Novo-Nordisk A/S v. Pfizer, Inc.
Exubera Patent Lawsuit

Drug Litigation Home > Pages 3 - 4 of 9 in Lawsuit

                  11.        On January 2,2001, United States Patent No. 6,167,880 (the “'880 patent”) was duly and legally issued to Aradigm, as assignee ofIgor Gonda, Reid M. Rubsamen, and Stephen J. Farr, for an invention entitled “Inhaled Insulin Dosage Control Delivery Enhanced by Controlling Total Inhaled Volume.” A copy of the '880 patent is attached hereto as Exhibit D.

                  12.        On April 18, 2006, United States Patent No. 7,028,686 (the “'686 patent”) was duly and legally issued to Aradigm, as assignee of Igor Gonda, Reid M. Rubsamen, and Stephen J. Farr, for an invention entitled “Inhaled Insulin Dosage Control Delivery Enhanced by Controlling Total Inhaled Volume.” A copy of the '686 patent is attached hereto as Exhibit E.

                  13.        Collectively, the '581, '620, '240, '880 and the '686 patents will be referred to as the “patents-in-suit.” Novo is presently the owner of each of the patents-in-suit.

Pfizer's Infringing Activities

                  14.        On December 27, 2004, Pfizer submitted to the United States Food and Drug Administration ("FDA") a New Drug Application ("NDA") No. 21-868 for Exubera (insulin human [rDNA origin]) Inhalation Powder, 1 mg and 3 mg, and Exubera Inhaler.

                  15.        Pfizer's NDA No. 21-868 provides for the use of its Exubera product in the treatment and control of diabetes mellitus and hyperglycemia in adult patients.

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                  16.        On January 27,2006, FDA approved Pfizer's NDA No. 21-868 for use as recommended in the Package Insert and Medication Guide submitted by Pfizer. The Package Insert and Medication Guide contain information about the insulin to be used with Exubera and instructions on the use of the Exubera Inhaler.

                  17.        Pfizer has announced plans to introduce Exubera for commercial sale in the United States in the beginning of September 2006.

                  18.        Upon information and belief, the use of Exubera by patients in the United States, according to the instructions provided by Pfizer, is a direct infringement of the patents-in-suit under 35 U.S.C. § 271(a).

Public Announcement of the FDA Decision

                  19.        Pfizer has been, is and will be inducing and/or contributing to infringement of the patents-in-suit by making, using, selling, offering to sell and/or importing its Exubera product in the United States in violation of 35 U.S.C. § 271(b) and (c).

                  20.        Upon information and belief, Pfizer has been, is and will be directly infringing the patents-in-suit in violation of 35 U.S.C. § 271(a) by using its Exubera product to treat patients in the United States.

                  21.        Pfizer's direct, contributory and inducement of infringement of the patents-in-suit is willful, wanton and in disregard of Novo's rights under the patents-in-suit.

                  22.        As a result of Pfizer's infringing activity, Novo has suffered, is suffering and will continue-unless Pfizer is enjoined-to suffer irreparable harm for which there is no adequate remedy at law. Novo is thus entitled to a preliminary and

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