[Ip-health] India's request for consultations with the European Union and the Kingdom of the Netherlands

Thiru Balasubramaniam thiru at keionline.org
Fri May 14 00:02:14 PDT 2010


My authorities have instructed me to request consultations with the  
European Union (the “EU”) and the Kingdom of the Netherlands (the  
“Netherlands”) pursuant to Article 4 of the Understanding on Rules and  
Procedures Governing the Settlement of Disputes, Article XXII:1 of the  
General Agreement on Tariffs and Trade 1994 (the “GATT 1994”) and  
Article 64.1 of the Agreement on Trade-Related Aspects of Intellectual  
Property Rights (the "TRIPS Agreement"), regarding the repeated  
seizures of consignments of generic drugs originating in India at  
ports and airports in the Netherlands on the ground of alleged  
infringement of patents subsisting in the Netherlands while these  
consignments were in transit to third country destinations (the  
“measures at issue”).


             Based on complaints of alleged infringement by alleged  
owners of patents over the last two years, customs authorities in the  
Netherlands have seized a substantial number of consignments of  
generic drugs from India in transit through the Netherlands. India  
understands that these seizures were made by applying the so-called  
“manufacturing fiction” under which generic drugs actually  
manufactured in India and in transit to third countries were treated  
as if they had been manufactured in the Netherlands.  These  
consignments were initially detained and later, either destroyed or  
returned to India.  In a few cases, the consignments were permitted to  
proceed to the destination country after considerable delay.   
Available evidence confirms that the customs authorities seized at  
least 19 consignments of generic drugs in 2008 and 2009 while in  
transit through the Netherlands, 16 of which originated in India. An  
illustrative list setting forth relevant details of some of these  
seizures is provided in the Annex to this request.


             The measures at issue also include the reiterated conduct  
and practice of seizing generic drugs in transit on the ground of  
alleged patent infringement and the following, among other, laws,  
rules, regulations, guidelines and administrative practices of the EU  
and of the Netherlands but only to the extent that they authorise or  
require the seizure or destruction of drugs in transit on the ground  
of alleged patent infringement:


             a.         Council Regulation (EC) No. 1383/2003 of 22  
July 2003;


             b.         Commission Regulation (EC) No. 1891/2004 of 21  
October 2004;


c.         Council Regulation (EEC) No 2913/92 of 12 October 1992;


d.         Directive 2004/48/EC of the European Parliament and of the  
Council of 29 April 2004;


e.         Regulation (EC) No 816/2006 of the European Parliament and  
of the Council of 17 May 2006;


f.          Relevant provisions of the Patents Act of the Kingdom of  
the Netherlands, 1995 (Rijksoctrooiwet 1995) (the “Patents Act”), as  
amended, including, without limitation, the provisions of Chapter IV  
thereof, especially Articles 53 and 79, and relevant rules,  
regulations, guidelines and administrative practices;


g.         Relevant provisions of the General Customs Act of the  
Netherlands (de Algemene douanewet (Adw)) (the “Customs Act”), as  
amended, including, without limitation, Articles 5 and 11 and relevant  
rules, regulations, guidelines and administrative practices;


h.         Customs Manual VGEM (30.05.00 Intellectual Property Rights,  
Version 3.1) (Douane Handboek VGEM, 30.05.00 Intellectuele  
eigendomsrechten, 6 April 2009, Versie 3.1) including, without  
limitation, the provisions of Chapter 6 and of other relevant Chapters;


i.          The Public Prosecutor’s Office Guide to Intellectual  
Property Fraud 20005A022 of 1 February 2006 (Aanwijzing  
intellectueleeignendomsfraude 2005A022) and the Public Prosecutor’s  
Office Directive (2005R013);


j.          Relevant provisions of the Criminal Code of the  
Netherlands (Het Nederlandse Wetboek van Strafrecht) including,  
without limitation, the provisions of Article 337, and relevant rules,  
regulations, guidelines and administrative practices; and


k.         Relevant provisions of the Criminal Procedure Code of the  
Netherlands and relevant rules, regulations, guidelines and  
administrative practices.


             This request also covers any amendments, replacements,  
extensions, implementing measures and any other related measures with  
respect to the laws, rules, regulations, guidelines and administrative  
practices of the EU and of the Netherlands set forth above.


             India considers that the measures at issue are, in  
several respects, inconsistent as such and as applied, with the  
obligations of the EU and the Netherlands under the following  
provisions of the GATT 1994 and of the TRIPS Agreement:


             1.         Paragraphs 2, 3, 4, 5 and 7 of Article V of  
the GATT 1994 because the measures at issue, inter alia, are  
unreasonable, discriminatory and interfere with, and impose  
unnecessary delays and restrictions on, the freedom of transit of  
generic drugs lawfully manufactured within, and exported from, India  
by the routes most convenient for international transit;


             2.         Article X of the GATT 1994, including, without  
limitation, Article X:3, because the measures at issue, inter alia,  
are not administered in a uniform, impartial and reasonable manner;


             3.         Article 28 read together with Article 2 of the  
TRIPS Agreement, Article 4bis of the Paris Convention, 1967 and the  
last sentence of paragraph 6(i) of the Decision of the General Council  
of August 30, 2003 on the Implementation of Paragraph 6 of the Doha  
Declaration on the TRIPS Agreement and Public Health (the “August 30,  
2003 Decision”) because a cumulative  reading of these provisions  
confirms, inter alia, that the rights conferred on the owner of a  
patent cannot be extended to interfere with the freedom of transit of  
generic drugs lawfully manufactured within, and exported from, India;


             4.         Articles 41 and 42 of the TRIPS Agreement  
because the measures at issue, inter alia, create barriers to  
legitimate trade, permit abuse of the rights conferred on the owner of  
a patent, are unfair and inequitable, unnecessarily burdensome and  
complicated and create unwarranted delays; and


             5.         Article 31 of the TRIPS Agreement read  
together with the provisions of the August 30, 2003 Decision because  
the measures at issue, inter alia, authorise interference with the  
freedom of transit of drugs that may be produced in, and exported  
from, India to Members of the World Trade Organization with  
insufficient or no capacity in the pharmaceutical sector that seek to  
obtain supplies of such products needed to address their public health  
problems by making effective use of compulsory licensing.


             India considers further that the measures at issue also  
have a serious adverse impact on the ability of developing and least- 
developed country members of the World Trade Organization to protect  
public health and to provide access to medicines for all.   
Accordingly, the provisions of the TRIPS Agreement referred to above  
must be interpreted and implemented in light of the objectives and  
principles set forth in Articles 7 and 8 of the TRIPS Agreement, the  
Doha Ministerial Declaration on the TRIPS Agreement and Public Health  
adopted on 14 November 2001 and in the light of Article 12(1) of the  
International Covenant on Economic, Social and Cultural Rights, which  
recognizes the right of all persons to the enjoyment of the highest  
attainable standard of physical and mental health.


We reserve the right to raise additional claims and legal matters  
regarding the measures at issue during the course of the consultations.


             We look forward to receiving your reply to this request  
to set a mutually convenient date for these consultations.




Annex


Seizures by Dutch Customs of Pharmaceutical Products

Originating in India during Transit through the Netherlands


1.                  Seizure in October 2008 at Schiphol airport  
(Netherlands) of a consignment of clopidigrel from India destined for  
Colombia, on the ground of infringement of one or more patents*  
alleged to be valid and enforceable in the Netherlands and owned or  
licensed by Sanofi-Aventis.


2.                  Seizure in November 2008 at Schiphol airport  
(Netherlands) of a consignment of abacavir from India, purchased on  
behalf of UNITAID and destined for Nigeria, on the ground of  
infringement of one or more patents alleged to be valid and  
enforceable in the Netherlands and owned or licensed by Glaxo.


3.                  Seizure in November 2008 at Schiphol airport  
(Netherlands) of a consignment ofolanzapine from India destined for  
Peru, on the ground of infringement of one or more patents alleged to  
be valid and enforceable in the Netherlands and owned or licensed by  
Eli Lilly & Co.


4.                  Seizure in November 2008 at Schiphol airport  
(Netherlands) of a consignment ofrivastigmine from India and destined  
for Peru on the ground of infringement of one or more patents alleged  
to be valid and enforceable in the Netherlands and owned or licensed  
by Novartis AG.


5.                  Seizure in December 2008 at Schiphol airport  
(Netherlands) of a consignment of losartan from India and destined for  
Brazil on the ground of infringement of one or more patents alleged to  
be valid and enforceable in the Netherlands and owned or licensed by  
E.I. Du Pont de Nemours and Co. Inc., Merck & Co. Inc. and Merck Sharp  
& Dohme B.V.


* In this Annex, “patents” also refers to, and includes, supplementary  
protection certificates.



------------------------------------------------------------


Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)
thiru at keionline.org


Tel: +41 22 791 6727
Mobile: +41 76 508 0997








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