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Thursday, June 27, 2024 7:50:12 PM
Amarin should craft its discovery requests to obtain comprehensive information about how the generic manufacturers, PBMs, and insurers collected, analyzed, and used data related to icosapent ethyl prescriptions. Here's what Amarin should consider asking for during litigation discovery:
Internal Communications:
• Discussions about marketing generic icosapent ethyl for cardiovascular risk reduction
• Strategies for capturing Vascepa's market share in the cardiovascular indication
Marketing Materials:
• Any content mentioning cardiovascular benefits or referencing the REDUCE-IT trial
• Materials comparing generic icosapent ethyl to Vascepa
Sales Data:
• Breakdown of sales to cardiologists or practices known for cardiovascular treatment
• Any data tracking off-label use for cardiovascular risk reduction
Market Research:
• Analyses of Vascepa's market share for cardiovascular risk reduction
• Studies on physician perception of generic icosapent ethyl for cardiovascular use
Communications with Healthcare Providers:
• Any discussions about using generic icosapent ethyl for cardiovascular risk reduction
• Responses to provider questions about off-label cardiovascular use
Press Releases and Public Statements:
• Statements comparing generic icosapent ethyl to Vascepa
• Any mentions of cardiovascular benefits or the REDUCE-IT trial
Regulatory Documents:
• Discussions about the decision to use a skinny label
• Internal debates about including cardiovascular information on the label
Business Plans:
• Strategies for entering the cardiovascular risk reduction market
• Projections for off-label use in cardiovascular patients
Clinical Data:
• Any analysis of generic icosapent ethyl's effectiveness for cardiovascular risk reduction
• Comparisons of generic product to Vascepa for cardiovascular outcomes
Communications with PBMs and Insurers:
• Discussions about coverage for cardiovascular risk reduction
• Efforts to secure favorable formulary placement for all icosapent ethyl uses
Training Materials:
• Instructions on how to respond to questions about cardiovascular benefits
• Any content mentioning off-label promotion or the cardiovascular indication
Patent Analysis:
• Assessments of the strength of Amarin's cardiovascular method patents
• Strategies for navigating these patents
Formulary Communications:
• Efforts to secure formulary placement without restriction to severe hypertriglyceridemia
• Any mention of cost savings for cardiovascular use
Pricing Strategy Documents:
• Analyses of pricing impact on cardiovascular market share
• Strategies to compete with Vascepa in the cardiovascular space
Sales Representative Call Notes:
• Any mentions of cardiovascular benefits to healthcare providers
• Discussions about off-label use for cardiovascular risk reduction
Executive Communications:
• High-level strategies for competing in the cardiovascular risk reduction market
• Discussions about the impact of the cardiovascular indication on business
Third-Party Agreements:
• Contracts for services related to marketing for cardiovascular uses
• Agreements with key opinion leaders in cardiology
Pharmacovigilance Reports:
• Any data on adverse events in patients using the drug for cardiovascular risk reduction
• Comparisons of safety profile to Vascepa in cardiovascular patients
Communications with Other Generic Manufacturers:
• Discussions about market strategy for cardiovascular use of icosapent ethyl
• Any agreements related to marketing or pricing for this indication
Financial Records:
• Revenue projections specifically for cardiovascular risk reduction use
• Investment decisions related to capturing the cardiovascular market
Amarin should ensure that these requests cover a relevant time period, typically starting from when the generic manufacturers began developing their icosapent ethyl products through the present. The company should also be prepared for objections and negotiations over the scope of discovery, as some requests may be challenged as overly broad or burdensome.
This comprehensive discovery approach should help Amarin gather evidence to support its induced infringement claim by revealing how data was used to potentially encourage prescribing generic icosapent ethyl for the patented cardiovascular risk reduction indication.
It's the ratio, baby ... the EPA/AA ratio!
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