March 19, 2007 presentation to the San Diego County Bar Association IP Section, with a focus on: •Orphan Drug Exclusivity (Seven Years) •Five-Year Exclusivity •Three-Year Exclusivity •Pediatric Exclusivity (Six Months) •180-Day Exclusivity

1. Market Exclusivity Under
The Waxman-Hatch Act
San Diego County Bar Assn.
IP Section
March 19, 2007
Michael A. Swit, Esq.
Vice President, Life Sciences

2. 2
Types of Market Exclusivity
• Orphan Drug Exclusivity (Seven Years)
• Five-Year Exclusivity
• Three-Year Exclusivity
• Pediatric Exclusivity (Six Months)
• 180-Day Exclusivity

3. 3
Scope of Market Exclusivity
• Independent Of Patent Rights
• Prevents FDA From “Making Effective”
An Approval Of A Subsequent ANDA or
505(b)(2) NDA
• Does Not Prevent The Filing Of A Full
NDA On The Protected Drug or Indication
or other change subject to Exclusivity

4. Five-Year Exclusivity
• Available To NDAs
– Possibly – also 505(b)(2) NDAs
• Awarded For A New Chemical Entity (NCE)
• Effect On ANDAs: May Not Be Filed With
FDA Until Exclusivity Expires
• Exception For Paragraph IV ANDAs: May
Be Filed With FDA After 4 Of The 5 Years
Have Expired

5. Three-Year Exclusivity
• Available To NDAs And NDA Supplements
• Awarded For “New” Clinical Studies “Essential”
To The Approval Of The NDA And “Conducted
Or Sponsored By” The Applicant
• Attaches To The New Or Changed Item (Dosage
Form, Indication, Strength, Etc.)
• Effect On ANDAs
– May Be Filed With FDA, And Reviewed, But Will Not
Be Approved Until Exclusivity Expires
– Results In A Tentative Approval Letter
– May Be Approved With “Carved Out” Labeling

6. 6
Exclusivity Terms
Orange Book Abbreviations
D = New Dosing Schedule (e.g., D-1 once a day application,
D-16 continuous intravenous infusion)
I = New Indication (e.g., I-26 treatment of liver flukes,
I-40 primary nocturnal enuresis)
NC = New Combination
NCE = New Chemical Entity
NDF = New Dosage Form
NE = New Ester or Salt of an Active Ingredient
NP = New Product (mint flavored)

7. 7
Exclusivity Terms
Orange Book Abbreviations
NPP = New Patient Population
NR = New Route
NS = New Strength
ODE = Orphan Drug Exclusivity
PC = Patent Challenge (180-Day Exclusivity)
PED = Pediatric Exclusivity
W = Exclusivity on this application expiring on this date has
been waived by sponsor.

8. 8
Problems Interpreting
Five-Year Exclusivity
• “New chemical entity” vs. “active moiety”
• No salt or ester
• No Enantiomers

9. 9
Problems Interpreting
Three-Year Exclusivity
• What are “new” clinicals?
• What is a drug “approved under subsection (b)
of section 505”?
• How does a person meet the “conducted or
sponsored” clinical investigations requirement?
• When is an investigation “essential” to approval?
• What are appropriate “studies”?
• How far does indication exclusivity extend?

10. 180-Day Exclusivity
• Available To ANDAs That Contain A Paragraph
IV Patent Certification
• Awarded For Challenging A Patent (Regardless Of
Success)
• Effect On Other ANDAs:
– Impacts Only Subsequently-Filed ANDAs with
Paragraph IV Patent Certifications
– May Be Filed With FDA, And Reviewed, But Will Not
Be Approved Until Exclusivity Expires
– Results In A Tentative Approval Letter

11. 11
Requirements for ANDA Exclusivity
• First Person to Submit Complete ANDA
(“First to File”)
• Containing a Paragraph IV Certification
• Challenging a Patent as Invalid or Not
Infringed
• Notice to Patent Holder and NDA Holder (if
different)
• Eligible for 180 Days of Exclusivity

12. 12
Medicare Modernization Act of 2004
• Award of 180-Day Exclusivity is Now Date
Dependent: Before or After August 18, 2003
• Trigger for Start of Exclusivity
– Before Aug. 18, 2003: Earlier of Date of Favorable Court
Decision in a Patent Lawsuit, or Date of First-to-File’s First
Commercial Marketing
– After Aug. 18, 2003: First-to-File’s First Commercial
Marketing (Only)
• Timing of Notice to NDA/Patent Holder
– Before Aug. 18, 2003: At ANDA Applicant’s Discretion
– After Aug. 18, 2003: Within 20 Days After ANDA
Applicant Receives Word From FDA That ANDA Is
Acceptable to Be Received

13. 13
Medicare Modernization Act of 2004
• After December 8, 2003, 180-Day Exclusivity May Be
Forfeited (New Section 505(j)(5)(D))
• By the Following Actions
– Withdrawal of ANDA
– Amendment or Withdrawal of Paragraph IV Certification
– Failure to Obtain Tentative Approval Within 30 Months
– Collusive Agreement with Another ANDA Applicant, NDA Holder
or Patent Owner
– Expiration of the Patent
– Failure to Market Within 75 Days of: ANDA Approval, 30 Months
Since ANDA Submission, Final Court Decision, Lawsuit Settlement,
Withdrawn Patent

14. 14
Historical Controversies Over
180-Day Exclusivity
• What is a “Complete” Application?
• Must First Filer Be Sued?
• Must First Filer “Successfully Defend” Lawsuit?
• What is a “Court Decision” That Triggers 180-Day
Exclusivity?
– 1999: FDA Regulation Said Appellate Court
– 1997-2000: Court Rulings Said Trial Court
– 2000: FDA Guidance Said First Court That Decides the Patent Is
Invalid, Unenforceable or Not Infringed
– After Aug. 18, 2003: No Court (Only Trigger Is First Filer’s First
Commercial Marketing)

15. 15
Problems Interpreting
180-Day Exclusivity
• Does Later Filer Ever Get ANDA Exclusivity?
• What About Patents Not Filed Promptly With
FDA (“Late Listed” Patents)?
• Can There Be “Shared” Exclusivity?
– Based on Differing Product Characteristics
– Based on Multiple Patents
– Based on Same-Day Filing of ANDAs
• Can exclusivity be “sold”?

16. 16
Problems Interpreting
180-Day Exclusivity
• Can the ANDA Applicant Force a Patent
Infringement Suit?
– Possibly, via Declaratory Judgment Action
• What Are the Potential Consequences of Settling
the Patent Lawsuit?
– Risk of Lawsuit by Plaintiff’s Lawyers, Patient Groups,
Shareholders, Competing Generic Companies, FTC
– After Jan. 4, 2004: Must Notify FTC & DOJ Within
10 Business Days of Settlement

17. Pediatric Exclusivity
• Available To NDAs and NDA Supplements
• Awarded For Clinical Data In Children
• Eligible Drugs – Those that May Produce
Health Benefits in Children (Interpreted
Broadly)
• Attaches To the New Or Changed Item
(Dosage Form, Indication, Strength, Etc.), But
for All of NDA Holder’s Drugs With That
Same Active Moiety

18. 18
Pediatric Exclusivity
• Effect On ANDAs
– May Be Filed With FDA, And Reviewed, But Will Not
Be Approved Until Exclusivity Expires
– Results In A Tentative Approval Letter
– May Be Approved With “Carved Out” Labeling
– Interrupts and Delays 180-Day Exclusivity
• Pediatric Rule requiring drug’s assessment in
children – initially struck down, but reauthorized
by Pediatric Research Equity Act of 2003
• Applied to Suitability Petitions for ANDAs

19. 19
Questions?
Call, e-mail, fax or write:
Michael A. Swit, Esq.
Vice President, Life Sciences
THE WEINBERG GROUP
336 N. Coast Highway 101, Suite C
Encinitas, CA 92024
760-633-3343 ♦ 760-633-3501 (fax)
michael.swit@weinberggroup.com
http://www.weinberggroup.com

20. 20
About your speaker …
Michael A. Swit, Esq., is Vice President, Life Sciences at THE WEINBERG GROUP, where he develops and
ensures the execution of a broad array of regulatory and other services to clients, both directly and through outside
counsel. His expertise includes FDA and CMS development strategies, compliance and enforcement initiatives,
recalls and crisis management, submissions and related traditional FDA regulatory activities, labeling and
advertising, and clinical research efforts for drug, biologic, device, IVD, and other life sciences companies, as well
as those in the food and dietary supplement industries.
Mr. Swit has been addressing critical FDA legal and regulatory issues since 1984. His vast and multi-faceted
experience includes serving for three and a half years as corporate vice president, general counsel and secretary of
Par Pharmaceutical, a prominent, publicly-traded, generic drug company and, thus, he brings an industry and
commercial perspective to his work with FDA-regulated companies. Mr. Swit then served for over four years as
CEO of FDANews.com, a premier publisher of FDA regulatory newsletters and other specialty information products
for the FDA-regulated community. His private FDA regulatory law practice has included service as Special Counsel
in the FDA Law Practice Group in the San Diego office of Heller Ehrman White & McAuliffe and with the Food &
Drug Law practice at McKenna & Cuneo, both in the firm’s Washington office and later in San Diego. He first
practiced FDA regulatory law with the D.C. office of Burditt & Radzius.
Mr. Swit has taught and written on a wide variety of subjects relating to FDA law, regulation and related commercial
activities, including, since 1989, co-directing a three-day intensive course on the generic drug approval process and
editing a guide to the generic drug approval process, Getting Your Generic Drug Approved. A former member of the
Food & Drug Law Journal Editorial Board, he also has been a prominent speaker at numerous conferences
sponsored by such organizations as RAPS, FDLI, and DIA.

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