On January 11, 2018, Celltrion, Inc., Celltrion Healthcare, Co. Ltd. (collectively “Celltrion”), Teva Pharmaceuticals International GmbH, and Teva Pharmaceuticals USA (collectively “Teva”) filed suit against Genentech, Inc., Hoffmann-La Roche Inc., and City of Hope seeking declaratory judgment that thirty-eight patents relating to Herceptin® (trastuzumab) are non-infringed, invalid, and/or unforceable. According to Celltrion and Teva, a substantial controversy of “sufficient immediacy and reality to warrant the issuance of a declaratory judgment” exists between the parties due to Celltrion’s filing of an application under the BPCIA that seeks approval to market a trastuzumab biosimilar product.  Teva is Celltrion’s exclusive partner for the selling and distribution of the trastuzumab biosimilar in the United States.

According to the complaint, the FDA accepted Celltrion’s biosimilar application on July 28, 2017, and since that time the parties have been engaged in the so-called “patent dance” portion of the BPCIA.  In particular, on August 11, 2017, Celltrion produced its biosimilar application to Genentech as well as “other detailed information regarding the manufacturing processes used to make [the trastuzumab biosimilar].”  On October 10, 2017, Genentech then provided a list of forty patents that it believed could be reasonably asserted against Celltrion’s proposed biosimilar. The parties exchanged detailed statements asserting the factual and legal basis for their respective positions on infringement and validity of the patents identified by Genentech.  On January 11, 2018, Celltrion notified Genentech that it wished to litigate all of the patents Genentech identified on its list, and filed a declaratory judgment action.

A summary chart identifying the patents-in-suit, and Celltrion’s requested relief for each patent is provided below:

As we previously reported, Celltrion filed two petitions for inter partes review (“IPR”) of the ʼ213 patent, and review on both petitions was instituted on December 1, 2017.  In addition, review has been instituted on the ʼ441 patent, the ʼ549 patent, the ʼ196 patent, and the ʼ379 patent.

Herceptin® is a monoclonal antibody that interferes with human epidermal growth factor receptor (HER2)/neu.  The produce is indicated for the treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have received one or more chemotherapy regimens for their metastatic disease.

We will continue to keep you updated on future developments.