Date post: | 22-Jun-2015 |
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Law |
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#OTCDrugs
ACI’s 3rd Annual Legal Regulatory and Compliance Forum on Over the Counter Drugs
Serena Farquharson-Torres
Global Head CHC Patents Sanofi
Patent Strategies in the OTC Space
Alison Kessler
Global Head of Patents
Novartis Consumer Health
October 27-28, 2014
Tweeting about this conference?
#OTCDrugs
Patent Strategies in OTC Space
•Patent Considerations for Switch
•Patent Filing Strategy
#OTCDrugs
Patent Considerations for Switch
FTO: Identify patents covering product
RX –GX switches (3rd party and internal launch plans)
Determine launch plans in view of risk tolerance
#OTCDrugs
Patent considerations Identifying Blocking patent
FTO patent search
• Identify patents blocking path to market
• Expiration date
•Claim scope
•Patent family
#OTCDrugs
Patent considerations RX to Generics Switch Status
Status of blocking patent
•Review status of Hatch-Waxman related procedures of third parties
•Review whether US and EX-US are in force or not.
•Review internal company plans for any RX to GX switches in view of the plan for RX to OTC switch.
#OTCDrugs
Patent considerations Risk tolerance for launch
Launch at risk of being sued.
Revoke patents
License patent/Joint Marketing agreement
Create non-infringing alternatives
Post Grant Review of Patents (if relevant)
Wait for patent to expire
#OTCDrugs
Patent Filing Strategy
• File or not to file
•Where to file
#OTCDrugs
Patent filing strategy Purpose of filing • Stop copiers • New product under umbrella brand: Branded
• Private Label or Store brands
• Counterfeit
• Create Freedom to Operate
• Establish ownership of Innovation • Create business opportunities (licenses)
• Private label negotiate change to non-infringing alternatives or move shelf space of product.
• Marketing campaign of novel product
#OTCDrugs
Patent filing strategy Defensive filing
•
#OTCDrugs
Types of Patents
• Formulation
•Dosage Forms
•Method of use
•Process
•Design
#OTCDrugs
Patent Value Life Cycle
Time
Val
ue
Unique Dosage Form
Compound
Packaging, Particular Formulation, etc.
Time
Val
ue
Patent Life Cycle
Brand Life Cycle
Very narrow patent only covering product
#OTCDrugs
OTC Patents Examples
• Formulations • Delsym • Mucinex extended release tablets
• Dosage Forms • AZ crystallinity patents (Prilosec) • New combination of actives
• Method of Use • Rx-to-OTC switch self-selection (Merck statin selection patent) • New method of treating
• Process • FFP method to produce small pharmaceutical granules patent enforced
against Reckitt/Adams (Mucinex)
• Design • P&G bottle design case
#OTCDrugs
Merck self selection Patent Example
#OTCDrugs
Design Patent Example Crest mouthwash bottle
• Insert P&G design patent here
#OTCDrugs
Design Patent Example, Mechanical Features
15
•U.S. D614,968 • Priority of Jul 2009,
• Issued 4 May 2010
• Expiry 4 May 2024
Voltaren® Easy-To-Open Cap
#OTCDrugs
International Patent Filing
HIGHEST % SALES
FAST PATENTS
ENFORCEMENT
COMPETITION
BRANDED vs PRIVATE LABEL
LAUNCH PLANS
#OTCDrugs
To Enforce or Not To Enforce • EXPENSE vs SALES
• NON-INFRINGING ALTERNATIVES
• OB LISTED PATENT
• TIME CONSTRAINTS
• TIME CONSTRAINTS
#OTCDrugs
#OTCDrugs
Thank You!