Court Decisions Litigation Manufacturing 
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.
Law 360
AUGUST 13, 2024
Chip manufacturer Nvidia Corp. Supreme Court victory over investors who accuse the company of downplaying its reliance on the crypto mining market, arguing that a lower court decision allowing the case to move forward "eviscerates the guardrails that Congress erected to protect the public from abusive securities litigation."
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FDA Law Blog
DECEMBER 7, 2023
Gonzalez — The annual Enforcement, Litigation, and Compliance Conference put on by the Food and Drug Law Institute (“FDLI”) took place in Washington this week. FTC Supreme Court decision stripping FTC of its ability to obtain restitution or disgorgement under Section 13(b) of the Federal Trade Commission Act. By Steven J.
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. Rather, an appellant must show concrete injury caused by the PTAB decision and redressability of that injury. Neapco Holdings LLC, et al. , Patreon, Inc.,
LexForti
APRIL 22, 2021
According to the facts, the brothers Balkrishna and Nagaraj Setty signed an agreement for partnership where they became the joint owner of the incense manufacturing company. Later, the brothers started their own competing manufacturing companies in separate Indian Cities i.e., Bangalore and Mumbai.
Patently O
NOVEMBER 8, 2021
The 2017 Supreme Court decision in TC Heartland gave renewed teeth to the venue statute governing litigation. Celgene Corp. Mylan Pharma ( Fed. There are two different ways to show proper venue: Venue by Residence : Venue is proper if the defendant(s) reside in the district where the case is filed.
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