I didn’t make the claim that the expired patent prevented the practice.
My comment was a quick and sloppy summary from my memory of an interview from several years ago. I think it was the EconTalk with the author of Drug Wars.
A more detailed and comprehensive list of these tactics to reduce competition either during or after patent expiry:
Patent-related strategies:
• Building “patent thickets” by filing multiple patents on different aspects of the same drug (formulation, dosing, manufacturing processes)
• “Evergreening” - seeking new patents on minor modifications to extend exclusivity periods
• Filing continuation patents and divisional applications to extend patent timelines
Product lifecycle management:
• “Product hopping” - making minor reformulations or switching to extended-release versions just before generic entry to move patients to the new version
• Discontinuing older versions that generics would reference
Legal and regulatory tactics:
• Pay-for-delay settlements where brand companies pay generics to postpone market entry
• Manipulating FDA safety programs (REMS) to make it difficult for generics to obtain necessary samples for testing
• Citizen petitions to the FDA raising questions about generic equivalence
Market-based approaches:
• Launching “authorized generics” through subsidiaries to capture generic market share
• Exclusive dealing arrangements with pharmacy benefit managers
My comment was a quick and sloppy summary from my memory of an interview from several years ago. I think it was the EconTalk with the author of Drug Wars.
A more detailed and comprehensive list of these tactics to reduce competition either during or after patent expiry:
Patent-related strategies:
• Building “patent thickets” by filing multiple patents on different aspects of the same drug (formulation, dosing, manufacturing processes) • “Evergreening” - seeking new patents on minor modifications to extend exclusivity periods • Filing continuation patents and divisional applications to extend patent timelines Product lifecycle management: • “Product hopping” - making minor reformulations or switching to extended-release versions just before generic entry to move patients to the new version • Discontinuing older versions that generics would reference
Legal and regulatory tactics:
• Pay-for-delay settlements where brand companies pay generics to postpone market entry • Manipulating FDA safety programs (REMS) to make it difficult for generics to obtain necessary samples for testing • Citizen petitions to the FDA raising questions about generic equivalence
Market-based approaches:
• Launching “authorized generics” through subsidiaries to capture generic market share • Exclusive dealing arrangements with pharmacy benefit managers