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.

When will the "suitable opportunity" arise for changing an obsolete definition?

Let's all be pen-friends
with the European Commission

The SPC Blog thanks international patent consultant Dr Herwig von Morzé for sight of some interest and relevant correspondence between him and Oliver Vahhelyi on behalf of the European Commission (DG Internal Market and Services).

The background is as follows: since the consolidated text of Regulation 469/2009 of 6 May 2009 concerning the creation of a supplementary protection certificate for medicinal products (codified version, replacing Council Regulation 1768/92 of 18 June 1992) still includes the now obsolete definition of "medicinal product" and requires amendment incorporating the new definition, Dr von Morzé wrote to the Commission as follows:

"The above-identified consolidated Regulation at least in the version available to me which was published in OJEU 16.6.2009 L152/1-L 152/10 requires revision of the definition of ‘medicinal product’ in Art. 1(a). The new definition of ‘medicinal product’ in Art. 1(2) of Directive 2001/83/EC as amended by Directive 2004/27/EC published 28.11.2004 in OJ L-311, pages 67-128 reads as follows:

‘2. Medicinal product:
(a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or
(b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.’

As to the significance of the new definition please refer to Recital 7 of Directive 2004/27/EC.

Article 1(a) of Regulation (EC) No. 469/2004 still recites the previous, somewhat vague definition of ‘medicinal product’ which has been superseded by the new definition clarifying which actions exerted by the active substances of a medicinal product would be ‘restoring, correcting or modifying physiological functions’ (see the clause in bold above) .

The Hecht-Pharma GmbH judgment of the European Court of Justice C-140/07 of 15 January 2009 succinctly explains the significance of the expansion and the clarification achieved by the new definition:

‘33 As is apparent from recital 7 in the preamble thereto, the purpose of the amendments made by Directive 2004/27 to the definition of a medicinal product is to take account of the emergence of new therapies and of the growing number of so-called ‘borderline’ products. Also, in order to avoid doubts as to the applicable rules, the definition was made more precise and now specifies the type of action – pharmacological, immunological or metabolic – which a medicinal product must exert with a view to restoring, correcting or modifying human physiological functions.’

It must be assumed that the provisions of Regulation (EC) No. 469/2009/EC are set out to apply to all medicinal products within the ambit of the new definition. Regulatory concepts are not only key factors for administering and interpreting the Regulation but also must be incorporated in the codified Regulation in the version applicable as of the date of its codification to avoid uncertainty, improper limitations of its scope and unnecessary litigation.

I would be most grateful for your comments and would like to know which action would be taken to revise the definition".

for the European Commission (DG Internal Market and Services), Oliver Vahhelyi has responded as follows:

"Regulation (EC) 469/2009 indeed still uses the definition of medicinal products of Directive (EC) 2001/83 prior to the amendments made in 2004 by Directive (EC) 2004/27 of 31 March 2004.

We will consider introducing the definition of medicinal products of Directive (EC) 2001/83 as amended into Regulation (EC) 469/2009 when the most suitable opportunity arises to make such a technical adjustment.

I hope this information is useful to you".

"When the most suitable opportunity arises" is anyone's guess.  Readers' suggestions as to when we might see this amendment are welcomed.

Paediatric Extensions in European Countries

We recently posted a compilation of data by Martijn de Lange on drugs that had positive opinions on compliance with PIPs along with information on the corresponding SPCs in the Netherlands. Alice de Pastors has now supplemented this data with the status of paediatric extensions for selected drugs in different European countries:

1. Caspofungin

EU market authorization for Cancidas from Merck Sharp & Dohme Inc.

Paediatric extensions for caspofungin SPC

- Extensions granted until 23 or 24 April 2017 in Austria, Germany, Denmark,

France, The United-Kingdom, Greece, Ireland, Italy, The Netherlands, Sweden,

Slovenia;

- Extensions pending in Belgium, Finland, Portugal (possible expiry date

24 April 2017), Czech Republic (6 September 2017), Slovakia (7 July 2018)

- No extension data available for Bulgaria, Spain, Hungary, Luxembourg, Norway,

Poland, Romania (NO SPC pending)

- No SPC for Cyprus, Estonia, Iceland, Latvia, Lithuania, Malta.

5. Zoledronic acid

EU market authorization for Zometa from Novartis Europharm Limited

Paediatric extensions for zoledronic acid SPC

->for Novartis patents filed in November 1987 (EP275821)

- Extensions granted until 15 or 16 May 2013 in Germany, France, The United-

Kingdom, The Netherlands, Sweden, Denmark (20 May 2013),Ireland (19 May 2013),

Slovenia (8 October 2013);

- Extensions pending in Austria, Belgium, Italy (possible expiry date 16 May

2013), Finland (17 May 2013);

- No extension data available for Cyprus, Spain, Greece, Hungary, Luxembourg,

Norway, Portugal, Romania;

- No SPC in Bulgaria, Czech Republic, Estonia, Iceland, Latvia, Lithuania, Malta,

Poland.

-> for basic patent EP 258618 to Roche Diagnostics GmbH

No extension data available.

6. Losartan

National market authorization for Cozaar from Merck Sharp & Dohme Inc.

Paediatric extensions for losartan SPC

Extensions granted until 1 or 2 March 2010 in Austria, Belgium, Germany,

Denmark, Finland, France, The United-Kingdom, Ireland, Italy, The Netherlands,

Sweden, until 1 December 2010 in Latvia;

- No extension data available for Cyprus, Luxembourg, Norway.

- No SPC in other EU countries.

10. Valsartan

National market authorization for Diovan from Novartis Europharm Limited

Paediatric extensions for valsartan SPC

- Extensions until 12 November 2011 granted in The Netherlands, Sweden;

- Extensions pending in Germany, Denmark, Finland, The United-Kingdom,

(possible expiry date 12 or 13 November 2011);

- No extension data available for Austria, Belgium, France, Ireland, Italy,

Luxembourg, Latvia, Norway, Portugal;

- No SPC in other EU countries.

7.Anastrozole

National market authorization for Arimidex from AstraZeneca AB

Paediatric extensions for anastrozole SPC

- Extensions until 10, 11 or 12 February 2011 granted in Austria, Belgium,

Germany, Denmark, Finland, France, The United-Kingdom, Ireland, Italy, The

Netherlands, Sweden;

- No extension data available for Luxembourg, Norway.

- No SPC in other EU countries.

8.Abatacept

EU market authorization for Orencia from Bristol-Myers Squibb Pharma

Paediatric extensions for abatacept SPC

- Extensions until 15 or 16 December 2017 granted in Austria, Germany,

Denmark, The Netherlands, Ireland (30 December 2017);

- Extensions pending in Belgium, Finland, France, The United-Kingdom (possible

expiry date 15 or 16 December 2017);

- No extension data available for Cyprus, Spain, Greece, Hungary, Italy, Lithuania,

Luxembourg, Latvia, Norway, Portugal, Sweden, Slovenia.

- No SPC in other EU countries.

Patent extensions: some academic perspectives?

The John Marshall Review of Intellectual Property Law (RIPL) has now published issue one, volume 10 (you can view it here). In the first of its four lead articles, Verne Luckow and Steven Balsarotti write about their empirical study on patent applicants seeking longer patent term adjustments (PTAs).  This study concludes that an understanding calculations behind patent term extensions is the key to the development of licensing and ownership strategies for patented technologies. While this article deals with US extensions relating to delays in grant caused by USPTO bureaucracy, not to European-style SPC extensions, one of the authors' findings will interest readers of this weblog because it indicates judicial attitudes towards the pharma sector as well as signalling originating pharma's intentions with regard to its proprietary technology:

"... Despite the intent of Congress to compensate applicants for delays in prosecution in an industry-independent manner, applicants seeking reconsideration of a patent term adjustment in Federal District Court are highly-biased toward institutions seeking patents on pharmaceutical and related biotechnology inventions. Unlike patent term extensions, which are sought in a six-month period prior to regulatory approval and sale of a pharmaceutical product, and often long after a patent has issued claiming the product, court cases identifying patents needing longer PTAs provide early notice to the public, including investors and competitors, of technologies considered to have particular value to the applicant. ...".

Professor Reichman

The SPC Blog has learned that, this Monday, the distingushed US academic Professor Jerome H. Reichman (Duke University School of Law, Durham, North Carolina), gave a lecture at CEIPI in Strasbourg on "Patents and Public Health: Legal, Economic and Public Policy Aspects of Access to Medicines". If any reader of this was present, can he or she let us know whether this lecture covered the public health and policy aspects of patent term extension, so that we can contact Professor Reichman if necessary and ask for a copy of what he said?

Date for the 2011 SPC Blog's seminar: when is best for you?

The SPC Blog is looking forward to running its third seminar this coming Spring, kindly hosted by the London office of Olswang LLP. There's a poll at the top of this weblog's side bar, so you can click the range of dates that suits you best. Do please let us know your preference!

Details of the conference programme will be available in due course.

Positive opinions on PIPs

Since 2008, the European Medicines Agency (EMA) has reported twenty positive opinions on compliance with a Paediatric Investigation Plan (PIP). The opinions are an important step towards obtaining the compliance statement required for obtaining an SPC extension.

Martijn de Lange (Netherlands Patent Office) has compiled information on the opinions from the EMA site with information on the status of corresponding Dutch SPCs, if any, from the Dutch Patents Registry and kindly shares it with us below.

2008: 5 positive opinions issued

1. Caspofungin

EU market authorization for Cancidas from Merck Sharp & Dohme Inc.

Dutch SPC nr. 300076, basic patent EP 620232 to Merck Sharp & Dohme Corp.

Last day of protection: 2017.04.23

This includes the 6 months extension that was granted

2. Ribavirin

EU market authorization for Rebetol from Schering-Plough Europe

SPC application nr.300083 based on EP 643970 to ICN Pharmaceuticals rejected in 2004

3. Peginterferon alfa-2b

(based on EMEA-000384-PIP01-08)

EU market authorization for ViraferonPeg from Schering-Plough Europe

Dutch SPC nr. 300127, basic patent EP 809996 to F. Hoffmann-La Roche AG

Last day of protection: 2017.06.19

SPC extension not yet requested

4. Peginterferon alfa-2b

(based on EMEA-000071-PIP01-07)

EU market authorization for PegIntron/ViraferonPeg from Schering-Plough Europe

Dutch SPC nr. 300127, basic patent EP 809996 to F. Hoffmann-La Roche AG

Last day of protection: 2017.06.19

SPC extension not yet requested

5. Zoledronic acid

EU market authorization for Zometa from Novartis Europharm Limited

Dutch SPC nr. 300058, basic patent EP 275821 to Novartis AG

Last day of protection: 2013.05.15

This includes the 6 months extension that was granted

Dutch SPC nr. 300059, basic patent EP 258618 to Roche Diagnostics GmbH

Last day of protection: 2012.07.24

SPC extension not yet requested

2009: 8 positive opinions issued

6. Losartan

National market authorization for Cozaar from Merck Sharp & Dohme Inc.

Dutch SPC nr. 950009, basic patent EP 253310 to E.I. du Pont de Nemours and Company

Last day of protection: 2010.03.01

This includes the 6 months extension that was granted

7.Anastrozole

National market authorization for Arimidex from AstraZeneca AB

Dutch SPC nr. 970012, basic patent EP 296749 to AstraZeneca UK Limited

Last day of protection: 2011.02.10

This includes the 6 months extension that was granted

8.Abatacept

EU market authorization for Orencia from Bristol-Myers Squibb Pharma

Dutch SPC nr.300303, basic patent EP 606217 to Bristol-Myers Squibb Company

Last day of protection: 2017.12.15

This includes the 6 months extension that was granted

9.Colesevelam

EU market authorization for Foster/Kantos/Inuvair from Genzyme Europe

Dutch SPC nr. 300159, basic patent EP 764174 to Genzyme Corp.

SPC extension not yet requested

10. Valsartan

National market authorization for Diovan from Novartis Europharm Limited

Dutch SPC nr. 970001, basic patent EP 443983 to Novartis AG

Last day of protection: 2011.05.12

Request for SPC extension currently (30.09.10) pending

11. Purified diphtheria toxoid / Purified tetanus toxoid / Five component acellular pertussis [Purified Pertussis Toxoid (PT), Purified Filamentous Haemagglutinin (FHA), Purified Fimbriae Types 2 and 3 (FIM), and Purified Pertactin (PRN)] / Inactivated poliomyelitis vaccine (Vero) – Type 1 (Mahoney), Type 2 (MEF-1) and Type 3 (Saukett) / Purified polyribosylribitol phosphate capsular polysaccharide of Haemophilus influenzae type b covalently bound to Tetanus protein (PRP-T)

EU market authorization for Pediacel from Sanofi Pasteur MSD

Dutch SPC nr.300443, basic patent EP 835663 to GlaxoSmithKline Biologicals S.A

Last day of protection: 2015.10.01

SPC extension not yet requested

SPC applications nrs. 300403 and 300404 based on EP 1666057 and 300185, 300187 and 300188 based on EP 747058 all to Medeva are currently pending in view of ECJ C-332/10

12. Leucine / potassium acetate / cysteine / glutamic acid / praline / alanine / glycine / histidine / isoleucine / magnesium acetate tetrahydrate / olive oil, refined / methionine/ ornithine hcl / phenylalanine / tryptophan / valine/ taurine / tyrosine / sodium chloride / arginine / calcium chloride dihydrate / aspartic acid / serine / threonine / sodium glycerophosphate, hydrated / soya-bean oil, refined / lysine monohydrate / glucose monohydrate

Market authorization for ? from Baxter World Trade SA/NV

No Dutch SPC

13. Atorvastatin

National market authorization for Sortis, Lipitor, Tahor, Xarator, Zarator, Liprimar, Totalip, Torvast, Cardyl from Pfizer

Dutch SPC nr. 970034, basic patent EP 247633 to Warner-Lambert Company

Last day of protection: 2011.11.06

SPC extension not yet requested

2010: 7 positive opinions issued

14. Montelukast

National market authorization for Singulair from Merck Sharp & Dohme Ltd.

Dutch SPC nr. 990009, basic patent EP 480717 to Merck Frosst Canada Ltd.

Last day of protection: 2012.08.24

SPC extension not yet requested

15. Latanoprost

National market authorization for Xalatan from Pfizer Global Research & Development

Dutch SPC nr. 970039, basic patent EP 364417 to Pharmacia Aktiebolag

Last day of protection: 2011.07.17

SPC extension not yet requested

16. Human papillomavirus1 Type 6 L1 protein / human papillomavirus1 Type 11 L1 protein / human papillomavirus1 Type 16 L1 protein / human papillomavirus1 Type 18 L1 protein

EU market authorization for Gardasil from Sanofi Pasteur MSD

Dutch SPC nr. 300318, basic patent EP 647140 to Georgetown University

Last day of protection: 2018.06.23

Dutch SPC nr. 300264, basic patent EP 1015561 to Medimmune

Last day of protection: 2021.09.19

Dutch SPC nr. 300269, basic patent EP 1165126 to Merck & Co

Last day of protection: 2021.09.19

In all three cases SPC extension not yet requested

17. Nomegestrol acetate / 17 beta-estradiol

Market authorization for ? from Organon N.V.

No Dutch SPC

18. Esomeprazole

National market authorization for Nexium from AstraZeneca AB

Dutch SPC nr. 300027, basic patent EP 124495 to Aktiebolaget Hässle

Last day of protection: 2009.02.27

So SPC expired before extension could be filed

19. Midazolam

Market authorization for ? from ViroPharma SPRL

Dutch SPC application nr. 980040 based on NL 193145 withdrawn in 1999

20. Nevirapine

EU market authorization for Viramune from Boehringer Ingelheim International GmbH

Dutch SPC nr. 990022, basic patent EP 429987 to Boehringer Ingelheim Pharmaceuticals Inc. and Boehringer Ingelheim Pharma GmbH

Last day of protection: 2012.12.22

SPC extension not yet requested

Thanks Martijn!

New UK Office Manual changes affect SPCs

A number of changes have just been incorporated into the October 2010 version of the UK Intellectual Property Office's Manual of Patent Practice. Among other changes, SPC sections SPM3.02.1, SPM3.02.3 have been amended in light of Yeda Research and Development Company Ltd v Comptroller General of Patents and the Court of Justice reference in Medeva's SPC Applications and Georgetown University, Loyola University of Chicago, and University of Rochester’s SPC Applications.

You can read the current version of the SPC section here. A line in the left-hand margin highlights text which you won't find in the earlier January 2010 version.

Even more about HPV vaccines and SPCs

Just in case you're not immune to issues around SPCs for HPV vaccines, here's the latest juicy case (BL O/335/10) that was decided before the UK Intellectual Property Office (IPO):

The University of Queensland and CSL Limited filed 8 SPC applications at the IPO: 6 different applications to single Human Papilloma Virus (HPV) L1 protein virus-like particles (VLPs) (2 applications for HPV 16, 2 applications for HPV 18, 1 application for HPV11 and 1 application for HPV6), 1 application for a product comprising HPV16 and HPV18 L1 protein LPV, and 1 application for a product comprising HPV6, HPV11, HPV16 and HPV18 L1 protein LPVs. The applications were based on basic patents EP 0595935, EP 1298211 and EP 1359156. The marketing authorisations for Cervarix and Gardasil/Silgard were used to support the applications.

The issues raised here are similar to those in the Medeva and Georgetown et al. cases and concern the interpretation of Articles 3(a) and 3(b) of the Regulation. The IPO therefore proposed to defer further consideration of the applications until the outcome of the references to the Court of Justice of the European Union (CJEU) in relation to the Medeva and Georgetown cases. The applicant however requested a decision to be issued based on the papers on file so that, if the IPO were to refuse the applications, the decision could be appealed and a further referral to the CJEU could be made and considered at the same time as the other HPV-related cases.

The hearing officer, Dr. L. Cullen, found that the 6 SPC applications directed to single HPV L1 protein VLPs did not meet the requirement of Article 3(b) of the Regulation because neither of the MAs cited was a valid authorisation to place any of the single HPV L1 protein VLP products on the market as a medicinal product. Each MA related to a combination of active ingredients rather than a single active ingredient.

Moreover, the HPV combination applications did not meet the requirement of Article 3(a) of the Regulation because the basic patents did not protect combination HPV L1 protein VLP products, but only related a method for preparing single HPV L1 protein VLPs, HPV L1 protein VLPs made by this method and vaccines prepared from HPV L1 protein VLPs made by this method. Nothing in the patents suggested that the single HPV products could be used in combination with each other.

The applications were rejected in accordance with Article 10(4) after the application was provided with an opportunity to correct the irregularities of the application.

The complete decision is available here.

Circadin appeal now published in the RPC

Back in May The SPC Blog reported briefly that Mr Justice Arnold (Patents Court, England and Wales) dismissed an appeal against the Intellectual Property Office's refusal to grant a supplementary protection certificate for Circadin.

The judge's decision has now been reported in full, together with a helpful headnote, in volume 127, issue 9, of the Reports of Patent, Design and Trade Mark Cases (RPC), published by Oxford University Press on behalf of the Intellectual Property Office.

Vaccines causing trouble once more....

Here we go again, another question on Article 3(b) referred to the CJEU, this time via Georgetown University (and others) - with yet another vaccine patent (referral here).

The question referred is the same as question 6 in the Medeva vaccine reference (reported here) on Article 3(b).

Specifically:

Does the SPC Regulation and, in particular, Article 3(b), permit the grant of a Supplementary Protection Certificate for a single active ingredient or combination of active ingredients where:
(a) a basic patent in force protects the single active ingredient or combination of active ingredients within the meaning of Article 3(a) of the SPC Regulation; and
(b) a medicinal product containing the single active ingredient or combination of active ingredients together with one or more active ingredients is the subject of a valid authorisation granted in accordance with Directive 2001/83/EC or 2001/82/EC which is the first marketing authorisation that places the single active ingredient or combination of active ingredients on the market?

Chastened that IPKAT posted this information before us, the SPC blog raises a weekend glass to that team!

SPC search in Denmark and Switzerland: a reader asks ...

One of our readers, head of IPM in an Indian pharma company, has written to ask for some advice:

"I want to know the I would like to know how to search the SPC details in Denmark and Switzerland. I have been trying for a long time but couldn't reach the right URL. Can you please help me in this regard?"

If anyone has some helpful hints, can he or she please post them as a comment below this blogpost?

New Swedish PRV search service includes SPCs

PRV, the Swedish Patent and Registration Office, has announced a new online service. The Swedish Patent Database is a free search service which covers Swedish patents. Requiring no login, the database covers not just Swedish patents and published patent applications but also European patents validated in Sweden, EP applications published under §88 of the Swedish Patents Act, granted EP patents whwhich designate Sweden (these are searchable in the database for six months from the EPO’s grant date), Supplementary Protection Certificates and their extensions.

The database, which is updated every night, offers access to searchable full text for all patent documents, as well as bibliographic data, information about classification, status, fees and registration, and links to File Inspection. The website adds:

"A Supplementary protection certificate search makes it possible to search through applications for supplementary protection certificate as well as granted SPC’s and extension of SPCs".

Court of Justice says "no" to Kirin Amgen, "yes" to Member States' transitional discretion

The Court of Justice handed down its ruling this morning in Case C‑66/09, Kirin Amgen Inc. v Lietuvos Respublikos valstybinis patentų biuras, Amgen Europe BV, a reference for a preliminary ruling from the Lietuvos Aukščiausiasis Teismas (Lithuania) dating back to 10 February 2009.

What was this about? In short, Kirin Amgen owned a 1994 European patent for Aranesp, which was extended to Lithuania. In June 2001 Kirin Amgen obtained a Community marketing authorisation and then lodged an application for an SPC with the Lietuvos Respublikos valstybinis patentų biuras (the Lithuanian Patent Office), accompanying the application with its Community marketing authorisation. The SPC having been refused initially and on several appeals, Kirin Amgen maintained that the fact that it held a Community marketing authorisation was sufficient to obtain an SPC in Lithuania: it did not exceed the six-month period for lodging its application, because that period had to be calculated from 1 May 2004, the date upon which the Republic of Lithuania acceded to the European Union. The Lietuvos Aukščiausiasis Teismas (Supreme Court of Lithuania) stayed the proceedings before it and asked the Court of Justice for a preliminary ruling on the following questions:

‘(1) Is the date, referred to in Article 19(2) of Regulation No 1768/92, upon which that regulation enters into force to be understood for [the Republic of] Lithuania as the date of its accession to the European Union?

(2) Should the answer to the first question be in the affirmative, what is the relationship between Article 19 and Article 7 of Regulation No 1768/92 when calculating the six-month period and which of those articles is it necessary to apply in a case?

(3) Did an authorisation to place a product on the market in the European Community enter into force unconditionally in the Republic of Lithuania from the date of its accession to the European Union?

(4) Should the answer to the third question be in the affirmative, can the entry into force of the authorisation to place the product on the market be equated to its grant for the purposes of Article 3(b) of Regulation No 1768/92?’

Today the Court ruled as follows:

"Articles 7 and 19a(e) of Council Regulation ... 1768/92 ..., as amended by the Act concerning the conditions of accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic ..., must be interpreted as not allowing the holder of a valid basic patent in respect of a product to apply to the competent Lithuanian authorities, within six months of the date upon which the Republic of Lithuania acceded to the European Union, for the grant of a supplementary protection certificate where an authorisation to place that product on the market as a medicinal product was obtained more than six months before accession under Council Regulation ... 2309/93 ... laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products, but the product did not obtain a marketing authorisation in Lithuania".

In its analysis of the legal position, the Court justified its position in the following terms:

"45 As regards the objective pursued by Regulation No 1768/92, it is admittedly true that the regulation establishes a uniform solution at European Union level by creating an SPC which may be obtained by the holder of a national or European patent under the same conditions in each Member State and by providing, in particular, for a uniform duration of protection (see, by analogy, Case C-350/92 Spain v Council [1995] ECR I-1985, paragraph 34, and Hässle, paragraph 37). As is apparent from the sixth recital in its preamble, that regulation seeks thereby to prevent the heterogeneous development of national laws leading to disparities likely to create obstacles to the free movement of medicinal products within the Community and thus directly affect the establishment and the functioning of the internal market.

46 Nevertheless, certain Member States wished, in accordance with the 10th recital in the preamble to that regulation, to safeguard for a longer period the achievement of other legitimate objectives, concerning their public-health policies, and, in particular, ensure the financial stability of their health system by supporting the generic medicinal product manufacturing industry (see, to this effect, Hässle, paragraph 38).

47 In order to take account of those differences in assessment, Articles 19 and 19a of Regulation No 1768/92 contain different relevant dates as a transitional measure. The setting of those dates according to the Member State thus appears to be justified inasmuch as each of them shows the assessment made by each Member State in the light, in particular, of its health system, the organisation and financing of which vary from one Member State to the next (see, by analogy, Hässle, paragraphs 39 and 40).

48 It follows from the foregoing that the objective pursued by Regulation No 1768/92 of according uniform protection for a medicinal product throughout the European Union does not preclude transitional provisions, resulting from the accession negotiations, which may mean that it is not possible to apply for an SPC for certain medicinal products in certain Member States. This outcome, which may impede, even if only temporarily, that objective and the functioning of the internal market, is justified by the legitimate objectives concerning health policies, including, as the case may be, the financial stability of the health systems of the Member States (see, to this effect, Hässle, paragraph 46).

49 In the circumstances of the main proceedings, it would run counter to the outcome of the negotiations which led to the accession of the Republic of Lithuania to the European Union to accept that a holder of a Community marketing authorisation such as the holder in the main proceedings can rely on Article 7 of Regulation No 1768/92 to obtain an SPC in Lithuania. Article 19a(e) of that regulation provides for the possibility of applying to the competent Lithuanian authorities for grant of such an SPC only on the basis of a first marketing authorisation obtained in Lithuania before the accession of that State. As has been stated in paragraph 33 of the present judgment, that provision does not lay down any derogation concerning products which have been the subject of a Community marketing authorisation.

50 Furthermore, if the entry into force of a Community marketing authorisation in a new Member State could be equated to its grant there, every Community marketing authorisation would confer entitlement to the grant of an SPC if it were applied for within six months of the accession of such a Member State to the European Union, even if the date of grant of that marketing authorisation were prior to the dates for the obtaining of an authorisation that are referred to in the transitional provisions of Regulation No 1768/92. This would also run counter to the outcome of the accession negotiations.

51 To give an example concerning another Member State, it would be possible, if the grant of a marketing authorisation were equated to its entry into force, for the holder of a Community marketing authorisation obtained before 1 May 2004 to apply in the Czech Republic for an SPC until 30 November 2004, although Article 19a(a)(ii) of Regulation No 1768/92 provides for the lodging of such an application, so far as concerns that Member State, only within six months of the date on which the first marketing authorisation was obtained.

52 Consequently, the wording and the context of Articles 3(b), 7 and 19a(e) of Regulation No 1768/92 as well as the objective of the latter, and in particular the objective pursued by its transitional provisions, preclude the entry into force of the Community marketing authorisation from being equated to its grant within the meaning of Article 3(b)".