EpiPen RICO Ruling Opens Door for Private AKS Enforcement
As we previously reported, trial in Regeneron Pharmaceutical, Inc.’s BPCIA case against Mylan Pharmaceuticals Inc. and Biocon Biologics, Inc. (collectively, “the Biocon Defendants”) regarding the Biocon Defendants’...more
On April 12, 2024, the Federal Circuit dismissed CAFC Appeal No. 24-1402 and Cross-Appeal No. 24-1405 for lack of jurisdiction following its February 22, 2024 order directing Regeneron and Mylan / Biocon to show cause why the...more
Appeals from and redacted memorandum and opinion in support of judgment in Regeneron v. Mylan (aflibercept) BPCIA case filed - As we previously reported, trial in Regeneron Pharmaceutical, Inc.’s BPCIA case against Mylan...more
On August 18, Samsung Bioepis Co., Ltd. (“Samsung Bioepis”), filed a petition for Inter Partes Review, IPR2023-01312, challenging the validity of claims 1-18 of U.S. Patent No. 10,464,992, assigned to Regeneron...more
We previously reported on the opening post-trial briefs in Regeneron’s BPCIA case against Mylan and Biocon (who was added as a defendant after the original defendant, Mylan, transferred its rights to the aflibercept...more
As we have previously reported, Regeneron’s BPCIA case against Mylan regarding Mylan’s proposed aflibercept biosimilar is proceeding on an expedited schedule, with a two-week trial scheduled to begin on June 12, 2023, in the...more
As we have previously reported, Regeneron’s BPCIA case against Mylan regarding Mylan’s proposed aflibercept biosimilar is proceeding in the U.S. District Court for the Northern District of West Virginia, with a two-week trial...more
As we have previously reported, Regeneron’s BPCIA case against Mylan regarding Mylan’s proposed aflibercept biosimilar is proceeding on an expedited schedule, with a two-week trial scheduled to begin on June 12, 2023. On...more
As we previously reported, Regeneron’s BPCIA case against Mylan regarding Mylan’s proposed aflibercept biosimilar is proceeding on an expedited schedule, with a two-week trial scheduled to begin on June 12, 2023, less than a...more
On Friday, December 16, 2022, Regeneron moved to dismiss Mylan’s inequitable conduct defense and counterclaim against two of the six patents asserted in the parties’ BPCIA suit concerning Mylan’s proposed biosimilar to EYLEA....more
As we previously reported, the Northern District of West Virginia ordered an expedited trial in Regeneron’s aflibercept BPCIA case against Mylan. Regeneron had asserted 24 patents in its complaint....more
On Tuesday, December 6, Regeneron filed an expedited motion to compel Mylan’s compliance with the protective order in the parties’ BPCIA litigation concerning Mylan’s proposed aflibercept biosimilar of EYLEA. Regeneron...more
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. The PTAB ruled in...more
As we reported last week, the Northern District of West Virginia court has ordered an expedited trial in Regeneron’s aflibercept BPCIA case against Mylan. As required by the court’s scheduling order, on October 28,...more
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....more
Regeneron filed a complaint yesterday against Mylan in the U.S. District Court for the Northern District of West Virginia, alleging infringement of twenty-four patents under the BPCIA based on Mylan’s submission of an aBLA...more
In Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc., No. 2019-2402 (Fed. Cir. Nov. 5, 2020), the Federal Circuit clarified the venue analysis of 28 U.S.C. § 1400(b), which controls venue for patent...more
The 10th anniversary of the U.S. biosimilar pathway the Biologics Price Competition and Innovation Act of 2009 (BPCIA) is quickly approaching and marks an expansion of the U.S. biosimilar market. The BPCIA, signed into law...more
Here are some recent developments in U.S. legal proceedings relating to biosimilars: On December 10, 2018, in the Southern District of Florida, Apotex filed a motion to dismiss the patent infringement complaint that Amgen...more
Today, the U.S. FDA announced that it has approved Mylan’s aBLA for Fulphila™ (pegfilgrastim-jmdb), a biosimilar of Amgen’s Neulasta®. This approval marks the eleventh FDA licensure of a biosimilar product under the BPCIA...more
Below is a rundown of some recent developments in BPCIA litigations concerning biosimilars of Neupogen® (filgrastim) and/or Neulasta® (pegfilgrastim). Amgen v. Adello (filgrastim) - As we previously reported, in March,...more
Over the past several weeks, there have been numerous developments in U.S. patent litigation activity relating to biosimilars of Neupogen® (filgrastim) and Neulasta® (pegfilgrastim). Below is a summary of these developments....more
Amgen has filed patent infringement claims against Mylan and its subsidiaries over Mylan’s proposed biosimilar version of Neulasta (pegfilgrastim). Neulasta, a long-acting version of Amgen’s Neupogen (filgrastim), is a...more
Mylan filed an amicus brief in support of Apotex’s petition for certiorari in Amgen v. Apotex. Mylan’s arguments focus on the Federal Circuit’s interpretation of the BCPIA as requiring 180 days of pre-marketing notice after...more
On October 14, 2016, Mylan Pharmaceuticals and the Biosimilars Council, a subsidiary of the Generic Pharmaceuticals Association (GPhA), filed amicus briefs in support of granting review in Apotex v. Amgen, No. 16-332. As...more