AUTH/2351/8/10: Lilly v Roche – Promotion of Tarceva and the meaning of “first-line maintenance” (No breach on appeal) | PMCPA Case

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Key facts

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Case number	AUTH/2351/8/10
Parties	Eli Lilly and Company Limited v Roche Products Limited
Product	Tarceva (erlotinib)
Therapy area	Non-small cell lung cancer (NSCLC)
Materials	Leavepiece (TARC00522 / revised TARC00601); Advertisement in Oncology Times (TARC00568a); Sponsored feature in Oncology News (TARC00592)
Main issue	Use of the term “first-line maintenance” and whether it was misleading/inconsistent with the Tarceva SPC; plus clarity of intended therapeutic use on the front of the leavepiece
Applicable Code year	2008
Clauses considered	3.2, 7.2
Panel finding	Breaches of Clauses 3.2 and 7.2 were ruled for “first-line maintenance” claims (leavepiece, advertisement, sponsored feature); no breach for absence of therapeutic use on the front page of the new leavepiece
Appeal outcome	Appeal by respondent successful on all points; no breach of Clauses 3.2 and 7.2
Complaint received	19 August 2010
Case completed	10 November 2010

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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Eli Lilly complained about Roche’s promotion of Tarceva (erlotinib) in a leavepiece (ref TARC00522 / revised TARC00601), an advertisement in Oncology Times (ref TARC00568a) and a sponsored feature in Oncology News (ref TARC00592).
Lilly alleged the materials claimed Tarceva was licensed for “first-line maintenance” in advanced NSCLC, and that this wording was ambiguous/misleading and not consistent with the Tarceva SPC.
Lilly also objected that the front of the leavepiece said Tarceva was “now licensed for first-line maintenance in patients with stable disease” without clarifying the intended therapeutic use (advanced NSCLC), potentially implying broader/unlicensed use.
During inter-company dialogue Roche withdrew and amended the original leavepiece because unfolding could separate “Tarceva as first-line” from “maintenance therapy,” potentially creating ambiguity.
The Panel considered “first-line maintenance” was not used in the Tarceva SPC and ruled it misleading/inconsistent with the SPC in the leavepiece, advertisement and sponsored feature.
Roche appealed. The Appeal Board concluded experienced oncologists would not be misled and that the Code does not require identical SPC wording, only that claims are not inconsistent with the SPC.

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Final outcome (Appeal Board): No breach of the Code.
No breach of Clauses 3.2 and 7.2 in relation to the leavepiece, advertisement, or sponsored feature.
Roche’s appeal was successful on all points.

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