Post on 08-May-2015
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GENERIC LAUNCHES AND RISK MITIGATION
Supriya Ramacha
Copyright 2012 BananaIP
Website: www.bananaip.comBlog: www.bananaip.com/sinapse-blog
AGENDA
Product launch
Risks in product launch
Risk mitigation strategies
PRODUCT LAUNCH - GENERIC
PRODUCT LAUNCH
Risk free routePatent expiryWork around
At-risk routeChallenge/Infringe
RISKS IN PRODUCT LAUNCHES
BACKGROUND
Patent Rights
Make
Use
Sell
Offer for sale
Import
Territorial
Term
PATENT RISKS
Standard Patent Term
Term extensionsPatent office delaysRegulatory delays
US-TERM EXTENSIONS
Patent process-Patent term adjustments (PTA)
One day extension - every day delayedObjective = 17 years
TypesA delays (failure to act-14-4-4-4 rule)B delays (pendency beyond 3 years)C delays (special situation)
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?
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?
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
PATENT TERM EXTENSIONS
Regulatory process-Patent term extensions (PTE)1/2 Testing phase + Approval phase
Calculationmax of 5 years extensionNMT 14 years of potential marketing exclusivity
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?
PTEs depends on the no. of potential exclusive marketing term available.
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
PTE
CalculationDoes not include anytime before the date of patent
issue
Total patent term= Standard patent term + PTA + PTE
EUROPE
Regulatory process- Supplementary protection certificate (SPC)SPC Term= (1st MA date - patent filing date) - 5
years.territorial
Calculation5 years max (+6 months)NMT 15 years of potential marketing exclusivity
Total patent term = Standard Patent term + SPC
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?
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?
REGULATORY HURDLES IN GENERIC LAUNCH
Copyright 2012 Brain League
REGULATORY HURDLES
Regulatory exclusivitiesData exclusivityOther exclusivity
US EXCLUSIVITIES
Data exclusivity- 5 years
(+1.5 to 2 years) Other exclusivity-
New clinical study exclusivity-3 yearsOrphan drug exlusivity-7 yearsPediatric exclusivity-6 months
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)
RISK MITIGATION STRATEGIES
RISK MITIGATION STRATEGIES
Risk free launchesIdentify blocking patents- FTO analysisUnderstanding expiry
Infringement/ ChallengingIdentify evidences – Invalidation
Work aroundTechnology Landscaping
FTO ANALYSIS
Copyright 2012 Brain League
EVALUATE FTO
Search
Patent databases-blocking patent/application
Analysis
Infringement
ANALYSIS
Infringement factors
Territorial
Term
Claims
TECHNOLOGY LANDSCAPE ANALYSIS
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