As we previously reported here and here, Celltrion filed suit against Genentech seeking declaratory judgment that a host of patents covering Rituxan® and Herceptin® were non-infringed, invalid, and/or unenforceable. Genentech responded by moving to dismiss, arguing that Celltrion’s claims were statutorily barred by the BPCIA. As we reported here, the Court agreed with Genentech and
As we previously reported here and here, Celltrion filed suit against Genentech seeking declaratory judgment that a number of patents relating to Herceptin® (trastuzumab) and Rituxan® (rituximab) are non-infringed, invalid, and/or unenforceable. In response, Genentech filed a motion to dismiss in both cases arguing that the case was statutorily barred under the BPCIA. On May
The Patent Trial and Appeal Board (“the Board”) has decided not to institute inter partes review (“IPR”) on two patents owned by Biogen and Genentech. Pfizer, Inc. (“Pfizer”) filed two petitions asserting that the patents, U.S. Patent Nos. 8,206,711 (“the ’711 patent”) and 7,682,612 (“the ’612 patent”), were invalid as obvious in view of prior
In October, we reported on a growing number of IPR challenges to Genentech’s U.S. Patent No. 6,407,213 (“the ʼ213 patent”) to Carter. The ’213 patent, “Method for making humanized antibodies,” which Genentech has stated in SEC filings covers technology used in developing the breast cancer drug Herceptin® (trastuzumab), has since been asserted or is otherwise
On February 2, 2018, U.S. District Judge George H. Wu granted Genentech’s motion to dismiss a complaint brought by Amgen in the Central District of California seeking a declaratory judgment of non-infringement, invalidity, and unenforceability of twenty-seven patents related to Genentech’s cancer treatment biologic, Avastin® (bevacizumab).[i]
Judge Wu issued a tentative decision on January
We previously reported that on January 11, 2018, Celltrion, Inc., Celltrion Healthcare, Co. Ltd. (collectively “Celltrion”), Teva Pharmaceuticals International GmbH, and Teva Pharmaceuticals USA (collectively “Teva”) filed suit seeking declaratory judgment that thirty-eight patents relating to Herceptin® (trastuzumab) are non-infringed, invalid, or unenforceable. That same day, Celltrion and Teva also filed a suit seeking declaratory
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
The FDA has only approved eight biosimilar products to date. The second most recently approved biosimilar is Mvasi (bevacizumab-awwb), which is manufactured by Amgen and was approved as a biosimilar to Genentech’s Avastin (bevacizumab) on September 14, 2017.[1]
On October 6, 2017—about three weeks after the FDA approved Mvasi—Amgen provided Genentech with a notice
As previously reported, earlier this year Celltrion, Inc. (“Celltrion”) filed petitions seeking inter partes review (“IPR”) of certain Genentech patents covering Herceptin® (trastuzumab). In particular, Celltrion challenged the patentability of certain claims of U.S. Patent Nos. 7,846,441 (“the ʼ441 patent”); 7,892,549 (“the ʼ549 patent”); 6,626,196 (“the ʼ196 patent”); 7,371,379 (“the ʼ379 patent”). Earlier this month,
As we previously reported, Celltrion filed three petitions seeking inter partes review (“IPR”) of two patents related to Genentech and Biogen’s Rituxan® (rituximab). Celltrion filed two petitions seeking review of U.S. Patent No. 7,682,612 (“the ʼ612 patent”) and one petition seeking review of U.S. Patent No. 8,206,711 (“the ʼ711 patent”). The PTAB has now reached