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Monday 4 October 2010

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!

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