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Competition Cases on Product Denigration: What Can You Say About Competing Products?

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(1)

Competition Cases on

Product Denigration:

What Can You Say About

Competing Products?

(2)

Key Cases by the French Competition

Authority

Sanofi-Aventis Decision in May 2013 imposing a fine of €40.6 million

Upheld by Paris Court of Appeal in December 2014

(3)

Sanofi - Facts

Plavix (clopidrogrel) – blood thinner used to prevent blood clots and heart attacks

Sanofi had patent on a salt that extended beyond basic patent, so generic had to use a different salt

(4)

Sanofi - What Can You Say?

Generic has different salt, but the health authority has found that this difference does not affect the efficacy or safety profile of the generic.

Generic has different salt.

Generic has different salt because we have a patent on our salt.

(5)

Schering-Plough – Facts

Subutex ( high-dosage buprenorphine or HDB) – used to treat heroine addiction

(6)

Schering-Plough – What Can You Say?

Generic is more soluble because it has different excipients, so a greater risk that it may be dissolved and injected rather than swallowed as a pill.

Generic is more soluble, so a greater risk that it may be dissolved and injected rather than swallowed as a pill. We have supporting evidence

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Key Points for Competition Authorities

Key Points Doctors are risk averse and sceptical about

new drugs or generic versions of new drugs; they do not understand pharmacology or laws on generic marketing approvals and intellectual property.

Detailing visits are a key source of information for doctors.

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Criticisms of Denigration Cases

Criticisms Inconsistent with regulatory regime, which recognizes that generics may be different – no automatic

substitution in some Member States and doctors retain final say in some Member States.

Differences between products may exist even after finding of bioequivalence.

If discussions with health authorities about differences could give rise to competition issues, risk of restricting information made available to HCPs.

Is this really a competition law problem? Laws on misleading and comparative advertising and unfair

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Golden Rules

Practical

Guidance Statements should be objective, complete and reliable; they should not be incorrect or misleading.

Do not suggest problem with safety or efficacy of generic without supporting evidence.

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