Meaning of 'product' in US patent extensions

"An ‘active ingredient’ of a drug must be present when the drug is administered" is the title of a Current Intelligence note by Bart A. Gerstenblith (Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, Washington, DC) on the US decision in PhotoCure ASA v Kappos, 603 F.3d 1372 (Fed. Cir. 2010). This District Court, Eastern District of Virginia, decision concerns the interpretation of the patent term extension provisions of the Drug Price Competition and Patent Term Restoration Act 1984 (the ‘Hatch-Waxman Act’).  It considers the term ‘product’ in 35 USC §156(a), explaining that it means the active ingredient that is present in a drug when administered, not necessarily the ‘active moiety’ of the drug.

This note has been published on the Advance Access service of the Journal of Intellectual Property Law & Practice (JIPLP), but has been made fully available to all on the jiplp weblog here.

A chance to comment on the Yeda reference, but you'd better be quick

No time to cook the turkey and eat it if you're planning
to comment to the UK IPO on Case C-518/10

In October of this year the Court of Appeal for England and Wales sought a preliminary ruling from the Court of Justice of the European Union in Case C-518/10 Yeda Research and Development Company and Aventis Holdings (see earlier note on The SPC Blog here). Essentially, what the Court of Appeal wanted to know, taking into account Article 3(a) of Regulation 469/2009, Article 26 of the Community Patent Convention and s.S60(2) of the UK Patents Act 1977, was whether the criteria for determining that a product is “protected by a basic patent in force” includes whether a supply of a product would infringe the basic patent by way of indirect or contributory infringement based on Article 26 of the Community Patent Convention (implemented by S60(2) of the Patents Act).

The UK's Intellectual Property Office has just issued an email circular today, stating:

"If you would like to comment on this case please e-mail policy@ipo.gsi.gov.uk before 6 January 2010 [presumably this should be 2011]".

Given that the IPO must have known about this reference since October, and given that much of the UK is closed for business for most of the time between now and 6 January 2011, does anyone know why this invitation has been issued so late?  If it's any consolation, the IPO routinely gives interested parties only a few days' notice of the deadline for commenting on references to the Court of Justice.

The deadline for the receipt of observations by the Court of Justice itself is believed to be 25 February 2011.

"No, no, Novartis", says court, you can't join in!

Daiichi Sankyo Co Ltd v Comptroller General of Patents [2010] EWHC 2898 (Pat) is a decision of Mr Justice Floyd (Patents Court, England and Wales) almost exactly a month ago, on 5 November. Perhaps because it is a small decision and was not made available on BAILII, it slipped past The SPC Blog, which thanks Mr Justice Arnold for pointing out that the decision has remained unnoticed on the blogosphere.

Under Article 3(a) of Regulation 469/2009

"A certificate shall be granted if, ...

(a) the product is protected by a basic patent in force".

This was an application by Novartis, under the Civil Procedure Rules (CPR) r.19.2(2)(a), for an order that it be joined as a party to proceedings in which questions were to be referred to the Court of Justice of the Euroepan Union on the interpretation of Article 3(a) of Regulation 469/2009. Under r.19

""The court may order a person to be added as a new party if -
"(a) it is desirable to add the new party so that the court can resolve all the matters in dispute in the proceedings; or
"(b) there is an issue involving the new party and an existing party which is connected to the matters in dispute in the proceedings, and it is desirable to add the new party so that the court can resolve that issue".

What had happened here is that Daiichi had appealed against the Comptroller's decision to refuse to grant an SPC in relation to a combination of olmesartan medoxomil and hydrochlorothiazide (olmesartan medoxomil being one of a range of compounds disclosed in one of Daiichi's European patents, while the diuretic hydrochlorothiazide was used as an anti-hypertensive agent but was not one of the claimed agents).  While Daiichi's SPC application was turned down as being non-compliant with Article 3(a), the court proposed to refer questions to the Court of Justice for a preliminary ruling on the interpretation of that article.

What, then, was Novartis's interest? Teva was suing Novartis in Italy, Belgium and the Netherlands, alleging that Novarrtis's SPC for a combination of Valsartan and hydrochlorothiazide was invalid since the product in question was not protected by the basic patent -- thus also raising a question under Article 3(a). There were also proceedings in Belgium in which it was argued that a generic combination product could not infringe the SPC for Valsartan alone.  According to Novartis, therefore, that any judgment on the reference which was to be made in Daiichi's case would be of direct relevance at least to some of the proceedings which it faced, and joining Novartis would bring "a new perspective" to these proceedings.

Mr Justice Floyd rejected the application, having concluded that it was not appropriate to join Novartis as a party since the requirements of CPR.19.2(2)(a) were not satisfied. It could not be said that, with the presence of the existing parties, the matters in dispute in the present proceedings could not be adequately and properly resolved and Novartis had failed to show that its involvement was needed in order to assist either the Patents Court or the Court of Justice to reach a conclusion.

The judge added that Novartis's interest was solely in the outcome of a question of law, on which submissions would be made both by Daiichi and by the Comptroller.  Adding extra parties would not have any beneficial effect.