E l du Pont de Nemours & Company v Comptroller of Patents
| Jurisdiction | England & Wales |
| Judge | Lord Justice Jacob,Lord Justice Stanley Burnton,Lord Justice Ward |
| Judgment Date | 17 September 2009 |
| Neutral Citation | [2009] EWCA Civ 966 |
| Court | Court of Appeal (Civil Division) |
| Docket Number | Case No: A3/2009/1085(A) |
| Date | 17 September 2009 |
[2009] EWCA Civ 966
IN THE COURT OF APPEAL (CIVIL DIVISION)
ON APPEAL FROM THE CHANCERY DIVISION
John Baldwin QC (sitting as a Deputy Judge of the Chancery Division)
Royal Courts of Justice
Strand, London, WC2A 2LL
Lord Justice Ward
Lord Justice Jacob and
Lord Justice Stanley Burnton
Case No: A3/2009/1085(A)
CH 2009 APP 0210
Iain Purvis QC and Peter Prescott QC (instructed by Lovels LLP) for the Appellant
Miss Charlotte May (instructed by The Treasury Solicitor) for the Respondent
Hearing date: 19 August 2009
Lord Justice Jacob:
This case is about an application by du Pont for a so-called “paediatric extension” to the term of its Supplementary Protection Certificate (SPC) for a medicine called losartan. This is sold by its licensee, Merck, under the trade mark Cozaar.
Du Pont originally patented losartan by a patent applied for on 9 th July 1987. This expired 20 years later, on 9 th July 2007. To sell a medicine in the EU you need a marketing authorisation (MA). This is by virtue of the provisions of Directive 2001/83/EC which superseded Directive 65/65EEC to like effect. The first MA to place losartan on the market within the EU was Danish, granted on 26 th September 1994. So some seven years of marketing under patent protection was lost.
The SPC system was devised for cases of lost time such as that of losartan. The general scheme, provided for by the SPC Regulation EEC/1768/92 as amended (now replaced by a codified version EC/469/2009) is to provide protection equivalent to patent protection for a medicine when there has been lost time caused by the MA process. The period of extra protection is calculated according to a formula set out in the Regulation. Under the SPC scheme an SPC has to be applied for in each Member State where it is wanted – there is no central scheme. Quite why, I do not know. In this country the application is made to the Patent Office (which now goes by the trendy but pointless “operating name” of “UK Intellectual Property Office”).
Du Pont applied in 13 Member States for an SPC. An SPC was granted in all cases. They were due to expire on 1 st September 2009.
Provision has been made for a possible extension for 6 months of an SPC by the Paediatric Regulation EC/1901/2006. This amended the SPC Regulation as well as containing its own specific provisions.
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.
Broadly the scheme is this. The SPC holder agrees a research programme into the treatment of children with the medicine. The agreement is with a scientific body called the Paediatric Committee, part of the European Medicines Agency. The programme is called a “paediatric investigation plan” (PIP). If you carried that out properly (and the Committee agrees you did), and take proper steps to publish the results including getting an appropriate modification of your MAs (of which more anon) you are entitled to a 6 month extension.
By an application of 18 th February this year du Pont sought such an extension in the UK and 12 other Member States. We are told that it has been granted in 8 out of the 13 and refused in none, save in this country. Without going into the detail it seems that the basis of grant in various countries differs.
In the UK the Hearing Officer, Dr Cullen (with du Pont's consent, given to speed things up, working on the papers alone) by a decision of 9 th April held that the application did not comply with the rules in the SPC Regulation as amended by the Paediatric Regulation. He set a deadline of 6 th July for the defects to be rectified. But it is the Comptroller of Patents' contention that in fact that is not possible – because the defects were such that could not be rectified and there is no power to put things right.
In fact all the defects (if defects they are) have now been put right. But, says the Comptroller, that is too late even though the basic SPC has not yet expired. The Comptroller fairly and properly, however, accepts that if it is possible to grant the extension on the basis that things have been put right now, then such an extension should be granted. For that purpose he would be willing to extend a time period for putting things right.
On appeal, the Deputy Judge, John Baldwin QC, upheld Dr Cullen's decision. The matter comes to us in vacation as an expedited appeal with the permission of the Deputy Judge. I granted expedition because without it the appeal even if successful might be pointless. It is not clear whether an SPC can be extended after it has expired. And in any event third parties would be in a position to enter the market when the SPC expired. Generic companies, quite understandably and quite lawfully, endeavour to enter a market as soon as protection expires.
As I have said, the SPC Regulation was amended by the Paediatric Regulation. I shall use the text as amended.
Article 7(3) of the SPC Regulation provides rules about the timing of an application for an SPC and for an application for an extension. It says:
Article 7 Application for a certificate
3. The application for an extension of the duration may be made when lodging the application for a certificate or when the application for the certificate is pending and the appropriate requirements of Article 8(1)(d) or Article 8(2), respectively, are fulfilled.
4. The application for an extension of the duration of a certificate already granted shall be lodged not later than two years before the expiry of the certificate.
5. Notwithstanding paragraph 4, for five years following the entry into force of Regulation (EC) No 1901/2006, the application for an extension of the duration of a certificate already granted shall be lodged not later than six months before the expiry of the certificate.
So after the transitional period, if you want an extension, you will have to lodge your application for it not later than two years before expiry of the main SPC. But the period is only six months before expiry for the transitional period of five years following entry into force of the Paediatric Regulation.
This case of course falls within the transitional period. Because the SPC for losartan would expire on 1 st September, the application for an extension had to be in before 1 st March. We were told that Merck had proceeded as fast as they could. They made their application for an extension on 18 th February putting in all the materials they could at that time. The Patent Office position is that those materials were deficient and that the position cannot be remedied.
What then are the materials which an application must contain? These are set out in Article 8 of the SPC Regulation as amended. The Article provides both for what an application for a basic SPC and for an extension must contain. I set it out in full:
Article 8 Content of the application for a certificate
1. The application for a certificate shall contain:
(a) a request for the grant of a certificate, stating in particular:
(i) the name and address of the applicant;
(ii) if he has appointed a representative, the name and address of the representative;
(iii) the number of the basic patent and the title of the invention;
(iv) the number and date of the first authorisation to place the product on the market, as referred to in Article 3(b) and, if this authorisation is not the first authorisation for placing the product on the market in the Community, the number and date of that authorisation;
(b) a copy of the authorisation to place the product on the market, as referred to in Article 3(b), in which the product is identified, containing in particular the number and date of the authorisation and the summary of the product characteristics listed in Article 11 of Directive 2001/83/EC or Article 14 of Directive 2001/82/EC;
(c) if the authorisation referred to in point (b) is not the first authorisation for placing the product on the market as a medicinal product in the Community, information regarding the identity of the product thus authorised and the legal provision under which the authorisation procedure took place, together with a copy of the notice publishing the authorisation in the appropriate official publication;
(d) where the application for a certificate includes a request for an extension of the duration:
(i) a copy of the statement indicating compliance with an agreed completed paediatric investigation plan as referred to in Article 36(1) of Regulation (EC) No 1901/2006;
(ii) where necessary, in addition to the copy of the authorisation to place the product on the market as referred to in point (b), proof of possession of authorisations to place the product on the market of all other Member States, as referred to in Article 36(3) of Regulation (EC) No 1901/2006.
Art. 8(1)(d)(i) of the SPC Regulation cross refers to Art. 36(1) of the Paediatric Regulation. Although only the first sub-section is...
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