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Forum-Selection Clause in a Franchise Agreement Establishes Jurisdiction Over “Closely Related” Companies That Did Not Sign the Agreement

USA - January 27 2021 A Colorado court concluded that a forum-selection clause in a franchise agreement established jurisdiction over companies that did not sign the…

D. Brian Kacedon, Anthony D. Del Monaco, John C. Paul, Cecilia Sanabria

FDA Final Guidance on Amendments and Requests for Final Approval to Tentatively Approved ANDAs

USA - November 3 2020 On September 28, 2020, FDA issued final guidance on amendments and requests for final approval to tentatively approved ANDAs. The guidance contains…

Court Upholds Patent Eligibility of “Method of Preparation” Claims in Modified Opinion

USA - August 6 2020 In Illumina, Inc. v. Ariosa Diagnostics, Inc., No. 2019-1419 (Fed. Cir. Aug. 3, 2020), the Federal Circuit denied Appellees’ petition for a rehearing…

Elizabeth D. Ferrill

FDA Draft Guidance on Content and Format for Instructions for Use

USA - July 12 2019 On July 1, 2019, FDA issued draft guidance on the content and format of Instructions for Use (IFU) documents that accompany prescription drugs…

Justin J. Hasford

State Sovereign Immunity Does Not Apply to IPR Challenges

USA - June 24 2019 In Regents of the University of Minnesota v. LSI Corp., Nos. 18-1559 et al. (Fed. Cir. June 14, 2019), the Federal Circuit reversed the PTAB’s…

Kevin D. Rodkey