On February 6, 2026, the USPTO updated its guidance on anonymous requests for ex parte reexamination. When a patent has previously been the subject of an IPR or PGR that produced a final written decision on at least one claim, an anonymous requester must now include an affirmative statement that the real party in interest
In the evolving biosimilar landscape, patent challenges remain a critical strategy to clear the path for market entry. Recent reforms at the Patent Trial and Appeal Board (PTAB) under Director John Squires have significantly altered the inter partes reviews (IPRs) landscape, leading to a steep decline in institution rates. While this shift may initially appear
The U.S. Patent and Trademark Office (USPTO) recently instituted two of Mylan’s petitions seeking Inter Partes Review of Regeneron’s U.S. Patent No. 9,669,069 B2 (the “’069 Patent,” subject of IPR2021-00880) and U.S. 9,254,338 B2 (the “’338 Patent,” subject of IPR2021-00881), finding that Mylan (now part of Viatris) established a reasonable likelihood in prevailing in showing
On October 26, 2021, the Patent Trial and Appeal Board (PTAB) granted Regeneron’s petition to institute an inter partes review (IPR) of Novartis’s patent U.S. Pat. No. 9,220,631 (“the ’631 patent”), which covers a pre-filled glass syringe for injecting a VEGF-antagonist into the eye. This is the second time the PTAB reviewed Regeneron’s petition to
On September 16, 2021, eleven congressional leaders (“the Signors”) sent a letter to Andrew Hirshfeld, the acting director of the United States Patent and Trademark Office (“USPTO”), requesting the USPTO to reevaluate the Patent Trial and Appeal Board’s (“PTAB”) view on discretionary denials of petitions for inter partes review (“IPR”). The Office uses discretionary denials
In the context of Immunex’s patent on IL-4 antibodies, the Federal Circuit says yes.
On October 13, 2020, the Federal Circuit affirmed the Patent Trial and Appeal Board’s (the “Board”) final written decision in IPR2017-01884, holding invalid all claims of U.S. Patent No. 8,679,487 (“the ’487 patent”) assigned to Immunex. The ‘487 patent is drawn
Recently, the Federal Circuit Court of Appeals dismissed Pfizer Inc.’s (“Pfizer”) appeal for lack of Article III standing. Pfizer had filed an inter partes review (“IPR”) against Chugai Pharmaceutical Co. (“Chugai”) arguing that U.S. Patent Nos. 7,332,289 and 7,927,815 (“the patents-at-issue”) were unpatentable. The patents at issue are directed towards methods of manufacturing rituximab. Specifically,
On February 14, 2019, the PTAB issued final written decisions in two separate IPRs filed by Sanofi-Aventis, Genzyme Corp., and Regeneron Pharmaceuticals (collectively “Sanofi”) against U.S. Patent No. 8,679,487 (“the ʼ487 patent”) assigned to Immunex Corporation (“Immunex”). Claim 1 of the ʼ487 patent is the only independent claim, and it is directed to “an isolated
The PTAB recently denied institution of two IPRs filed by CSL Behring LLC, CSL Behring GMBH, and CSL Behring Recombinant Facility AG (collectively “CSL”) targeting U.S. Patent No. 9,623,091 (“the ʼ091 patent”) owned by Bioverativ Therapetutics, Inc. (“Bioverativ”). More specifically, on January 6, 2019, the PTAB denied institution of IPR2018-01313 (“the ʼ313 IPR”), and on
We previously wrote about Genentech’s U.S. Patent No. 6,407,213 (“the ’213 patent”) to Carter, first in October 2017, and more recently in March 2018. At the time of our last update, the ’213 patent had been at issue in six district court litigations, and had been the subject of ten filed IPR petitions,