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Latest From Legal Issues

US FDA Revokes Orphan Drug Designation For Indivior’s Sublocade

In first-of-its-kind decision, agency concludes it relied on unreasonable assumptions regarding total market size, and failed to consider information about other dosage formulations, in granting designation for buprenorphine under the cost recovery provision; however, the FDA reaffirms that scope of Sublocade’s three-year exclusivity will keep Braeburn’s Brixadi off the market for another year.

Legal Issues FDA

HIV PrEP Patent Dispute Escalates As HHS Files Suit Against Gilead

Trump administration wants the HIV drug maker to license HHS patents related to pre-exposure prophylaxis. Lawsuit follows Gilead’s request in August for the USPTO’s PTAB to conduct an inter partes review of the four-year-old patents.

Intellectual Property Infectious Diseases

'Super Dramatic' Ruling On PTAB Judges' Unconstitutional Status Will Have 'Limited Fallout'

Patent owners can challenge US Patent and Trial and Appeal Board's decisions on grounds the judges were not constitutionally appointed in a narrow number of cases, but they may have difficulty winning a different outcome.

Legal Issues Intellectual Property

Namenda Product Hopping Settlement Surpasses Most Recent DOJ Agreements

Direct purchasers' $750m settlement with Allergan is at least the second involving product hopping claims; only one DOJ settlement surpassed this amount in the past year.

Legal Issues Intellectual Property

UK Industry ‘Exasperated’ As Third Brexit Extension Prolongs Uncertainty

The UK will not leave the EU on 31 October, and the government is now expected to push for a general election in December in an attempt to break the political deadlock.

United Kingdom Brexit

Belgian Court Overturns Parallel Export Ban

A ban on the parallel exporting of medicines from Belgium did not achieve the desired objective of preventing drug shortages, and was also against EU rules, the Constitutional Court has ruled.

Belgium Distribution
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