Court Decisions Litigating Manufacturing Statute 
FDA Law Blog
JANUARY 11, 2024
Important to note here is that each interchangeable biosimilar was first approved as a biosimilar and each biosimilar manufacturer had been sued under the so-called “patent dance” procedure prior to seeking licensure of the biosimilar products as interchangeable.
Patently O
FEBRUARY 24, 2022
Eligibility under Section 101 : American Axle & Manufacturing, Inc. 20-1394 (CVSG requested October 4, 2021); Undermining Jury Decisions : Olaf Sööt Design, LLC v. Qualcomm , a case focusing on appellate standing following an IPR final written decision favoring the patentee. Neapco Holdings LLC, et al. , Patreon, Inc.,
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Patently O
NOVEMBER 8, 2021
The 2017 Supreme Court decision in TC Heartland gave renewed teeth to the venue statute governing litigation. Although the notice letter is a critical aspect of the Hatch-Waxman process, the Federal Circuit found that the letter was not an “act of infringement” as required by the venue statute.
SCOTUSBlog
APRIL 20, 2022
Two pending petitions raise the question of the constitutionality of state statutes providing that corporations are deemed to have consented to “general” personal jurisdiction by virtue of having registered to do business in a state. Some older Supreme Court decisions support that theory of consent. Returning Relists.
FDA Law Blog
SEPTEMBER 29, 2021
The 340B program, authorized under Section 340B of the Public Health Services Act and administered by HRSA, imposes a ceiling price on pharmaceutical manufacturer sales to “covered entities,” which are certain health clinics that receive federal funding and certain types of safety net hospitals to provide them drugs at lower prices.
ClimateChange-ClimateLaw
OCTOBER 20, 2020
Each month, Arnold & Porter and the Sabin Center for Climate Change Law collect and summarize developments in climate-related litigation, which we also add to our U.S. climate litigation charts. 1442, or the civil-rights removal statute, 28 U.S.C. Truck Trailer Manufacturers Association, Inc. and non-U.S.
ClimateChange-ClimateLaw
OCTOBER 7, 2019
Each month, Arnold & Porter and the Sabin Center for Climate Change Law collect and summarize developments in climate-related litigation, which we also add to our U.S. climate litigation charts. American Fuel & Petrochemical Manufacturers v. and non-U.S. EPA remanded the standards but did not vacate the rule.
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