1. Intellectual Property
Strategies
ANDAs & 505(b)(2) NDAs
Navigating the Regulatory and Development Pathways
October 10 -11, 2005
Wyndham Newark Airport
Elizabeth, New Jersey
Stan Antolin and Walter Boyd
Patent Attorneys
Smith Moore LLP
Greensboro, NC
336.378.5200
336.378.5400 (fax)
www.smithmoorelaw.com
2. The Drug Price
Competition and Patent
Term Restoration Act
Patents and FDA
Hatch-Waxman Act
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7. Typical Generic
Development Cycle
File
Patent
Cert
File
DMF File
ANDA
ANDA
Approval
Stability Validation &
Brand
Portfolio Patent Sourcing Form &
pK Approval
Product Review Review Pre-Form Pilot Bio
Study Prep
9 mo. 2 mo. 6-12 mo. 12 mo. 5 mo. 12-18 mo.
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8. What Can Be Patented?
“Anything under the sun made by man”-
capable of being a machine, process,
article of manufacture, composition, or
an improvement thereof
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9. Useful
Patentable Novel
Invention Non-obvious
New chemical entities
Patentable Compositions of matter
Subject Matter (pharmaceutical)
Polymorphs
Relevant to
Methods of treatment
FDA Approval
New indications
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10. What is a Patent?
Does not give the
The right to exclude
owner any right to
others from making,
make or use his
using, selling, offering
own claimed
for sale, or importing
into the U.S. the product or process
product or process of 20 year term from
the claim filing date
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11. The Patent Bargain
For the U.S., law requires full
disclosure of the claimed invention
as of the day of filing
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12. Patent Infringement
Focus on Claims
Literal Infringement
• every claim element in accused
product/process
Doctrine of Equivalents
• accused device differs in
inconsequential ways from claim
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13. Hatch-Waxman
Brand Drug Companies
may seek restoration of some of the patent
life lost during the period of FDA
testing/approval up to five years (or no
more than 14 years between FDA approval
and patent expiration)
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15. Hatch-Waxman
Generic Manufacturers
• permitted to use safety and
effectiveness data submitted by Brand
companies
• need only demonstrate chemical and
biological equivalence
• may begin testing before the patent on
the proprietary drug expires
• first generic company to file an ANDA
gets 180 days of “exclusivity”
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16. Avoiding Patent
Infringement
Under Hatch-Waxman, generic companies filing
ANDAs are required to certify with the FDA that
their “copycat” drug will not infringe each and
every existing patent on the innovative drug they
seek to copy, which are listed in a printed
compendium known as “Approved Drug Products
with Therapeutic Equivalence,” but most
commonly called “The Orange Book”
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17. Typical Generic
Development Cycle
File
Patent
Cert
File
DMF
File
ANDA
ANDA
Approval
Stability Validation &
Brand
Portfolio Patent Sourcing Form &
pK Approval
Product Review Review Pre-Form Pilot Bio
Study Prep
9 mo. 2 mo. 6-12 mo. 12 mo. 5 mo. 12-18 mo.
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18. Brand Patent Portfolio
26 yrs.
6 yrs. 16 yrs. 21 yrs.
11 yrs.
8.5 yrs.
New Process for Chemical Entity
Idea File App. @ 3-4.5 yrs Issues 20 yrs. Patent Term
21.2 yrs.
1.2 yrs. 11.2 yrs. 16.2 yrs.
6.2 yrs.
3.7 yrs.
New Indication
Idea File App. @ 3-4.5 yrs Issues 20 yrs. Patent Term
10 yrs. 20 yrs. 25 yrs.
0 yrs.
5yrs. 15 yrs.
2.5 yrs
New Chemical Entity
@ 3-4.5 yrs Issues
Idea Office Action Patent Term Extended
File App. @ 1.5 yrs Publishes
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20. Generics’ Response
Patent Space Analysis
• study Brand’s patent portfolio for weaknesses
• file blocking patents
• study Brand’s patents for flaws
• reexamination
• negotiation with Brand
• license and/or cooperative work with Brands
Design Around Brand’s Patent
ANDA or 505(b)(2) NDA
• infringement settlements
• declaratory actions
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21. Types of ANDA Filings
Paragraph I
Generic Entry
No patent filed
One or more
FDA Approval
generic applicants
Immediate
may enter the
Paragraph II
market
Patent has
expired
FDA Approval
Paragraph III
May approve,
Patent will expire
Valid after
on ‘X’ date
patent expiry
Generic Entry
May or may not
enter, Depends on
Paragraph IV
FDA Approval the court ruling in
Patent not expired
May approve favor or against
Generic claims
before patent the generic
Patent ‘invalid’
expiry applicant
or ‘not infringed’
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22. Paragraph IV
180-Day Period of Exclusivity
• first generic company to file an ANDA is given
the exclusive right to market its generic version
of a patented drug for 180 days
30-Month Stay Protection
• when a generic company files an ANDA, the
Brand company has 45 days to decide whether
to sue the company for patent infringement
• filing the lawsuit stays FDA’s approval of ANDA
until the earliest of
date of patent expiration
•
final determination of non-infringement or patent invalidity by a
•
court
expiration of 30 months from the receipt of notice of the
•
paragraph IV certification
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23. Paragraph IV
Paragraph IV Certification If patent holder does not sue within 45 days,
Patent has not expired, but generic applicant FDA may approve ANDA; generic applicant
certifies that patent is invalid or not infringed is entitled to 180-day exclusivity
by its product
When 30-month stay expires
If patent holder sues within 45 days, the
action automatically triggers a 30-month
stay on FDA action
FDA may approve ANDA; first generic
applicant is entitled to 180-day exclusivity
When 30-month stay has not expired
If court rules in favor of generic company,
FDA may approve ANDA; first generic
applicant is entitled to 180-day exclusivity
If court rules in favor of brand-name
company, FDA may not approve ANDA
If patent expires; FDA may approve
until patent expires; no generic may enter
ANDA; one or more generics may
until patent expires; no applicant is entitled to
enter; no applicant is entitled to 180-
180-day exclusivity
day exclusivity
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24. Generic Development Cycle
Paragraph IV & Litigation
FDA Starts
30-month
Stay of
Approval
File
Appellate
Patent
Court
Cert
File
Decision
DMF
Lower
Brand Files
File ANDA Launch
Court
Infringement
ANDA Approval
Decision
Suit
Generic
Development
Program
30 mo. 6-12 mo.
34 - 40 mo. 3 mo.
Timeline is 66 to 72 months
If 1st generic and successful, granted 180 days of generic market exclusivity
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25. Patent Infringement Suits
Costly
• average cost of defending over
$2 million
Time-Consuming
• average time - filing to final appeal is about 3-5
years
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26. Patent Infringement Suits
Risk Reduction Measures
• always seek advice of patent counsel before
beginning any activity
• freedom-to-operate, more than just “The Orange
Book”
• increased damage awards for infringers who do
not seek advice of patent counsel before
undertaking activity that is found to infringe
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27. Patent Infringement Suits
Risk Reduction Measures
• only a well-reasoned opinion of invalidity or
noninfringement can protect against an
increased damages award
• the attorney providing the opinion must be a
patent attorney
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28. Contact Information
Walter Boyd
Stan Antolin
Smith Moore LLP Smith Moore LLP
300 N. Greene Street 300 N. Greene Street
Suite 1400 Suite 1400
Greensboro, NC 27401 Greensboro, NC 27401
336.378.5516 336.378.5537
336.378.5400 (fax) 336.378.5400 (fax)
stan.antolin@smithmoorelaw.com walter.boyd@smithmoorelaw.com
www.smithmoorelaw.com
