Webinar

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”

This content is provided for general informational purposes only, and your access or use of the content does not create an attorney-client relationship between you or your organization and Cooley LLP, Cooley (UK) LLP, or any other affiliated practice or entity (collectively referred to as “Cooley”). By accessing this content, you agree that the information provided does not constitute legal or other professional advice. This content is not a substitute for obtaining legal advice from a qualified attorney licensed in your jurisdiction and you should not act or refrain from acting based on this content. This content may be changed without notice. It is not guaranteed to be complete, correct or up to date, and it may not reflect the most current legal developments. Prior results do not guarantee a similar outcome. Do not send any confidential information to Cooley, as we do not have any duty to keep any information you provide to us confidential. This content may be considered Attorney Advertising and is subject to our legal notices.