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Regulatory Requirements › Prescription Drugs › Statutory Interpretation

ArentFox Schiff

Vertex’s Attempt to Redefine AKS Falls Short: Key Insights for Pharma Manufacturers

ArentFox Schiff on

In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General (OIG), manufacturers have contested the OIG’s...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Hatch-Waxman Requires Patent Term Extension for Reissued Patents To Be Based on Original Patent

Sterne, Kessler, Goldstein & Fox P.L.L.C. on

The Federal Circuit held in Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., 23-2254 that a reissued patent receives patent term extension (PTE) based on the issue date of the original patent, not the reissue patent,...more

Morgan Lewis

Manufacturers Challenge CMS’s Definitions of ‘QSSD’ and ‘Bona Fide Marketing'

Morgan Lewis on

Drug manufacturers remain steadfast in their efforts to challenge the constitutionality of the Inflation Reduction Act’s mandatory price negotiation provisions. Recently filed suits contend that CMS has impermissibly expanded...more

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