Legal Litigation Manufacturing Statute 
FDA Law Blog
MARCH 24, 2024
By Faraz Siddiqui — As drug manufacturers battle the Health Resources and Services Administration (“HRSA”) in federal courts over the role of 340B contract pharmacies, an Eighth Circuit decision to uphold a 2021 Arkansas law may render those cases inconsequential in that state. Code Ann. § 23-92-604(c)(1), (2) (Act 1103).
FDA Law Blog
NOVEMBER 7, 2021
Kirschenbaum — On September 30, we blogged about the ongoing dispute and litigation around the use of contract pharmacies under the 340B Drug Discount Program (click here ). A key issue before the court was whether, despite the relevant statute’s silence on the issue, Congress intended to allow the use of contract pharmacies.
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JURIST
NOVEMBER 8, 2021
This doctrine allows the government to potentially dismiss litigation that would require disclosure of information damaging to national security. involves a complicated copyright dispute between two clothing manufactures. A lawsuit was filed in 2011 but was dismissed based on state secrets privilege. H&M Hennese & Mauritz, L.P
FDA Law Blog
OCTOBER 4, 2023
As such, that statute was unjust, confiscatory and violated their constitutional due process rights. Because Plaintiffs are not legally compelled to participate in the Program—or in Medicare generally—they have not shown a strong likelihood of success on the merits of their due process case.” See Order at 15, 21. Order at 24.
Patently O
JUNE 15, 2021
Although it required invention in name, it was really just becoming a replacement to monopolies barred by the Statute of Monopolies (1624). . Instead of deriving peace, honour, and affluence from their incessant labour and incomparable skill, they have sunk under vexation and the pressure of litigation. Van Ness argues that the U.S.
Patently O
JULY 17, 2022
Instead, a generic manufacturer can sell its product with a “skinny label” that “carves out” any patented uses found in the brand drug’s labeling—and thereby avoid inducing infringement of the brand manufacturer’s patent rights. The petition was filed by highly regarded Supreme Court litigator William Jay (Goodwin) on July 11, 2022.
FDA Law Blog
SEPTEMBER 19, 2023
On the heels of its powerful (and unprecedented) amicus brief in Paragraph IV litigation between Jazz and Avadel concerning a patent covering a Risk Evaluation and Mitigation Strategy (“REMS”) listed in the Orange Book, the Federal Trade Commission (“FTC”) is gearing up to tackle anticompetitive Orange Book listing practices.
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