2015 was a milestone year for biosimilars in the U.S. It was also our first year bringing you the latest biosimilars news and analysis. Here are our picks for the top-five most significant events in the world of biosimilars this year: 5) 2015 saw a marked increase in inter partes review…
IPR2016-00383 (Genzyme Corp.) (U.S. Patent No. 6,331,415) Petitioner: Genzyme Corp. Patent: U.S. Patent No. 6,331,415 Patent Title: Methods of Producing Immunoglobulins, Vectors and Transformed Host Cells for Use Therein Patent Owner: Genentech, Inc. and City of Hope
IPR2016-00408 (Boehringer Ingelheim) (U.S. Patent No. 8,889,135) Petitioner: Boehringer Ingelheim Corp., Boehringer Ingelheim International GmbH, Boehringer Ingelheim Pharma GmbH & Co. KG, Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA Corp. Patent: U.S. Patent No. 8,889,135 Patent Title: Methods of Administering Anti-TNFα Antibodies Patent Owner: AbbVie Biotechnology Ltd. IPR2016-00409 (Boehringer Ingelheim) (U.S. Patent No. 8,889,135) Petitioner:…
Sandoz has requested an extension of its deadline to file a petition for a writ of certiorari in Amgen v. Sandoz. As we covered previously, after the Federal Circuit denied the parties’ petitions for rehearing en banc in Amgen v. Sandoz, a 90-day clock began running on the parties’ time to file…
As part of our continuing coverage, we are following the parties’ briefing in the appeal of the preliminary injuction, which prohibits Apotex’s launch of its pegfilgrastim biosimilars, in Amgen v. Sandoz. As we have previously reported, Apotex filed a motion to expedite the appeal of the preliminary injunction. Last week,…
As we’ve covered previously, Apotex has moved to expedite the briefing schedule for its appeal of the district court order in Amgen v. Apotex, in which the district court granted Amgen a preliminary injunction prohibiting Apotex from launching its biosimilar pegfilgrastim product until at least 180 days after FDA licensure of the product. Today,…
As we covered last week (here), Apotex is appealing the district court’s grant of a preliminary injunction to Amgen in Amgen v. Apotex. Apotex has now moved to expedite the briefing schedule on its appeal in the Federal Circuit. In its motion, Apotex explains: “Under the district court’s order, Apotex suffers immediate harm because the launch…
The Federal Circuit recently denied en banc rehearing of Ariosa Diagnostics, Inc. v. Sequenon, Inc.. The original panel decision is at 788 F.3d 1371, (Fed. Cir. Jun. 12, 2015). In the original panel decision, Judges Linn, Wallach, and Reyna decided that the claims at issue were drawn to not- patentable…
On December 7 Samsung Bioepis and Merck announced that Samsung Bioepis had received approval for its RENFLEXIS product by the Ministry of Food and Drug Safety in Korea. RENFLEXIS, a biosimilar version of Janssen Biotech’s Remicade (infliximab), was approved for the treatment of rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative…
After winning a preliminary injunction in Amgen v. Apotex, Amgen now hopes to capitalize on that win in another pending BPCIA case, Amgen v. Hospira, which is being litigated in the District of Delaware. Amgen filed a notice of supplemental authority in the Hospira case citing the Florida District Court’s order in Apotex in an attempt to provide further support for…