RFEM’s Biosimilars IPR Dashboard provides current information on IPR proceedings related to proposed biosimilar products.
Genentech Files Two New Lawsuits Against Celltrion Alleging Infringement of Patents Related to Rituxan® and Herceptin®
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
District Court Grants Genentech’s Motions to Dismiss Celltrion’s Declaratory Judgment Actions in Herceptin® and Rituxan®-Related Suits
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
Genentech’s Carter ’213 Patent Asserted and Challenged
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
Celltrion and Teva File Declaratory Judgment Action Against Thirty-Seven Rituxan®-related Patents
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
Celltrion and Teva File Declaratory Judgment Action Against Thirty–Eight Herceptin®-related Patents
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
Litigation vs. Licensing: Manufacturers of the Two Most Recently Approved Biosimilars Take Different Approaches to Reference Drug Patents
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
PTAB Institutes Review on Four Celltrion Petitions Targeting Herceptin®
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,
Genentech’s Carter ʼ213 Patent Continues to Draw IPR Challenges
Samsung Bioepis (“Bioepis”) has joined a growing list of challengers to Genentech’s U.S. Patent No. 6,407,213 (“the ʼ213 patent”) issued to Carter, et al. by filing two new petitions for inter partes review (“IPR”). The ʼ213 patent, entitled “Method for Making Humanized Antibodies,” is generally directed to antibodies with humanized variable domains comprising non-human complementarity
Pfizer Files Another IPR Against Genentech’s ʼ441 Patent
On October 3, 2017, Pfizer, Inc. (“Pfizer”) filed a petition for inter partes review (“IPR”) against U.S. Patent No. 7,846,441 (“the ʼ441 patent”), assigned to Genentech, Inc. (“Genentech”), entitled “Treatment with anti-ErbB2 antibodies.” The ʼ441 patent is related to Genentech’s Herceptin® (trastuzumab) product. Last November, Pfizer announced positive results in a pivotal safety and efficacy