Defendant
12 cases as defendant.
Mylan Pharmaceuticals Inc. was a global generic and specialty pharmaceuticals company founded in 1961 by Milan Puskar and Don Panoz. Before its merger, Mylan's principal executive offices were in Hatfield, UK, with a "Global Center" in Canonsburg, Pennsylvania, U.S. In November 2020, Mylan merged with Upjohn, Pfizer's off-patent medicine division, to form Viatris Inc. Viatris Inc. is now a public company headquartered in Canonsburg, Pennsylvania, trading on Nasdaq under the ticker VTRS. As of 2024, Viatris reported approximately 32,000 employees and revenues of US$14.7 billion.
The company, as part of Viatris, develops, manufactures, and markets a broad portfolio of medicines, including branded, generic, biosimilar, and over-the-counter (OTC) drugs, as well as active pharmaceutical ingredients (APIs). Its extensive product range covers therapeutic areas such as cardiovascular, infectious disease, oncology, immunology, and central nervous system (CNS) disorders. Historically, Mylan was known for its HIV/AIDS retroviral drugs and the EpiPen auto-injector.
Mylan Pharmaceuticals Inc. has consistently demonstrated the litigation posture of an operating company defending its products. The company has appeared as a defendant in all two of its tracked patent litigation cases and has no recorded appearances as a plaintiff. These cases were heard in the West Virginia Northern District Court and the U.S. Court of Appeals for the Federal Circuit.
A notable legal context for Mylan Pharmaceuticals Inc. involves cases filed by Regeneron Pharmaceuticals, Inc., specifically "Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc. et al." This ongoing litigation is characteristic of patent disputes frequently encountered by pharmaceutical companies regarding their drug formulations and intellectual property.
Regeneron secured a district court victory finding Mylan infringed US Patent 11084865. A subsequent settlement between Regeneron and Biocon (Mylan's associate) led to the dismissal of the district court case and a related Federal Circuit appeal (CAFC Appeal No. 24-2002), allowing commercialization of Mylan's biosimilar in 2026.
One of the few actions filed outside the District of New Jersey, asserting U.S. Patent No. 7,968,569 against Mylan.
Celgene sued Mylan entities in N.D. West Virginia over generic lenalidomide. The case was resolved by a stipulated consent judgment/injunction on July 23, 2021.
Celgene sued Mylan Pharmaceuticals, Mylan Inc., and Mylan N.V. in the Northern District of West Virginia (1:20-cv-00003), asserting U.S. 7,855,217 among other patents. The case settled on July 21, 2021, and terminated July 23, 2021 (ANDA No. 213912).
Consent judgment entered July 21/23, 2021, enjoining Mylan from infringing the Patents-in-Suit, including the '498 patent, until expiration and dismissing all claims with prejudice.
Merits action asserting '708 claim 3 for infringement and challenging claims 1, 2, 3, and 19 for validity. After a five-day bench trial, the court found Mylan's ANDA products infringe claim 3 (Doc. 204, Oct. 26, 2022); Mylan appealed.
A patent infringement suit filed by Regeneron Pharmaceuticals Inc. against Mylan Pharmaceuticals Inc. in the West Virginia Northern District Court, asserting US patent 10828345 within the context of the Aflibercept MDL.
ANDA suit against Mylan (ANDA No. 208005) asserting the '405 patent; settled with proposed consent judgment and injunction filed 2020-10-26; later dispute over post-CAFC launch led to TRO entered 2022-10-11.
Voluntarily dismissed without prejudice by stipulation; parallel action proceeded in N.D. W. Va.
Federal Circuit appeal of the 2:19-cv-05802 venue dismissal; affirmed on Nov. 5, 2021, holding Mylan lacked a regular and established place of business in New Jersey and that the ANDA submission, not the paragraph IV notice letter, is the operative infringing act.
Appeal captioned Celgene Corporation v. Mylan Pharmaceuticals Inc.; related to the D.N.J. Mylan venue dismissal and the consolidated 2019 action.
Federal Circuit appeal from D.N.J. 2:19-cv-05802. Affirmed dismissal for improper venue as to MPI and Mylan Inc. and failure to state a claim as to Mylan N.V.