Lipitor paediatric extension surprise: judge doesn't refer questions to CJEU

Dr Reddy's Laboratories (UK) Ltd & Another v Warner-Lambert Company LLC [2012] EWHC 3715 (Pat) is a Patents Court for England and Wales ruling of Mr Justice Roth -- who is not one of the usual Patents Court judges [though it seems that he is now officially a Patents Court judge: see the Comment posted below this article]. This action however required the judge to exercise purely legal skills rather than to possess technical knowledge of the field in which the patent had been granted.

In brief, Pfizer applied for and was granted a paediatric extension for Atorvastatin (Lipitor). Dr Reddy's challenged the grant of the paediatric extension on three grounds:

(1) The European Medicines Agency (EMA) acted ultra vires it powers under the Paediatric Regulation by approving a paediatric investigation plan (PIP) that let Pfizer to defer completion of the third of its three required studies. The circumstances in which studies in a PIP may be started but not finished are expressly defined by the Regulation and must be covered by a deferral under Article 20. No such deferral was applied for by Pfizer or granted in this case. Accordingly, the PIP was not lawfully approved under the Paediatric Regulation and Pfizer was therefore not entitled to the extension.  

(2) Under Article 45(3), a paediatric extension should be granted only when significant studies contained in the PIP have been completed. Here, none of the relevant bodies made an assessment as to whether either of the two studies which had been completed was significant; and, on the facts, they were clearly not significant.  

(3) Even if, contrary to ground (1), it was legitimate for the EMA to approve a PIP that required the initiation but not the completion of the third study, under Article 36 Pfizer was not entitled to a paediatric extension unless it included, within its application for a marketing authorisation, the results of the completed third study.

The learned judge dismissed all three challenges, describing the third as "misconceived", and declined to follow what seems almost standard practice these days when he decided that there was no need to make a reference to the Court of Justice of the European Union relating to the second ground.

The decision is quite long -- some 76 paragraphs -- and would have benefited from being just a little bit longer, if Roth J had added a short paragraph at the end which summarised what he actually decided.

The fight for atorvastatin: further news

According to a recent piece in Dispensing Doctor, "Teva and Pfizer set the date for Lipitor patent battle: Asda strikes no-involvement deal", by Ailsa Colquhoun, a date in late November has been mooted for the Lipitor patent validity trial due to take place at the High Court of Justice in London [on earlier proceedings in this dispute see here]. If Teva's challenge succeeds, it will be legally entitled to release the generic atorvastatin stock currently held by wholesalers. According to the news item:

"The trial takes place some six months before the scheduled expiry of the current UK patent supplementary protection certificate (SPC) for Lipitor. ...

In the meantime, Pfizer has shown no sign of abating the legal pressure on dispensers.  On Friday, July 22, Pfizer announced that it had struck a deal in the High Court to exclude Asda from the ongoing legal action against Teva and other wholesalers, in return for a promise not to deal or dispense generic atorvastatin. However, at the same hearing, Pfizer named Day Lewis in its ongoing action against Teva and others, and has signalled its intention to pursue an injunction and full financial recompense from the chain".

UK Atorvastatin hearing for 11 July

Chemist and Druggist reported last week that a court order was made in favour of Pfizer, restraining the sale and distribution of generic atorvastatin by AAH Pharmaceuticals, Phoenix Healthcare Distribution and Teva UK. The order states that, until a further hearing scheduled for July 11, the three companies must not advertise, offer for sale, sell or supply any atorvastatin other than that supplied by Pfizer or that agreed in orders placed before the injunction was issued.

The named claimant in the proceedings is Warner-Lambert Co, which Pfizer acquired in 2000. According to Pfizer:

"The patent at issue is covered by a supplementary protection certificate (SPC) that does not expire until November 2011, and Pfizer has applied for a six-month paediatric extension to the SPC. In 2005, the same court had rejected a challenge to the patent by Ranbaxy, finding that a generic atorvastatin product would infringe Pfizer's patent covering atorvastatin, the active ingredient in Lipitor. That decision was affirmed on appeal."

A spokesperson for Teva said the company was disappointed that Pfizer had used the courts to prevent customers receiving further stocks, adding:

"Our view is that the patent protection in place for Lipitor is invalid; and we intend to win the case and resume supply as soon as possible".

The order was made by Patents Court judge Mr Justice Floyd.