FDA Data Exclusivity Guidance: Emerging Patent Challenges and Opportunities

Navigating Complexities of Exclusivity, New Developments, and the Implications for ANDAs and Hatch-Waxman Litigation

Recording of a 90-minute premium CLE webinar with Q&A

Conducted on Thursday, April 10, 2014

Recorded event now available

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Course Materials

This CLE course will provide patent counsel with a review of the new FDA draft guidance and examine the impact of the FDA's wholly revised interpretation of the new chemical entity (NCE) exclusivity provisions and will offer strategies to maximize data exclusivity.


On Feb. 21, 2014, the FDA issued new draft guidelines going forth prospectively to grant five years of NCE data exclusivity to combination drug products with at least one new active moiety. Paradoxically, at the same time, the FDA denied the petitions that led to the new draft guidelines.

Counsel to companies with new NDAs and possibly those with new supplemental NDAs must understand the implications of these guidelines now, particularly with respect to combination therapy drug products (combo drug products).

For any combo drug product in which at least one active moiety is new, the NDA filer can get five-year data exclusivity, even if the drug product also contains an active moiety previously approved. If the combo drug product contains no new active moiety, but only at least one moiety that has previously been approved, the NDA filer gets three years' data exclusivity.

The data exclusivity periods of five- and three-years run irrespective of, but concurrent with, any applicable patent term, and stops approval of any ANDAs before certain time periods. But the five-year data exclusivity, advantageously to the NDA holder, sets a time bar on the filing of any ANDA after approval, whereas the three-year data exclusivity sets only a time bar on ANDA approval but no time bar on the filing of an ANDA.

Listen as our authoritative panel of patent attorneys reviews the momentous draft guidelines and recent citizen’s petition decisions, all taken in context with data exclusivity and its relation to ANDA filings and Hatch-Waxman litigation. The panel will also suggest patent and business strategies to maximize data exclusivity in light of the new landscape.



  1. FDA data exclusivity and how it relates to Hatch-Waxman
  2. Past guidelines
    1. Five-year data exclusivity
    2. Three-year data exclusivity
  3. FDA’s new draft guidelines and denial of citizen petitions: prospective five-year data exclusivity for some combo drug products
    1. Qualifying subject matter
    2. Limitations on ANDA filing and relation to Hatch-Waxman
    3. Applicability to prospective NDAs
  4. Patent and business strategies to maximize data exclusivity in light of both the new and old landscape


The panel will review these and other key questions:

  • How does the new FDA draft guidance change the landscape of NCE exclusivity?
  • What are the implications of the FDA's new interpretation of NCE exclusivity for Hatch-Waxman litigation?
  • What strategies should companies and counsel employ to maximize data exclusivity?

Following the speaker presentations, you'll have an opportunity to get answers to your specific questions during the interactive Q&A.


Irving, Thomas
Thomas L. Irving

Finnegan Henderson Farabow Garrett & Dunner

Mr. Irving has 35 years of experience in the field of IP law. His practice includes due diligence, patent prosecution,...  |  Read More

Donna M. Meuth
Donna M. Meuth
Associate General Counsel

Ms. Meuth has diverse experience in intellectual property law, including patent portfolio management, patent...  |  Read More

Lauren L. Stevens, Esq.
Lauren L. Stevens, Esq.
Global Patent Group

Ms. Stevens practices strategic client counseling and patent procurement in the pharmaceutical area, including the...  |  Read More

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