On 20 December 2012, the Patents Court of England and Wales rejected a challenge brought by Dr. Reddy’s Laboratories against the six month paediatric extension of the Supplementary Protection Certificate (SPC) for Pfizer’s cholesterol-lowering product atorvastatin (Lipitor).1 This is the first judgment on a challenge to a paediatric extension under the Paediatric Regulation.2 This advisory summarises the judgment.  

Atorvastatin was covered in the UK by an SPC which originally extended patent protection until November 2011.  

In July 2008, the European Medicines Agency (EMA) agreed on a Paediatric Investigation Plan (PIP) for atorvastatin. That PIP required two studies to be completed and a third to be started (and then completed as part of a separate Risk Management Plan). Pfizer completed the first two studies, started the third, and applied for an indication for paediatric use. That indication was approved by the European Commission in July 2010 and then by the UK authority (MHRA) in November 2010.  

On that basis, Pfizer obtained a six month paediatric extension of the SPC, lasting until May 2012. Dr. Reddy’s Laboratories challenged that extension, claiming that the first two studies under the PIP were not significant, and the third study had to be completed before any entitlement arose to the six month extension.  

The key findings of the Court were:

  • „„The requirement that studies be “significant” (under Article 45(3) of the Paediatric Regulation) is a transitional one which did not apply in this case, where all studies in the PIP were completed after the Paediatric Regulation entered into force in 2007. The Court noted that both the EMA’s expert committee (the PDCO) and the MHRA had stated that the completed studies were significant, but given its finding that the requirement did not apply, the Court did not need to consider the point further.
  • The requirement to start (but not complete) the third study was lawful under the Paediatric Regulation. A PIP must include studies to generate the “necessary data determining the conditions in which the medicinal products may be used to treat the paediatric population”, but can also include requirements to start additional studies.
  • Even if the requirement to start (but not complete) the third study had been a technical breach of the Paediatric Regulation, the Court had a discretion to revoke the extension (under Article 16 of the SPC Regulation3), not an obligation, and this would be an appropriate case where the extension should not be revoked.  

The Paediatric Regulation was intended to encourage research into the use of medicines for children. This judgment provides the pharmaceutical industry with greater clarity as to the scope of its obligations, and certainty that the reward of a paediatric extension will be upheld.