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an in-house perspective

Patent Settlements Generally. Broad range of business terms available Accused infringer takes a licenseExclusive/sole licensee v. Non-exclusiveRoyalty-bearing v. royalty-freeMarket entry on a date certain or uninterrupted market presenceOther consideration

JasminFlorian
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an in-house perspective

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    1. An In-House Perspective Avoiding Pitfalls in Settling Pharmaceutical Patent Disputes Hatch-Waxman Litigation Patricia Clarke Lukens Johnson & Johnson

    3. Hatch-Waxman Settlements FTC and FDA have a significant post-settlement role, affecting the negotiations although not present at the table Legal landscape particularly unsettled Few cases, few bright line rules to follow

    4. Hatch-Waxman Settlements “Safe Harbor” of apportioning remaining patent life How realistic for a patent with 10 or 15 years to expiration? Payment of royalty

    5. Hatch-Waxman Settlements “Something of Value” – means what exactly? Reverse cash payment is the obvious case How to bridge the settlement gap if transferring something of value is prohibited?

    6. Hatch-Waxman Settlements Form of Dismissal of Suit For multiple ANDA suits, admission of validity and infringement Uncertainty surrounding first filer’s exclusivity Uncertainty surrounding any filer’s approval status Part of the court order, or in a separate settlement agreement

    7. Protecting the Patentee’s Rights Obtain a written legal opinion that patent is valid and enforceable and the litigation to enforce it (and list it in the Orange Book) was reasonable Walk-away provisions in settlement agreement Dismissal/withdrawal of lawsuit without prejudice Agreement to abandon settlement and reinstate lawsuit upon FTC action Effect on generic company’s approval or exclusivity Cooperation provisions to address FTC questions

    8. Settlement Drivers Complex business decision – not a mere proxy for merits of the patent suit Readiness of next generation products Readiness on authorized generic Avoidance of litigation costs

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