Case 1:16-cv-00308-TWP-MPB Document 199 Filed 12/14/17 Page 1 of 22 PageID #: 6456
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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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` v.
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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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`ENTRY ON MOTION FOR SUMMARY JUDGMENT OF NONINFRINGEMENT
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`This matter is before the Court on Defendants Dr. Reddy’s Laboratories, LTD.’s and Dr.
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`Reddy’s Laboratories, Inc.’s (collectively, “Dr. Reddy’s”) Motion for Summary Judgment of
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`Noninfringement of the U.S. Patent 7,772,209 (the “’209 Patent”) (Filing No. 132). Plaintiff Eli
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`Lilly and Company (“Lilly”) initiated this Hatch-Waxman litigation alleging that Dr. Reddy’s New
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`Drug Application No. 208297 and the use of the product described therein, infringe Lilly’s ‘209
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`Patent. On November 9, 2017, oral argument was held on the Motion at which the parties made
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`helpful presentations. For the reasons stated below, the Court determines that summary judgment
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`is not appropriate and Dr. Reddy’s Motion is denied.
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`I.
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`BACKGROUND
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`The ‘209 Patent describes a method of administering a chemotherapy drug, pemetrexed
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`disodium, with a pretreatment regimen of vitamin B12 and folic acid (“pretreatment regimen”),
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`which is marketed by Lilly under the trade name ALIMTA®. The ‘209 Patent has been the subject
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`of two previous trials before this Court. See Eli Lilly and Co. v. Teva Parenteral Medicines, Inc.,
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`126 F. Supp.3d 1037, 1038 (S.D. Ind. 2015)1. Those cases specifically concerned generic drug
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`1 The ‘209 Patent is also the subject of other pending infringement suits pending before this Court.
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`manufacturers that sought to market a generic version of ALIMTA® including labeling that
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`induced physicians to direct patients to take folic acid and vitamin B12 in accordance with the
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`pretreatment claims in the ‘209 Patent. Specifically, in the Teva case, the pretreatment regimen
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`and whether the steps of the claimed method could be attributed to a single actor was at issue. Id.
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`During prosecution of its patent application for ALIMTA®, the U.S. Patent and Trademark
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`Office originally rejected claim 2 of the ‘209 Patent as being anticipated by a prior art article,
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`Arsenyan et.al. (“Arsenyan”). Arsenyan concerned the administration of the compound
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`methotrexate.2 To avoid rejection of its patent in view of Arsenyan, Lilly narrowed the scope of
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`its claims from a broad category of antifolates to specifically pemetrexed disodium. (Filing No.
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`133-1 at 124; Filing No. 146 at 30.)
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`Dr. Reddy’s is a drug manufacturer and does not treat patients, therefore any infringement
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`would be based on indirect infringement. Dr. Reddy’s set out to avoid infringing the ‘209 Patent
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`by designing a different product. It ran experiments to investigate different salts, and chose
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`tromethamine. Unlike the generic drug manufacturers that used pemetrexed disodium in the
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`proposed generic drugs in previous trials, Dr. Reddy’s seeks to market a new product that uses
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`pemetrexed ditromethamine, rather than pemetrexed disodium.
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`A point of contention between the parties is whether pemetrexed ditromethamine was
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`excluded (thus designated public use) from the claims during patent prosecution by Lilly’s
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`specification and narrowing amendment from the term “antifolates” to “pemetrexed disodium.”
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`Tromethamine is an inorganic, metallic salt, whereas sodium is an organic, nonmetallic salt.
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`2 Both methotrexate and pemetrexed fall within the broader antifolate group, but they target different enzymes. (Filing
`No. 146 at 44.)
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`2
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`(Filing No. 135 at 8.) The liquid solution of both chemical compounds results in pemetrexed
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`treatment, but the powdered solid form of the two products differ as a result of the different salt
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`compounds used. The patient receives the liquid solution intravenously. The products are sold in
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`solid form. At issue is claim 12 of the ‘209 Patent. Claim 12 reads as follows:
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`12. An improved method for administering pemetrexed disodium to a patient in
`need of chemotherapeutic treatment, wherein the improvement comprises:
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`a) administration of between about 350 µg and about 1000 µg of folic acid prior to
`the first administration of pemetrexed disodium
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`b) administration of about 500 µg to about 1500 µg of vitamin B12, prior to the first
`administration of pemetrexed disodium; and
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`c) administration of pemetrexed disodium.
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`(Filing No. 1-1 at 9).
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`As previously noted, Dr. Reddy’s product uses a different pemetrexed compound:
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`pemetrexed ditromethamine. In addition, Dr. Reddy’s label on the administration of the
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`pemetrexed ditromethamine differs from Lilly’s in that Dr. Reddy’s label instructs that pemetrexed
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`ditromethamine should be reconstituted and diluted with 5% dextrose in water (“dextrose”),
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`whereas Lilly’s label instructs that the pemetrexed disodium should be reconstituted and diluted
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`in saline solution. (Filing No. 92-3; Filing No. 179-1.) Dr. Reddy’s label states “[c]oadminstration
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`of pemetrexed with other drugs and diluents has not been studied, and therefore is not
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`recommended.” (Filing No. 92-3 at 9.) Dr. Reddy’s label also instructs that the pretreatment
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`regimen be followed and mitigates the severe toxicities that pemetrexed can otherwise cause. Id.
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`at 42.
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`Both Dr. Reddy’s and Lilly’s labels indicate that its products are to be administered along
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`with cisplatin for some patients. Id. at 11. Before cisplatin can be administered to a patient it
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`requires and is standard practice to prehydrate it with saline to prevent serious kidney toxicity.
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`(Filing No. 146 at 13-14.) Dr. Reddy’s label instructs that the cisplatin be administered
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`intravenously approximately thirty minutes after the end of administration of pemetrexed
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`treatment. (Filing No. 92-3 at 37.) Saline is commonly used in intravenous administration for
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`many different drugs.
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`II.
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`LEGAL STANDARD
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`The purpose of summary judgment is to “pierce the pleadings and to assess the proof in
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`order to see whether there is a genuine need for trial.” Matsushita Electric Industrial Co. v. Zenith
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`Radio Corp., 475 U.S. 574, 587 (1986). Federal Rule of Civil Procedure 56 provides that summary
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`judgment is appropriate if “the pleadings, depositions, answers to interrogatories, and admissions
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`on file, together with the affidavits, if any, show that there is no genuine issue as to any material
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`fact and that the moving party is entitled to a judgment as a matter of law.” Hemsworth v.
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`Quotesmith.Com, Inc., 476 F.3d 487, 489-90 (7th Cir. 2007). In ruling on a motion for summary
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`judgment, the court reviews “the record in the light most favorable to the nonmoving party and
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`draw[s] all reasonable inferences in that party’s favor.” Zerante v. DeLuca, 555 F.3d 582, 584
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`(7th Cir. 2009) (citation omitted). However, “[a] party who bears the burden of proof on a
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`particular issue may not rest on its pleadings, but must affirmatively demonstrate, by specific
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`factual allegations, that there is a genuine issue of material fact that requires trial.” Hemsworth,
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`476 F.3d at 490 (citation omitted). “In much the same way that a court is not required to scour the
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`record in search of evidence to defeat a motion for summary judgment, nor is it permitted to
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`conduct a paper trial on the merits of a claim.” Ritchie v. Glidden Co., 242 F.3d 713, 723 (7th Cir.
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`2001) (citation and internal quotations omitted). Finally, “neither the mere existence of some
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`alleged factual dispute between the parties nor the existence of some metaphysical doubt as to the
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`material facts is sufficient to defeat a motion for summary judgment.” Chiaramonte v. Fashion
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`Bed Grp., Inc., 129 F.3d 391, 395 (7th Cir. 1997) (citations and internal quotations omitted).
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`III. DISCUSSION
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`As an initial matter, the Court notes that Lilly recently changed its ALIMTA® label in
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`response to the Food and Drug Administration’s (“FDA”) instructions to change various aspects
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`of the label. Nevertheless, both parties agree that the new label does not change the substance or
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`legal theories of any of the briefings previously submitted to the Court and that the parties are
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`prepared to go forward with the proceedings as they currently stand. (Filing No. 182 at 7-10.)
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`Lilly argues that Dr. Reddy’s product infringes under two theories: literal infringement
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`and the doctrine of equivalents. (Filing No. 146 at 19.) The Court will first address the embedded
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`claim construction issue and then address each infringement theory.
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`A.
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`Claim Construction
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`The claims define the scope of patent protection. Johnson & Johnston Associates, Inc. v.
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`R.E. Service Co., Inc., 285 F.3d 1046, 1052 (Fed. Cir. 2002). The words of a claim are generally
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`given their ordinary and customary meaning, as understood by a person of skill in the art (“POSA”)
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`when the patent was filed. Phillips v. AWH Corp., 415 F.3d 1303, 1312-13 (Fed. Cir. 2005) (en
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`banc). When the ordinary meaning of a claim is disputed, the Federal Circuit has directed courts
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`to look to the patent specification, which is the single best guide to the meaning of a disputed term.
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`Id. at 1315 (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)).
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`“The construction that stays true to the claim language and most naturally aligns with the patent’s
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`description of the invention will be, in the end, the correct construction.” Phillips, 415 F.3d at
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`1316. Courts may also consider extrinsic evidence, such as expert testimony or dictionaries, but
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`such evidence is “less significant” than the patent specification and prosecution history (i.e., the
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`written history of patentee’s prior dealings with the patent office). Id. at 1317. “Importantly, the
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`person of ordinary skill in the art is deemed to read the claim term not only in the context of the
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`particular claim in which the disputed term appears, but in the context of the entire patent,
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`including the specification.” Id. “[I]t is necessary to consider the specification as a whole, and to
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`read all portions of the written description, if possible, in a manner that renders the patent internally
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`consistent.” Budde v. Harley-Davidson, Inc., 250 F.3d 1369, 1379-80 (Fed. Cir. 2001). “A claim
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`construction that excludes a preferred embodiment. . .is rarely, if ever correct.” SanDisk Corp. v.
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`Memorex Products, Inc., 415 F. 3d 1278, 1285 (Fed. Cir. 2005) (citation and internal quotation
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`omitted).
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`At the hearing, the parties set forth different constructions of claim 12’s meaning. (See
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`Filing No. 182 at 23, 30.) It is undisputed that claim 12 is a method claim, but the parties
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`essentially dispute the meaning of “administration of pemetrexed disodium.” Lilly argues that
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`“administration of pemetrexed disodium” refers to the act of giving the patient the liquid solution
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`of pemetrexed disodium after it has been diluted and reconstituted because no salt form is given
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`to patients. (Filing No. 182 at 30.) Lilly explains that its experts have opined that a POSA would
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`understand claim 12 to embrace the meaning of a solution with pemetrexed ions and two sodium
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`ions that is given to patients intravenously. Id. Dr. Reddy’s argues that this construction would
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`improperly require “changing each instance of ‘pemetrexed disodium’ in the claims to a ‘solution
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`comprising pemetrexed ions and sodium ions.’” (Filing No. 167 at 3.)
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`“Claim construction begins with the language of the asserted claims.” SanDisk, 415 F.3d
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`at 1284 (citation omitted). As stated previously the relevant asserted claim at issue is
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`“administration of pemetrexed disodium”. The dispute between the parties’ different claim
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`construction arguments turns on the word “administration”. This is primarily due to the fact that
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`the patient receives the product through a liquid solution, but ALIMTA® is sold in solid or salt
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`form.3
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`The Federal Circuit prefers intrinsic evidence over extrinsic evidence in construing claims.
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`See Phillips, 415 F.3d at 1317 (“However, while extrinsic evidence ‘can shed useful light on the
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`relevant art,’ we have explained that it is ‘less significant than the intrinsic record in determining
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`‘the legally operative meaning of claim language.’’”) (citations omitted). Turning to the intrinsic
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`evidence first, the Court begins with the specification. The specification must conclude with the
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`claims “particularly pointing out and distinctly claiming the subject matter” which the applicant
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`regards as his invention. See 35 U.S.C. §112. This apprises the public of the metes and bounds
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`of the subject matter for which the inventor seeks patent protection.
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`The ‘209 Patent’s specification distinctly claims pemetrexed disodium. The prosecution
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`history is consistent with this result. “The court must always consult the prosecution history, when
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`offered in evidence, to determine if the inventor surrendered disputed claim coverage.” SanDisk,
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`415 F.3d at 1286. Here, the prosecution history reveals that the amendments to the detailed
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`3 Although Dr. Reddy’s product is not on the market yet, it is also being proposed to sell in a solid form.
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`description section of the specification as well as the claims were made in response to the U.S.
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`Patent and Trademark Office’s (“Patent Office”) rejections. (Filing No. 133-1 at 147-48.) Lilly
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`limited the chemical compound used in claim 12 to pemetrexed disodium. “As a basic principle
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`of claim interpretation, prosecution disclaimer promotes the public notice function of the intrinsic
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`evidence and protects the public’s reliance on definitive statements made during prosecution.
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`SanDisk, 415 F.3d at 1287 (citation omitted).
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`Unlike pemetrexed disodium, the parties’ dispute over the word “administration” is not
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`completely resolved by resorting to intrinsic evidence alone. The specification, claims, nor
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`prosecution history do not resolve this dispute. “There is no ‘clear and unmistakable’ disclaimer
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`if a prosecution argument is subject to more than one reasonable interpretation, one of which is
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`consistent with a proffered meaning of the disputed term.” Id. (citation omitted). The ‘209 Patent
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`does reveal that it is a method invention, but the claims do not address how ALIMTA® i.e.,
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`pemetrexed disodium, is actually given to the patient. That requires reading the label’s detailed
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`directions. Both products’ labels require the powdered form of the drugs to be diluted and
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`reconstituted, using different liquid solvents.4 The expert reports shed light on what a POSA
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`would understand “administration” to mean. The Court finds it very persuasive that both products
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`are administered in liquid form to be indicative that a POSA would understand the ‘209 Patent to
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`refer to a method of liquid administration of pemetrexed disodium.
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`What happens to pemetrexed disodium or pemetrexed ditromethamine after the liquid
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`solution is prepared and administered to the patient is not a question that needs to be resolved in
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`4 Lilly’s label requires saline, while Dr. Reddy’s label requires dextrose.
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`construing claim 12. In any event, the parties agree on the science of what happens during the
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`administration of the liquid solution the patient. “And Dr. Chabner is saying, well, I think people
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`would understand the claim to mean this. And, basically, what he’s saying is, because that makes
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`sense, that’s what Lilly should have done, people know that it’s the pemetrexed that matters.”
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`(Filing No. 182 at 51) (emphasis added). The patient receives pemetrexed treatment. “Claim
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`construction is a matter of resolution of disputed meanings and technical scope, to clarify and when
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`necessary to explain what the patentee covered by the claims, for use in the determination of
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`infringement. It is not an obligatory exercise in redundancy.” U.S. Surgical Corp., v. Ethicon,
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`Inc., 103 F.3d 1554, 1568 (Fed. Cir. 1997). Having already determined based on the intrinsic
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`evidence, Lilly claimed “pemetrexed disodium,” the Court declines further claim construction
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`based on Lilly’s assertion that the term “embraces the administration in liquid form of pemetrexed
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`ions in combination with two sodium ions. (Filing No. 182 at 30.) In sum, the Court construes
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`claim 12’s “administration of pemetrexed disodium” language to refer to a liquid administration
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`of pemetrexed disodium. The liquid administration is accomplished by dissolving the solid
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`compound pemetrexed disodium into solution as instructed by the ALIMTA® label. This
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`construction is consistent with the ‘209 Patent’s specification and the plain meaning of claim 12
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`as well as the prosecution history. It is undisputed that a POSA would understand that the ‘209
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`Patent refers to a method of liquid administration because pemetrexed is the active ingredient that
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`treats the cancer and the patient receives the solution intravenously. Further, this construction
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`adheres to the bedrock patent claim construction principle to not exclude a preferred embodiment
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`i.e., pemetrexed disodium, and renders the patent internally consistent.
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`B.
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`Literal Infringement
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`“Literal infringement requires a patentee to prove by a preponderance of the evidence that
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`every limitation of the asserted claim is literally met by the allegedly infringing device.” Biovail
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`Corp. Intern. v. Andrx Pharmaceuticals, Inc., 239 F. 3d 1297, 1302 (Fed. Cir. 2001). Lilly’s theory
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`of literal infringement involves Dr. Reddy’s product’s use in combination with certain patients that
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`require another chemotherapy drug called cisplatin. In these instances, Dr. Reddy’s label instructs
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`that the pemetrexed product is to be infused thirty minutes before cisplatin. Cisplatin requires
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`prehydration with saline solution—sodium chloride. (Filing No. 146 at 2.) Lilly contends that the
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`cisplatin use and pemetrexed infusion will overlap because they are administered thirty minutes
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`apart and that when this happens Dr. Reddy’s product will mix with the saline solution due to the
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`prehydration requirement. The resulting solution will contain pemetrexed molecules and sodium
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`and tromethamine ions that disassociate from each other. Lilly explains that Dr. Reddy’s product
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`will be mixed with saline solution as it is being infused into a patient through the same intravenous
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`line as the saline prehydration. The resulting solution will contain pemetrexed and sodium ions—
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`that is pemetrexed disodium.
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`Dr. Reddy’s responds that Lilly’s theory of literal infringement would require healthcare
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`providers to completely disregard its label instructions to use the Dr. Reddy’s product with
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`dextrose solution only. Lilly relies on the fact that the label does not explicitly instruct not to use
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`saline and that a POSA would know that saline is suitable for use with pemetrexed drugs as Lilly’s
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`product has been safely administered with saline for over a decade. (Filing No. 146 at 15.) Dr.
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`Reddy’s label states that co-administration of Dr. Reddy’s products with other diluents has not
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`been studied and is therefore not recommended. Dr. Reddy’s argues that Lilly’s literal
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`infringement claim must prove that the Dr. Reddy’s label instructs users to mix the Dr. Reddy’s
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`product with saline. Dr. Reddy’s label also states that its product should not mix with anything
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`except dextrose before it is infused. Dr. Reddy’s also explains that even if healthcare providers
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`mixed Dr. Reddy’s pemetrexed ditromethamine with saline this would not be “administration of
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`pemetrexed disodium” as required by Lilly’s patent claims.
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`The claim construction issue has been resolved as a liquid administration of pemetrexed
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`disodium. For purposes of summary judgment, the Court must credit Lilly’s literal infringement
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`theory that cisplatin’s requirement and established practice of saline prehydration would overlap
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`with the pemetrexed infusion and the two would mix via healthcare providers administering both
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`through the same intravenous line. Furthermore, because saline contains sodium ions that this
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`would result in infringement when Dr. Reddy’s pemetrexed ditromethamine product is mixed with
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`the saline resulting in a liquid administration of the pemetrexed disodium solution. Based on the
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`foregoing, viewing the facts in a light favorable to Lilly, there are disputed issues of material fact
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`as to whether every limitation of the asserted claim is literally met by the allegedly infringing
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`device. Thus, Dr. Reddy’s Motion for Summary Judgment of Noninfringement (Filing No. 132)
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`is denied as to literal infringement.
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`C.
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`Doctrine of Equivalents
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`“The doctrine of equivalents extends the right to exclude beyond the literal scope of the
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`claims.” Johnson, 285 F.3d at 1053. “The doctrine of equivalents allows the patentee to claim
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`those insubstantial alterations that were not captured in drafting the original patent claim but which
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`could be created through trivial changes.” Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co.,
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`535 U.S. 722, 733 (2002). The doctrine of equivalents is restricted by the “all limitations” rule
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`and the prosecution history estoppel rule by limiting the range of equivalents when claims have
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`been narrowed. See Pozen Inc. v. Par Pharmaceutical, Inc., 696 F.3d 1151, 1167. Dr. Reddy’s
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`argues that Lilly’s doctrine of equivalents infringement claim is foreclosed by prosecution history
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`estoppel, the disclosure dedication rule, and doctrine of vitiation. The Court will address each of
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`these threshold arguments in turn.
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`1.
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`Prosecution History Estoppel
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`Dr. Reddy’s argues that prosecution history estoppel bars Lilly’s doctrine of equivalents
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`claim at the threshold as a matter of law. (Filing No. 182 at 12.) It is undisputed that Lilly
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`narrowed its broader antifolates claim to pemetrexed disodium during prosecution to avoid
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`Arsenyan prior art. It is also undisputed that Dr. Reddy’s product would fall within the scope of
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`the original antifolates claim. Under Festo, Lilly’s narrowing amendment triggers a presumption
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`of surrender that Lilly must rebut to sustain its doctrine of equivalents claim. Festo, 535 U.S. at
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`725. Festo held three exceptions to defeat prosecution history estoppel:
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`The equivalent may have been unforeseeable at the time of the application; the
`rationale underlying the amendment may bear no more than a tangential relation to
`the equivalent in question; or there may be some other reason suggesting that the
`patentee could not reasonably be expected to have described the insubstantial
`substitute in question. In those cases the patentee can overcome the presumption
`that prosecution history estoppel bars finding an equivalence.
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`Id. at 740-41. Lilly argues that the tangential exception applies here, in that the different salt forms
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`of pemetrexed used bear no more than a tangential relationship to the rationale for the underlying
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`amendment. (Filing No. 146 at 23.) Lilly concedes that the amendment was to overcome a
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`rejection in view of Arsenyan, however it explains that Arsenyan is a prior art article about the
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`administration of a compound called methotrexate, also an antifolate but distinguishable from
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`pemetrexed.
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`Dr. Reddy’s incorrectly reads Festo to hold that the rationale for the amendment must be
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`both unforeseeable and tangential, but explains that even if tangential is an independent basis, Lilly
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`is nevertheless precluded from asserting doctrine of equivalents because Lilly’s narrowing
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`amendment went to the identity of a particular type of antifolate—pemetrexed disodium. (Filing
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`No. 167 at 6.) Dr. Reddy’s goes on to cite Lilly’s prosecution of the European equivalent of the
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`‘209 Patent where Lilly claimed pemetrexed broadly and used a dependent claim to claim the salt
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`form: pemetrexed disodium. (Filing No. 182 at 16U.) This argument goes to foreseeability that
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`Lilly allegedly knew how to draft a broad pemetrexed claim that was not narrowly limited to
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`disodium salt.
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`Lilly argues that for the tangential exception “it makes no difference whether Lilly ‘limited
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`the scope of drugs in the claimed method’ in a way that turned out to exclude the accused
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`pemetrexed ditromethamine.” Because pemetrexed, the active drug substance, actually treats the
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`cancer patient, and pemetrexed disodium and pemetrexed ditromethamine are very similar, this
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`exception necessarily presents a battle of the experts issue. In fact, it is undisputed that a POSA
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`would understand that pemetrexed is the active antifolate (or drug) in both products.
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`In Regents of University of Cal. v. Dakocytomation Cal. Inc., the Federal Circuit held that
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`a patentee’s narrowing amendment that centered on a method of blocking to avoid prior art that
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`did not involve blocking was tangential to the particular nucleic acid used to accomplish the
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`blocking. 517 F. 3d 1364, 1378 (Fed. Cir. 2008). The patent at issue in that case claimed “blocking
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`nucleic acid” which was construed by the district court to involve human DNA, whereas the
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`Case 1:16-cv-00308-TWP-MPB Document 199 Filed 12/14/17 Page 14 of 22 PageID #: 6469
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`accused product used synthetic (not human) nucleic acids referred to as peptide nucleic acids. Id.
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`The district court granted summary judgment of noninfringement to the maker of the accused
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`products because it held that the patentees had narrowed the scope of “blocking nucleic acid”
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`during prosecution which barred the patentees from asserting the peptide nucleic acid equivalent.
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`Id. The Federal Circuit reversed holding “[t]he prosecution history therefore reveals that in
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`narrowing the claim to overcome the prior art rejections, the focus of the patentees’ arguments
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`centered on the method of blocking—not on the particular type of nucleic acid that could be used
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`for blocking.” Id. Thus, the Federal Circuit found the narrowing amendment was tangential.
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`The present case is similar to the distinction presented in Regents. The ‘209 Patent’s
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`specification describes a method for pemetrexed disodium treatment. Lilly’s expert opined that a
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`POSA would understand pemetrexed is the active antifolate that inhibits the enzymes at issue and
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`treats the cancer. Dr. Reddy’s argues that the salt form used in the patent goes to the identity of
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`the antifolate that Lilly sought to claim and is thus barred from claiming pemetrexed as a class
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`under prosecution history estoppel.
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`The prosecution history reveals that the Patent Office rejected various Lilly claims due to
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`the prior art Arsenyan.
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`Claims 2, 7, 10, 31 are rejected under 35 U.S.C. 102(b) as being anticipated by
`Arsenyan et al. (Abstract; Onkol., Nauchn., (1978) 12(10); 49-54. Arsenyan et al.
`teaches a method of pretreating mammals (mice) with various types of cancer with
`methylcobalamin (a vitamin B12 derivative which reduces methylmalonic acid)
`then administering methotrexate (an antifolate), and reports increased tumor
`inhibition and survival with methylcobalamin treatment.
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`(Filing No. 133-1 at 115.) The Arsenyan prior art rejection also served as the basis for an
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`obviousness rejection. (Filing No. 133-1 at 117.) The prior art rejections thus went to
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`patentability. The Patent Office’s communications do not refer to pemetrexed broadly, but also
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`refer to pemetrexed disodium in combination with the pretreatment regimen as not being
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`anticipated by the prior art. This is probably because ALIMTA® is sometimes used
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`interchangeably with pemetrexed disodium during Lilly’s patent prosecution. (See Filing No. 133-
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`1 at 136.) At one point the Patent Office rejected Lilly’s use of the trade name ALIMTA® in its
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`claims as being vague and indefinite language, and Lilly responded with substituting pemetrexed
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`disodium for ALIMTA®. (Filing No. 133-1 at 115.)
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`To overcome the prior art rejection, Lilly argued that the invention was new and
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`nonobvious because it used the pretreatment regimen in combination with administration of
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`pemetrexed disodium to treat the cancer and reduce the toxicities associated with pemetrexed
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`disodium administration. (Filing No. 133-1 at 127.) The narrowing amendment (from antifolates
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`as a class to pemetrexed disodium) was only tangential to the accused pemetrexed equivalent—
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`pemetrexed ditromethamine. Thus, Lilly has met its burden of showing that it did not surrender
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`the equivalent in question because the choice of pemetrexed salt is tangential to the reasons for the
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`amendment and summary judgment is precluded on this issue.
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`2.
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`Disclosure Dedication Doctrine
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`Dr. Reddy’s argues that Lilly’s equivalents claim is also barred by the disclosure dedication
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`rule. “[W]hen a patent drafter discloses but declines to claim subject matter. . .this action dedicates
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`that unclaimed subject matter to the public.” Johnson, 285 F. 3d at 1054. “[T]he public notice
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`function of patents suggests that before unclaimed subject matter is deemed to have been dedicated
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`to the public, that unclaimed subject matter must have been identified by the patentee as an
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`alternative to a claim limitation.” Pfizer, 429 F. 3d 1379.
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`Case 1:16-cv-00308-TWP-MPB Document 199 Filed 12/14/17 Page 16 of 22 PageID #: 6471
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`It is undisputed that the ‘209 Patent’s specifications do not expressly disclose pemetrexed
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`ditromethamine. Dr. Reddy’s bases its disclosure dedication argument on the fact that the ‘209
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`Patent referenced another patent, Akimoto, and the pemetrexed salt derivatives described by
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`Akimoto would include pemetrexed ditromethamine. (Filing No. 167 at 13.) Lilly responds that
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`“[t]he Federal Circuit has recognized the possibility of using the specification of a different patent
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`only where it was expressly incorporated by reference.” (Filing No. 146 at 28.)
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`The disclosure dedication rule has limitations. Generic references in a written specification
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`do not necessarily dedicate all members of a particular genus to the public. SanDisk Corp. v.
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`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.’
`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 iden