Dr Reddy's Laboratories (UK) Ltd & Anor v Warner-Lambert Company LLC

Article 16 of the Regulation (EC) 469/2009 gives the court a discretion to revoke a paediatric extension. An extension is not necessarily invalid because an agreed paediatric investigation plan arguably included a study beyond the regulatory bodies’ strict powers, particularly where the applicant accepted and complied with the plan. Article 45(3) of the Regulation (EC) 1901/2006 is transitional and does not apply where all studies in the plan were initiated after the Regulation entered into force.

Dr Reddy’s Laboratories challenged the six-month paediatric extension granted to Pfizer’s supplementary protection certificate for atorvastatin. The challenge followed approval of a paediatric investigation plan, a positive compliance opinion, marketing-authorisation decisions and the UK IPO’s grant of the extension.

The issues were whether the plan unlawfully deferred completion of a three-year study, whether Article 45(3) required significant studies to be completed, and whether the application had to include the results of that study.

1. Article 16(1) of the Regulation (EC) 469/2009 uses “may”, unlike the mandatory language of Article 15(1). Revocation is therefore discretionary. The court may decline to revoke for technical non-compliance, particularly where the defect has been cured or would produce an unduly formalistic result.
2. The PIP required the third study to be initiated by 31 March 2009 but imposed no completion date. The statutory deferral provisions concern postponement of initiation or completion for specified scientific, technical or public-health reasons. A study continuing beyond the PIP completion date did not itself constitute a deferral.
3. Pfizer accepted and complied with the agreed PIP. It was therefore not open to Dr Reddy’s to challenge the extension on the basis that the third study should not have been included. Even if its inclusion exceeded the regulatory power, the breach was technical and would not justify revocation.
4. The Article 28(3) compliance statement is the exclusive basis on which an applicant establishes compliance for the purpose of obtaining an extension, as explained in EI Du Pont de Nemours & Co v UK Intellectual Property Office [2009] EWCA Civ 966. That did not necessarily exclude a third-party challenge under Article 16, but the point did not require final determination.
5. Article 36(1) was satisfied because the PIP required initiation, not completion, of the third study. Article 45(3) was transitional and did not apply where all studies included in the PIP were initiated after the Regulation entered into force. The claim was dismissed.