On May 25, 2017, Pfizer, Inc. (“Pfizer”) filed two new petitions for inter partes review (“IPR”) of U.S. Patent No. 6,407,213 (“the ’213 patent”). The ‘213 patent, entitled “Method for Making Humanized Antibodies,” issued on June 18, 2002. Although the IPR petitions do not identify a particular biologic, Genentech has publicly stated that the technology claimed by the ’213 was used in the development of Herceptin® (trastuzumab), as well as several other products. Genetech applied for a patent term extension of the ’213 patent under the Drug Price Competition and Patent Term Restoration Act of 1984 based on the regulatory review period of its biologic license application for Lucentis® (ranibizumab), and Genentech applied for a patent terms extension of a different patent in the same patent family based on the regulatory review period for Avastin® (bevacizumab).
The new proceedings are IPR2017-01488 and IPR2017-01489. Hospira, a Pfizer company, has filed IPR petitions challenging claims of other patents related to Herceptin® (trastuzumab), as we reported earlier this year here and here. In those cases, Hospira was identified as the real party in interest and Pfizer was also identified as a party having interest. The only real party-in-interest identified for Petitioner in these two new IPR filings is Pfizer. The fact that Hospira was not also identified as interested party in the petitions could possibly indicate that these petitions were filed as part of a patent strategy related to other products in Pfizer’s development pipeline, in addition to trastuzumab.
Celltrion has also filed IPR petitions challenging several patents related to Herceptin® (trastuzumab), including the ’213 patent, as discussed here, here, and here. Mylan is also seeking approval of a trastuzumab biosimilar and had filed two IPR petitions challenging the ’213 patent. Those petitions were withdrawn, as we reported in this post in March 2017, as part of a global settlement agreement that Mylan and Biocon entered into with Genentech and Roche related to Mylan’s proposed trastuzumab biosimilar. A complete list of IPRs related to trastuzumab and other proposed biosimilar products can be found in RFEM’s IPR Dashboard.