On June 27, Axinn partners Aziz Burgy and Jason Murata spoke at American Conference Institute's 14th Summit on Biosimilars & Innovator Biologics held June 27-28 in Boston.
Aziz spoke on a panel entitled, "Preparing for Biosimilar Carve Outs: Will Skinny Labelling Work for Biosimilars?" Panelists discussed:
- Balancing the cost savings resulting from lowered litigation risk with the loss of market opportunities resulting from carve-out.
- How the skinny label regime will work with biosimilar products that have interchangeable designation.
- Potential liability faced by insurers for placement of skinny label on formularies.
- Whether carve-outs will add to the perception that the biosimilar product is different than and not as effective as the reference product.
Jason moderated a panel entitled, "Hedging Your Bets Ahead of Amgen v Sanofi: Anticipating how the Supreme Court’s Enablement Ruling will Affect Biologic Patent Portfolio Strategies." Panelists discussed:
- Alternate strategies for drafting enforceable claims.
- Implementing new strategies for drafting enforceable claims in view of the Supreme Court’s decision.
- The nuances between written description and enablement.
- Reconciling whether written description is met when the specification discloses formulas.