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1. GENERIC LAUNCHES AND RISK
MITIGATION
Supriya Ramacha
Copyright 2012 BananaIP
Website: www.bananaip.com
Blog: www.bananaip.com/sinapse-blog

2. AGENDA
 Product launch
 Risks in product launch
 Risk mitigation strategies

3. PRODUCT LAUNCH -
GENERIC

4. PRODUCT LAUNCH
 Risk free route
Patent expiry
Work around
 At-risk route
Challenge/Infringe

5. RISKS IN PRODUCT
LAUNCHES

6. BACKGROUND
 Patent Rights
 Make
 Use
 Sell
 Offer for sale
 Import
 Territorial
 Term

7. PATENT RISKS
 Standard Patent Term
 Term extensions
Patent office delays
Regulatory delays

8. US-TERM EXTENSIONS
 Patent process-Patent term adjustments (PTA)
One day extension - every day delayed
Objective = 17 years
Types
A delays (failure to act-14-4-4-4 rule)
B delays (pendency beyond 3 years)
C delays (special situation)

9. EXAMPLE
 Billy owns a US patent application for a drug “X” filed
on Jan 1st
2002, for which he receives the first office
action on June 1st
2003. The patent is issued on Jan 1st
2005. Silly, a generic drug maker, wants to launch “Y,”
the generic version of the drug.
 Launch date?

10.  Bopi files a US patent application for a drug “Alpha”
filed on Jan 1st
1998, for which it receives the first
office action on June 1st
2000. The patent is issued on
Jan 1st
2005. Dopi, a generic drug maker, wants to
launch “Beta,” the generic version of the drug.
 PTA?

11. EXAMPLE
 Billy’s application for a drug “X” filed on Jan 1st
2002
receives the first office action on June 1st
2003.
 Billy’s patent is issued on March 1st
2007 after paying
the issue fee on Sept 1st
2006
 Silly’s Launch date ?
 Wyeth Vs Kappos case

12. PATENT TERM EXTENSIONS
 Regulatory process-Patent term extensions (PTE)
1/2 Testing phase + Approval phase
 Calculation
max of 5 years extension
NMT 14 years of potential marketing exclusivity

13. EXAMPLE
 Mandoz files for a US patent on “Mentos” on April 1st
2000. The patent is issued on July 1st
2002. It
subsequently files an IND application effective on July
1st
2003.
 Mandoz files an NDA on July 1st
2005 and receives
approval on July 1st
2006.
 Possible extension?
 Actual extension?
 Launch date?

14. PTEs depends on the no. of potential exclusive
marketing term available.

15. EXAMPLE
 Mandoz files for a US patent on “Mentos” on April 1st
2000. It files an IND application effective on July 1st
2002. The patent was issued on July 1st
2003.
 Mandoz files for an NDA on July 1st
2005 and receives
NDA approval on July 1st
2006.
 Possible extension?
 Actual extension?
 Launch date?
 Sprycel Tablets, Dasatinib,US6596746

16. PTE
 Calculation
Does not include anytime before the date of patent
issue
 Total patent term= Standard patent term + PTA + PTE

17. EUROPE
 Regulatory process- Supplementary protection
certificate (SPC)
SPC Term= (1st
MA date - patent filing date) - 5
years.
territorial
Calculation
5 years max (+6 months)
NMT 15 years of potential marketing exclusivity
 Total patent term = Standard Patent term + SPC

18. EXAMPLE
 Dizer, a French applicant, obtains a national
marketing approval on Jan 1st
2000, for a product
protected by a patent with the filing date of Jan 1st
1990.
 Dizer has also received a marketing approval in
Britain on Jan 1st
1997.
 Launch date?

19. EXAMPLE
 Banana & Co. files for a patent in France on Jan 1st
1998 for a drug “Todi” and receives a national
marketing approval on Jan 1st
2001. It also files for a
patent in Spain on Jan 1st
1999 and receives a
marketing approval in Spain on Jan 1st
2000.
 Launch date in France?

20. REGULATORY HURDLES IN
GENERIC LAUNCH
Copyright 2012 Brain League

21. REGULATORY HURDLES
 Regulatory exclusivities
Data exclusivity
Other exclusivity

22. US EXCLUSIVITIES
 Data exclusivity- 5 years
(+1.5 to 2 years)
 Other exclusivity-
New clinical study exclusivity-3 years
Orphan drug exlusivity-7 years
Pediatric exclusivity-6 months

23. EUROPE
 Currently- 6 or 10 years
(+1 to 3 years)
 New- 8+2+1 regime
 Current- (2001/83/EC Directive)
 New- (2001/83/EC Directive as amended by 2004/27/EC)

25. RISK MITIGATION
STRATEGIES

26. RISK MITIGATION STRATEGIES
 Risk free launches
Identify blocking patents- FTO analysis
Understanding expiry
 Infringement/ Challenging
Identify evidences – Invalidation
 Work around
Technology Landscaping

27. FTO ANALYSIS
Copyright 2012 Brain League

28. EVALUATE FTO
 Search
Patent databases-blocking patent/application
 Analysis
Infringement

29. ANALYSIS
 Infringement factors
Territorial
Term
Claims

30. TECHNOLOGY LANDSCAPE
ANALYSIS

32. ©2011Intellecture
(www.intellectureindia.com)

33. TECHNOLOGY MAP

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