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Bayer Healthcare, LLC v. Zoetis Inc.

United States District Court, N.D. Illinois, Eastern Division

August 6, 2016

BAYER HEALTHCARE, LLC, Plaintiff,
v.
ZOETIS INC., Defendant.

          Bayer Healthcare LLC, Plaintiff, represented by Peter Benjamin Bensinger, Jr., Bartlit Beck Herman Palenchar & Scott LLP, J. Scott McBride, Bartlit Beck Herman Palenchar & Scott LLP, Katherine G. Minarik, Bartlit Beck Herman Palenchar & Scott LLP, Katherine Marquess Swift, Michael J. Valaik, Bartlit Beck Herman Palenchar & Scott LLP & Reid M. Bolton, Bartlit Beck Herman Palenchar & Scott Llp.

          Pfizer Inc., Defendant, represented by Mark Alan Pals, Kirkland & Ellis LLP, Amanda Jean Hollis, Kirkland & Ellis LLP, Dean A. Monco, Wood, Phillips, Katz, Clark & Mortimer, George V. Desh, Kirkland & Ellis Llp, Marcus Edward Sernel, Kirkland & Ellis LLP, Reid P. Huefner, Kirkland & Ellis LLP & Thomas William Osier, Kirkland & Ellis LLP.

          Pfizer Inc., Counter Claimant, represented by Mark Alan Pals, Kirkland & Ellis LLP, Amanda Jean Hollis, Kirkland & Ellis LLP, Dean A. Monco, Wood, Phillips, Katz, Clark & Mortimer, George V. Desh, Kirkland & Ellis Llp, Marcus Edward Sernel, Kirkland & Ellis LLP & Reid P. Huefner, Kirkland & Ellis LLP.

          Bayer Healthcare LLC, Counter Defendant, represented by Peter Benjamin Bensinger, Jr., Bartlit Beck Herman Palenchar & Scott LLP, Katherine G. Minarik, Bartlit Beck Herman Palenchar & Scott LLP, Katherine Marquess Swift & Reid M. Bolton, Bartlit Beck Herman Palenchar & Scott Llp.

          MEMORANDUM OPINION AND ORDER

          EDMOND E. CHANG, District Judge.

         I. Introduction

         This patent case between Bayer Healthcare, LLC and Pfizer, Inc.[1] is a fight about patent number 5, 756, 506 (the '506 patent), which is owned by Bayer. The '506 patent covers a process for treating bovine respiratory disease using "a pharmaceutically effective composition comprising a fluoroquinolone... in one high dose, single treatment."[2] In September 2012, the Court issued a claim-construction order after holding a Markman hearing. After discovery closed, Pfizer moved for reconsideration of the claim-construction order and for summary judgment on a number of invalidity defenses, including anticipation, obviousness, and lack of written description. Bayer responded with its own cross-motions against these invalidity claims; it also moved for summary judgment on infringement (to which Pfizer cross-moved for non-infringement) and summary judgment against Pfizer's prior invention defense. After these motions were fully briefed, the parties reported that a settlement was likely and asked the Court to refrain from deciding on the pending motions. But settlement discussions were unsuccessful, so the Court now addresses these motions. For the reasons explained below, the Court decides as follows:

• Pfizer's motion to reconsider the claim-construction order, R. 355, is denied.
• Pfizer's motion for summary judgment for invalidity based on the lack of written description, R. 297, is denied. Bayer's cross-motion for summary judgment against Pfizer's written description defense, R. 349, is granted.
• Pfizer's motion for summary judgment for invalidity based on anticipation and obviousness, R. 302, is denied. Bayer's cross-motion for summary judgment against Pfizer's anticipation and obviousness defenses, R. 345, is granted.
• Bayer's motion for summary judgment against Pfizer's prior invention defense, R. 295, is denied.
• Bayer's motion for summary judgment on infringement, R. 270, is denied as to both direct infringement and inducement. Pfizer's cross-motion for summary judgment on non-infringement, R. 355, is granted as to direct and contributory infringement, but denied as to inducement.

         II. Background

         A. Fluoroquinolones

         Bovine respiratory disease (BRD), which is also called "shipping fever, " is a serious problem in the cattle industry that causes significant cattle deaths each year. DSOF (Anticipation/Obviousness) ¶¶ 29, 38; R. 300-17, Def.'s Exh. 17, Babish Report ¶ 51; R. 309-14, Def.'s Exh. 14, Clay Report ¶ 64.[3] It is primarily caused by the bacteria pasturella haemolytica and pasturella multocida. PSOF (Written Description) ¶ 380; Babish Report ¶ 52; R. 309-7, Def.'s Exh. 7, 1/17/13 Papich Dep. 236:5-9; R. 309-18, Def.'s Exh. 18, 1990 Veterinary Medicine Textbook at PFE_BAY0002969. Bayer and Pfizer are pharmaceutical companies that make animal health products; in the late 1980s and early 1990s, both companies sought to develop new treatments for BRD using fluoroquinolones. PSOF (Anticipation/Obviousness) ¶¶ 251, 259; R. 348-18, Pl.'s Exh. 97, 6/19/12 Copeland Dep. 41:9-44:20; R. 348-13, Pl.'s Exh. 92, 7/20/12 Boettner Dep. 68:15-22; R. 321, Pl.'s Exh. 60, Pfizer 93-052 Study. Fluoroquinolones are a class of antimicrobials[4] that were invented in the 1970s and 1980s and later used to combat diseases in food-producing animals. DSOF (Written Description) ¶ 7; Clay Report ¶ 27; R. 353-12, Pl.'s Exh. 131, Papich Report ¶ 13. All fluoroquinolones share the same basic chemical structure and kill bacteria by targeting two enzymes: DNA Gyrase and Topoisomerase IV. PSOF (Written Description) ¶ 374; Papich Report ¶¶ 14-15; Clay Report ¶ 28; Babish Report ¶ 41. In the late 1980s and early 1990s, various studies investigated the pharmacokinetics (how the body affects a drug's absorption, distribution, and metabolism) as well as the pharmacodynamics (how a drug affects the body) of fluoroquinolones. R. 309-22, Def.'s Exh. 22, 1993 Craig Article ("Pharmacodynamics of Antimicrobial Agents as a Basis for Determining Dosage Regimens"); R. 309-25, Def.'s Exh. 25, 1993 Sullivan Article (investigating pharmacokinetics and pharmacodynamics in article entitled "Evaluation of the Efficacy of Ciprofloxacin against Streptococcus pneumoniae by Using a Mouse Protection Model"); R. 309-21, Def.'s Exh. 21, 1995 Meinen Article ("Pharmacokinetics of enrofloxacin in clinically normal dogs and mice and drug pharmacodynamics in neutropenic mice with Escherichia coli and staphylococcal infections").

         In the early to mid-1990s, a number of fluoroquinolones were believed to be effective at treating BRD, including danofloxacin, enrofloxacin, and ciprofloxacin, although the full range of fluoroquinolones was still unknown. PSOF (Written Description) ¶ 28; R. 348-27, Pl.'s Exh. 106, 1991 Giles and Grimshaw Article ("Efficacy of danofloxacin in the therapy of acute bacterial pneumonia in housed beef cattle"); R. 300-9, Def.'s Exh. 9, 1/24/13 Clay Dep. 209:14-18 (explaining that "there are any number of fluoroquinolones that could be effective"). The literature also began to reveal that fluoroquinolones were concentration-dependent drugs, meaning (as the name suggests) that the effectiveness of these drugs depends on whether the drug's concentration in the blood or tissue has reached a certain minimum inhibitory concentration (MIC) needed to kill the bacteria. DSOF (Anticipation/Obviousness) ¶¶ 51-53; 1993 Craig Article at PFE_BAY0002229 ("Since the aminoglycosides and quinolones[5] demonstrate concentration-dependent killing, large doses should produce similar or superior bacterial killing than multiple small doses.... The major goal of a dosage regimen for these drugs would be to maximize concentration."); 1993 Sullivan Article at PFE_BAY0002234 ("[O]ptimal dosing of quinolones may involve the use of large single doses to attain the high levels in serum necessary to achieve a high ratio of maximum concentration in serum/MIC."); 1995 Meinen Article at BHC00036079 ("With concentration-dependent bactericidal activity, the rate and extent of killing increases as the concentration of the drug increases."); Babish Report ¶¶ 46-48. In contrast, the effectiveness of time-dependent drugs depends on maintaining the drug in the bloodstream at a concentration above the MIC for an extended period of time. DSOF (Anticipation/Obviousness) ¶¶ 51, 53; Babish Report ¶ 47; 1995 Meinen Article at BHC00036076 ("For antimicrobials that kill by time-dependent mechanisms, the pharmacokinetic value that correlates with efficacy is the time that serum concentration remains above the [MIC] or the pathogen."). Bayer, on the other hand, disagrees that a person having ordinary skill in the art would have appreciated the concentration-dependent nature of fluoroquinolones at the time.

         In the United States, fluoroquinolones became commercially available to treat BRD in 1995. Pl.'s Resp. DSOF (Written Description) ¶ 23; R. 300-13, Def.'s Exh. 13, 5/15/13 Clay Dep. 12:17-19. Around this time, the conventional fluoroquinolone treatment for BRD involved several doses given over multiple days. PSOF (Anticipation/Obviousness) ¶ 241; R. 348-11, Def.'s Exh. 90, 6/13/12 Giles Dep. 55:17-23, 77:12-15, 205:8-21; 7/20/12 Boettner Dep. 48:3-11. For example, a typical regimen could be 1.25 mg/kg given once for three to five days. Id .; see also 6/13/12 Giles Dep. 63:23-64:17; 1991 Giles and Grimshaw Article at PFE_BAY0000654 (testing a 1.25 mg/kg dose of danofloxacin given once daily for three consecutive days, and two additional days if pneumonia was still present); R. 304-7, Pl.'s Exh. 47, 1987 Bauditz Article at PFE_BAY0000465[6] (recommending a 2.5 mg/kg dose over three days for calves). Even though it was known that fluoroquinolones were concentration-dependent rather than time-dependent, a multi-day dosage remained the conventional regimen, as there were still perceived benefits to maintaining the dosage in the bloodstream for an extended period of time, such as to prevent resistance and relapse. PSOF (Anticipation/Obviousness) ¶ 243; 1993 Craig Article at PFE_BAY0002229-30 (even though fluoroquinolone efficacy "was dependent on the amount of drug administered, not on how often it was administered... there might be other reasons for preferring certain dosage regimens, " including to prevent "[t]he emergence of resistant organisms"); 1993 Sullivan Article at PFE_BAY0002235 (some bacterial diseases like pneumococcus "may present a special penetration problem for ciprofloxacin, i.e., slow rate of antimicrobial uptake that allows effective concentrations to be attained only after several days of multiple dosing"). As explained in more detail later in the Opinion, Pfizer disagrees with this point, arguing that the concentration-dependency quality of fluoroquinolones obviated the need for multi-day dosing regimens.

         The parties do agree that there was increasing motivation in the cattle and pharmaceutical industries to develop a single-dose treatment for BRD. DSOF (Anticipation/Obviousness) ¶¶ 38-44; Babish Report ¶ 51; Clay Report ¶ 64; R. 309-15, Exh. 15, 1/24/13 Clay Dep. 78:2-80:1; R. 309-17, Def.'s Exh. 17, 1990 Gorham Article at PFE_BAY0000658-59. A single-dose treatment would save money by reducing the time and resources needed to identify and treat sick animals, decreasing tissue damage caused by injections, and minimizing the stress on cattle from multiple treatments. Id. As a result, the pharmaceutical industry began moving towards a single-dose product that was long acting-that is, a drug that would be administered once, but that would stay in the bloodstream for an extended period of time, so that the overall length of treatment remained the same. PSOF (Anticipation/Obviousness) ¶¶ 245-48, 251; 6/19/12 Copeland Dep. 44:4-14, 45:23-46:6, 94:23-95:9, 259:7-24. Both Bayer and Pfizer's development efforts, as explained below, reflected that trend.

         B. Bayer's Fluoroquinolone Development

         1. Bayer's Research

         In the 1980s, Bayer began developing a multi-day regimen using enrofloxacin, a type of fluoroquinolone, for the treatment of BRD. PSOF (Prior Invention) ¶ 126; R. 310, Pl.'s Exh. 46, 6/19/12 Copeland Dep. 41:9-42:2. The enrofloxacin showed broad antibacterial activity in low concentrations, efficacy against resistant strains, high absorption ability, and good tolerance in all species. 1987 Bauditz Article at PFE_BAY0000460. The recommended dose and length of treatment for calves was 2.5 mg/kg for three days. Id. at PFE_BAY0000465.

         Because of the desire for a more convenient treatment regimen, Bayer began pursuing a long-acting (or sustained-release) formulation[7] of fluoroquinolone that could be given in a single dose-that is, a drug that was administered only once, but that maintained a certain blood MIC level for an extended period of time. PSOF (Prior Invention) ¶¶ 125, 127; 6/19/12 Copeland Dep. 44:4-14, 94:7-95:9, 259:7-24. But after the sustained-release formulas did not provide the desired results, Bayer changed course and began testing a single-shot treatment that was not long acting-that is, a high dose that did not maintain a MIC level for an extended period of time. Id.; PSOF (Prior Invention) ¶¶ 128-29; R. 311, Pl.'s Exh. 48, 8/4/10 Copeland Dep. 155:4-156:17.

         In October 1994, Bayer conducted a study (labeled the 94A-002 Study) that compared three different dosages of enrofloxacin on cattle suffering from BRD: (1) 0 mg/kg (a control); (2) 2.5 mg/kg given once daily for three days; (3) 7.5 mg/kg given once or 15 mg/kg given once. R. 312, Pl.'s Exh. 49, Bayer 94A-002 Study at BHC00036543. "The objective of this study was to determine if a single elevated dose of enrofloxacin was as effective as the established daily dose of 2.5 mg/kg given once daily for three days." Id. at BHC0003642. Evaluating outcomes of mortality rates, percentage of lung consolidation, and weight gain after the treatment regimens, the study concluded that "[t]he three treatment groups were not significantly different from each other in any of the variables examined." Id. at BHC00036543. Further, "[t]hese data support[ed] the 7.5 mg/kg dose of enrofloxacin given once subcutaneously as an equivalent efficacious alternative to the 2.5 mg/kg dose of enrofloxacin given daily for three days. The 15.0 mg/kg dose given once was not more efficacious than the 7.5 mg/kg dose." Id.

         2. The '506 Patent

         The results of the 94A-002 Study led Bayer to file the '506 patent on May 27, 1997, as a continuation of an earlier application filed on June 27, 1995. Def.'s Resp. PSOF (Prior Invention) ¶ 131; '506 Patent at [22] (listing filing date of May 27, 1997), col. 1 ll. 4-5 (explaining that "[t]his application is a continuation of application Ser. No. 08/496, 117, filed June. 27, 1995, now abandoned"). The patent was issued on May 26, 1998. Id. at [45]. The background of the '506 patent explains that although the established fluoroquinolone treatment at the time involved daily doses for three to five consecutive days, the prior "art has not taught use of a single elevated dose of a fluoroquinolone to treat the likes of bovine respiratory diseases, " in part "due to the perceived need for a special formulation to prolong the blood levels." Id. col. 1 ll. 18-21, 27-27. But "[s]urprisingly, it has been found that a single, high dose of fluoroquinolones can be administered to effectively treat" BRD, and this dose "replace[d] repeated treatments without the need for special prolonged release formulations." Id. col. 2 ll. 14-18, col. 1 ll. 28-31. The patent then gives three example studies; the first compared three different enrofloxacin dosing regimens- 2.5 mg/kg for three days, 7.5 mg/kg once, and 15 mg/kg once (plus a control of no treatment)-and concluded that the three treatment groups were equally successful, as measured by mortality rates, lung consolidation, and weight gain. Id. col. 2 ll. 25-49. This first example reflected Bayer's 94A-002 experiment, as explained above. The second example in the patent compared three dosages of enrofloxacin-5.0 mg/kg once, 7.5 mg/kg once, and 2.5 mg/kg over three days (with a control of no treatment)-with a single injection of tilmicosin, which is a long-acting non-fluoroquinolone (with the brand name Micotil). Id. col. 2 l. 51 to col. 3 l. 11; Clay Report ¶ 21 ("Micotil, also known as tilmicosin, was a member of the macrolide class of drugs... Micotil was also a type of treatment known in the field as a long acting' drug."). The results concluded that the "7.5 mg/kg of enrofloxacin given as a single injection is as effective as 3 daily injections of 2.5 mg/kg enrofloxacin. It is also as effective as a single injection of the long acting tilmicosin." '506 Patent col. 3 ll. 8-11. The third example in the patent tested enrofloxacin on swine, and also concluded that the single 7.5 mg/kg and 10 mg/kg doses were as effective as three daily injections of 2.5 mg/kg. Id. col. 3 ll. 12-37.

         After describing the studies, the '506 patent claimed, in relevant part:

1. A process for treating a bacterial infection in an animal in need thereof comprising administering to said animal a pharmaceutically effective composition comprising a fluoroquinolone, an ester, or a salt thereof in one high dose, single treatment.
...
4. The process of claim 1, wherein the bacterial infection is bovine respiratory disease.
5. The process of claim 4, wherein the bovine respiratory disease is caused by Pasturella, haemolytica or Pasturella multocida.

Id. col. 4 ll. 10-28.

         In the fall of 1998, after conducting the 94A-002 Study and filing the '506 patent application, Bayer launched a product called Baytril 100 (or Baytril for short), which Bayer characterizes as the "commercial embodiment of the '506 patent." PSOF (Prior Invention) ¶ 132. The label described Baytril as an "antimicrobial solution that contains enrofloxacin, a broad-spectrum fluoroquinolone antimicrobial agent" to treat BRD associated with mannheimia haemolytica, pasteurella multocida and haemophilus somnus. R. 304-12, Pl.'s Exh. 52, Baytril Label at BHC00023580. The drug could be administered as a single-dose therapy of 7.5 to 12.5 mg/kg, or as a multiple-day therapy of 2.5 to 5.0 mg/kg given once daily for three days, and up to five days for "animals which have shown clinical improvement but not total recovery." Id. The label also informed that "[s]election of the appropriate dose and duration of therapy should be based on an assessment of the severity of disease, pathogen susceptibility and clinical response." Id.

         C. Pfizer's Fluoroquinolone Development

         1. Pfizer's Research

         Like Bayer, Pfizer was also working on various BRD treatments; in the 1980s, it released LA-200, which was a long-acting formulation of tetracycline (another type of antibiotic). Def.'s Resp. PSOF (Prior Invention) ¶ 141; Clay Report ¶ 22. Pfizer also began working on a fluoroquinolone product; in 1989, it began a several-year investigation of danofloxacin in a long-acting formulation. R. 354-31, Def.'s Exh. 31, Pfizer Notebook 18531 at PBA_00292761-62 ("Long-Acting I.M.[8] Injectable Development"); R. 354-32, Def.'s Exh. 32, Pfizer Notebook 20730 at PBA_00176095-97 (listing several danofloxacin index entries with "LA" dosage, including "Preparation of Danofloxacin LA formulations for Testing in Cattle in Terre Haute"); R. 354-33, Def.'s Exh. 33, Pfizer Notebook 22960 at PBA_00176715-16 (listing several danofloxacin index entries with "LA" dosage); R. 354-34, Def.'s Exh. 34, Pfizer Notebook 24463 at PBA_00177022-23 (same); R. 354-35, Def.'s Exh. 35, Pfizer Notebook 24673 at PBA_00177345-51 (same). Although Pfizer argues that it was testing a single, high dose of danofloxacin, DSOF (Prior Invention) ¶¶ 201-02, all of the excerpts of the early laboratory records that were provided to the Court clearly state "long-acting" or "LA." Id.

         At the same time, Pfizer was also conducting pharmacokinetic and injection site toleration tests on cattle for various danofloxacin formulations and dosages. DSOF (Prior Invention) ¶ 203; R. 354-39, Def.'s Exh. 39, Pfizer 91-017 Study at PBA_00178179 (noting a 2.5 mg/kg dose, but unclear as to the duration of therapy); R. 354-41, Def.'s Exh. 41, Pfizer 92-019 Study at PBA_00178168 (noting a 6 mg/kg dose in various oil vehicles, but unclear as to the duration of therapy), PBA_00178172 (listing experiment title as "Long-Acting Formulations of Danofloxacin-Pharmacokinetics"); R. 351-42, Def.'s Exh. 42, Pfizer 92-009-5 Study at PBA_00178194 (listing objective of "Discovery-Pharmacokinetics Screen and Injection Site Toleration (CP-133, 805-Danofloxacin Pro-drug)"). One of these tests did involve a single injection of 25 mg/ml in water, but the study was focused on observations of the injection site, rather than the drug's effect on BRD caused by pasturella haemolytica or pasturella multocida. DSOF (Prior Invention) ¶ 203; R. 354-40, Def.'s Exh. 40, Pfizer 91-009 Study at PBA_00178144 (listing objective of "Discovery Cattle Injection Site Toleration Screen"). Pfizer published the results of these studies in various articles. DSOF (Prior Invention) ¶ 204; R. 354-46, Def.'s Exh. 46, 1991 Giles and Magonigle Article ("Clinical pharmacokinetics of parenterally administered danofloxacin in cattle"); R. 354-45, Def.'s Exh. 45, 1992 Mann Article ("Pharmacokinetic study of danofloxacin in cattle and swine").

         In 1993, Pfizer began "full-scale efficacy testing" of danofloxacin treatments for BRD, focusing on the long-acting formulation. DSOF (Prior Invention) ¶ 206. For example, experiment number 1831B-60-93-050 ("the 93-050 Study") compared a "conventional" multi-day regimen with two long-acting formulations. Id.; R. 320, Def.'s Exh. 59, Pfizer 93-050 Study at PFE_BAY0001277. Pfizer tested a saline control as well as three treatment groups, one of which was "CP 76, 136-27 (1.25 mg/kg, SIDX3, IM), " which scientist Wayne Boettner explained was the "conventional formulation" of 1.25 mg/kg dose given once daily for three days. Pfizer 93-050 Study at PFE_BAY0001278; 7/20/12 Boettner Dep. 48:3-11. This conventional dose was compared to two "gelled oil formulations" with doses of 6 mg/kg and 3.75 mg/kg. Pfizer 93-050 Study at PFE_BAY0001278. Pfizer hoped that these gelled oil formulations would produce a long-acting drug. 7/20/12 Boettner Dep. 48:12-49:15. [REDACTED\]

         [REDACTED\]

         After conducting the 93-050 Study, Pfizer conducted experiment number 1831B-60-93-052 ("the 93-052 Study"), which was entitled "Comparative evaluation of the therapeutic efficacy of conventional and single-shot formulations of danofloxacin (CP 76, 136) against natural bovine respiratory disease." DSOF (Prior Invention) ¶¶ 206-208; Pfizer 93-052 Study. This time, the test materials included (1) a saline control; (2) 25 mg/ml danofloxacin in a formulation of "mesylate in water"; (3) 60 mg/ml danofloxacin in a formulation of "zwitterion in Terramycin-LA vehicle (peak-only profile)"; (4) 60 mg/ml danofloxacin in a formulation of "zwitterion in phosphate buffer with suspending agents (tail-only profile)"; (5) 60 mg/ml danofloxacin in a formulation of "mesylate in sesame oil gelled with 1.5% aluminum monostearate (peak and tail profile, positive control)"; and (6) 60 mg/ml danofloxacin in a formulation of "sulfate in Synergistin vehicle (peak and tail profile)." Pfizer 93-052 Study at PFE_BAY0001305-06. Test material number two, the 25 mg/ml danofloxacin, was the conventional dosage of 1.25 mg/kg administered over three days. Id. at PFE_BAY0001304; 7/20/12 Boettner Dep. 73:1-20. And according to Pfizer, "peak and tail" profiles-test items five and six-were long-acting formulations that sustain the drug concentration over a period of time, while the "peak only" formulation-test item three-had a high concentration that rapidly trailed off. DSOF (Prior Invention) ¶ 211; R. 354-27, Def.'s Exh. 27, 6/7/12 Mann Dep. 39:2-40:16. The 93-052 Study ultimately concluded that "formulations which induced either peak-only or peak and tail plasma pharmacokinetic profiles provided efficacy similar to that observed with the conventional dose and regimen." Pfizer 93-052 Study at PFE_BAY0001304. Further, "presentations of danofloxacin which induce either a substantial peak plasma concentration or moderate peak concentrations in combination with a sustained release provide efficacy similar to or better than that observed with the conventional dose and regimen." Id. So Pfizer contends that this 93-052 Study revealed that the single high-dose treatment with a "peak only" profile, which was a non-long-acting formulation, was just as effective as a multi-day dose. DSOF (Prior Invention) ¶¶ 212-213. Pfizer also claims that the "peak only" formulation used in the 93-052 Study was the most successful and ultimately commercialized. Id. ¶ 214. Bayer, on the other hand, disputes that Pfizer had successfully created a non-long-acting, single-dose BRD treatment in the 93-052 Study. Pl.'s Resp. DSOF (Prior Invention) ¶¶ 212-214; see also R. 378, Pl.'s Reply (Prior Invention) at 11-12.

         On December 2, 1994, Pfizer's danofloxacin formulation committee sent a memo to Dr. A. C. Goudie summarizing its conclusions about its danofloxacin development efforts. DSOF (Prior Invention) ¶ 217. The Goudie Memo stated that single-shot danofloxacin did not work well:

In order to meet the future needs of this market, we initiated a research program in 1990 seeking a formulation of danofloxacin which delivered efficacy against BRD following a single injection that would be comparable or superior to the best available treatments. Many different pharmaceutical technologies were evaluated in pursuit of this ambitious objective. Unfortunately, we were not able to identify a single-shot danofloxacin presentation, and we have since halted this research due to greatly diminished prospects for future success.

         R. 325, Pl.'s Exh. 64, Goudie Memo at PBA_00229315 (emphasis added). According to Bayer, the Goudie Memo shows that Pfizer abandoned its work on a single-shot BRD treatment and pursued a two-shot product instead. PSOF (Prior Invention) ¶ 147. But Pfizer asserts that it continued to work on a single-dose danofloxacin product from 1994 to 1997, despite the recommendations in the Goudie Memo. DSOF (Prior Invention) ¶¶ 217-220; R. 345-13, Def.'s Exh. 13, 95-206 Study (testing the plasma pharmacokinetics of single-dose 1.25 mg/kg, 6 mg/kg and 10 mg/kg treatments); R. 285, Pl.'s Exh. 20, Pfizer 96-249 Study (testing a single-dose 8 mg/kg treatment in an Idaho feedlot); R. 286, Pl.'s Exh. 21, Pfizer 96-250 Study (testing a single-dose 8 mg/kg treatment in a California feedlot); R. 287, Pl.'s Exh. 22, Pfizer 97-258 Study (testing a single-dose 8 mg/kg treatment in a Texas feedlot); R. 288, Pl.'s Exh. 23, Pfizer 97-261 Study (testing a single-dose 8 mg/kg treatment in a Nebraska feedlot).

         2. A180

         In 1996, Pfizer was preparing for the release of Advocin 180 (or A180 for short), a new single-dose danofloxacin treatment that could also be used as a two-shot treatment. DSOF (Prior Invention) ¶ 221. Bayer was aware of Pfizer's ongoing work during this time period; in May 1996, Bayer noted in its Baytril Market Launch Plan that "Advocin is a fluoroquinolone. Its stage of development and regulatory approval is most threatening to Baytril. We are uncertain where Pfizer is in its development and registration of Advocin, however we know that they are pursuing development of danofloxacin as a single-dose product." DSOF (Prior Invention) ¶ 239; R. 354-74, Def.'s Exh. 74, Baytril Launch Plan at BHC00132747. In October 1996, Pfizer completed its Full Development Plan for danofloxacin, explaining that "[s]trategic administration of one to two high-dose injections of danofloxacin 18% injectable solution will provide effective therapy for Bovine Respiratory Disease and [REDACTED\] while meeting the needs of customers who demand low frequency regimens for cattle." DSOF (Prior Invention) ¶ 221; R. 354-60, Def.'s Exh. 60, Pfizer Full Dev. Plan at PBA_00041166. The report discussed plans to release the product across the world. Id.

         In 1998, after completing additional testing, Pfizer submitted an application to the Food and Drug Administration (FDA) to register A180 as both a single-shot and two-shot treatment. DSOF (Prior Invention) ¶ 222; R. 354-9, Def.'s Exh. 9, 4/29/98 Pfizer Letter to FDA at PBA_00003170-71 (requesting review of Advocin "at a single dose of 8 mg/kg body weight... or two injections of 6 mg/kg body weight... administered 48 hours apart."). But in 2002, the FDA expressed concerns with potential bacterial resistance and rejected the single-shot product in the human food safety portion of the approval process. DSOF (Prior Invention) ¶ 223; R. 354-11, Def.'s Exh. 11, 1/15/02 FDA Letter to Pfizer at PBA_00022249 ("[B]ecause of the results of the bacterial resistance study with respect to Treatment 3 (10 mg/kg, SID X 1), this [issuance of a human food safety technical section complete letter] is not possible. We recommend that you consider a similar request for the proposed conditions of use in Treatment 2 (6 mg/kg, q48 × 2) alone."). Ultimately, for various Zbusiness reasons, Pfizer decided not to pursue approval of the single-shot danofloxacin product in the United States, though Pfizer did move forward with its two-shot product. DSOF (Prior Invention) ¶¶ 224-225; R. 354-6, Def.'s Exh. 6, 6/13/12 Giles Dep. 242:20-245:13. In October 2002, Pfizer received FDA approval for its two-shot A180 product, DSOF (Prior Invention) ¶ 226; R. 354-65, Def.'s Exh. 65, 10/02/02 FDA Letter to Pfizer, with an approved dosage of two 6 mg/kg injections given 48 hours apart. PSOF (Infringement) ¶ 10; R. 279, Pl.'s Exh. 10, 5/16/12 Pollreisz Dep. 19:6-24.

         3. Advocin

         In January 2012, around ten years after A180 was released, the FDA approved an additional dosage regimen for A180 "for the treatment of bovine respiratory disease in beef cattle... associated with Mannheimia haemolytica, and Pasteurella multocida in beef cattle." PSOF (Infringement) ¶ 20; R. 273-15, Pl.'s Exh. 15, 77 Fed. Reg. 4226 (January 27, 2012). A180 could now be used as a single-dose 8 mg/kg treatment. Id. at 4227.

         Pfizer began rebranding A180, which could now be used as a single or double-dose treatment, as Advocin. Def.'s Resp. PSOF (Infringement) ¶¶ 9-19, 22, 38-49; R. 273-13, Pl.'s Exh. 13, 1/27/12 Pfizer Webinar 33:19-34:1 ("And the third equally fundamental attribute, it has to work in a single-dose regimen. Products that do not work in a single-dose regimen are not really practical in today's environment. So [we] wanted to make the awareness of a single-dose regimen [] more prominent with a new brand and a chance to introduce this."). Pfizer also began comparing Advocin to Baytril; in an internal presentation called the "Advocin Launch Plan, " Pfizer explained that there were "only two existing FQ [fluoroquinolone] BRD treatment drugs at present: Baytril (enrofloxacin) [and] A-180 (danofloxacin)." R. 280, Pl.'s Exh. 11, Advocin Launch Plan at PBA_00056448. The launch plan also stated that "Baytril holds 94% MS [market share] of the FQ [fluoroquinolone] market" and "is the second largest BRD treatment product in feedlot/stocker markets" with sales of $64 million, as compared to A180's $4 million. Id. In comparison to Baytril, A180 also had "poor product adoption" because the "[t]wo-shot FQ [was] less convenient versus one-shot Baytril." Id. at PBA_00056445. Recognizing that Bayer's '506 patent was expiring in 2015, [REDACTED\] Id. at PBA_00056458. [REDACTED\] Id. Pfizer's other marketing materials similarly highlighted Advocin's single-dose characteristic and drew direct comparisons to Baytril. E.g., R. 283, Pl.'s Exh. 16, Advocin Ad (stating "battle of the BRD antimicrobials" and "Advocin vs. Baytril" underneath a photo of the two products); R. 273-17, Pl.'s Exh. 17, 1/26/12 Pfizer Webinar 27:10-13 ("You now have a second option with a single injection or a single-day regimen fluoroquinolone. Our plan is to make it a cost-effective alternative to Baytril."); R. 292, Pl.'s Exh. 28, Advocin Presentation at PFE_BAY0000037 (explaining that the "3 key messages" were "single shot FQ, cost-effective alternative to Baytril, [and] 4 day withdrawal time"); R. 293, Pl.'s Exh. 29, 2012 Priority Update Letter at PBA_00294438 ("Pfizer Animal Health is excited to announce that you have a new single dose fluoroquinolone to treat cattle with bovine respiratory disease (BRD)... ADVOCIN is an injectable antimicrobial with the following key benefit[]: Cost-effective alternative to Baytril® (enrofloxacin)...."). And J.P. Pollreisz, Pfizer's technical services veterinarian, remembers speaking to ten to fifteen individual customers about using Advocin as a single-dose regimen and was aware of three customers who actually did. PSOF (Infringement) ¶¶ 47-49; 5/16/12 Pollreisz Dep. 157:9-158:24.

         D. Present Litigation

         On January 30, 2012, Bayer brought this lawsuit against Pfizer for direct and induced infringement of the '506 patent. R. 1, Compl. In its Answer, Pfizer asserted various defenses and counterclaims, including non-infringement and invalidity "for failure to satisfy... 35 U.S.C. §§ 101, 102, 103, 112 and/or for being in violation" of any other section of Title 35. R. 67, Answer at 13-15. The Court held a Markman hearing about the meaning of "one high dose, single treatment" in Claim 1 of the '506 patent, R. 224, which Pfizer argued was indefinite. But the Court held that this claim was valid, and that the disputed terms "mean[t] the effective single dose that prevents death and cures the disease to the equivalent degree of lower, multiple doses." R. 226, 9/18/12 Order at 7. After discovery closed, both parties filed various summary judgment motions. First, Bayer moved for summary judgment on direct and induced infringement. R. 270. Pfizer then cross-moved for non-infringement on direct, contributory, and induced infringement, R. 355, and also moved to reconsider the claim construction order of "one high dose, single treatment, " id. Pfizer also moved for summary judgment on invalidity for lack of a written description, R. 297, anticipation, R. 302, and obviousness, id., against all of which Bayer cross-moved, R. 349 (written description), R. 345 (anticipation), id. (obviousness). Finally, Bayer also moved for summary judgment against Pfizer's prior-invention defense, R. 295, to which Pfizer did not cross-move. The parties attempted to settle the case but ultimately were unsuccessful. R. 427.

         III. Legal Standards

         A. Summary Judgment Standard

         Summary judgment must be granted "if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." Fed.R.Civ.P. 56(a). A genuine issue of material fact exists if "the evidence is such that a reasonable jury could return a verdict for the nonmoving party." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). In evaluating summary judgment motions, courts must view the facts and draw reasonable inferences in the light most favorable to the non-moving party. Scott v. Harris, 550 U.S. 372, 378 (2007). When both parties move for summary judgment, the Court must draw reasonable inferences in Bayer's favor on Pfizer's motion, and vice-versa on Bayer's motion. The Court may not weigh conflicting evidence or make credibility determinations, Omnicare, Inc. v. UnitedHealth Grp., Inc., 629 F.3d 697, 704 (7th Cir. 2011), and must consider only evidence that can "be presented in a form that would be admissible in evidence." Fed.R.Civ.P. 56(c)(2). The party seeking summary judgment has the initial burden of showing that there is no genuine dispute and that she is entitled to judgment as a matter of law. Carmichael v. Vill. of Palatine, 605 F.3d 451, 460 (7th Cir. 2010); see also Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986); Wheeler v. Lawson, 539 F.3d 629, 634 (7th Cir. 2008). If this burden is met, the adverse party must then "set forth specific facts showing that there is a genuine issue for trial." Anderson, 477 U.S. at 256.

         B. Motion for Reconsideration Standard

         Pfizer also moves to reconsider the Court's prior claim construction Order. R. 355. A court may reconsider an interlocutory ruling "at any time before the entry of a judgment adjudicating all the claims and all the parties' rights and liabilities." Fed R. Civ. P. 54(b). Motions for reconsideration serve the narrow purpose of correcting manifest errors of law or fact or presenting newly discovered evidence. Rothwell Cotton Co. v. Rosenthal & Co., 827 F.2d 246, 251 (7th Cir. 1987) (citation omitted). Thus, a motion to reconsider is proper when "the Court has patently misunderstood a party, or has made a decision outside the adversarial issues presented to the Court by the parties, or has made an error not of reasoning but of apprehension." Bank of Waunakee v. Rochester Cheese Sales, Inc., 906 F.2d 1185, 1191 (7th Cir. 1990) (citation omitted). But a motion for reconsideration "does not provide a vehicle for a party to undo its own procedural failures, and it certainly does not allow a party to introduce new evidence or advance arguments that could and should have been presented to the district court prior to the judgment." Bordelon v. Chi. Sch. Reform Bd. of Trs., 233 F.3d 524, 529 (7th Cir. 2000) (citation and quotations omitted); see also Caisse Nationale de Credit Agricole v. CBI Indus., Inc., 90 F.3d 1264, 1270 (7th Cir. 1996) ("[R]econsideration is not for rehashing previously rejected arguments.").

         In the context of claim construction, a motion for reconsideration may be raised at any stage of the case. E.g.,Jack Guttman, Inc. v. Kopykake Enters., Inc., 302 F.3d 1352, 1361 (Fed. Cir. 2002) (after preliminary injunction ruling); Bone Care Int'l LLC v. Pentech Pharm., Inc., 2010 WL 3023423, at *1 (N.D. Ill. July 30, 2010) (after Markman hearing). Indeed, the Federal Circuit has noted that "[d]istrict courts may engage in a rolling claim construction, in which the court revisits and alters its interpretation of the claim terms as its understanding of the technology evolves." Jack ...


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