringement.” Eli
Lilly & Co. v. Actavis Elizabeth LLC, 435 F. App'x 917, 926 (Fed. Cir. 2011) (citing AstraZeneca
LP v. Apotex, Inc., 633 F.3d 1042, 1060 (Fed.Cir.2010)).
This Court has determined that Dr. Reddy’s product infringes the ‘209 Patent under the
doctrine of equivalents. Accordingly, it cannot avoid intent or infringement on the bases that it
possessed a “good faith belief that its proposed product[s] would not infringe.” Moreover, the
Court finds, based on a preponderance of the evidence, Dr. Reddy’s label instructs users to perform
the patented method by both inducing and contributing to infringement and that Dr. Reddy’s had
the requisite specific intent and knowledge that its label would cause such infringement. Dr.
Reddy’s product does not have a substantial noninfringing use to avoid contributory infringement.
A physician administering Dr. Reddy’s product would constitute direct infringement under §
271(a); thus, the use the Dr. Reddy’s NDA products would constitute inducement and contributory
infringement of the ‘209 Patent by Dr. Reddy’s under 35 U.S.C. § 271(b), (c).
III. CONCLUSION
Based upon the foregoing findings of fact and conclusions of law, the Court concludes that
Lilly has shown by a preponderance of the evidence that the asserted claims of the ‘209 Patent
would be infringed by Dr. Reddy’s product under the doctrine of equivalents based upon
inducement and contributory infringement. The Court finds that Dr. Reddy’s product indirectly
infringes the asserted claims of the ‘209 Patent, and finds in favor of Eli Lilly And Company and
against Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd.. Final judgment shall
issue separate from this Entry.
SO ORDERED.
Date: 6/22/2018
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DISTRIBUTION:
Adam L. Perlman
WILLIAMS & CONNOLLY LLP
aperlman@wc.com
Anne N. DePrez
BARNES & THORNBURG LLP
(Indianapolis)
adeprez@btlaw.com
Alec T. Swafford
WILLIAMS & CONNOLLY LLP
aswafford@wc.com
Jan M. Carroll
BARNES & THORNBURG, LLP
(Indianapolis)
jan.carroll@btlaw.com
Bruce Roger Genderson
WILLIAMS & CONNOLLY LLP
bgenderson@wc.com
Rory O’Bryan
HARRISON & MOBERLY (Indianapolis)
robryan@harrisonmoberly.com
Christopher T Berg
WILLIAMS & CONNOLLY LLP
cberg@wc.com
Stephen E. Arthur
HARRISON & MOBERLY (Indianapolis)
sarthur@harrisonmoberly.com
Galina I. Fomenkova
WILLIAMS & CONNOLLY LLP
gfomenkova@wc.com
Charles A. Weiss
HOLLAND & KNIGHT LLP
charles.weiss@hklaw.com
David M. Krinsky
WILLIAMS & CONNOLLY, LLP
dkrinsky@wc.com
Jeffery B. Arnold
HOLLAND & KNIGHT LLP
jeffery.arnold@hklaw.com
Dov P. Grossman
WILLIAMS & CONNOLLY, LLP
dgrossman@wc.com
Merri C Moken
HOLLAND & KNIGHT LLP
merri.moken@hklaw.com
James P. Leeds
ELI LILLY AND COMPANY
jleeds@lilly.com
Eric H. Yecies
HOLLANDS & KNIGHT LLP
eric.yecies@hklaw.com
Charles E. Oswald, IV
HARRISON & MOBERLY
coswald@harrisonmoberly.com
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