Eli Lilly & Co. v. Hospira, Inc.
| Decision Date | 15 June 2018 |
| Docket Number | Case No. 1:16-cv-03460-TWP-MPB |
| Parties | ELI LILLY AND COMPANY, Plaintiff, v. HOSPIRA, INC., Defendant. |
| Court | U.S. District Court — Southern District of Indiana |
Before the Court are the parties' cross-motions for summary judgment. Eli Lilly and Company ("Lilly") initiated this Hatch-Waxman litigation against Defendant Hospira, Inc. ("Hospira") for infringement of Lilly's U.S. Patent 7,772,209 ("the '209 Patent"). On April 6, 2018, Hospira filed a Motion for Summary Judgment of Non-Infringement on its New Drug Application ("NDA") No. 208746, on the bases that there is no plausible theory pled under which Hospira would infringe the patent in suit and the doctrine of equivalents does not expand the scope of Lilly's patent to include Hospira's product. (Filing No. 73.) On April 27, 2018, Lilly filed a Cross-Motion for Summary Judgment of Infringement. (Filing No. 78.) For the reasons stated below, the Court grants Lilly's Cross-Motion for Summary Judgment, and denies Hospira's Motion for Summary Judgment.
The '209 Patent describes a method of administering the chemotherapy drug, pemetrexed disodium, with a pretreatment regimen of vitamin B12 and folic acid (the "pretreatment regimen"), which is marketed by Lilly under the trade name ALIMTA®. The '209 Patent has been the subject of previous trials before this Court. See Eli Lilly and Co. v. Teva Parenteral Medicines, Inc., 126 F. Supp.3d 1037, 1038 (S.D. Ind. 2015).1 Two of those cases specifically concerned generic drug manufacturers that sought to market a generic version of ALIMTA® including labeling that induced physicians to direct patients to take folic acid and vitamin B12 in accordance with the pretreatment claims in the '209 Patent. Specifically, in the Teva case, the pretreatment regimen and whether the steps of the claimed method could be attributed to a single actor was at issue. Id. On February 1 and 2, 2018, this Court held a bench trial in Eli Lilly & Co. v. Dr. Reddy's Laboratories, Ltd., No. 1:16-cv-308-TWP-MPB (the "Dr. Reddy's Case") involving primarily the same alleged infringing drug product at issue in this action: pemetrexed ditromethamine.2
During prosecution of its patent application for ALIMTA®, the U.S. Patent and Trademark Office originally rejected claim 2 of the '209 Patent as being anticipated by a prior art article, Arsenyan et.al. ("Arsenyan"). Arsenyan concerned the administration of the compound methotrexate.3 (Filing No. 76-3 at 105.) To avoid rejection of its patent in view of Arsenyan, Lilly narrowed the scope of its claims from a broad category of antifolates to specifically pemetrexed disodium. (Filing No. 76-3 at 123.)
Similar to the issue in Dr. Reddy's Case, Hospira has also developed and designed a competing pemetrexed drug product, which uses a salt base, tromethamine, rather than the sodium base contained in Lilly's product.4 Hospira seeks to market its product in the form of a new product that uses pemetrexed ditromethamine, unlike the generic drugs in previous trials before the Court.In large part, the issues in the present case and the Dr. Reddy's Case are the same. However, unlike Dr. Reddy's label, Hospira's label instructs that it can be reconstituted in saline solution (like ALIMTA®) in addition to 5% dextrose solution (like Dr. Reddy's product). (Filing No. 49-29; Filing No. 74-1 at 15-16.)
A point of contention between the parties is whether pemetrexed ditromethamine was excluded (thus, designated public use) from the claims during patent prosecution by Lilly's specification and narrowing amendment from the term "antifolates" to "pemetrexed disodium". The liquid solution of both chemical compounds results in pemetrexed treatment, but the powdered solid form of the two products differ as a result of the different salt compounds used. The patient receives the liquid solution intravenously. Both products are sold in solid form. (Filing No. 74-1 at 17; Filing No. 79 at 14.) Claim 12 of the '209 Patent, a dispositive issue (agreed by the parties) regarding whether or not Hospira's product infringes was construed in the Dr. Reddy's Case by this Court. (Filing No. 79-3 at 6.) Claim 12 reads as follows:
(Filing No. 1-1 at 9). The Court construed administration of pemetrexed disodium to refer to a liquid administration of pemetrexed disodium. (No. 1:16-308-TWP-MPB, ECF 199 at 9.) In the claim construction, the Court did not address the science of what happens when pemetrexed disodium is dissolved in aqueous solution in construing claim 12. Id. at 8-9. Nevertheless, Hospira and Lilly agree that based on the Court's construction in the Dr. Reddy's Case, that claim 12 wouldnecessarily encompass any solution containing pemetrexed and sodium ions because it is undisputed that when pemetrexed disodium is dissolved in solution, pemetrexed disodium would not exist as an ionically bonded compound. (Filing No. 79 at 9; Filing No. 79-3 at 8). Rather the liquid solution contains pemetrexed and disodium (or tromethamine) ions disassociated from one another.5 Id. Thus, the solution that is administered to the patient would not contain pemetrexed disodium as an ionically bonded salt, and instead would contain disassociated pemetrexed and sodium ions in solution. The Court directs the parties to the Dr. Reddy's Case for the analysis of the claim construction ruling, which binds the identical claim at issue in this case.
The purpose of summary judgment is to "pierce the pleadings and to assess the proof in order to see whether there is a genuine need for trial." Matsushita Electric Industrial Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986). Federal Rule of Civil Procedure 56 provides that summary judgment is appropriate if "the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law." Hemsworth v. Quotesmith.Com, Inc., 476 F.3d 487, 489-90 (7th Cir. 2007). In ruling on a motion for summary judgment, the court reviews "the record in the light most favorable to the nonmoving party and draw[s] all reasonable inferences in that party's favor." Zerante v. DeLuca, 555 F.3d 582, 584 (7th Cir. 2009) (citation omitted). However, "[a] party who bears the burden of proof on a particular issue may not rest on its pleadings, but must affirmatively demonstrate, by specific factual allegations, that there is a genuine issue of material fact that requires trial." Hemsworth, 476 F.3d at 490 (citation omitted). "In much the same way that a court is not required to scour therecord in search of evidence to defeat a motion for summary judgment, nor is it permitted to conduct a paper trial on the merits of a claim." Ritchie v. Glidden Co., 242 F.3d 713, 723 (7th Cir. 2001) (citation and internal quotations omitted). Finally, "neither the mere existence of some alleged factual dispute between the parties nor the existence of some metaphysical doubt as to the material facts is sufficient to defeat a motion for summary judgment." Chiaramonte v. Fashion Bed Grp., Inc., 129 F.3d 391, 395 (7th Cir. 1997) (citations and internal quotations omitted). This notion applies equally where, as here, opposing parties each move for summary judgment in their favor pursuant to Rule 56. I.A.E., Inc. v. Shaver, 74 F.3d 768, 774 (7th Cir. 1996).
Lilly argues that Hospira's product infringes under two theories: literal infringement and the doctrine of equivalents. (Filing No. 79 at 18, 23.) Hospira raises three non-infringement defenses to Lilly's infringement theories. (Filing No. 74-1 at 5.) The Court will address each argument in turn.
"Literal infringement requires a patentee to prove by a preponderance of the evidence that every limitation of the asserted claim is literally met by the allegedly infringing device." Biovail Corp. Intern. v. Andrx Pharmaceuticals, Inc., 239 F. 3d 1297, 1302 (Fed. Cir. 2001). Lilly contends that Hospira's product will literally infringe when it is reconstituted in saline according to Hospira's proposed labeling instructions. (Filing No. 79 at 18.) It is undisputed as manufactured pemetrexed ditromethamine is a separate, distinct compound from the claimed pemetrexed disodium. (Filing No. 74-1 at 24; Filing No. 79 at 18.) Thus, in solid form Hospira's product does not contain pemetrexed disodium. Hospira's product may be reconstituted and diluted pursuant toeither saline preparation or dextrose preparation. (Filing No. 74-1 at 24.) Lilly contends that the saline preparation will literally infringe the '209 Patent.
Lilly has presented unrebutted expert testimony as to the chemical makeup of Hospira's product reconstituted in saline solution that would be administered to a patient. (Filing No. 78-1; Filing No. 78-2.) Additionally, Hospira concedes that under the Court's claim construction in the Dr. Reddy's Case, that its product, in accordance with its proposed labeling, literally infringes the '209 Patent. (Filing No. 79-3 at 12.) Saline solution contains sodium chloride, which also dissociates (at the molecular level) completely into sodium and chloride ions when dissolved in the solution. (Filing no. 79-2 at 12-13.) Because it is undisputed that, in liquid administration, pemetrexed is the active moiety that exerts chemotherapeutic effect to the patient, in that the pemetrexed...
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