On January 31, 2014, Phigenix, Inc. (“Phigenix”) filed a lawsuit in federal district court in Georgia alleging that the sale and use of the drug Kadcyla by Genentech, Inc. (“Genentech”) infringed U.S. Patent No. 8,080,534B2, assigned to Phigenix, under 35 U.S.C. Section 271. Particularly, Phigenix alleges that Genentech’s distribution of prescribing information to healthcare professionals such as physicians throughout the United States, infringes the patent.
U.S. Patent No. 8,080,534B2
U.S. Patent No. 8,080,534B2, (“the ’534 Patent”) issued on December 20, 2011, to Carlton D. Donald and is titled Targeting PAX2 for the Treatment of Breast Cancer . The ‘534 Patent relates to the treatment of breast cancer by administering a composition that inhibits PAX2 expression or PAX2 activity to the patient. The relevant claims of the ’534 Patent recite:
1.A method for treating a breast condition in a subject, comprising administering to a breast tissue of the subject, a composition that (1) inhibits PAX2 expression or PAX2 activity, (2) expresses DEFB1 or (3) inhibits PAX2 expression or PAX2 activity and expresses DEFB1.
13. The method of claim 1, further comprising the step of: administering to the subject an effective amount of an anti-ERBB-2 agent.
14. The method of claim 13, wherein the said anti-ERBB-2 agent is Herceptin.
15. The method of claim 1, further comprising the step of: administering to the subject an effective amount of an anti-Her-2 agent.
16. The method of claim 15, wherein the anti-Her-2 agent is Trastuzumab.
The ’534 Patent also claims administering the composition to patient after determining the PAX2-DEFB1 expression ratio in a breast cancer tissue isolated from the patient. A representative test-and-treat claim recites:
19. A method for treating a breast condition in a subject, comprising: (a) determining the PAX2-to-DEFB1 expression ratio in a diseased breast tissue from said subject; (b) determining the ER/PR status of said diseased breast tissue from said subject; and (c) based on the results of (a) and (b), administering to a breast tissue of said subject, a first composition that (1) inhibits PAX2 expression or PAX2 activity, (2) expresses DEFB1 or (3) inhibits PAX2 expression or PAX2 activity and expresses DEFB1.
Genentech’s Product Information
Genentech makes and sells ado-trastuzumab emtansine, an antibody directed against the ERBB-2 receptor, under the trade name Kadcyla. Phigenix alleges that according to Genentech’s literature, Kadcyla or ado-trastuzumab emtansine, is the first HER-2 targeted treatment of its kind for metastatic breast cancer. Kadcyla is conjugate made up of the monoclonal antibody trastuzumab (the same monoclonal antibody in Herceptin, also sold by Genentech) and a microtubule inhibitor, for the treatment of patients with HER-2 positive metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Genentech is alleged to actively induce healthcare professionals to infringe the ’534 Patent by the distribution of prescribing information to healthcare professionals for Kadcyla.
Claims for Relief
Phigenix asserts that Genentech’s past and continuing infringement of the ’534 Patent has irreparably harmed and continues to irreparably harm Phigenix. Phigenix seeks monetary damages and that the court permanently enjoin Genentech from infringing, contributing to the infringement of, and inducing infringement of the ’534 Patent during the life of the ’534 Patent.
