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Friday, July 04, 2025 4:43:10 PM
Amarin's Post-Launch Enforcement Strategy: Pursuing Launched Generics Under Teva
The Current Battlefield
With multiple generic icosapent ethyl products already on market, Amarin's litigation posture shifts from prevention to active enforcement. The Teva precedent becomes even more powerful in this post-launch context.
Critical Teva Finding for Post-Launch Cases:
o "courts can consider all evidence, including the label, expert testimony, and marketing and promotional materials to assess infringement"
o "This was a post-marketing case" - directly applicable to Amarin's current situation
Evidence Collection Against Active Generics
Amarin should be systematically documenting:
1. Marketing Materials Analysis Each generic manufacturer likely has created vulnerability through:
o Formulary presentations claiming "same active ingredient as Vascepa"
o Sales materials to pharmacy benefit managers
o Wholesaler communications about therapeutic interchange
o Any reference to cardiovascular benefits or REDUCE-IT
2. The "AB-Rating Trap" The Teva court specifically noted: "Teva in a press release telling the world that its generic is a substitute for GSK's COREG®"
Generic manufacturers have likely made similar statements about icosapent ethyl being:
o "Therapeutically equivalent to Vascepa"
o "FDA-approved generic version of Vascepa"
o "Same medication at lower cost"
3. Prescriber Communications Post-launch surveillance should capture:
o Detail aids used by generic sales forces
o CME sponsorships mentioning cardiovascular outcomes
o Formulary switch letters to physicians
o Prior authorization forms referencing cardiovascular criteria
The Indication Overlap Evidence
Expert Testimony Framework for Trial:
1. Clinical Practice Reality (Post-Launch Data) Now Amarin has actual prescription data showing:
o Generic prescriptions written by cardiologists (not just endocrinologists)
o Continuation therapy from Vascepa to generic (proving cardiovascular use)
o Insurance approvals based on REDUCE-IT criteria
o Pharmacy dispensing patterns showing cardiovascular patient populations
2. The "Partial Label" Argument Following GSK's successful approach:
o Severe hypertriglyceridemia (≥500 mg/dL) inherently includes cardiovascular patients
o No physician treats triglycerides >500 without considering cardiovascular risk
o The carved-out REDUCE-IT indication is clinically inseparable from the retained indication
3. Real-World Evidence Advantages Unlike pre-launch speculation, Amarin now has:
o Actual prescribing data showing generic use in REDUCE-IT patients
o Pharmacy claims data demonstrating indication overlap
o Physician survey evidence on prescribing intent
o Insurance coverage decisions treating generics as Vascepa substitutes
Why Physicians Prescribe Icosapent Ethyl: The Enforcement Angle
The medical rationale becomes evidence of induced infringement:
1. Cardiovascular Risk Reduction (The Protected Indication)
o REDUCE-IT established 25% MACE reduction
o This fundamentally changed why physicians prescribe
o Generic companies cannot credibly claim physicians ignore this data
2. The Triglyceride Treatment Fiction Expert testimony would establish:
o No modern physician treats triglycerides purely for pancreatitis prevention
o Treatment algorithms integrate cardiovascular risk assessment
o The 500 mg/dL threshold is arbitrary from a cardiovascular perspective
3. Guidelines as Evidence Current ACC/AHA guidelines recommend icosapent ethyl for:
o Cardiovascular risk reduction in appropriate patients
o Not merely triglyceride lowering
o Generic labels cannot override medical education
Amarin's Litigation Roadmap
1. Immediate Actions
o File induced infringement suits against each generic manufacturer
o Seek preliminary injunctions based on ongoing harm
o Request expedited discovery of marketing materials
2. Discovery Targets
o All promotional materials mentioning Vascepa
o Sales force training documents
o Formulary presentation decks
o Managed care contracts with therapeutic substitution language
3. Expert Development
o Prescribing physicians to testify on indication overlap
o Pharmacists on substitution practices
o Managed care executives on formulary decisions
o Epidemiologists to analyze prescription data
4. Damages Framework
o Lost sales from induced infringement
o Price erosion in the cardiovascular market
o Corrective advertising costs
o Ongoing royalties for continued infringement
The Strategic Opportunity
The Teva decision essentially validated that:
o Section viii carve-outs don't immunize post-launch conduct
o Marketing behavior can establish induced infringement
o Indication overlap is a factual question favoring patentees
With generics already launched and generating real-world evidence of cardiovascular use, Amarin has a stronger case than GSK had prospectively. Every generic prescription filled for a REDUCE-IT-eligible patient becomes evidence of induced infringement—transforming market erosion into litigation ammunition.
The enforcement campaign could effectively restore Amarin's market position through injunctions, damages, and ongoing royalties—potentially making generic entry economically unviable despite FDA approval.
It's the ratio, baby ... the EPA/AA ratio!
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