Biosimilars Market Access in the EU and USA
Settlement agreements in the USA and rights to get to market in the EU
- Licencing or challenging patents in the USA
- Negotiating settlement agreements
- First to market requirements for the main EU markets
- Negotiating exclusivity rights for the EU markets
Aims and objectivesThis course will prepare you for a biosimilar market entry in the EU or USA. It will give you a deeper understanding of the available options for negotiating, licencing and challenging patents, and how to promote your market entry with a distinctive pre-launch communication and appropriate tenders.
(from 08:30 registration)
- Choosing the right (patent) strategy
- Identifying relevant patents, including secondary patents
- Determining whether to licence or challenge the patents
- Ways to challenge patents (Patent Dispute Resolution) in the US: patent office procedures, court actions outside the BPCIA and the BPCIA 'patent dance'
- Potential impact of proposed changes to the Biologics Price Competition and Innovation Act (BPCIA), such as the proposed Biologic Patent Transparency Act and other proposed legislation to address perceived shortcomings of the BPCIA
10:30 Coffee break
- Negotiating and drafting settlement agreements before and during litigation
- Market and commercial activities the biosimilar applicant may engage in prior to the agreed launch date
- Planning market entry dates - first to market requirements a top priority
- Preparing tenders (national and supranational)
- Prelaunch communication (national and supranational) - doctors, health insurance companies, ...
15:15 Coffee break
- Biosimilars regulatory path to market
- Design arounds, avoiding infringement of rights: secondary patent landscapes and specific issues for biosimilars
- Relevant SPC law and third party "squatting"
- SPC manufacturing waiver - what is it and will it assist?
- Tracking third parties: regulatory and product development timelines
- "Clearing the way" and other litigation strategies
- Coordinating litigation and EPO proceedings
- Considering arrow declarations
16:45 Closing Discussion
17:00 Seminar end
Partner, Patent Attorney
Head of Market Access Biosimilars
Phone: +49 30 394043-0
Fax: +49 30 394043-999
- Legal, IP and market access expertise rolled into one course
- A focus on the US and EU markets
- A small group to ensure there is enough time for questions