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D.C. Circuit Sides with Manufacturers in Latest 340B Contract Pharmacy Case

FDA Law Blog

Kirschenbaum — Last week, the United States Court of Appeals for the District of Columbia ruled that Section 340B of the Public Health Service Act does not prohibit pharmaceutical manufacturers from imposing conditions on the distribution of discounted drugs to covered entities in the program. By Sophia R. Gaulkin & Alan M.

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Arkansas Law Prohibiting Manufacturer 340B Contract Pharmacy Restrictions Upheld by 8th Circuit

FDA Law Blog

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).

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Oklahoma Supreme Court overturns $465 million opioid ruling against Johnson & Johnson

JURIST

The Oklahoma Supreme Court reversed Tuesday a $465 million verdict against Johnson & Johnson (J&J) for public nuisance through its prescription opioid marketing campaign in the state. The Court applies the nuisance statutes to unlawful conduct that annoys, injures, or endangers the comfort, repose, health, or safety of others.

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District Court Finds Use of a Method to Manufacture a Product Does Not Indirectly Infringe a Patented Method to Design A Product

The IP Law Blog

Kronstadt), the Court granted the Defendant’s motion to dismiss Plaintiff’s indirect patent infringement claims for failure to sufficiently allege Defendant “made” the accused product. Plaintiff had argued that using the patented methods in the design process, which guides the subsequent manufacturing process, is sufficient to state a claim.

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Biden administration and drug manufacturer ask court to block suspension of mifepristone approval

SCOTUSBlog

Stressing that no court has ever before invalidated the FDA’s approval of a drug “based on a disagreement with the agency’s judgment about safety or effectiveness,” U.S. Stressing that no court has ever before invalidated the FDA’s approval of a drug “based on a disagreement with the agency’s judgment about safety or effectiveness,” U.S.

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Proposed Changes to Patent Law’s Proper Venue Statute: Venue Equity and Non-Uniformity Elimination Act of 2024

Patently O

by Dennis Crouch Law school civil procedure courses spend very little time on proper venue because, in most cases venue is proper so long as the district court has personal jurisdiction over the defendant. ” This provision ensures the venue statutes do not limit the ability to sue foreign defendants U.S.

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Second Circuit Agrees that Copay Assistance Programs May Violate the Anti-Kickback Statute

FDA Law Blog

Kirschenbaum — In a recent decision, the Second Circuit upheld the HHS Office of the Inspector General (OIG)’s position that Pfizer’s proposed copay assistance program for its high-cost heart treatment would violate the Federal Anti-Kickback Statute (AKS). The Second Circuit’s Interpretation of the Anti-Kickback Statute. Pfizer, Inc.

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