American Conference Institute?s 4th Advanced Forum on Biosimilars
When
June 5, 2013
Join Deirdre Sanders, Principal, on Wednesday, June 5, 2013 at the American Conference Institute's 4th Advanced Forum on Biosimilars. Deirdre will be co-speaking from 1:30 - 4:30pm on "Monoclonal Antibodies: Successful and Practical Strategies for Developing and Commercializing Antibody Therapies".
The number of monoclonal antibody therapies entering clinical testing and receiving marketing approval is increasing each year. These therapies are projected to be among the first products ripe for biosimilar challenge and they will be the most attractive targets for biosimilar competition. The session will focus on developing coordinated regulatory and patent exclusivity to protect investments in the development of innovative antibody products, on strategies for biosimilar and other competitors to attack and avoid patents, and on dealing with general freedom-to-operate challenges for antibodies. Do not miss this opportunity to dive into the intersection of intellectual property rights and commercialization strategies surrounding therapeutic antibodies.
Topics to be discussed include:
- Insights into platform patent technologies, including the Cabilly patents and other key patents impacting the ability of companies to bring therapeutic antibodies to the market
- Background and status update on the Cabilly patents and various litigation involving the portfolio
- What are the other key patents in this space that companies should be aware of as they move forward with patenting and commercializing antibodies?
- Takeaways from Biogen v. GlaxoSmithKline
- Antibody patent exclusivity strategies in light of case law developments
- Complying with written description and enablement requirements: Noelle v. Lederman, Ariad v. Lilly, Centocor v. Abbott, Abbott v. Centocor (IL12), Abbott v. Centocor (TNFalpha), and other cases
- Survey of post-KSR case law and EP cases: showing nonobviousness for antibodies
- Optimizing patent exclusivity against biosimilar competitors – claim scope and patent term
- Global strategies for antibody patenting
- Approaches to protect antibody therapies
- Developing reasonable patent portfolios
- “Subsequent innovative patents” – what’s worth protecting? Process, formulation, diagnostic, delivery device, and indication patents
- Freedom to Operate issues
- Use of AIA proceedings to clear the path: Inter partes review; Post grant review
- Licensing; Litigation strategies; Designing around
