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Diabetes Drug Makers
  Eli Lilly & Co.
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Novo-Nordisk A/S v. Pfizer, Inc.
Exubera Patent Lawsuit:
Pfizer’s Answer

(August 22, 2006)

Drug Litigation Home > Pages 4 - 6 of 12 in Pfizer's Answer

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admits that Exhibit E of the Complaint purports to be a copy of the ‘686 patent. Pfizer denies the remaining allegations of this paragraph.

                  13.        Pfizer admits that the Complaint purports to collectively refer to the ‘581, ‘620, ‘240, ‘880 and ‘686 patents as the “patents-in-suit.” Pfizer is without knowledge or information sufficient to form a belief as to the truth ofthe remainder ofparagraph 13 and, therefore, the remaining allegations of paragraph 13 are denied.

PFIZER’S ALLEGED INFRINGING ACTIVITIES

                  14.       Admitted

                  15.        Pfizer admits that the January 27, 2006 approval letter from the FDA to Pfizer states that “[t]his new drug application provides for the use of Exubera for the treatment of adult patients with diabetes mellitus for the control of hyperglycemia.” Pfizer denies the remaining allegations of this paragraph.

                  16.        Pfizer admits that FDA approved Pfizer’s NDA No. 21-868 on January 27, 2006 “for use as recommended in the agreed-upon labeling text.” Pfizer denies the remaining allegations of this paragraph.

                  17.        Admitted that Pfizer announced its intention to begin introduction of Exubera in the United States beginning September 2006. Pfizer denies the remaining allegations ofthis paragraph.

                  18.       Denied.

                  19.       Denied.

                  20.       Denied.

                  21.       Denied.

                  22.       Denied.

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COUNT I

                  23.        Pfizer repeats and incorporates herein its responses to paragraphs 1 through 22 as though they were fully set forth herein.

                  24.        Pfizer is without knowledge or information sufficient to form a belief as to the truth of Novo’s allegations regarding ownership of the ‘581 patent and, therefore, those allegations in paragraph 24 are denied. Pfizer denies the remaining allegations of this paragraph.

                  25.       Denied.

                  26.       Denied.

COUNT II

                  27.        Pfizer repeats and incorporates herein its responses to paragraphs 1 through 26 as though they were fully set forth herein.

                  28.        Pfizer is without knowledge or information sufficient to form a belief as to the truth of Novo’s allegation regarding ownership ofthe ‘620 patent and, therefore, those allegations in paragraph 28 are denied. Pfizer denies the remaining allegations of this paragraph.

                  29.       Denied.

                  30.       Denied.

COUNT III

                  31.        Pfizer repeats and incorporates herein its responses to paragraphs 1 through 30 as though they were fully set forth herein.

                  32.       

Pfizer is without knowledge or information sufficient to form a belief as to the truth of Novo’s allegation regarding ownership of the ‘240 patent and, therefore, those allegations in paragraph 32 are denied. Pfizer denies the remaining allegations ofthis paragraph.

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                  33.       Denied.

                  34.       Denied.

COUNT IV

                  35.        Pfizer repeats and incorporates herein its responses to paragraphs 1 through 34 as though they were fully set forth herein.

                  36.        Pfizer is without knowledge or information sufficient to form a belief as to the truth of Novo’s allegation regarding ownership of the ‘880 patent and, therefore, those allegations in paragraph 34 are denied. Pfizer denies the remaining allegations of this paragraph.

                  37.       Denied.

                  38.       Denied.

COUNT V

                  39.        Pfizer repeats and incorporates herein its responses to paragraphs 1 through 38 as though they were fully set forth herein.

                  40.        Pfizer is without knowledge or information sufficient to form a belief as to the truth of Novo’s allegation regarding ownership ofthe ‘686 patent and, therefore, those allegations in paragraph 40 are denied. Pfizer denies the remaining allegations of this paragraph.

                  41.       Denied.

                  42.       Denied.

COUNT VI

                  43.        Pfizer repeats and incorporates herein its responses to paragraphs 1 through 42 as though they were fully set forth herein.

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