A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here

Thursday 20 December 2012

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.


Anonymous said...

i think the hon judge has made up his mind on what the regulation should be interpretted as, without anyone actually knowing. the regulation seems to remain as ambiguous as it was before for innovators, generics and regulators. it now seems that any studies that are "negotiated" with the regulatory body will remain in the PIP without anyone actually knowing what and how it got there. i guess its a field day now for innovator companies

Anonymous said...

According to the new Patents Court guide, issued December 2012, Mr Justice Roth (and Mr Justice Vos) is now a judge of the Patents Court (http://www.justice.gov.uk/downloads/courts/patents-court/patent-court-guide.pdf).

The full list is:

Mann J
(Clerk: Susan Woolley - tel 020 7947 7964; Susan.Woolley@hmcts.gsi.gov.uk)
Warren J
(Clerk: Elizabeth Collum - tel 020 7947 7260; Elizabeth.Collum2@hmcts.gsi.gov.uk)
Morgan J
(Clerk: Heather Watson - tel 020 7947 6419; Heather.Watson@hmcts.gsi.gov.uk)
Norris J
(Clerk Emma Patrick - tel 020 7073 1728; Emma.Patrick@hmcts.gsi.gov.uk)
Floyd J [Judge in charge of the Patents Court]
(Clerk: Alison Hall - tel 020 7073 1740; Alison.Hall@hmcts.gsi.gov.uk)
Arnold J
(Clerk: Alison Lee - tel 020 7073 1789; Alison.Lee2@hmcts.gsi.gov.uk)
Roth J
(Clerk: Chris Ellis - tel 020 7947 6589; Chris.Ellis@hmcts.gsi.gov.uk)
Vos J
(Clerk: Robin Cliffe - tel 020 7947 7606; Robin.Cliffe@hmcts.gsi.gov.uk)