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`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF INDIANA
`INDIANAPOLIS DIVISION
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`ELI LILLY AND COMPANY,
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` Plaintiff,
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`DR. REDDY’S LABORATORIES, LTD., and
`DR. REDDY’S LABORATORIES, INC.,
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` 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
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`This matter was before the Court for a bench trial beginning on February 1, 2018 and
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`concluding on February 2, 2018, on the issue of infringement of U.S. Patent No. 7,772,209 (the
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`“‘209 Patent”). This is a Hatch-Waxman patent infringement action brought by Eli Lilly and
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`Company (“Lilly”), the owner of the ‘209 Patent, against Defendants Dr. Reddy’s Laboratories,
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`Inc. and Dr. Reddy’s Laboratories, Ltd. (collectively, “Dr. Reddy’s”) arising out of Dr. Reddy’s
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`filing of New Drug Application No. 208297 (the “NDA”) with the Food and Drug Administration
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`(“FDA”) seeking approval to market the product described therein. The ‘209 Patent describes a
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`method of administering a chemotherapy drug, pemetrexed disodium (“pemetrexed”), with
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`vitamins, which is marketed by Lilly under the trade name ALITMA®. Lilly is asserting that Dr.
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`Reddy’s drug product, which uses pemetrexed ditromethamine, infringes the ‘209 Patent. Dr.
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`Reddy’s contends that its product is not a generic drug, rather, its product uses a different chemical.
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`Particularly at issue is claim 12. The Court previously constructed claim 12 to refer to a liquid
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`administration of pemetrexed disodium. (Filing No. 199 at 9.) Having heard testimony and
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`considered the exhibits and arguments of the parties, the Court makes the following findings of
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`fact and conclusions of law pursuant to Federal Rule of Civil Procedure 52.
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`I. FINDINGS OF FACT
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`Lilly is a corporation organized and existing under the laws of the State of Indiana, having
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`its corporate offices and principal place of business at Lilly Corporate Center, Indianapolis, Indiana
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`46285. Lilly sells pemetrexed in the United States under the trademark ALIMTA® for treatment
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`of patients with malignant pleural mesothelioma, or for the initial treatment of locally advanced or
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`metastatic nonsquamous non-small cell lung cancer, and other forms of lung cancer. ALIMTA®
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`is covered under U.S. Patent No. 5,344,932, which is owned by The Trustees of Princeton
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`University and licensed exclusively to Lilly.
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`Dr. Reddy’s Ltd. is a drug manufacturer with a principal executive office at Hyderabad,
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`Telangana 500 034, India, and Dr. Reddy’s Inc. is a corporation organized and existing under the
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`laws of the State of New Jersey. Dr. Reddy’s is in the business of manufacturing, marketing, and
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`selling both generic and non-generic drug products. In December 2015, Dr. Reddy’s notified Lilly
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`that it had submitted to the FDA New Drug Application No. 208297, a product that will be
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`marketed as competing products to ALIMTA®
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`Dr. Clet Niyikiza (“Dr. Niyikiza”), the inventor of the ‘209 Patent, is a mathematician that
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`was employed by Lilly in the 1990s to help with the clinical development of cancer compounds.
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`In early 1997, Dr. Niyikiza performed a series of statistical analyses, known as multivariate
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`analyses, on more than 60 variables in patients participating in pemetrexed clinical trials in efforts
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`to better understand which patients were likely to develop the sporadic toxicities observed with
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`pemetrexed. The problem the invention solves is toxicity in patients receiving chemotherapeutic
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`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
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`B12 and folic acid. (Filing No. 231 at 35.)
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`The primary focus of this infringement trial is on whether Dr. Reddy’s label, specifically
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`the use of pemetrexed ditromethamine product described therein, infringes the ‘209 Patent, which
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`uses pemetrexed disodium, under the doctrine of equivalents. The ‘209 Patent covers the method
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`of administration of ALIMTA®, requiring that physicians co-administer the drug with folic acid
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`and vitamin B12 to reduce the incidence of patient toxicity caused by ALIMTA®. Claim 12 of the
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`‘209 Patent describes an improved method for administering pemetrexed disodium, comprising
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`“a) administration of between 3500 µg and about 1000 µg of folic acid prior to the first
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`administration of pemetrexed disodium; b) administration of about 500 µg to about 1500 µg of
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`vitamin B12, prior to the first administration of pemetrexed disodium; and c) administration of
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`pemetrexed disodium.” (Filing No. 1-1 at 9).
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`The parties disagree on the relevance of any chemical differences between pemetrexed
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`disodium and pemetrexed ditromethamine, nevertheless both Lilly’s and Dr. Reddy’s experts, Dr.
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`Bruce A. Chabner, M.D., (“Dr. Chabner”), Rodolfo Pinal (“Dr. Pinal”), and George Gokel (“Dr.
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`Gokel”), agreed on what the differences were between the two chemical compounds. Sodium is
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`an inorganic metallic salt, and tromethamine is an organic, nonmetallic salt. (Filing No. 231 at
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`181.) Tromethamine weighs more than sodium. Id. Because tromethamine can raise pH, it can
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`be used as buffer; however, sodium may not be used as a buffer because it cannot be used as a pH
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`adjuster. Id. at 158. Additionally, it is undisputed that pemetrexed disodium is more hygroscopic
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`and absorbs more than twice the amount of water than pemetrexed ditromethamine. Id. at 173.
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`As noted in the Court’s claim construction finding, regardless if pemetrexed disodium or
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`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
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`demonstrates that the person who solves the problems to which the claims are addressed requires
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`a medical oncologist.
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`II. CONCLUSIONS OF LAW
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`A.
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`Prosecution History Estoppel
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`In the Court’s amended Final Pretrial Entry, the Court permitted the parties, at trial, to
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`supplement the summary judgment record on the issue of prosecution history estoppel. (Filing
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`No. 216 at 4.) In its Entry on Motion for Summary Judgment of Noninfringement, the Court found
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`Lilly was not barred, as a matter of law under prosecution history estoppel, from asserting the
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`doctrine of equivalents. (Filing No. 199 at 15.) (“Lilly has met its burden of showing that it did
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`not surrender the equivalent in question because the choice of pemetrexed salt is tangential to the
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`reasons for the amendment and summary judgment is precluded on this issue.”)
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`As in the summary judgment briefing, Dr. Reddy’s continues to collapse the foreseeability
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`exception with the tangential exception, on which the Court relied in holding in Lilly’s favor.
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`Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 733 (2002). Dr. Reddy’s
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`focuses on the unexplained reason that Lilly limited the ‘209 Patent to pemetrexed disodium, in
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`essentially arguing that Lilly could have drafted a better claim. (“[A]” patentee cannot argue in
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`litigation that a narrowing amendment in prosecution was excessive, and that the patentee could
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`have avoided the prior art (and gained allowance) with a less severe amendment that would have
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`literally embraced the accused equivalent.” (Filing No. 234 at 6).) In any event, Lilly has explained
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`the reason for the narrowing amendment: it was narrowed to overcome a rejection in view of
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`Arsenyan, a prior art article about a different antifolate, methotrexate. (Filing No. 235 at 35.) The
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`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
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`analyzed. (Filing No. 232 at 42.) Accordingly, the Court again concludes that Lilly’s rationale
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`for limiting its claim to pemetrexed disodium (to avoid a rejection based on the prior art Arsenyan)
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`is tangential to the accused equivalent—pemetrexed ditromethamine. The Court directs the parties
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`to Filing No. 199 for a more detailed analysis regarding the Court’s holding that Lilly has rebutted
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`the presumption that prosecution history estoppel applies.
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`B.
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`Disclosure-Dedication Rule
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`Another issue, extensively briefed by the parties on summary judgment, was the disclosure-
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`dedication doctrine. Again, the trial record and the summary judgment record contain significant
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`overlap as to this issue. Because Lilly did not move for summary judgment on this issue, it was
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`not decided on summary judgment, rather it was fleshed out by expert testimony at the trial. The
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`disclosure-dedication rule bars a doctrine of equivalents claim when a patentee discloses but does
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`not claim subject matter. Johnson & Johnston Associates, Inc. v. R.E. Service Co., Inc., 285 F.3d
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`1046, 1054 (Fed. Cir. 2002).
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`As noted in the Court’s Entry on Motion for Summary Judgment of Noninfringement, it is
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`undisputed that the ‘209 Patent’s specification did not expressly disclose pemetrexed
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`ditromethamine. Rather, Dr. Reddy’s bases its disclosure-dedication argument on the fact that the
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`‘209 Patent referenced U.S. Patent No. 4,997,838 to Akimoto and that from Akimoto the
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`hypothetical person of skill in the art (“POSA”) could find pemetrexed ditromethamine disclosed
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`among the alternatives disclosed in Akimoto. (Filing No. 234 at 25-26.) Generic references in a
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`written specification do not necessarily dedicate all members of a particular genus to the public.
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`SanDisk Corp. v. Kingston Technology Co., Inc., 695 F.3d 1348, 1363 (Fed. Cir. 2012).
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`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.’
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`Id. (citations omitted). Although the ‘209 Patent did not expressly incorporate Akimoto by
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`reference, it cited that preferred examples of antifolates can be found in the derivatives described
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`by Akimoto. (Filing No. 1-1 at 5.) Because this issue hinged on what a POSA would recognize
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`as unclaimed subject matter disclosed in the ‘209 Patent specification and if Akimoto’s disclosures
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`in combination would disclose pemetrexed ditromethamine, it left a factual dispute for trial.
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`At trial, Dr. Pinal testified that Akimoto included pemetrexed and any “pharmaceutically
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`acceptable salt thereof.” (Filing No. 231 at 249.) From this concession, Dr. Reddy’s argues that
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`pharmaceutically accepted salts would include substituted ammonium salts of which tromethamine
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`is one of a few FDA-approved substituted ammonium salts. (Filing No. 234 at 24.) Thus, Dr.
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`Reddy’s contends that a POSA would have recognized pemetrexed in combination with
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`tromethamine as an alternative to pemetrexed disodium. (Filing No. 234 at 26-27.) Lilly responds
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`that while Dr. Pinal testified that pemetrexed is within the genus covered by Akimoto, Dr. Pinal
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`also testified that Akimoto disclosed a genus of thousands of antifolates. (Filing No. 231 at 227.)
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`Further, tromethamine is not specifically disclosed in any referenced patent nor is the compound
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`pemetrexed ditromethamine. (Filing No. 238 at 16-17.) Because Akimoto was not expressly
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`incorporated, as required, in the ‘209 Patent, and in any event Akimoto does not specifically
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`disclose pemetrexed ditromethamine as an alternative to pemetrexed disodium, the disclosure-
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`dedication rule does not bar Lilly’s doctrine of equivalents claim. At most, the reference to
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`Akimoto and what was contained therein amounts to a generic reference which does not dedicate
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`all members of a particular genus to the public.
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`C.
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`Doctrine of Equivalents
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`Lilly asserts, and the Court agrees, that healthcare providers using the proposed Dr.
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`Reddy’s product will directly infringe under the doctrine of equivalents, and that Dr. Reddy’s is
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`liable as an indirect infringer under 35 U.S.C. §§ 271(b) and (c).
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`As an initial matter, the relevant POSA must be defined for a doctrine of equivalents
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`analysis. “What constitutes equivalency must be determined against the context of the patent, the
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`prior art, and the particular circumstances of the case.” Warner-Jenkinson Co. v. Hilton Davis
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`Chem. Co., 520 U.S. 17, 24 (1997) (citation omitted). Thus, a POSA becomes an important factor
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`as to “whether persons reasonably skilled in the art would have known of the interchangeability of
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`an ingredient not contained in the patent with one that was.” Id. Dr. Reddy’s contends that the
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`POSA should be the type of person who solves the problems to which the claims are addressed
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`such as Dr. Niyikiza, the inventor of the patent.1 (Filing No. 234 at 28, 30.) (“The POSA could be
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`trained as a chemist, biochemist, pharmaceutical scientist, physician, or molecular biologist. The
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`POSA, even if he is a physician, should have a strong background in chemistry and biochemistry,
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`understand the folate pathways and metabolism, and have a solid grasp of acid-base.”) Dr. Reddy’s
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`proposed POSA would examine the doctrine of equivalents from the perspective of the chemical
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`and biochemical properties between pemetrexed disodium and pemetrexed ditromethamine.
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`(Filing No. 234 at 30.) Lilly responds that the ‘209 Patent makes clear, from the plain language
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`of the claims and testimony from the inventor, Dr. Niyikiza, that the POSA is directed to a medical
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`oncologist. (Filing No. 235 at 13.) Lilly’s proposed POSA would perform a doctrine of
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`equivalents analysis focusing on the medical treatment aspects of the claims. (Filing No. 238 at
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`19.) This Court has “previously defined the POSA as ‘a medical doctor who specializes in
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`1 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
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`involving vitamin deficiencies [,who] collaborated with medical oncologists who have knowledge
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`and experience in the treatment of cancer through the use of antifolates.’” Eli Lilly and Company
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`v. Teva Parenteral Meds., Inc., 1:10-cv-1376-TWP-MPB, 2012 WL 2358102, at *4 (S.D. Ind.
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`June 20, 2012), ECF 115 at 8. Essentially, the point of contention between the proposed POSAs
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`advanced by the parties is whether the POSA is a chemist or an oncologist.
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`Dr. Reddy’s POSA definition is defeated by the plain language of the ‘209 Patent as the
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`invention explicitly identifies it as “a method of reducing the toxicity associated with the
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`administration of an antifolate to a mammal. . .” (Filing No. 1-1 at 5). Lilly is correct that the
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`relevant POSA who works to mitigate the toxicities of chemotherapy would be an oncologist,
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`particularly an oncologist with extensive experience in the areas of nutritional sciences involving
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`vitamin deficiencies as confirmed by Dr. Chabner. Thus, equivalency is examined from an
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`oncologist POSA. The relevant POSA is critical (and dispositive) to resolving the doctrine of
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`equivalents analysis in the context of the claims as to whether the POSA would focus on the
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`different salt forms of pemetrexed disodium and pemetrexed ditromethamine as being substantial
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`differences, or instead would focus on the pemetrexed treatment that the patient receives.
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`The United States Supreme Court has set out two frameworks for evaluating equivalence—
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`the function, way, result test (whether the accused product performs ‘substantially the same
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`function in substantially the same way to obtain the same result’), and the insubstantial differences
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`test (whether the accused product or process is substantially different from what is patented).
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`Mylan Institutional LLC v. Aurobindo Pharma Ltd., 857 F.3d 858, 866–67 (Fed. Cir. 2017) (“Thus,
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`the Court seemingly blessed two equivalents tests, leaving to the lower courts in future cases the
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`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
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`differences test may be more appropriate in chemical arts cases. Id. (“The Supreme Court was
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`surely correct in stating that non-mechanical cases may not be well-suited to consideration under
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`the FWR test.”) Because equivalence in this case is based on chemical properties, the Court
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`determines that the insubstantial differences test is the more appropriate framework for evaluating
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`equivalence.
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`“Under the doctrine of equivalents, a claim limitation not literally met may be satisfied by
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`an element of the accused product if the differences between the two are ‘insubstantial’ to one of
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`ordinary skill in the art.” Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320
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`F.3d 1339, 1351 (Fed. Cir. 2003). “The doctrine of equivalents allows the patentee to claim those
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`insubstantial alterations that were not captured in drafting the original patent claim but which could
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`be created through trivial changes.” Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535
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`U.S. 722, 733 (2002). As noted previously, the relevant POSA, in this case, is a medical
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`oncologist. Dr. Chabner testified that the invention claimed in the ‘209 Patent relates to “using
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`pretreatment B12 and folic acid to mitigate the toxicity of pemetrexed when it’s given to a patient
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`with cancer.” (Filing No. 231 at 70.) Additionally, Dr. Chabner testified that the pemetrexed
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`disodium could not exert an anti-cancer effect in solid form, thus the POSA would understand that
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`pemetrexed disodium is administered by first putting it into solution and then intravenously
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`administering the solution to the patient for an anti-cancer effect. Id. at 72.
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`Under the relevant context that the claim relates to medical treatment, pemetrexed
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`ditromethamine treats the patient’s cancer in exactly the same way as pemetrexed disodium. It is
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`undisputed that when both pemetrexed disodium and pemetrexed ditromethamine are placed in
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`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
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`will be identical. (Filing No. 231 at 212.) Recognizing these similarities, Dr. Reddy’s relied on
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`Lilly’s clinical trials of pemetrexed disodium, in demonstrating the safety and efficacy of its
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`product, when it told the FDA that the salt form does not matter when it comes to treating the
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`patient to support approval of its NDA product. (Filing No. 231 at 80-81.) It is undisputed that
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`the products are bioequivalent; however, the parties disagree on whether there is patent
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`equivalence in the context of the claimed method. (Filing No. 234 at 42-43; Filing No. 238 at 24.)
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`“[W]hen a commercial product meets all of the claim limitations, then a comparison to that product
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`may support a finding of infringement.” Adams Respiratory Therapeutics, Inc. v. Perrigo Co.,
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`616 F.3d 1283, 1289 (Fed. Cir. 2010).
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`The differences in the chemical properties between pemetrexed disodium and pemetrexed
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`ditromethamine with regards to solubility, stability, pH, and buffering capacity are irrelevant in
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`the context of the claimed method including this Court’s claim construction. (Filing No. 234 at
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`42.) Additionally, the theoretical phenomenon of the difference of salting out between the two
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`products is irrelevant, as ALIMTA®’s label “requires the solution to be clear prior to
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`administration and specifically instructs physicians not to administer it if any particulate matter is
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`observed.” (Filing No. 235 at 22-23.) To be sure, the evidence shows that tromethamine differs
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`from sodium with regards to the chemical properties as alleged by Dr. Reddy’s. Lilly does not
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`dispute that there are differences when the products are in solid form, instead Lilly argues that the
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`differences are insubstantial. (Filing No. 231 at 80.) The Court agrees. The differences are
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`irrelevant in the context of the claimed method which is a liquid administration of pemetrexed
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`sodium. What is in fact ultimately administered to the patient is injectable pemetrexed ions that
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`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.
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`(See Filing No. 232 at 124-25; Filing No. 235 at 18.) Furthermore, Dr. Reddy’s incorrectly relies
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`on a chemist POSA in posing nonequivalence, who would not administer the drugs to a patient as
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`the ‘209 Patent is a claimed method of treatment. Accordingly, Lilly has shown by a
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`preponderance of the evidence that Dr. Reddy’s product is equivalent to Lilly’s product.
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`D.
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`Inducement and Contribution to Infringement of ‘209 Patent
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`A party can be held liable for indirect infringement by actively inducing or contributing to
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`direct infringement by others. 35 U.S.C. § 271(b), (c). Direct infringement occurs when one party
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`makes, uses, offers to sell, sells, or imports each element of a patented invention. 35 U.S.C. §
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`271(a). Because Dr. Reddy’s does not provide care to patients, the direct infringement is attributed
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`to the healthcare providers.
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`“Inducement requires that the alleged infringer knowingly induced infringement and
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`possessed a specific intent to encourage another’s infringement.” AstraZeneca LP v. Apotex, Inc.,
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`633 F.3d 1042, 1056 (Fed. Cir. 2010). Courts have inferred intent to induce infringement based
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`on the contents of labels. Id. (holding circumstantial evidence may suffice to prove specific intent
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`to induce infringement). Similarly, labels may also form the basis to infer intent under contributory
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`infringement when they instruct users to perform a patented method. See Eli Lilly & Co. v. Actavis
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`Elizabeth LLC, 435 F. App’x 917, 926 (Fed. Cir. 2011).
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`Relying on Commil USA, LLC v. Cisco Sys., Inc., 135 S. Ct. 1920, 1928 (2015), Dr.
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`Reddy’s contends that Lilly cannot prove Dr. Reddy’s specifically intended to infringe because
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`specific intent requires proof that Dr. Reddy’s knew the acts were infringing. (Filing No. 234 at
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`44.) As evidence that Dr. Reddy’s did not know its product would infringe the ‘209 Patent, Dr.
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`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
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`shown in the Hatch-Waxman context, particularly how specific intent can be inferred from an
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`accused product’s labeling. AstraZeneca LP v. Apotex, Inc. considered similar facts where
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`Apotex’s product development team testified that it “never intended to instruct or encourage either
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`physicians or patients to use its generic drug once-daily.” Id. However, AstraZeneca held “[t]he
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`pertinent question is whether the proposed label instructs users to perform the patented method. If
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`so, the proposed label may provide evidence of Apotex’s affirmative intent to induce
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`infringement.” Id. at 1060. Specific intent and liability for inducement are established if “the
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`product labeling that Defendants seek would inevitably lead some physicians to infringe.” Eli Lilly
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`and Company v. Teva Parenteral Meds., Inc., 845 F.3d 1357, 1368-69 (Fed. Cir. 2017); Takeda
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`Pharms. USA, Inc. v. West-Ward Pharm. Corp., 758 F.3d 625, 631 (Fed. Cir. 2015). Dr. Reddy’s
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`has provided no defense to the infringing pretreatment regimen portion of its label that this Court
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`has already found induced infringement in another case with label instructions substantively
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`identical to those in Dr. Reddy’s Label. Eli Lilly and Company v. Teva Parenteral Meds., Inc.,
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`No.1:10-cv-1376-TWP-MPB, 126 F.Supp.3d 1037 (S.D. Ind. Aug. 25, 2015).
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`As noted previously, administration of pemetrexed ditromethamine according to Dr.
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`Reddy’s label infringes Lilly’s product under the doctrine of equivalents. In a Hatch-Waxman
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`case such as this, infringement “is focused on the product that is likely to be sold following FDA
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`approval,” including the relevant knowledge of the parties at the time the product is sold. See
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`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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`12
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`Case 1:16-cv-00308-TWP-MPB Document 241 Filed 06/22/18 Page 13 of 14 PageID #: 7388
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`constitutes inducement to infringe that patent, and usually is also contributory infringement.” Eli
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`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
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`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
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`the requisite specific intent and knowledge that its label would cause such infringement. Dr.
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`Reddy’s product does not have a substantial noninfringing use to avoid contributory infringement.
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`A physician administering Dr. Reddy’s product would constitute direct infringement under §
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`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).
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`III. CONCLUSION
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`Based upon the foregoing findings of fact and conclusions of law, the Court concludes that
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`Lilly has shown by a preponderance of the evidence that the asserted claims of the ‘209 Patent
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`would be infringed by Dr. Reddy’s product under the doctrine of equivalents based upon
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`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
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`issue separate from this Entry.
`
`
`SO ORDERED.
`
`
`Date: 6/22/2018
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`
`
`13
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`Case 1:16-cv-00308-TWP-MPB Document 241 Filed 06/22/18 Page 14 of 14 PageID #: 7389
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`
`DISTRIBUTION:
`
`Anne N. DePrez
`BARNES & THORNBURG LLP
`(Indianapolis)
`adeprez@btlaw.com
`
`Jan M. Carroll
`BARNES & THORNBURG, LLP
`(Indianapolis)
`jan.carroll@btlaw.com
`
`Rory O’Bryan
`HARRISON & MOBERLY (Indianapolis)
`robryan@harrisonmoberly.com
`
`Stephen E. Arthur
`HARRISON & MOBERLY (Indianapolis)
`sarthur@harrisonmoberly.com
`
`Charles A. Weiss
`HOLLAND & KNIGHT LLP
`charles.weiss@hklaw.com
`
`Jeffery B. Arnold
`HOLLAND & KNIGHT LLP
`jeffery.arnold@hklaw.com
`
`Merri C Moken
`HOLLAND & KNIGHT LLP
`merri.moken@hklaw.com
`
`Eric H. Yecies
`HOLLANDS & KNIGHT LLP
`eric.yecies@hklaw.com
`
`
`
`
`
`Adam L. Perlman
`WILLIAMS & CONNOLLY LLP
`aperlman@wc.com
`
`Alec T. Swafford
`WILLIAMS & CONNOLLY LLP
`aswafford@wc.com
`
`Bruce Roger Genderson
`WILLIAMS & CONNOLLY LLP
`bgenderson@wc.com
`
`Christopher T Berg
`WILLIAMS & CONNOLLY LLP
`cberg@wc.com
`
`Galina I. Fomenkova
`WILLIAMS & CONNOLLY LLP
`gfomenkova@wc.com
`
`David M. Krinsky
`WILLIAMS & CONNOLLY, LLP
`dkrinsky@wc.com
`
`Dov P. Grossman
`WILLIAMS & CONNOLLY, LLP
`dgrossman@wc.com
`
`James P. Leeds
`ELI LILLY AND COMPANY
`jleeds@lilly.com
`
`Charles E. Oswald, IV
`HARRISON & MOBERLY
`coswald@harrisonmoberly.com
`
`
`
`14
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`