On August 18, 2021, Fresenius Kabi USA, LLC and Fresenius Kabi SwissBioSim GmbH (collectively, “Fresenius”) filed Petitions for Inter Partes Review of U.S. Patent No. 10,874,677 (IPR 2021-01336) and U.S. No. 5,80,264 (IPR 2021-01288) . The ‘264 patent claims are directed to methods of treating rheumatoid arthritis patients using a…
In the long-awaited decision in United States v. Arthrex, Inc., the U.S. Supreme Court confirmed that the Patent Trial and Appeal Board is unconstitutionally structured, but held that the correct remedy is more limited than the one the U.S. Court of Appeals for the Federal Circuit had granted. Instead of…
On March 1, 2021, the Supreme Court heard oral argument on Arthrex and the constitutionality of IPRs. Listen here for insightful analysis of the arguments from our Supreme Court and IPR experts, William Jay, David Zimmer, and Linnea Cipriano.
As previously reported, in February 2019, the Patent Trial and Appeal Board issued final written decisions in two IPR proceedings initiated by Sanofi challenging the U.S. Patent No. 8,679,487 (the ’487 patent) owned by Immunex. In IPR2017-01884, the Board held that the challenged claims of the ‘487 patent were unpatentable…
On October 2, 2020, the United States Patent and Trademark Office (USPTO) adjusted its patent fees for the first time in almost three years, including an approximately 5% increase to most fees impacted by the rule. For IPRs, the minimum fees increased from $30,500 to $41,500, including the fee for a…
Today, the Supreme Court denied three petitions for certiorari challenging the constitutionality of subjecting patents issued prior to the America Invents Act (“AIA”) to inter partes review (“IPR”). See Celgene v. Peter; Collabo v. Sony Corp.; Enzo v. Becton, Dickinson and Company. In all three underlying cases, the U.S. Court of Appeals for the Federal Circuit had…
Alexion Pharmaceuticals’ SOLIRIS (eculizumab) is approved in the U.S. for the treatment of paroxysmal nocturnal hemoglobinuria (PHN), atypical hemolytic uremic syndrome (aHUS), myasthenia gravis (gMG), and neuromyelitis optica spectrum disorder (NMOSD). Amgen’s ABP 959 is a biosimilar to SOLIRIS undergoing clinical trials with a phase 3 clinical trial initiated earlier…
As we previously reported, Mylan filed a number of IPR petitions challenging a total of seven of Sanofi-Aventis’s patents related to Lantus® (insulin glargine injection). On May 29, 2020, the PTAB issued Final Written Decisions in eight of Mylan’s pending petitions concerning four patents finding most of the challenged claims…
On April 27, 2020, the Federal Circuit issued a non-precedential opinion ruling that Pfizer failed to establish Article III standing in a pair of IPR appeals. At the PTAB, Pfizer had challenged the validity of Chugai’s patents (7,332,289 and 7,927,815) covering processes relevant to the manufacture of rituximab. In support…
We previously covered the Patent Trial and Appeal Board’s (the “Board”) institution of inter partes reviews filed by Mylan challenging the validity of various Sanofi patents relating to devices for administering insulin glargine: IPR2018-01675, IPR2018-01676 (Patent 8,603,044 B2); IPR2018-01678, IPR2018-01679, IPR2019-00122 (Patent 8,992,486); IPR2018-01680, IPR2018-01682 (Patent 9,526,844 B2); and IPR2018-01684 (Patent…