Paragraph IV (Para IV) Filing | Overview & Strategies

Paragraph IV (Para IV) Filing is a certification under the Hatch-Waxman Act that allows a generic drug applicant to challenge a brand-name drug’s patent by claiming either non-infringement or patent invalidity. If successful, the first applicant receives 180 days of market exclusivity, creating a significant commercial advantage. However, the brand-name company can sue within 45 days, triggering a 30-month stay on FDA approval unless the case is resolved earlier.

Key Strategies for Para IV Filing Success

Early Patent Analysis & Selection

Identify weak or easily challengeable patents from the Orange Book.
Focus on prior art and obviousness to strengthen invalidity claims.

Strong Legal & Scientific Justification

Develop robust non-infringement arguments (e.g., different formulation, polymorphs, or process).
Use prior art and expert opinions to support invalidity claims.

First-to-File Advantage

Filing first ensures 180-day exclusivity, delaying other generics.

Risk Assessment & Settlement Options

Assess the likelihood of a 30-month stay and potential litigation costs.
Consider settlements (Authorized Generics, licensing deals) to mitigate risks while securing market entry.

Regulatory & Manufacturing Readiness

Ensure ANDA submission is strong, with robust bioequivalence (BE) data.
Prepare for immediate market launch after litigation or exclusivity approval.

Patent Challenge & Litigation Strategy

Use Inter Partes Review (IPR) or declaratory judgments to challenge weak patents.
Engage in strategic settlements to secure early market entry.

Market & Pricing Strategy

Plan competitive pricing to maximize revenue before full generic competition.
Secure supply chain and distribution agreements for rapid market penetration.

Conclusion

A well-executed Para IV filing strategy can provide a significant competitive advantage, but it requires strong legal, scientific, and regulatory preparation. Success depends on patent selection, litigation strategy, and market readiness.

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Resource Person: Moinuddin syed. Ph.D, PMP®

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