The 10th National Strategy Summit on Paragraph IV Litigation of the Hatch-Waxman Act will feature esteemed judges, leading in-house counsel and experienced practitioners. Discussion will include tactics, tools, strategies and insight on litigating Hatch-Waxman cases.
Details and registration
For more information, please email Jess Karas.
Featured agenda item
Monday, September 13, 2021: 3:05 pm ET
Analyzing the Difference in Pharmaceutical IP Litigation in Relation to Orphan Drugs
Cooley partner Sanya Sukduang will speak at this session.
Government regulators constantly encourage pharmaceutical companies in the research for treatments of what the FDA defines as a “rare disease”. In an effort to further incentivize the development of these products, the FDA has put a different set of exclusivities in place to protect the IP rights of a product manufacturer as compensation for their work.
- Filing for an orphan drug designation and the 7-year exclusivity window associated with the product’s approval
- Examining the FDA’s acceptance of generic product applications and the indications which must be shown within it
- Analyzing the summary judgement from ‘Catalyst Pharmaceuticals v Jacobus Pharmaceutical’ defining “market exclusivity”