Strategy Summit on Paragraph IV Litigation

September 13 – 14, 2021
Event details
September 13 – 14, 2021
12:00 – 12:00 am Eastern Standard Time

Event summary

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. 

For more information, please email Jess Karas.

Featured agenda item 

Analyzing the Difference in Pharmaceutical IP Litigation in Relation to Orphan Drugs

Monday, September 13, 2021: 3:05 pm ET

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.

Topics include

  • 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”

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