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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