Ball and Barnett note now available online

Last week this weblog noted the publication, in issue 2 of volume 10 of the Bio-Science Law Review (published six times a year by Lawtext), of a note by Jonathan Ball and Elizabeth Barnett (Norton Rose), "High Court Upholds UK's Strict Approach on Paediatric Extension to SPCs". This note on E I Du Pont Nemours & Co [2009] EWHC 1112 (Ch), now somewhat overtaken by events (see the comments posted on last week's note) but still of interest, can now be read in full here.

The SPC Blog thanks Nicholas Gingell of Lawtext for making this pdf available.

Losartan in Italy

The SPC Blog has recently heard from Micaela Modiano of Modiano and Partners that the Italian PTO also granted the pediatric extension for losartan in Italy, see excerpt here from the Italian PTO online IP rights database.

Micaela comments -

"It is also interesting that in Italy the regulatory agency (AIFA) issued an official communication, here, published in the Italian OJ, indicating not only that it had accepted the variation determined by the addition of the pediatric indication, but also that "Therefore, the patent owner or SPC owner has the right to a 6-month extension of the period provided for." (see highlighted sentence in the official communication)

As far as we know, this is the first time that the Italian regulatory agency has officially commented on something that would then be taken up by the Italian PTO (usually, it's the other way round, i.e. the Italian regulatory agency uses the Italian PTO sources for determining when SPCs expire and in turn determining when a generic MA request can be submitted, according to a certain interpretation of the Italian IP code made by the Italian regulatory agency the correctness of which is currently unclear).

We were told by the Italian PTO that they welcomed the Italian regulatory agency communication as the PTO examiners feel that they are unable to determine when the studies made by the SPC owner justify the pediatric extension and when they don't. It remains to be seen whether an official communication by the Italian regulatory agency as made in the losartan case will thus become the standard practice in case of pediatric studies."

More on Losartan - this time from Ireland

We are pleased to have heard from Yvonne McKeown from MacLachlan & Donaldson in Ireland that the Irish Patent Office has granted a paediatric extension for Losartan (see Irish Patent Office Official Journal extract here).

Losartan paed-ex in the UK: a new case note

The newly-minted issue 2 of volume 10 of the excellent Bio-Science Law Review (published six times a year by Lawtext) carries a note by Jonathan Ball and Elizabeth Barnett, both of London law firm Norton Rose, on paediatric extensions. Entitled "High Court Upholds UK's Strict Approach on Paediatric Extension to SPCs", this is an analysis of the Patents Court for England and Wales in E I Du Pont Nemours & Co [2009] EWHC 1112 (Ch), the Losartan application (noted here on The SPC Blog).

Since the publisher of the Bio-SLR is an old friend, I'll see if I can persuade him to let blog readers have sight of this four-page note in pdf format.

CORRECTION Human drug extensions in the US: article now available online

Correction: the wrong link to the article was added to the earlier version of this post.

Further to our previous post, Oxford University Press has very kindly agreed to allow readers of The SPC Blog to gain free access to Jeffrey S. Boone's article, "Patent term extensions for human drugs under the US Hatch–Waxman Act". You can read his excellent piece in full here. The SPC Blog thanks OUP for its kindness.

Patent extension for human drugs in the US: a fresh critique

Patent term extension is not a solely European preoccupation, though readers of this weblog might sometimes wonder whether Europe ("the home of the SPC") was the only theatre of war between those who seek to extend their chance of enjoying their hard-earned patent protection and those who, in the name of competition, fight them tooth and nail. There's plenty going on in the United States too. That this is so is evident from an article published this month: "Patent term extensions for human drugs under the US Hatch–Waxman Act". It's written by Jeffrey S. Boone (Vice President, Intellectual Property, Covidien, based in Hazelwood, MO) and you can find it in the Oxford University IP flagship publication, the peer-reviewed Journal of Intellectual Property Law & Practice 2009 4(9):658-664. The abstract reads as follows:

"Legal context: The US Drug Price Competition and patent Term Restoration Act of 1984 was a major revision to US pharmaceutical law. A significant provision of that law was the ability, under specific circumstances, to obtain an extension of the term of a patent that claims a new drug. The determination of eligibility for a patent extension is a complex matter that has been subject to differing interpretations by the courts and regulatory agencies.

Key points: This article reviews the circumstances under which a patent can be extended, how an application for extension is submitted, and how the term of extension is calculated. A case study is presented to further illustrate the procedures.

Practical significance: By limiting when a generic product can be launched, the determination of whether a patent is eligible for a patent term extension can have a major economic impact on both the innovator company and generic competitors. An understanding of patent term extension eligibility is a critical part of the life-cycle analysis of pharmaceuticals".

ECJ Ruling on AHP Manufacturing v BIE

The judgement is out on ECJ case C-482/07 AHP Manufacturing BV v Bureau voor de Industriële Eigendom, also operating under the name Octrooicentrum Nederland, available here in French, German, Dutch and other languages, but unfortunately, not yet in English.

Here are the essentials questions and (distilled) answers:

1. Does Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products, as subsequently amended, and more specifically Article 3(1)(c) thereof, preclude the grant of a certificate to the holder of a basic patent for a product for which, at the time of the submission of the application for a certificate, one or more certificates have already been granted to one or more holders of one or more other basic patents? - No

2. Does Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products, as subsequently amended, and more specifically recital 17 and the second sentence of Article 3(2) thereof, give rise to a different answer to Question 1? - No

Art. 3(1)(c) of Council Regulation 1768/92, in consideration of Art. 3(2) second sentence of Regulation 1610/96, should be interpreted such that it does not preclude the grant of a certificate to the holder of a basic patent for a product for which at the time of submission of the application, one or more certificates have already been granted to one or more holders of one or more basic patents. (see paragraph 43 of the decision)

3. When answering the previous questions, is it relevant whether the last application submitted, like the previous application or applications, is submitted within the period prescribed by Article 7(1) of Regulation (EEC) No 1768/92 or that prescribed by Article 7(2) of Regulation (EEC) No 1768/92? - No

4. When answering the previous questions, is it relevant whether the period of protection afforded by the grant of a certificate pursuant to Article 13 of Regulation (EEC) No 1768/92 expires at the same time as, or at a later time than, under one or more certificates already granted for the product concerned? - No

5. When answering the previous questions, is it relevant that Regulation (EEC) No 1768/92 does not specify the period within which the competent authority, as referred to in Article 9(1) of that Regulation, must process the application for a certificate and ultimately grant a certificate, as a result of which a difference in the speed with which the authorities concerned in the Member States process applications may lead to differences between them as to the possibility of a certificate being granted? - No

We'll provide more specifics on the reasoning in a later posting.

Synthon v Merz: questions for the ECJ

The questions referred to the Court of Justice of the European Communities for a preliminary ruling in Synthon v Merz by Mr Justice Floyd (Patents Court, England and Wales) -- reported by the SPC Blog here -- have just been posted on the Curia website for all to see. The case is now Case C-195/09 Synthon BV v Merz Pharma Gmbh & Co KG. The questions referred read as follows:

"1. For the purposes of Articles 13 and 19 of Council Regulation ... 1768/92, is an authorisation a "first authorization to place ... on the market in the Community", if it is granted in pursuance of a national law which is compliant with Council Directive 65/65/EEC, or is it necessary that it be established in addition that, in granting the authorisation in question, the national authority followed an assessment of data as required by the administrative procedure laid down in that Directive?

2. For the purposes of Articles 13 and 19 of Council Regulation ... 1768/92, does the expression "first authorization to place ... on the market in the Community", include authorisations which had been permitted by national law to co-exist with an authorisation regime which complies with Council Directive 65/65/EEC?

3. Is a product which is authorised to be placed on the market for the first time in the EEC without going through the administrative procedure laid down in Council Directive 65/65/EEC within the scope of Council Regulation ... 1768/92 as defined by Article 2?

4. If not, is an SPC granted in respect of such a product invalid?"

We await the answers with excitement and trepidation ...