SCOTUSBlog
MARCH 20, 2023
The case involves a dispute between Jack Daniel’s (the largest American whiskey manufacturer) and VIP Products (the second-largest American dog toy manufacturer). 7 Tennessee Sour Mash Whiskey” manufactured by “Jack Daniel’s,” the toy refers to a “Bad Spaniel” that makes “Old No. 2 on your Tennessee carpet.”
FDA Law Blog
JUNE 15, 2022
Circuit, but today, the Supreme Court reversed again and upheld the District Court’s opinion in American Hospital Assn v. Writing for a unanimous court, Justice Kavanaugh explained that the Medicare statute provides CMS a choice between two options on how to set reimbursement rates for drugs provided in the hospital outpatient setting.
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FDA Law Blog
SEPTEMBER 30, 2022
As we reported, on November 5, 2020, the District Court held that the relator could not plausibly plead the requisite scienter because Forest’s interpretation of the ambiguous statute was objectively reasonable and CMS did not warn Forest away from that interpretation through authoritative guidance. Burr , 551 U.S.
FDA Law Blog
NOVEMBER 30, 2022
Last month the United States Court of Appeals for the Second Circuit affirmed the district court’s decision to dismiss a False Claims Act (FCA) ( 21 U.S.C 3729) quit tam suit, alleging that Grifols USA, Grifols Biologicals, Grifols, S.A.,
Patently O
AUGUST 8, 2022
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. process that the machine or manufacture perform. ‘(B) B) HUMAN GENES AND NATURAL MATERIALS.
Patently O
FEBRUARY 10, 2022
The collaborative idea was that Eddings would manufacture the sheaths because Junker did not have that capability. Thus, the court has held that an offer-to-manufacture doesn’t count. In reviewing the letter, the court noted that the terms appeared quite complete.
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. This all sounds complicated, I know.
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