Generic Drugs, Skinny Labels, and Liability for Off Label (Infringing) UseHikma's petition seeks clarification on generic drug marketing liability regarding 'skinny labels' under patent law.
Tax Victory for Generic Drug Companies: Federal Circuit Affirms ANDA Litigation Expenses are DeductibleGeneric pharmaceutical companies can now deduct legal expenses from patent litigation as ordinary business expenses.
Supreme Court Preview: Will "Skinny Labels" Get a Weight Check?The Supreme Court will address the issue of generic drug manufacturers and potential patent infringement in the Hikma v. Amarin case.
FDA hasn't inspected nearly 2,000 drug plants since before COVID pandemicFDA inspections of pharmaceutical firms remain significantly behind pre-pandemic levels, raising contamination risks in critical medications.
Senate Committee Advances PREVAIL ActThe PREVAIL Act is set to change PTAB procedures, impacting patent challenges and potentially affecting generic drug pricing.New provisions aim to balance patent protection with access to affordable medications.
Gilead Agrees to Allow Generic Version of Groundbreaking H.I.V. Shot in Poor CountriesGilead aims to broaden access to lenacapavir through generic production in low-income countries but excludes middle-income nations, highlighting healthcare disparities.
Generic Drugs, Skinny Labels, and Liability for Off Label (Infringing) UseHikma's petition seeks clarification on generic drug marketing liability regarding 'skinny labels' under patent law.
Tax Victory for Generic Drug Companies: Federal Circuit Affirms ANDA Litigation Expenses are DeductibleGeneric pharmaceutical companies can now deduct legal expenses from patent litigation as ordinary business expenses.
Supreme Court Preview: Will "Skinny Labels" Get a Weight Check?The Supreme Court will address the issue of generic drug manufacturers and potential patent infringement in the Hikma v. Amarin case.
FDA hasn't inspected nearly 2,000 drug plants since before COVID pandemicFDA inspections of pharmaceutical firms remain significantly behind pre-pandemic levels, raising contamination risks in critical medications.
Senate Committee Advances PREVAIL ActThe PREVAIL Act is set to change PTAB procedures, impacting patent challenges and potentially affecting generic drug pricing.New provisions aim to balance patent protection with access to affordable medications.
Gilead Agrees to Allow Generic Version of Groundbreaking H.I.V. Shot in Poor CountriesGilead aims to broaden access to lenacapavir through generic production in low-income countries but excludes middle-income nations, highlighting healthcare disparities.