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.