#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

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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!