Genentech's Distribution of Prescribing Information to Physicians is Alleged to Infringe Method Patent

24 February 2014 Personalized Medicine Bulletin Blog

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.

This blog is made available by Foley & Lardner LLP (“Foley” or “the Firm”) for informational purposes only. It is not meant to convey the Firm’s legal position on behalf of any client, nor is it intended to convey specific legal advice. Any opinions expressed in this article do not necessarily reflect the views of Foley & Lardner LLP, its partners, or its clients. Accordingly, do not act upon this information without seeking counsel from a licensed attorney. This blog is not intended to create, and receipt of it does not constitute, an attorney-client relationship. Communicating with Foley through this website by email, blog post, or otherwise, does not create an attorney-client relationship for any legal matter. Therefore, any communication or material you transmit to Foley through this blog, whether by email, blog post or any other manner, will not be treated as confidential or proprietary. The information on this blog is published “AS IS” and is not guaranteed to be complete, accurate, and or up-to-date. Foley makes no representations or warranties of any kind, express or implied, as to the operation or content of the site. Foley expressly disclaims all other guarantees, warranties, conditions and representations of any kind, either express or implied, whether arising under any statute, law, commercial use or otherwise, including implied warranties of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Foley or any of its partners, officers, employees, agents or affiliates be liable, directly or indirectly, under any theory of law (contract, tort, negligence or otherwise), to you or anyone else, for any claims, losses or damages, direct, indirect special, incidental, punitive or consequential, resulting from or occasioned by the creation, use of or reliance on this site (including information and other content) or any third party websites or the information, resources or material accessed through any such websites. In some jurisdictions, the contents of this blog may be considered Attorney Advertising. If applicable, please note that prior results do not guarantee a similar outcome. Photographs are for dramatization purposes only and may include models. Likenesses do not necessarily imply current client, partnership or employee status.

Related Services

Insights