Dr Reddy's Laboratories (Uk) Ltd and Another v Warner-Lambert Company Llc
| Jurisdiction | England & Wales |
| Judge | Mr Justice Roth |
| Judgment Date | 20 December 2012 |
| Neutral Citation | [2012] EWHC 3715 (Pat) |
| Date | 20 December 2012 |
| Court | Chancery Division (Patents Court) |
| Docket Number | Case No: HC11 CO3027 |
[2012] EWHC 3715 (Pat)
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Royal Courts of Justice
Strand, London, WC2A 2LL
Mr Justice Roth
Case No: HC11 CO3027
Mark Brealey QC and Ms Julianne Kerr Stevenson (instructed by Innovate Legal) for the Claimants
Ms Kelyn Bacon and Mr Max Schaefer (instructed by Arnold & Porter (UK) LLP) for the Defendant
Hearing dates: 20, 21 and 22 November 2012
Approved Judgment
I direct that pursuant to CPR PD 39A para 6.1 no official shorthand note shall be taken of this Judgment and that copies of this version as handed down may be treated as authentic.
INTRODUCTION
This case concerns the interpretation of Regulation (EC) 1901/2006 ("the Paediatric Regulation") and its application in the process which led to the grant of a six month extension of the Supplementary Protection Certificate ("SPC") to the defendant for its medicinal product, atorvastatin. Atorvastatin is a very successful product used to treat elevated cholesterol-related complaints in both adults and children, marketed in the United Kingdom under the name "Lipitor".
The claimants (together "Dr Reddy's") are a substantial producer of generic medicines. The first claimant is a subsidiary of the second claimant but for the present purposes it is not necessary to distinguish between them. The defendant is a company within the Pfizer group and I shall refer to it, as it was throughout the trial, as "Pfizer". Pfizer is a leading and well-known manufacturer of pharmaceutical products.
Dr Reddy's apply to set aside the extension to the SPC granted to Pfizer under Article 36 of the Paediatric Regulation. Since this extension expired on 6 May 2012, the purpose of Dr Reddy's claim is now to establish a basis for the recovery of damages pursuant to a cross-undertaking given by Pfizer in a Consent Order of 17 November 2011. However, the issues for decision at this stage are whether the extension to the SPC for atorvastatin ("the paediatric extension") was validly granted and, if so, whether it should be revoked.
Dr Reddy's were represented at trial by Mark Brealey QC and Ms Julianne Kerr Stevenson, and Pfizer was represented by Ms Kelyn Bacon and Mr Max Schaefer. I am grateful for their written and oral arguments and the Court has also been substantially assisted by a full agreed statement of facts prepared in advance of the trial. Although a number of witness statements have been served, in the event neither side felt it necessary to cross-examine the other side's witnesses and, indeed, very little reference was made to the witness evidence in the course of the trial.
THE LEGISLATIVE REGIME
To assess this challenge to the paediatric extension, it is necessary to appreciate the scheme of the legislation. The following is intended as a general, and necessarily oversimplified, summary.
Marketing Authorisation
In the United Kingdom, as in most countries, authorisation is required to place a medicine on the market. Within the EU, the process of generating such marketing authorisation has been harmonised and in part centralised by what is referred to as the "Medicinal Products Code", which is now set out in Directive 2001/83/EC. For the most part, a marketing authorisation is issued nationally by the "competent authority" of the individual Member State, pursuant to an application made to that authority. However, Articles 32–34 of Directive 2001/83 provide for what is sometimes referred to as a "centralised referral" procedure. Under that procedure, the applicant may request an opinion from the Committee for Medicinal Products for Human Use ("CHMP"), which is the scientific advisory body to the European Medicines Agency ("EMA"). If the CHMP issues an opinion and report in favour of granting a marketing authorisation, that report is sent to the Commission, which then issues a decision in respect of the application. That decision, however, does not itself constitute the grant of a marketing authorisation but is addressed to the Member States which are then bound to act in accordance with the terms of the decision and issue their own, national, marketing authorisation.
In addition, it should be noted that Regulation (EC) 726/2004 introduced a centralised procedure for the grant of marketing authorisation for a limited range of products. For those products, a single, EU marketing authorisation may be granted. However, atorvastatin is not one of those products.
Supplementary Protection Certificate (SPC)
The provision of SPCs by way of extended patent protection for medicines was introduced in the EU in 1992. It is now governed by Regulation (EC) 469/2009 ("the SPC Regulation"). The rationale for the SPC, as stated in recital (4) of the SPC Regulation is that:
"…the period that elapses between the filing of an application for a patent for a new medicinal product and authorisation to place the medicinal product on the market makes the period of effective protection under the patent insufficient to cover the investment to put into the research."
Since medicines, in particular those requiring lengthy and expensive research, will not be developed unless they have sufficient patent protection, there was also a concern that lack of extended protection would lead to the relocation of pharmaceutical research away to countries that offered better protection. As a result, some Member States introduced their own system of national SPCs and the EU regime was therefore also designed to introduce uniform protection across all Member States.
An SPC takes effect at the end of the basic patent period and extends the life of the patent for a period equal to that which elapsed between the date of lodging the application for the patent and the date of the first marketing authorisation, but subject in any event to a maximum period of five years: see Article 13 of the SPC Regulation.
Paediatric extension
Provision for a six-month extension to the SPC was introduced by the Paediatric Regulation which took effect on 26 January 2007. The background to this legislation was explained by Jacob LJ in EI Du Pont de Nemours & Co v UK Intellectual Property Office [2009] EWCA Civ 966, [2010] RPC 6, at [6]:
"The Paediatric Regulation was to encourage specific research – and dissemination of knowledge about its results —into already known medicines as to their applicability for children. Prior to the Regulation there was no specific incentive for such research. If you discovered a new medicine you could patent it. You could then get an SPC if there was delay in getting an MA. And that was that. There was no particular requirement or incentive for going on to investigate whether the medicine was suitable (or unsuitable) for children or had particular application for children. The Paediatric Regulation provides an incentive – an extra six months of protection —for having conducted such research."
The context was further explained by the EU General Court in Case T-52/09Nycomed Danmark ApS v European Medicines Agency (judgment of 14 December 2011). The court noted that at the date on which the Paediatric Regulation was adopted more than 50% of the medicines administered to children in Europe had not been authorised for such use and had not been subject to appropriate trials: para 39.
The objective of the Regulation is helpfully set out in the recitals, as follows:
"(1) Before a medicinal product for human use is placed on the market in one or more Member States, it generally has to have undergone extensive studies, including pre-clinical tests and clinical trials, to ensure that it is safe, of high quality and effective for use in the target population.
(2) Such studies may not have been undertaken for use in the paediatric population and many of the medicinal products currently used to treat the paediatric population have not been studied or authorised for such use. Market forces alone have proven insufficient to stimulate adequate research into, and the development and authorisation of, medicinal products for the paediatric population.
(3) Problems resulting from the absence of suitably adapted medicinal products for the paediatric population include inadequate dosage information which leads to increased risks of adverse reactions including death, ineffective treatment through under-dosage, non-availability to the paediatric population of therapeutic advances, suitable formulations and routes of administration, as well as use of magistral or officinal formulations to treat the paediatric population which may be of poor quality.
(4) This Regulation aims to facilitate the development and accessibility of medicinal products for use in the paediatric population, to ensure that medicinal products used to treat the paediatric population are subject to ethical research of high quality and are appropriately authorised for use in the paediatric population, and to improve the information available on the use of medicinal products in the various paediatric populations. These objectives should be achieved without subjecting the paediatric population to unnecessary clinical trials and without delaying the authorisation of medicinal products for other age populations.
…
(6) The establishment of a system of both obligations and rewards and incentives has proved necessary to achieve these objectives. …"
Under the Paediatric Regulation, a Paediatric Committee ("PDCO") was established within the EMA. As noted in recital (8), it was to be a committee "with expertise and competence in the development and assessment of all aspects of medicinal products to treat paediatric populations."
As the General Court noted in Nycomed, the Paediatric Regulation...
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IP Bulletin - Spring 2013
...for a paediatric extension, the extension would not be revoked. Dr Reddy's Laboratories (UK) Ltd v Warner-Lambert Company LLC [2012] EWHC 3715 (Pat), 20 December The claimant Dr Reddy's Laboratories (UK) Ltd ("Dr Reddy's"), a producer of generic medicines, applied to the court to set aside ......