As we previously reported, Biogen sued Sandoz and Polpharma (“Defendants”) in a BPCIA litigation related to Defendants’ natalizumab biosimilar. On October 19, 2022, Biogen filed a Motion for Preliminary Injunction and Motion...more
In October 2022, we reported that Biogen was seeking a preliminary injunction in its BPCIA case brought in the District of Delaware against Sandoz relating to Sandoz’s proposed multiple sclerosis biosimilar of TYSABRI...more
This week, Genentech filed separate lawsuits against Biogen and Millennium, alleging breach of a license agreement to the Cabilly patents (U.S. Patent No. 6,331,415 and 7,923,221)....more
Biogen seeks a preliminary injunction in its BPCIA case against Sandoz related to Sandoz’s proposed biosimilar of TYSABRI (natalizumab). On October 20, 2022, the Court issued a sealed order on the parties’ joint...more
On September 9, 2022, Biogen filed a complaint in the District of Delaware against Sandoz and Polpharma Biologics. Biogen’s complaint is filed under seal. Based on the list of 28 asserted patents, the case appears to...more
On July 11, 2022, Teva filed a cert petition with the Supreme Court, seeking review of the Federal Circuit’s split per curiam opinion holding that Teva’s label for its generic drug Coreg induced doctors to infringe a GSK...more
To satisfy the written description requirement under 35 U.S.C. 112, a patent specification must describe the claimed invention in such sufficient detail that a person of skilled in the art (POSA) can reasonably conclude that...more
Venue and Pleading Infringement in Hatch-Waxman Litigation Turn on Location and Identity of ANDA Filer - In Celgene Corp. v. Mylan Pharm. et al., Appeal No. 21-1154, the Federal Circuit held that in Hatch-Waxman...more
BECAUSE DEFENDANT’S NDA PRODUCT DOES NOT INCLUDE ANY SALT OR ESTER OF THE ACTIVE INGREDIENT IN PLAINTIFF’S REFERENCE DRUG, PATENT TERM EXTENSION DID NOT APPLY AND JUDGMENT OF NON-INFRINGEMENT WAS AFFIRMED. Case...more
On February 11, 2020, in the Biogen v. Amgen BPCIA litigation regarding MVASI (bevacizumab-awwb), Amgen’s biosimilar of AVASTIN, Judge Colm Connolly of the Delaware District Court denied most of Genentech’s motion to dismiss...more
It has been nearly 10 years since the U.S. Biosimilars Pathway (the Biologics Price Competition and Innovation Act) was enacted. The first biosimilar product in U.S. history was approved and launched in 2015. Ten biosimilars...more
On December 6, 2019, the Federal Circuit will hear oral argument in a rituximab-related appeal by Biogen. The appeal stems from a final written decision of the Patent Trial and Appeal Board (PTAB) in an inter partes review...more
There are presently seven biosimilar-related appeals pending before the Federal Circuit. Two of those appeals, Amgen v. Sandoz (Case No. 18-1551) and Amgen v. Coherus (Case No. 18-1993), are from district court judgments in...more
On November 11, 2017, Pfizer, Inc. filed a petition for inter partes review (IPR) of Biogen and Genentech’s US Patent No. 8,545,843, which relates to a method of treating vasculitis with rituximab. (IPR2018-00086.) On May 31,...more
Below are recent updates in biosimilar-related IPR proceedings: GENERAL BIOLOGICS PATENTS - On December 1, 2017, the Board granted institution of four IPRs on Celltrion’s petitions (IPR2017-01373 and IPR2017-01374) and...more
The PTAB remains a busy venue for biologics patents. Here are some IPR updates from the weeks since our last IPR update...more
In the past few days, Pfizer has filed petitions for IPR of two of Biogen’s patents related to rituximab: IPR2017-01166 on U.S. Patent 8,329,172 and IPR2017-01167 on U.S. Patent 8,577,244. According to the petitions, the...more
Celltrion has filed three petitions for IPR of Biogen’s patents related to rituximab: IPR2017-01093, challenging U.S. Patent 8,329,172; IPR2017-01094 challenging U.S. Patent 8,557,244; and IPR2017-01095 challenging U.S....more
The USPTO Patent Trial and Appeals Board (PTAB) declined to institute Inter Partes Review (IPR) proceedings against three Biogen Idec TYSABRI patents. The IPR petitions were filed by Swiss Pharma International, and asserted...more
Yesterday, Celltrion filed a petition for inter partes review of Biogen’s U.S. Patent No. 7,820,161, which is directed to the use of rituximab to treat rheumatoid arthritis. We will continue to monitor and report on updates...more
It’s time for an update on Kyle Bass’s efforts to rid America of the pharmaceutical patents that support high priced drugs. Between February and September 2015, at least eleven investment funds organized by J. Kyle Bass and...more