As we previously reported, on September 20, 2017, Pfizer filed an antitrust lawsuit against Johnson & Johnson (J&J) in the U.S. District Court for the Eastern District of Pennsylvania alleging that J&J has engaged in an anticompetitive scheme to protect its Remicade® (infliximab) product. On November 28, 2017, J&J filed…
Last week, in the ongoing Immunex v. Sanofi patent litigation regarding Immunex’s claims of infringement against Sanofi and Regeneron’s Dupixent® (dupilumab) product, the Defendants moved for summary judgment of invalidity of the sole patent-in-suit, the ‘487 patent, on the ground that the patent’s claims are indefinite. According to Defendants’ brief,…
The February edition of the Annals of the Rheumatic Diseases published a Recommendation titled, “Consensus-based recommendations for the use of biosimilars to treat rheumatological diseases.” A panel of rheumatologists, dermatologists, gastroenterologists, and pharmacologists, as well as patients and regulators, were assembled to conduct a study aimed at developing recommendations regarding…
Last week, Johnson & Johnson held its earnings call for the fourth quarter of 2017. During the call, company representatives discussed an 8% decline in U.S. sales for Remicade as Johnson & Johnson “continued to compete in the phase of biosimilar entries.” As we previously reported, there are two biosimilars…
Clover Biopharmaceuticals, a clinical-stage biotech company based in Chengdu, China, and General Electric announced last week that Clover had selected General Electric’s FlexFactory biomanufacturing platform for Clover’s new manufacturing facility, to be located in the Changxing Economic and Technological Development Zone. The facility, which is scheduled to open in the second half of 2018, will feature…
On January 15, 2018, Swedish company XBrane Biopharma issued a press release stating that, in December 2017, it signed a non-binding letter of intent with Chinese company CR Pharma regarding XLucane, a ranibizumab biosimilar. According to the press release, XBrane and CR Pharma intend to take Xlucane to market in China,…
Last week, Sandoz announced a new collaboration with Asian biopharmaceutical company Biocon to “to develop, manufacture and commercialize multiple biosimilars in immunology and oncology for patients worldwide. Under the terms of the agreement, both companies will share responsibility for end-to-end development, manufacturing and global regulatory approvals for a number of…
On January 11, 2018, Celltrion and Teva filed two lawsuits against Genentech in the District Court for the Northern District of California. Case No. 3:18-cv-00274 relates to Celltrion’s Herzuma®, its trastuzumab biosimilar. According to the complaint, Celltrion and Teva seek a declaratory judgment of non-infringement, invalidity, and/or unenforceability of 38…
We previously reported on Genentech’s complaint in the District of Delaware alleging that Amgen’s MVASI™ (bevacizumab-awwb) infringes over twenty Genentech patents and Amgen’s motion to transfer that complaint to the Central District of California. Today Amgen filed its reply (redacted) in support of transfer. In its reply, Amgen addresses Genentech’s…
As we previously reported, on ex parte reexamination, the Examiner rejected all claims of U.S. Patent No. 6,284,471, a patent covering Janssen’s Remicade® (infliximab), as invalid for obviousness-type double patenting (“OTDP”). The USPTO’s Patent Trial and Appeal Board affirmed the rejection and Janssen appealed the PTAB’s decision to the Federal Circuit. …