USA Law and Practice Contributed by: Jim Hurst, Jeanna Wacker, Sam Kwon and Ashley Ross, Kirkland & Ellis
5. Relief Available for Patent Infringement 5.1 Preliminary Injunctive Relief In the US, a PI may be granted before or during trial – or even pending appeal. FRCP 65 dictates that a court may issue a PI only if the movant provides a bond sufficient to pay the costs and damages sustained by any party found to have been wrongfully enjoined as determined by the court. A court may issue a PI only on actual notice to the adverse party – by personal service or oth - erwise – of the injunction, such that the patent owner gives the defendant sufficient advance notice in order to allow the accused infringer to prepare and present its defence. If a court issues an injunction, enforcement is administered via its contempt authority. A party could move for contempt to sanction the party who fails to comply with the court order. Typical contempt sanctions include a monetary fine or fee-shifting. 5.2 Final Injunctive Relief A permanent injunction is a court order requiring a person to do or cease doing a specific action that is issued as a final judgment in a case. Unlike PIs, permanent injunctions generally do not require bonds. In ANDA actions, upon a find - ing of infringement, courts are required to order a permanent injunction such that the effective date of approval is not earlier than the patent expira - tion date (35 USC Section 271(e)(4)). Likewise, upon a finding of infringement by an aBLA appli - cant, a court must order a permanent injunction prohibiting any further infringement of the patent until expiration of the infringed patent.
This is due at least to the fact that biologics can present a difficult question of what is the relevant “active ingredient”. 4.2 Paediatric Extensions Paediatric exclusivity extensions exist for both small molecule drugs under the Hatch-Waxman framework and biologics under the BPCIA. Pae - diatric exclusivity under either is granted where a sponsor has submitted paediatric studies on the active moiety in their drug product – in response to a written request from the FDA – and con - fers on the applicant an additional six months of exclusivity for drug products containing the moiety (21 USC Section 355a and 42 USC Sec - tion 262(m)). 4.3 Paediatric-Use Marketing Authorisations In the US, the sponsor who conducts pediatric studies as requested by the Secretary of Health and Human Services can obtain a six-month pediatric exclusivity extension for any listed pat - ent that satisfies 21 USC Section 355a(b)(1)(B). If no patent or exclusivity is in place, the six-month pediatric exclusivity does not create a new inde - pendent exclusivity period. 4.4 Orphan Medicines Extensions The Orphan Drug Act provides seven years of market exclusivity upon FDA approval of a des - ignated orphan drug. This exclusivity prevents approval of the same drug for the same orphan indication. Different orphan indications for the same drug may each earn their own seven-year exclusivity periods once approved. Because orphan drug exclusivity is indication-specific, a generic applicant may “carve out” the protected orphan indication from its label in order to enter the market.
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