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.

SPCs and the "Salt" Problem No.2

Issue 4 of 2010 of Sweet & Maxwell's Intellectual Property Quarterly (IPQ) carries an interesting and highly relevant article by Dr Herwig von Morzé -- who is well known to readers of this weblog (click here).  The article, "SPCs and the "Salt" Problem No.2", has an abstract that reads as follows:

"Several provisions of the medicinal product SPC Regulation 1768/92 (codified as Regulation 469/2009) have been subject to interpretation and clarification by the ECJ. Because the initial administrative interpretation of a provision is undertaken by 27 national patent offices, it is not surprising that different national outcomes will result. Different outcomes may be confirmed at a national judicial level, unless a national court refers the issue to the ECJ.

Recital 14 of the plant protection product SPC Regulation 1610/96 has been subject to diverse national interpretation. This Recital also applies mutatis mutandis to the interpretation of several provisions of Regulation 469/2009. It concerns the issue of an SPC for a derivative of an active substance based on a second marketing authorisation issued for the derivative if an earlier authorisation exists for the active substance.

The article proposes the application of an existing regulatory approach to prevent disharmony within the EU. Notwithstanding the differences between EU and US law, recent US case law appears to support the appropriateness of the regulatory approach proposed in this article".

Losartan: a modern parable

“Losartan: a modern parable of pharma patent lifecycle management” is the title of a useful and interesting short article by Dr Duncan Curley and Dr Amanda Easey of Innovate Legal, published in the November 2010 issue of Intellectual Property Magazine. Via Wavedata comes this link to it. Many thanks, everyone, for letting The SPC Blog share it with our readers.

A new blog team member

The SPC Blog welcomes a new face to its blogging team:  James Kinnaird (right). 

A qualified European Patent Attorney and Chartered UK Patent Attorney, James is a member of the Royal Society of Chemistry. His professional experience include drafting and prosecuting patent applications, managing and devising strategies for worldwide patent portfolios, due diligence exercises and obtaining non-patent IP protection for pharmaceutical products. He has also been involved in opposition and appeal work before the European Patent Office.

A member of the patent team at Olswang LLP, James is a graduate of the University of Glasgow and possesses a doctorate from Cambridge University.  After obtaining post-doctoral experience at Columbia University, New York City, he worked as a medicinal chemist for a multi-national pharmaceutical company and is a named inventor on two patents derived from his research work.

We look forward to James's contributions to the blog.

Court of Justice rules on Hus(s)ar SPC

Napoleonic Hussar: an early
experiment in European unity?

The Court of Justice gave its ruling earlier today in Case C‑229/09, Hogan Lovells International LLP, formerly Rechtsanwaltssozietät Lovells v Bayer CropScience AG.  This was a reference for a preliminary ruling under Article 234 EC from the Bundespatentgericht.

Bayer owned a European patent covering, inter alia, a herbicide known as iodosulfuron. The application for this patent was filed on 12 February 1992; the patent issued on 11 November 1998 with an expiry date of 13 February 2012.  On 13 December 1998, an application to have iodosulfuron included in Annex I to Directive 91/414 [concerning the placing of plant protection products on the market] was lodged with the German authorities by an undertaking the rights of which were subsequently acquired by Bayer.  On 9 March 2000 the German authority issued a marketing authorisation to Bayer for a herbicide based on that substance, sold under the name ‘Husar’.  This was a provisional MA, issued on the basis of a provision of national law designed to transpose Article 8(1) of Directive 91/414. In order to take account of Commission Decision 2003/370 [allowing Member States to extend provisional authorisations granted for the new active substances iodosulfuron-methyl-sodium, indoxacarb, S-metolachlor, Spodoptera exigua nuclear polyhedrosis virus, tepraloxydim and dimethenamid‑P], the expiry date of that provisional MA, initially fixed at 8 March 2003, was put back to 21 May 2005.

On 17 July 2003 the Bundespatentgericht granted Bayer an SPC for iodosulfuron and some of its salts and esters for the period between 13 February 2012, the expiry date of the European patent and 9 March 2015. In calculating the duration of the certificate, the Bundespatentgericht took the view that the provisional MA of 9 March 2000 was the first MA.  On 25 September 2003 the Commission included iodosulfuron in Annex I to Directive 91/414 by means of Commission Directive 2003/84.

On 13 January 2005 the German authority issued a definitive MA to Bayer for Husar on the basis of the national provisions transposing Article 4 of Directive 91/414. Its expiry date was fixed at 31 December 2015.

The word is spelled 'Husar'
but an image search reveals
use of 'Hussar' only

Lovells brought an action before the Bundespatentgericht for annulment of the SPC of 17 July 2003, arguing that it was invalid in the light of Regulation 1610/96 [concerning the creation of a supplementary protection certificate for plant protection products].  Under Article 3(1)(b) of that regulation an SPC may be issued only after a definitive MA has been issued under the conditions laid down in Article 4 of Directive 91/414. In this case, however, the MA of 9 March 2000 was a provisional MA coming under Article 8(1) of that directive.

Bayer challenged that interpretation of Article 3(1)(b), which it considered contrary to the general scheme of that regulation and to the practice of the competent national authorities. The Bundespatentgericht decided to stay proceedings and to refer the following question to the Court for a preliminary ruling:

‘For the purpose of the application of Article 3(1)(b) of Regulation No 1610/96, must account be taken exclusively of [a MA] under Article 4 of Directive 91/414 … or can a certificate also be issued pursuant to [a MA] which has been granted on the basis of Article 8(1) of Directive 91/414 …?’

Today the court ruled as follows:

"Article 3(1)(b) of Regulation ... 1610/96 ... must be interpreted as not precluding a supplementary protection certificate from being issued for a plant protection product in respect of which a valid marketing authorisation has been granted pursuant to Article 8(1) of Council Directive 91/414 ..., as amended by Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005".

Dutch speaking readers can note this decision on the excellent Boek9.nl blog here

Lithuanian Kirin Amgen ECJ reference: a local lawyer comments

Readers will recall the recent ruling of the Court of Justice of the European Union in Case C‑66/09, Kirin Amgen Inc. v Lietuvos Respublikos valstybinis patentų biuras, Amgen Europe BV, noted on The SPC Blog here. A note on this decision, "ECJ preliminary ruling on patent law referral from Supreme Court", has now been published on International Law Office. This note, written by Edita Ivanauskienė (Lideika Petrauskas Valiunas ir partneriai LAWIN), concludes with the observation that the Court of Justice took a strict position regarding the issuing of supplementary protection certificates in a new Member State, demonstrating "the potential consequences of EU accession for the medicinal product's patent protection".

Yeda application heads for ECJ on indirect/contributory infringement issue

The SPC Blog thanks Tom Mitcheson (3 New Square) for letting us know that the Court of Appeal for England and Wales is making a further reference to the Court of Justice of the European Union for a preliminary ruling in Yeda Research and Development Company Ltd and Aventis Holdings Inc v Comptroller General of Patents (for earlier litigation on this matter see the SPC Blog here).

By an order of 8 October 2010 (here) the Court of Appeal seeks further guidance relating to Article 3(a) of Regulation 469/2009. It seeks to ask, in particular:

"If the criteria for deciding whether a product is 'protected by a basic patent in force' under Article 3(a) ... include or consist of an assessment of whether the supply of the product would infringe the basic patent, does it make any difference to the analysis if infringement is by way of indirect or contributory infringement based on Article 26 of the Community Patent Convention, enacted as s.60(2) Patents Act 1077 in the UK, and the corresponding provisions in the laws of other Member States of the Community?"

We've not yet had time to read the order in full (it runs to 17 pages) but will post further on this reference if it seems appropriate to do so.

Medeva note in latest BioSLR

The Bio-Science Law Review, published six times a year by Lawtext Publishing Ltd, often carries features relating to SPCs. The current issue -- volume 11, issue 1 -- is no exception. It carries a case comment by Sangeeta Puran (Mayer Brown International LLP) entitled "Reference to ECJ in Medeva BV v The Controller General of Patents concerning the conditions to be satisfied for the extension of patent term of patents for medicinal products in the EU". The abstract of this case comment reads as follows:

"In the EU, the term of a national patent or a European patent for drug products is extended through the grant of a supplementary protection certificate. This is governed by Council Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products.

The system recognises that significant periods of the 20 year patent term are lost due to the time it takes to obtain marketing authorisation for a new drug. The Court of Appeal has recently referred to the ECJ questions concerning the conditions that must be satisfied for the grant of a supplementary protection certificate, including whether it can be granted in relation to a patent which does not disclose all the active substances or components in the marketed drug. The current UK approach precludes an extension in such a case because the patent cannot be construed to "protect" the product as required by the regulation, even where the product and patent pass the "infringement test", that is the manufacture or supply of the product would infringe the patent. Other Member States, however, have adopted the infringement test, resulting in an important divergence in the approaches within the EU in respect of the same application for supplementary protection and resulting in dicta repeatedly calling for clarification by the higher court. This case note considers the issues that have led to the current reference to the ECJ and the diverging constructions that will be considered by it when determining the correct approach for patent term extension in the EU".

This piece features two useful figures, one being an example of a project lifecycle curve viewed from a cash flow perspective, the other being a graphic representation of the active ingredients/substances in the Medeva proceedings as they relate to the basic patent. marketing authorisations and SPC products.