UNITED STATES DISTRICT COURT 

NORTHERN DISTRICT OF ILLINOIS 

EASTERN DIVISION 

BAYER HEALTHCARE LLC, 

Plaintiff, 

v. 

PFIZER, INC., 

Defendant. 

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Civil Action No. 1:12-cv-00630 

Hon. Judge Edmond E. Chang 

FILED UNDER SEAL 

PFIZER INC.’S RESPONSES TO BAYER’S STATEMENT OF MATERIAL FACTS IN 

SUPPORT OF ITS MOTION FOR PARTIAL SUMMARY JUDGMENT DISMISSING 

PFIZER’S ANTICIPATION AND OBVIOUSNESS DEFENSES 

Pursuant to Local Rule 56.1, Pfizer Inc. (“Pfizer”) submits these Responses to “Bayer’s 

Statement Of Facts Supporting Its Cross-Motion For Partial Summary Judgment Dismissing 

Pfizer’s Anticipation And Obviousness Defenses. (“Asserted Facts”). 

GENERAL OBJECTIONS 

Pfizer objects to Bayer’s inclusion of opinions and arguments in their list of Asserted 

Facts, including, for example, Asserted Facts 243-51, 255, 258, 263-65, 267, 268, 269, 271, 273, 

278, 280, 284, 289. Opinions and arguments do not comply with Local Rule 56.1, which 

requires a party opposing a motion for summary judgment to set forth the “material facts.” 

Pfizer further objects to Bayer’s inclusion of assertions that are not relevant, much less 

material, to the issues involved in Bayer’s motion for Summary Judgment. Irrelevant assertions 

likewise do not comply with Local Rule 56.1’s requirement that Plaintiffs set forth only “entitle 

the moving party to a judgment as a matter of law.” 

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SPECIFIC OBJECTIONS AND RESPONSES 

ASSERTED FACT #241 RESPONSE: 

Pfizer incorporates by reference its response to Bayer SOF 135.

 Bayer Ex. 90 (D.I. 

348) at 77. 

ASSERTED FACT #242 RESPONSE:

Pfizer incorporates by reference its response to Bayer SOF 136. 

ASSERTED FACT #243 RESPONSE: 

Pfizer objects to this Asserted Fact as vague and ambiguous, irrelevant and immaterial to 

Bayer’s motion, and thus disputed. A person having ordinary skill in the art in 1995 would have 

believed that a successful treatment of BRD with a fluoroquinolone could be done in a one high 

dose, single treatment. Pfizer Ex. 10 (D.I. 309), Nov. 19, 2012 Babish Rep. at e.g., ¶¶ 125-426; 

Pfizer Ex. 11 (D.I. 309), Nov. 19, 2012 Grooms Rep. at 29-61. Additionally, Dr. Grooms 

testified that Bayer Ex. 91 (D.I. 248) at 89-90. Dr. 

Pollreisz merely testified that relapse is a significant concern for customers of BRD treatments. 

The cited Dr. Pollreisz testimony has nothing to do with whether a “person of ordinary skill 

believed that successful treatment of BRD with fluoroquinolones required the antibiotic to 

remain in the animal’s system for a prolonged period in order to eradicate bacteria and prevent 

relapse.” 

ASSERTED FACT #244 RESPONSE: 

Pfizer objects to this Asserted Fact as vague and ambiguous, irrelevant and immaterial to 

Bayer’s motion, and thus disputed. Persons of skill knew that concentration dependency teaches 

that the amount of dose and not dose frequency was the relevant factor, and that large single 

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PFE-BAY0002970. 

ASSERTED FACT #247 RESPONSE: 

Pfizer objects to this Asserted Fact as vague and ambiguous, and irrelevant and 

immaterial to Bayer’s motion, and thus disputed. Dr. Boettner testified that whether a drug is 

“long-acting” depends on the context of the particular drug, which Bayer’s asserted fact does not 

provide. For example, Advocin can be considered long-acting. Pfizer Ex. 17 (D.I. 357), Clay 

Dep. at 64. 

. Ms. Elliott considers Advocin to be long 

acting relative to a daily injection product. Ex. 31, Elliott Dep. 37. 

ASSERTED FACT #248 RESPONSE: 

Pfizer objects to this Asserted Fact as vague and ambiguous, and irrelevant and 

immaterial to Bayer’s motion, and thus disputed. Ms. Elliott’s full testimony was that longacting is a relative term that would include Baytril 100: 

Q. The single-dose products that were on the market in the second half 

of the 1990s, you mentioned LA-200 and Micotil. Those are both longacting products, correct? 

 A. Yes. Well, again, long-acting is a relative term. 

*** 

Q. Well, Baytril 100 is not a long-acting product, is it? 

A. It's as long as Micotil. It's -- which we just said was a long-acting 

product. 

Ex. 31, Elliot Dep. 174-75. 

Ms. Elliott considers Advocin to be long acting relative to a daily injection product. Ex. 

31, Elliott Dep. 37. Additionally, the products that were FDA-approved in the mid-1990s are not 

relevant to the full scope of what was known in the art in the mid-1990s. No fluoroquinolones 

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Response to Bayer SOF 125, 127. Pfizer is not in a position to be able to admit or deny the 

knowledge of Bayer that is described in the asserted fact. Additionally, the citations provided by 

Bayer do not fully support the asserted fact. 

 Pfizer further dispute the use of “long-acting.” For example, Advocin can be considered 

long-acting. Pfizer Ex. 17 (D.I. 357), Clay Dep at 64. There is no bright line between longer 

acting formulations and other formulations. Pfizer Ex. 12 (D.I. 309), Jan. 4, 2013 Babish Rep. ¶ 

6. Ms. Elliott considers Advocin to be long acting relative to a daily injection product. Ex. 31, 

Elliott Dep. 37. 

ASSERTED FACT #252 RESPONSE: 

Pfizer incorporates by response its response to Bayer SOF 126. Pfizer further disputes 

the use of “long-acting.” For example, Advocin can be considered long-acting. Pfizer Ex. 17 

(D.I. 357), Clay Dep. at 64. There is no bright line between longer acting formulations and other 

formulations. Pfizer Ex. 12 (D.I. 309), Jan. 4, 2013 Babish Rep. ¶ 6. Ms. Elliott considers 

Advocin to be long acting relative to a daily injection product. Ex. __, Elliott Dep. 37. 

ASSERTED FACT #253 RESPONSE: 

Pfizer incorporates by response its response to Bayer SOF 128. Pfizer further dispute the 

use of “long-acting.” For example, Advocin can be considered long-acting. Pfizer Ex. 17 (D.I. 

357), Clay Dep. at 64. There is no bright line between longer acting formulations and other 

formulations. Pfizer Ex. 12 (D.I. 309), Jan. 4, 2013 Babish Rep. ¶ 6. Ms. Elliott considers 

Advocin to be long acting relative to a daily injection product. Ex. 31, Elliott Dep. 37. 

ASSERTED FACT #254 RESPONSE:

Pfizer incorporates by response its response to Bayer SOF 129. 

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357), Clay Dep. at 64. There is no bright line between longer acting formulations and other 

formulations. Pfizer Ex. 12 (D.I. 309), Jan. 4, 2013 Babish Rep. ¶ 6. Ms. Elliott considers 

Advocin to be long acting relative to a daily injection product. Ex. 31, Elliott Dep. 37. 

ASSERTED FACT #260 RESPONSE: 

Pfizer incorporates by response its response to Bayer SOF 134. Pfizer further disputes 

the use of “long-acting.” For example, Advocin can be considered long-acting. Pfizer Ex. 17 

(D.I. 357), Clay Dep. at 64. There is no bright line between longer acting formulations and other 

formulations. Pfizer Ex. 12 (D.I. 309), Jan. 4, 2013 Babish Rep. ¶ 6. Ms. Elliott considers 

Advocin to be long acting relative to a daily injection product. Ex. 31, Elliott Dep. 37. 

ASSERTED FACT #261 RESPONSE:

Pfizer incorporates by response its response to Bayer SOF 143. Pfizer further disputes 

the use of “long-acting.” For example, Advocin can be considered long-acting. Pfizer Ex. 17 

(D.I. 357), Clay Dep. at 64. There is no bright line between longer acting formulations and other 

formulations. Pfizer Ex. 12 (D.I. 309), Jan. 4, 2013 Babish Rep. ¶ 6. Ms. Elliott considers 

Advocin to be long acting relative to a daily injection product. Ex. 31, Elliott Dep. 37. 

ASSERTED FACT #262 RESPONSE: 

Pfizer objects to this Asserted Fact as vague and ambiguous, irrelevant and immaterial to 

Bayer’s motion, and thus disputed. The key component of the vehicle used in LA-200, the 

“peak-only” formulation in the 93-052 study, and Advocin is the same. Pfizer SOF 32-37 re 

Non-infringement (D.I. 357). Additionally, some consider Advocin to include a long-acting 

formulation. Pfizer SOF 38, 39 re Non-infringement (D.I. 357); see also Ex. 31, Elliott Dep. 37. 

ASSERTED FACT #263 RESPONSE: 

Pfizer incorporates by response its response to Bayer SOF 144. 

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ASSERTED FACT #268 RESPONSE: 

Pfizer incorporates by response its response to Bayer SOF 152. 

ASSERTED FACT #269 RESPONSE: 

Pfizer incorporates by response its response to Bayer SOF 153. Pfizer further responds 

that Bayer’s Ex. 108 makes no mention and has no connection to any study performed by Bayer 

and Bayer has not provided any evidence or arguments suggesting otherwise. 

ASSERTED FACT #270 RESPONSE: 

Pfizer incorporates by response its response to Bayer SOF 154. 

ASSERTED FACT #271 RESPONSE: 

Pfizer objects to this Asserted Fact as vague and ambiguous, irrelevant and immaterial to 

Bayer’s motion, and thus disputed. For the same reasons that there is no nexus between any 

commercial success by Baytril 100 and the asserted claims, there is no nexus between any 

commercial success by Advocin and the asserted claims. See e.g., Pfizer Ex. 10 (D.I. 309), Nov. 

19, 2012 Babish Rep. ¶ 429; Pfizer Ex. 11 (D.I. 309), Nov. 19, 2012 Grooms Rep. at 61-62; 

Pfizer Ex. 13 (D.I. 309), Jan. 4, 2013 Grooms Rep. at 28; Ex. 32, Jan. 4, 2013 Leonard Rep. at 1. 

Pfizer incorporates by further response Pfizer Feb. 15, 2013 SOF 28-31 (D.I. 357). 

ASSERTED FACT #272 RESPONSE: 

Pfizer objects to this Asserted Fact as vague and ambiguous, irrelevant and immaterial to 

Bayer’s motion, and thus disputed. Pfizer further disputes the asserted fact to the extent it 

suggests that Pfizer did not include the concentration dependent references in its invalidity 

contentions. See e.g., Bayer Ex. 83 (D.I. 348) at Exhibit 2 (listing “Drusano, Meinen, Craig, 

Sullivan”). 

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a one high dose, single treatment. Pfizer Ex. 11 (D.I. 309), Nov. 19, 2012 Grooms Rep. at 34-

36; see also Pfizer Ex. 9 (D.I. 309), ‘853 patent at 9:24-33. 

ASSERTED FACT #276 RESPONSE: 

Pfizer objects to this Asserted Fact as irrelevant and immaterial to Bayer’s motion, and 

thus disputed. The ‘853 patent discloses that, with respect to cattle suffering from BRD, a range 

of treatments are available, including a single dose treatment. Pfizer Ex. 9 (D.I. 309), ‘853 

patent at 9:24-33; 

 

 Further, Bayer does not challenge the presumed 

enablement of the ‘853 patent. Also, Pfizer disputes that “the only cattle disease known to be 

treatable with a single dose before 1995 was E. Coli diarrhea.” For example, the ‘979 patent 

describes treating BRD with a single dose of a fluoroquinolone and is prior art to the ‘506 patent. 

Pfizer Ex. 29 (D.I. 309), ‘979 patent at 4:38-46. Pfizer was working on and successfully reduced 

to practice a single dose danofloxacin treatment by 1993. D.I. 354, Pfizer SOF in Opp. to 

Bayer’s Prior Invention Motion at SOF ¶¶ 201-207. Further, there were at least five single-dose 

treatments for BRD in June of 1995. Pfizer Ex. 15 (D.I. 309), Clay 1/24/2013 Dep. 46. 

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ASSERTED FACT #277 RESPONSE: 

Pfizer objects to this Asserted Fact as vague and ambiguous, irrelevant and immaterial to 

Bayer’s motion, and thus disputed. The ‘853 patent explicitly states “once to twice a day, for 1 

to 15, preferably 1 to 5 days, where appropriate repeated.” Included in this disclosure is once for 

one day. The ‘853 patent also does not qualify this once for one day treatment as not being 

applicable to shipping fever in cattle (i.e., BRD). 

ASSERTED FACT #278 RESPONSE: 

Pfizer objects to this Asserted Fact as vague and ambiguous, irrelevant and immaterial to 

Bayer’s motion, and thus disputed. Dr. Babish and Dr. Clay explained in detail how the ‘853 

patent anticipates the asserted claims. Pfizer Ex. 10 (D.I. 309), Nov. 19, 2012 Babish Rep. ¶¶ 

210-222; Pfizer Ex. 11 (D.I. 309), Nov. 19, 2012 Grooms Rep. at 34-38; Pfizer Ex. 12 (D.I. 309), 

Jan. 4, 2013 Babish Rep. ¶¶ 61-66; Pfizer Ex. 13 (D.I. 309), Jan. 4, 2013 Grooms Rep. at 21-23. 

 

, however that does not support Bayer’s statement of fact that Pfizer’s experts failed to 

explain how the ‘853 patent discloses each and every limitation of the claims. 

ASSERTED FACT #279 RESPONSE: 

Pfizer objects to this Asserted Fact as irrelevant and immaterial to Bayer’s motion, and 

thus disputed. 

ASSERTED FACT #280 RESPONSE: 

Pfizer objects to this Asserted Fact as irrelevant and immaterial to Bayer’s motion, and 

thus disputed. Pfizer further incorporates by reference its response to Bayer SOF 262 to note 

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discloses a single dose treatment. Pfizer Ex. 29 (D.I. 348) at 4:39-42 (“it is preferred that the 

present method consist of orally administering an effective amount of the composition in a single 

dosage to a ruminant in need thereof”) 

ASSERTED FACT #284 RESPONSE: 

Pfizer objects to this Asserted Fact as irrelevant and immaterial to Bayer’s motion, and 

thus disputed. The single dose Dr. Grooms testified about with respect to dogs is not the only 

disclosure in the ‘160 patent of a single dose. See e.g. Pfizer Ex. 10 (D.I. 309), Nov. 19, 2012 

Babish Rep ¶ 239; Pfizer Ex. 11 (D.I. 309), Nov. 19, 2012 Grooms Rep. at 39. 

ASSERTED FACT #285 RESPONSE: 

Pfizer objects to this Asserted Fact as irrelevant and immaterial to Bayer’s motion, and 

thus disputed. Pfizer does not dispute that Dr. Grooms testified that the ‘160 patent does not 

expressly state “use of fluoroquinolone single dose for BRD.” However, a verbatim statement of 

“use of fluoroquinolone single dose for BRD,” “one high dose, single treatment” or “bovine 

respiratory disease” is not required in the ‘979 patent for it to disclose a one high dose, single 

treatment of BRD. Moreover, the ‘160 patent discloses each and every element of the claims. 

See e.g., Pfizer Ex. 10 (D.I. 309), Nov. 19, 2012 Babish Rep ¶¶ 239-40; Pfizer Ex. 11(D.I. 309), 

Nov. 19, 2012 Grooms Rep at 39; Pfizer Ex. 12 (D.I. 309), Jan. 4, 2013 Babish Rep ¶¶ 72-75; 

Pfizer Ex. 13 (D.I. 309), Jan. 4, 2013 Grooms Rep at 23-24. 

ASSERTED FACT #286 RESPONSE: 

Pfizer objects to this Asserted Fact as irrelevant and immaterial to Bayer’s motion, and 

thus disputed. Pfizer does not dispute that Column 3 of the Seki application does not disclose a 

BRD treatment because it discloses an eye infection treatment. However, Pfizer disputes that the 

Seki Application fails to disclose a single dose BRD treatment in Column 4. See e.g., Pfizer Ex. 

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10 (D.I. 309), Nov. 19, 2012 Babish Rep ¶ 251; Pfizer Ex. 11 (D.I. 309), Nov. 19, 2012 Grooms 

Rep. at 40-42. 

ASSERTED FACT #287 RESPONSE: 

Pfizer objects to this Asserted Fact as vague and ambiguous, irrelevant and immaterial to 

Bayer’s motion, and thus disputed. Dr. Grooms only testified that pharmacokinetic studies do 

not expressly disclose a treatment for BRD. Bayer Ex. 91 (D.I. 348) at 404:3-5. Dr. Giles 

testified that a dosing regimen is tested in Giles I. Bayer Ex. 90 (D.I. 348) at 43-44. Dr. Mann 

merely testified that Mann II does not disclose a disease model study. Bayer Ex. 112 (D.I. 348) 

at 62-64. Moreover, pharmacokinetic studies can be used to determine a method treating BRD. 

Pfizer Ex. 10 (D.I. 309), Nov. 19, 2012 Babish Rep ¶¶ 57-61; Pfizer Ex. 11 (D.I. 309), Nov. 19, 

2012 Grooms Rep. at 43; Pfizer Ex 12 (D.I. 309), Jan. 4, 2013 Babish Rep. ¶¶ 35-39; Pfizer Ex 

13 (D.I. 309), Jan. 4, 2013 Grooms Rep. at 16-17.

ASSERTED FACT #288 RESPONSE: 

Pfizer objects to this Asserted Fact as vague and ambiguous, and thus disputed. Dr. 

Grooms testified that Drusano “recommend[s] ... one-day treatments.” Bayer Ex. 91 (D.I. 348) 

at 164. Dr. Babish only testified that Drusano does not provide data for a study of a single-dose 

treatment. Bayer Ex. 85 (D.I. 348) at 251-52. Dr. Babish also would not agree that Craig does 

not suggest a single-dose treatment. Id. at 265. With respect to Meinen, Dr. Babish only 

testified that Meinen does not provide data for a study of a single-dose treatment. Id. at 269-70. 

Dr. Babish made the same limited testimony with respect to Sullivan. Id. at 260. Drusano, 

Craig, Meinen, and Sullivan teach that fluoroquinolones are concentration dependent and 

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therefore provide an expectation of success in using a fluoroquinolone in a one high dose, single 

treatment. Pfizer Ex. 10 (D.I. 309), Nov. 19, 2012 Babish Rep ¶¶ 45-50; Pfizer Ex. 11 (D.I. 

309), Nov. 19, 2012 Grooms Rep. at 49; Pfizer Ex 12 (D.I. 309), Jan. 4, 2013 Babish Rep. at 11-

13; Pfizer Ex 13 (D.I. 309), Jan. 4, 2013 Grooms Rep. at 12-15. 

ASSERTED FACT #289 RESPONSE: 

Pfizer objects to this Asserted Fact as vague and ambiguous, and thus disputed. Gaunt, 

Backhouse, Kaplowitz, Moran, Morel and Siboulet are instructive to a person having ordinary 

skill in the art seeking a treatment for BRD. Pfizer Ex. 27 (D.I. 309), Papich Dep. Ex. 14 at 319; 

Pfizer Ex. 7 (D.I. 309), Papich Dep. 115-17; see also Pfizer Ex 12 (D.I. 309), Jan. 4, 2013 Babish 

Rep. ¶¶ 40-44; Pfizer Ex 13 (D.I. 309), Jan. 4, 2013 Grooms Rep. at 17-18. See also Pfizer SOF 

75, 76. 

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PFIZER’S ADDITIONAL STATEMENT OF MATERIAL FACTS

73. U.S. Pat. No. 4,800,039 discloses a method of “reducing turbidity in aqueous 

systems,” that includes “low-alkalinity systems (i.e., 150 ppm or less)” 

comprising two chemicals: (a) aluminum chlorohydrate; and (b) either a “watersoluble polyamines” or a “water-soluble dialkyl diallyl ammonium polymer[], 

wherein the weight ratio of (a) to (b) is at least 5:1, and preferably ranges from 

10:1 to about 100:1....” The “water-soluble polyamines” option preferably has a 

molecular weight ranging from 10,000-150,000 and the “water-soluble dialkyl 

diallyl ammonium polymer” option preferably has a molecular weight from 1,000 

to 5,000,000. Ex. 37, U.S. Pat. No. 4,800,039 at 2:20-3:6. 

74. Dr. Clay was asked the following questions and provided the following answers: 

Q: Right. This is my one opportunity to find out where in the 

words of claims 4 or 5 you think there is a limitation that would 

exclude what you deem to be long-acting or sustained-release 

formulations. And so if you can tell me what words in the claims 

you would link to what you're referring to in the specification, 

please do so now.

A: I can't point to a word there. 

Q: But your opinions you've provided on in particular 

invalidity in this case are premised on your understanding that the 

'506 patent claims exclude sustained-release or long-acting 

formulations? 

A: That is correct. 

Q: Would your overall opinion on invalidity change if I asked 

you to assume that the claims of the '506 patent do encompass 

long-acting or sustained-release formulations of a single-dose 

fluoroquinolone treatment of cattle with BRD? 

A: I'd have to assess that at the time. 

Q: You have not considered the question of whether the 

Claims 4 and 5 of the '506 patient are valid if we assume that 

sustained-release or long-acting formulations of fluoroquinolones 

are included within the scope of those claims? 

A: No, because I don't believe they're included. 

 Ex. 38, 1/24/13 Clay Dep. 60-61. 

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CERTIFICATE OF SERVICE

I hereby certify that on February 22, 2013, a true and correct copy of the foregoing 

document, PFIZER INC.’S RESPONSES TO BAYER’S STATEMENT OF MATERIAL 

FACTS IN SUPPORT OF ITS MOTION FOR PARTIAL SUMMARY JUDGMENT 

DISMISSING PFIZER’S ANTICIPATION AND OBVIOUSNESS DEFENSES, was served 

via ECF on the following counsel of record:

Peter B. Bensinger, Jr. 

Katherine G. Minarik 

Katherine M. Swift 

Reid M. Bolton 

Michael J. Valaik 

J. Scott McBride 

BARTLIT BECK HERMAN 

PALENCHAR & SCOTT LLP 

Courthouse Place, Suite 300 

54 West Hubbard Street 

Chicago, Illinois 60654 

Telephone: (312) 494-4400 

Facsimile: (312) 494-4440 

peter.bensinger@bartlit-beck.com 

katherine.minarik@bartlit-beck.com 

kate.swift@bartlit-beck.com 

reid.bolton@bartlit-beck.com 

michael.valaik@bartlit-beck.com 

scott.mcbride@bartlit-beck.com 

Dated: February 22, 2013 /s/ Marcus E. Sernel, P.C. 

Marcus E. Sernel, P.C. (#6202603) 

KIRKLAND & ELLIS LLP 

300 North LaSalle Street 

Chicago, Illinois 60654 

Telephone: (312) 862-2000 

Facsimile: (312) 862-2200 

marc.sernel@kirkland.com 

Attorney for Defendant Pfizer, Inc.

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