La selezione di nuovi prodotti generici per una azienda chimico-farmaceutica richiede un approccio multidisciplinare che comporta l’utilizzo di diversi criteri di selezione e competenze focalizzate a valutare:

• le opportunità di business (dimensione totale del mercato, trend di mercato, possibili carenza sul mercato, ect),
• la competenza di un'azienda a lavorare su di una particolate classe di composti e tecnologie,
• l'esistenza di possibili esclusività brevettuali e di leggi locali che regolano la  protezione del mercato di nuovi APIs dopo l’approvazione alla introduzione in commercio.

Il workshop ha lo scopo di chiarire i criteri per la definizione del "time to market" per l'introduzione di un nuovo farmaco generico nei mercati Statunitense ed Europeo in considerazione delle esclusività di brevetto esistenti e delle diverse procedure di approvazione e protezione dei generici negli Stati Uniti e in Europa.

Programma preliminare

1. Scouting generics: Definition of a generic drug (differences between the brand name and generic), Bioequivalent drug (Pharmacokinetic and Pharmacodynamic properties), Government regulations in Europe and USA (FDA and EMA agencies), Generics: exclusivity and patent protection, Economical aspects of the market exclusivity in the Pharmaceutical field, marketing approval of a drug in USA:  NDA ANDA, OTC and BLA, marketing approval of a drug in Europe (centralized and decentralized agencies of the member states).
2. Europe patent procedure and other types of European market protection: Procedure up to publication of the application, Publication of the European patent application, Examination procedure, Opposition procedure, Limitation and revocation procedure, Appeals procedure, Divisional applications. National validation. Period of validity and possible extension of the expiry date and market protection in Europe (SPC and Exclusivity). Case histories.
3. US patent procedure and other types of US market protection: US Provisional Application, Non-Provisional Application, Published Patent Application, Continuation/Divisional Application, Reissue application. Filing date Pre-AIA v. AIA; Post-Issuance Amendments. Re-examination. Derivation proceeding (35 U.S.C. § 135(a); 37 C.F.R. § 42.405(c)). Period of Validity of the Patent protection, possible extensions and other types of market protection in USA (Patent Terms Extended Under 35 USC §156 and 154; Exclusivity; Orphan Drug Exclusivity (ODE); New Chemical Exclusivity (NCE); Paediatric Exclusivity (PED); Generating Antibiotic Incentives Now (GAIN)). Case histories.
4. Patentability, patent research and technical opinion: Prior art search and technical opinion (Freedom to operate, Non- infringement opinion, Patent status). Patent invalidity and non -infringement, Request for disclosure. Use of Databases. Legal effects of NIF and FTO. Litigation in Europe and USA. Compulsory license. Examples of FTO, NIF and Patent status.
5. The generic approval Process in USA and in Europe. New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Hatch-Waxman Act; ANDA certification clauses: Paragraph I, II, III and IV applications. Marketing authorization procedures in EU; evergreen practises and secondary patents; article 102 TFEU. Intellectual property, market exclusivity and scouting generics: definition of the “time to market”. Subpoena. Case histories.