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The court has issued a scheduling order in Regeneron's aflibercept BPCIA case against Mylan. The court scheduled a 2-week trial in June 2023, less than a year from Regeneron's filing of its complaint in August 2022.

On December 22, 2025, the FDAapprovedmAbxience and Amneal's Biologics Licensing Applications (BLAs) for BONCRESA (denosumab-mobz) and OZILTUS (denosumab-mobz)...

On March 5, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court for the Northern District of West Virginia's entry of a preliminary injunction preventing Celltrion, Inc. ("Celltrion") from launching CT-P42, its aflibercept biosimilar of EYLEA®.

On July 14, 2025 Fresenius filed two IPR petitions challenging Regeneron's patents related to aflibercept. Regeneron has not asserted that Fresenius infringes either of these patents...

GlaxoSmithKline Biologicals SA and GlaxoSmithKline LLC (collectively, "GSK") recently filed suit in the District of Delaware against Pfizer, Inc. alleging that Pfizer's respiratory syncytial...

Late last week, GlaxoSmithKline Biologicals SA and GlaxoSmithKline LLC filed suit in the District of Delaware alleging that Pfizer, Pharmacia & Upjohn, BioNtech SE, BioNtech Manufacturing GMBH...

Late last month, a Patent Trial and Appeal Board ("PTAB") panel instituted two petitions that were filed separately by Celltrion and Biocon for inter partes review ("IPR") of Regeneron's U.S.

In the last few weeks, the PTAB has granted institution of eight IPRs filed by Merck on Johns Hopkins patents directed to methods of treatment using pembrolizumab.

As we previously reported, REGENXBIO's litigation against Sarepta, alleging infringement of U.S. Patent No. 11,680,274 (the "'274 patent") by Sarepta's gene therapy product, was stayed pending resolution of Sarepta's IPR...

On November 9, 2022, the PTAB issued final written decisions in IPR2021-00880 and IPR2021-00881, filed by Mylan on two Regeneron patents related to aflibercept—U.S. Patent Nos. 9,254,338 and 9,669,069.

There have been several recent developments in the PTAB with respect to Regeneron's aflibercept-dosing patents.

Join Michael Siekman, Allegra Padula, and Riley Wyberg as they open our webinar series with "The BPCIA Has Changed How Companies Should Be Protecting Innovative Biologics...

On October 22, 2025, the Office of Foreign Assets Control (OFAC) of the US Department of the Treasury designated OJSC Rosneft...

On September 29, 2025, the U.S. Department of Commerce's Bureau of Industry and Security (BIS) issued a rule, effective immediately, that amended the Export Administration Regulations to address diversion concerns regarding entities appearing on the Entity List and other restricted-party lists.

On January 29, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court for the Northern District of West Virginia's entries of preliminary injunction preventing....

A recent decision by the Appellate Division of the New York Supreme Court dealt a major blow to the investors involved in Luxor Cap. Grp. LP v. Altisource Asset Mgmt.

At the close of an extended term, on July 1, 2024, the U.S. Supreme Court expanded the time period for bringing a facial challenge to a federal agency rule.