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On April 27, 2020, the Federal Circuit issued a non-precedential opinion ruling that Pfizer failed to establish Article III standing in a pair of IPR appeals.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…
This week, the U.S. Court of Appeals for the Federal Circuit issued two rulings in biosimilar-related appeals from final written decisions by the Patent Trial and Appeal Board (PTAB) in inter partes review (IPR) proceedings. Genentech v. Iancu (USPTO), Nos. 19-1263, -1265, -1267, -1270 On March 26, 2020, the Federal…
As previously reported, earlier this year Fresenius filed a petition for inter partes review of claims 9-10, 13-21 and 23-30 of Amgen’s pegfilgrastim patent – U.S. Patent No. 9,643,997 (“997 patent”). The challenged claims of the ’997 patent relate to methods for purifying proteins of interest expressed in a non-native…
On the morning of July 11, Chief Judge Prost, Judge Linn, and Judge Hughes heard oral argument in Genentech v. Hospira, Case No. 18-1959. Genentech appealed from a final written decision by the Patent Trial and Appeal Board (PTAB) on IPR2016-01771 that invalidated U.S. Patent No. 7,622,115 (the ’115 patent)…
As we have reported here and here, over the past couple of years Mylan has filed a number of IPR petitions challenging a total of seven of Sanofi-Aventis’s patents related to Lantus® (insulin glargine injection). On April 2, 2019, the PTAB granted institution of two petitions (IPR2018-01675 and IPR2018-01676) challenging…
On April 11, 2019, in Novartis Pharmaceuticals Corp. v. Par Pharmaceutical Inc., a Hatch-Waxman case concerning the small-molecule drug Zortress® (everolimus), Judge Andrews of the District of Delaware ruled that IPR estoppel could apply on remand to the District Court even after a trial on the issue of invalidity had been…
Yesterday, the PTAB issued final written decisions in two IPR proceedings (IPR2017-01884 and IPR2017-01879) it instituted on February 15, 2018 against U.S. Patent No. 8,679,487 (the ’487 patent), held by Immunex. The ’487 patent is directed to isolated human antibodies that compete with a reference antibody for binding to human interleukin-4 (IL-4) receptor. …