IPO issues new SPC guide

The Intellectual Property Office in the United Kingdom has recently prepared, and now issued, a handsome new guide to SPCs, Supplementary Protection Certificates: Guide for Applicants, though for some souls who are unfamiliar with the subject a more welcome title might have been A Guide for the Perplexed, given the level of detail and conceptual complexity which accompanies almost every step of this topic in practice. Weighing in at 34 pages and attractively illustrated, this booklet, which is current to September 2009, aims

"to give a short introduction to the procedures for applying for a Supplementary Protection Certificate or an extension to a certificate in the United Kingdom. It is intended to serve as a guide only and is not an authoritative statement of the law on Supplementary Protection Certificates. It is therefore advisable to seek independent professional advice about any matters covered by this booklet and not to rely on the booklet alone".

The SPC Blog agrees that professional advice is a good idea; it would never do for a private individual who holds a pharmaceutical patent to go wandering off into the arcane area of patent term extension without at least having a quiet word or two with his friendy local lawyer ...

Seriously, this is a useful, well-structured, well-referenced guide which, when read by a client before meeting a lawyer, can save time, focus minds and dispel misapprehensions. The IPO should be congratulated for putting it together.

Synaptech for ECJ reference: to join with Synthon v Merz?

In Generics (UK) Ltd v Synaptech Inc [2009] EWHC 659 (Ch), Roger Wyand QC, sitting as a Deputy Judge in the Patents Court (England and Wales), held that the term "the first authorisation to place the product on the market" should be interpreted wherever it occurs in the European supplementary protection certificate (SPC) Regulation as referring to the first authorisation compliant with Directive 65/65/EEC. On this basis the Intellectual Property Office had correctly granted an SPC with a term calculated on the basis of a first Directive 65/65/EEC authorisation in 2000, rather than earlier non-compliant authorisations (see The SPC Blog here for comments on that decision).

Today the Courts Service has released this order of the Court of Appeal (Lords Justices Jacob and Rimer and Mr Justice Kitchin):

"UPON APPEAL from the order of Mr Roger Wyand QC, Deputy High Court Judge dated 9 June 2009

AND UPON HEARING Counsel for the Appellant and Counsel for the Respondent

IT IS ORDERED that

1) the questions set out in the Schedule to this Order concerning the interpretation of Regulation (EEC) 1768/92 be referred to the Court of Justice of the European Communities for a preliminary ruling in accordance with Article 234 of the Treaty establishing the European Community
2) this Court will request that the Court of Justice of the European Communities join this reference with the reference in pending Case C-195/09 Synthon v Merz, referred by Floyd J on 29 May 2009 [on which, see The SPC Blog here]
3) all further proceedings in this appeal be stayed until the Court of Justice of the European Communities has given its ruling on the said questions or until further order
4) the Senior Master shall forthwith, and without waiting for time to appeal against this Order to expire, transmit to the Registrar of the ECJ, pursuant to CPR Pt 68, this Order and the Schedule thereto
5) costs be reserved
6) there be liberty to apply".

The Schedule to this order can be read in full here. In short, the questions referred -- which overlap with those in Synthon v Merz, are as follows:

"(1) For the purposes of Article 13(1) of Council Regulation (EEC) No 1768/92, is the “first authorisation to place the product on the market in the Community” the first authorisation to place the product on the market in the Community which was issued in accordance with Council Directive 65/65/EEC (now replaced with Directive 2001/83/EC) or will any authorisation that enables the product to be placed on the market in the Community or EEA suffice?

(2) If, for the purposes of Article 13(1) of Council Regulation (EEC) No 1768/92, an “authorisation to place the product on the market in the Community” must have been issued in accordance with Directive 65/65/EEC (now replaced with Directive 2001/83/EC), is an authorisation that was granted in 1963 in Austria in accordance with the national legislation in force at that time (which did not comply with the requirements of Directive 65/65/EEC) and that was never amended to comply with Directive 65/65/EEC and was ultimately withdrawn in 2001 to be treated as an authorisation granted in accordance with Directive 65/65/EEC for that purpose?"

Losartan and Caspofungin in Denmark

As you may recall, the Blog reported that an application was made for the paediatric extension of Caspofungin in Denmark in February this year. Andreas Schmitt of A.S. Dataservices writes:

"Denmark has recently granted pediatric extensions for Losartan and Caspofungin (see here for page of Patent Journal).

The expiry date given for Caspofungin doesn't take the extension into account, but after contacting the Danish Patent Office, they informed me that the date will be corrected in one of the next issues of the journal."

Paediatric extensions: "more disharmony"

The cover story of the October 2009 issue of Informa's ten-times-a-year Patent World is a review by Ewan Nettleton (Bristows) entitled "Paediatric Extensions -- more SPC disharmony?" According to the appetiser on the journal's website,

"There has been a flurry of cases concerning supplementary protection certificates (SPCs) in recent months, several of which concern the so-called ‘paediatric extension’. These extensions to the term of an SPC were introduced into European legislation a couple of years ago as part of a package of measures to incentivise the pharmaceutical industry to conduct the necessary tests and trials to assess whether medicines are appropriate to administer to children".

The article, which sets out the basic legal propositions underpinning paediatric extensions, went to print before the Court of Appeal belatedly handed down its decision to reverse the decision of the High Court in E I du Pont Nemours & Co v United Kingdom Intellectual Property Office [2009] EWCA Civ 966 (see The SPC Blog here). In endorsing the Dutch approach which Ewan Nettleton summarises in his article, the Court of Appeal has done its bit to reduce the disharmony -- but there is still scope for discord ...

Grounds for Irish Losartan Decision Available

We follow up on our previous posting that the paediatric extension for Losartan was recently granted in Ireland - Dolores Cassidy of the Irish Patent Office has pointed out that the the grounds of the decision are now available here, on the Irish Patent Office website.

Court of Appeal for England and Wales rules on Losartan paediatric extension

The final version of the Court of Appeal's "mystery decision" in E I du Pont Nemours & Co v United Kingdom Intellectual Property Office [2009] EWCA Civ 966 , which was handed down in draft form on 19 September, has at last been made generally available today. This decision reverses that of John Baldwin QC, sitting as a High Court judge (see The SPC Blog here) in which he upheld the Intellectual Property Office's decision to refuse to grant a paedriatric extension to the term of an SPC for Losartan.

At para 59 Lord Justice Jacob (with whom the other appellate judges agreed) explains:

"We indicated at the conclusion of the oral hearing that the appeal would be allowed. This was necessary in order that the Patent Office could extend the SPC before it expired. These are my reasons for that decision. They are largely the same (though I fear expressed at much greater length) as those of the Dutch Patent office [noted here on the SPC Blog] which, by its letter of 2nd June, extended the corresponding Dutch SPC".

The SPC Blog welcomes further comment on this very full decision, and may provide some additional comments of its own in due course.

Losartan and third party oppositions in the Netherlands

As most seasoned SPC Blog readers will recall, third party Actavis lodged an objection with the Netherlands Patent Office against the decision by the Netherlands Patent Office to grant the extension of the term of the supplementary protection certificate to Dupont (reported here http://thespcblog.blogspot.com/2009/06/losartan-decision-in-netherlands.html).
The Netherlands Patent Office declared the petition inadmissible in view of article 19.2 of Reg. 469/2009 which rules out an opposition procedure against the granting of a certificate.

Actavis appealed at the Administrative chamber of the Court of the Hague, arguing in particular that article 19.2 only applies to the granting of certificates, not to the awarding of term extensions.

The Court has rejected this appeal (a copy of the decision is available here): There is nothing in the documentation concerning the Paediatric Regulation to suggest that the legislator found an opposition procedure against the granting of term extensions desirable, but an opposition procedure against the granting of certificates not. Furthermore article 16.2 of Reg. 469/2009 stipulates that any person may submit an application for revocation of the extension of the duration to the body responsible under national law for the revocation of the corresponding basic patent. That body under Dutch patent law is the Court of The Hague, section Civil, department Intellectual Property.

Unlike in the Netherlands, in some countries not only the courts but also the national patent offices have the power under their national patent law to revoke patents. This leads to a bit of a contradiction between article 16.2 and 19.2 (and also 15.2 and 19.2). We invite the Blog readers to comment on how these countries deal with such third party oppositions.

Losartan: now it's Latvia's turn

SPC enthusiast and expert Alice de Pastors has just told the SPC Blog that, in August of this year, the Latvian Patent Office published a notice regarding the issue of paediatric extension for Losartan. Alice also sent us an extract of page 1135 of Latvian Patent Gazette of 20 August 2009, adding: "The August Latvian Patent Gazette is available here". Thanks so much, Alice!

And if you're wondering what might cause hypertension in laid-back Latvia, here's a selection of tasty recipes, some of which are quite likely to clog up those arteries.