Transcript DRUG PATENTS – INFRINGEMENTS Dr. V. R. Srinivas

Cipla
Caring for life
AUGUST 2009
Cipla
CROSS BORDER SEIZURES
Dr. Alka Mehta
Cipla Limited
August 2009
Cipla
INTELLECTUAL PROPERTY
An intellectual property is any product or invention of
human intellect that is unique, novel, and non-obvious and
has some commercial value
Types of Intellectual Property
• Patents
• Copyrights; and
• Trademarks
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Patent - Definition
A patent is a monopoly right granted to an inventor, giving the
inventor the right for a limited period of time to prevent others from
making, using or selling his invention without due permission from
the inventor.
A patent can be
a) bought,
b) sold,
c) rented; or
d) hired
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Patent encourages
Innovation
Inventor
Government
Discloses
Apply
invention and
best mode of
practicing the Reward
invention
Grants Exclusive
Rights for the
Invention to
owner of patent
for limited period
of time
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RELEVANCE OF
PATENT INFORMATION
TECHNOLOGICAL
RELEVANCE
COMMERCIAL
RELEVANCE
LEGAL
RELEVANCE
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Infringement
whoever without authority makes, uses, offers to sell, sells, or
imports any patented invention during the term of the patent,
infringes the patent.
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Introduction:
Many countries do not have manufacturing capacity to produce
medicines and rely on the import of affordable generic medicines from
abroad in order to treat their populations. As such, the trade in
legitimate medicines between countries is fundamental to ensure
access to medicines for millions of people in the developing world.
Ensuring access to medicines in developing countries, as enshrined in
the Doha Declaration and the WTO decision, cannot be implemented
effectively if, on key transit routes, the risk exists that supplies can be
regularly subject to interception based on the assertion of patent
infringement in the transit country.
If patent protection is absent in the country of destination, there is no
basis for provisional holding actions to prevent possible foreign
infringement.
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When drug X is patented in Netherlands, but not South America, and a
Company exports X from India to South America, and the flight
containing drug X makes a stopover in Netherlands on the way to
South America, the drug on board the flight does not infringe the
Netherlands patent.
However, if the Company has reason to suspect that the (possible)
Dutch patent holder will have formulated a request for notification for
that particular drug; an alternative routing can prevent delay by
customs/seizures. This would force exporters to look at alternative
routes to send the medicines, which is likely to impact the cost
competitiveness of Indian generic drugs.
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
Council Regulation (EC) No. 1383/2003, permits customs authorities to seize goods passing through customs
of an EU member state when these goods are suspected of infringing patents granted and subsisting in these
countries, provided that the patent holder has registered in advance with the customs authorities.

The regulations permit customs to hold these goods for ten working days (or a further period provided for in
the regulations) and inform the patent holder of the seizure. The patent holder then has to apply to a civil court,
request a civil seizure and initiate legal proceedings in order to prove that infringement has taken place.

This authority to seize goods not only applies to goods that are destined for the EU country to which these
regulations apply, but also to goods that are merely passing through these ports on their way to another country
outside the EU. For example goods bound from India to South America, which are passing through an EU
member state, are also liable to be seized.

Courts in different EU member states appear to have pronounced different views on the legality of these
provisions, when the goods are not intended for an EU member country and the law is not completely settled in
this regard.

These provisions may have a significant impact on Indian companies, most of which use the EU route to
transport pharmaceutical products to markets where the patent is not recognized or the product is off patent. By
forcing Indian companies to opt for a different route to transport the goods to the intended market, the cost of
transport may significantly add to the cost of producing the pharmaceutical product, thus adversely impacting
the India's ability to remain competitive.

This is especially relevant in the case of bulk exports from India of the API (active pharmaceutical ingredient)
because it is one of the largest exporters in the world of these products. India's cost advantage may be reduced
if companies are constrained to send pharmaceutical products such as the bulk drug used for formulating much
needed medicines in the developing world through alternative routes. This will, obviously, also impact the
availability of much needed medicines in developing countries, to which India exports these goods.
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Facts
Three consignments of Indian-manufactured generic medicines –
seized last year while in transit in the EU – have been earmarked for
destruction by EU authorities. These consignments – of clopidogrel,
rivastigmine and olanzapine – were being exported from India to other
developing countries to treat patients with serious and life-threatening
conditions such as heart attacks, strokes, Alzheimer's disease,
Parkinson's disease and psychosis. Yet they were seized by Dutch
customs authorities on the basis of alleged patent infringement.
Although these medicines are not under patent in India or in the
destination countries, EU customs legislation still permits the
destruction of these life-saving medicines. A humanitarian
organisation, Médecins Sans Frontières (MSF), has highlighted several
other recent cases of generic medicines in transit in the EU that have
been detained, seized or destroyed.
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The root of the current wave of seizures is the blurring of the definition
between legitimate generic medicines and illegal counterfeit
medicines. It is vital to differentiate between illegal counterfeit
medicines – which the World Health Organization defines as medicines
having a false representation of identity and/or source – and legitimate
generic medicines, which are, in most cases, simply unbranded
versions of patented medicines.
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The current definition of counterfeit medicines by the World Health
Organization (WHO) and the one proposed by the WHO-backed International
Medical Products Anti-Counterfeiting Taskforce (IMPACT) is leading to such
interpretation of in-transit drug consignments from India.
Definition of “Counterfeit Goods”
1) Customs Legislation: Regulation (EC) 1383/2003 concerning customs
action against goods suspected of infringing certain IPR rights (…); Art. 2
Nr. 1a
i. goods, including packaging, bearing without authorization a trademark
identical to the trademark validly registered in respect of the same type of
goods…
ii. any trademark symbol (including a …brochure…) on the same conditions as
the goods referred to in point (i);
iii. packaging materials bearing the trademarks of counterfeit goods, presented
separately, on the same conditions as the goods referred to in point (i);
2) WHO Definition (2007):
“A medicial product is counterfeit when there is a false representation in
relation to its identity, history or source”.
 does not include IPR violations!
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According to Pharmexcil, companies whose consignments also ran into similar trouble
(other than as listed below) include JB Chemicals and Pharmaceuticals Ltd, Medico
Remedies Pvt. Ltd, Titan Pharma India Pvt. Ltd, and Mission Pharmaceuticals Ltd, all
based in Mumbai, and Hyderabad-based Sainor Pharma Pvt. Ltd.
Listed below are the consignments of Indian companies that were seized on grounds of
patent infringement by the Dutch customs authorities.
1. 15.10.08: Ind-Swift Laboratories Ltd (Clopidogrel Bilsulphate- API): Destined for
Columbia
A consignment valued at some $100,000 (Rs 49 lakh) of Ind-Swift in transit for
Venezuela was seized in November by customs authorities in the Netherlands under
suspicions of being counterfeit.
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Contd..
2. 27.11.08: Cipla Ltd, through Uni World Pharma Ltd, Dubai
(Olanzapine 10 mg Tabs): Destined for Peru.
Currently Eli Lilly and Cipla have been in negotiation.
3. 27.11.08: Cipla Ltd, through Uni World Pharma Ltd, Dubai
(Rivastigmine 3 mg Tabs): Peru.
Consignment released by Novartis.
4. 24.12.08: Dr Reddy’s Laboratories Ltd (Losartan - API): Destined for Brazil
A DRL shipment of the generic version of losartan was seized in transit in the
Netherlands. This shipment, on its way to Brazil, was held by the customs authority
at Rotterdam, which said it infringed the patent of the original drug—Cozaar.
Losartan is not patented in India or Brazil. The patent for Cozaar in the Netherlands
is held by DuPont, while US-based pharma multinational Merck and Co. holds the
marketing rights."
5. A consignment of HIV/AIDS medicines by Aurobindo Pharma Ltd meant for use
in Nigeria was seized by Dutch officials. The grounds on which they were allegedly
seized again is that they contained counterfeit goods.
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Dr. Reddy's Case

Background: A consignment of 500 Kg of Losartan potassium was
bound for Brazil. It was seized in transit by the Netherlands customs
authorities under the authority of an EC council regulation, permitting
the seizure of goods on suspicion of patent infringement in the
Netherlands. Apparently, Losartan is protected in the Netherlands by a
product patent of Merck/Dupont which is valid until September 2009.
The only issue was one of patent infringement in the Netherlands. The
value of the consignment seized is $ 55,000 and not $500,000 as
mentioned in the media.

Subsequently Dr. Reddy's discussed the matter with the patent holders
and secured the release of the goods from the custody of the customs
authorities. Merck/Dupont agreed to release the goods to Dr. Reddy's
on Thursday (8th Jan) and the goods are now back in India.
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The Dutch government has asked the European Commission (EU) for
a review of the EU Customs regulations. The Dutch government has
taken up this damage control exercise after developing countries
strongly criticised the seizure of consignments of Losartan.
Subsequent to these seizures which prompted India and Brazil to issue
very strong statements against this action, DRL opted to back down
and have its consignment returned to India.
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In addition to Brazil and India, those voicing concerns about access to
medicines and customs were: Argentina, Bolivia, Burkina Faso, China, Costa
Rica, Cuba, Ecuador, Egypt, Indonesia, Israel, Nigeria, Pakistan, Paraguay,
Peru, South Africa, Thailand and Venezuela.
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The statement made by the European Commission, on behalf of the
European Union, at the WTO General Council on 3 February, stresses
that the seizure was allowed by TRIPS and that it was based on
provisions in EU customs law that allow customs to temporarily detain
goods.
However, the EC Regulation No 1383/2003 goes beyond the
obligations required under the TRIPS Agreement, in which a footnote*
clearly states that goods in transit can be kept outside the field of
application of the general customs procedures.
*Footnote: It is understood that there shall be no obligation to apply such procedures to
imports of goods put on the market in another country by or with the consent of the right
holder, or to goods in transit.
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


Article 41 of the TRIPS Agreement also states that any intellectual enforcement
measures should “be applied in such a manner as to avoid the creation of barriers to
legitimate trade.” Finally, the 2001 Doha Declaration on TRIPS and Public Health –
signed by the members of the European Union - underlines that “the TRIPS Agreement
can and should be interpreted and implemented in a manner supportive of WTO
Members' right to protect public health and, in particular, to promote access to
medicines for all.”
Article 51
Suspension of Release by Customs Authorities
Members shall, in conformity with the provisions set out below, adopt procedures to
enable a right holder, who has valid grounds for suspecting that the importation of
counterfeit trademark or pirated copyright goods may take place, to lodge an application
in writing with competent authorities, administrative or judicial, for the suspension by
the customs authorities of the release into free circulation of such goods. Members may
enable such an application to be made in respect of goods which involve other
infringements of intellectual property rights, provided that the requirements of this
Section are met. Members may also provide for corresponding procedures concerning
the suspension by the customs authorities of the release of infringing goods destined for
exportation from their territories.
Article 54
Notice of Suspension
The importer and the applicant shall be promptly notified of the suspension of the
release of goods according to Article 51.
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As per Generics Bulletin dated March 11, 2009

Dutch customs officials contradicted the World Trade Organization’s (WTO’s)
agreement on trade-related aspects of intellectual-property rights (TRIPS) and broke the
European Union’s commitments under the WTO’s Doha Declaration, members of the
European Parliament (MEPs) have asserted in a letter to the EU Commissioners for
Trade and for Taxation and Customs Union.

Highlighting recent Dutch seizures of losartan being shipped from India to Brazil and of
abacavir that was in transit from India to Nigeria, the MEPs insist “seizures of generic
drugs within the EU are becoming an increasingly widespread problem”. The European
Regulation cited by the European Commission at the WTO General Council
(Generics bulletin, 13 February 2009, page 11) “goes beyond the obligations required
under the TRIPS agreement, in which a footnote clearly states that goods in transit can
be kept outside the field of application of the general customs procedures”, the MEPs
maintain.

Latching onto a letter sent by Médicins Sans Frontières (Generics bulletin, 6 March
2009, page 13), the MEPs call on the Commission to clarify its position on EC
Regulation 1383/2003 and its application to medicines.
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At the WTO TRIPS Council of 3 March the DG Trade official justified
the recent seizures of generic medicines on the basis of the need to
combat the entry of fake medicines into the EU. The cases that we
have outlined above involved legitimate generic medicines and not
fake, counterfeit or pirated medicines.
The original purpose of Regulation 1383/2003 was to combat
counterfeit and pirated goods and not to detain goods that infringe
IPRs.
The EC Regulation 1383/2003 must be changed in order that customs
officials have clear guidance on its implementation and therefore avoid
disrupting legitimate trade.
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WHO issues mild statement on transit of medicines,
on March 13th, 2009
The WHO has just issued a statement on the transit of medicines. It is
short and mild. The statement does not mention goods in transit in the
title. It does not mention at all that medicines have been seized. The best
part of the statement is the following quote:
“ Ensuring that the interests of trade and health are appropriately
managed, also means that the flow of legitimate medicines, including
generic medicines, is not impeded”
The action part of the statement is weak, however:
“ In relation to this issue, WHO is continuing to follow developments and
consulting with Member States and relevant international
intergovernmental organizations. WHO also understands that there is
ongoing dialogue among the parties concerned to resolve the matter.
Given the public health impact of this issue, WHO remains ready to
provide, upon request, technical and policy support to Member States.“
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Views of NGOs
The following are the views of few NGOs on role of the WHO in addressing public
health concerns over goods in transit.


Buko Pharma-Kampagne, Christian Wagner-Ahlfs ([email protected]).
"Cheap generics are essential for developing countries. Each attempt to label legally
produced generics as counterfeit or product piracy, affects public health. We ask WHO
to use its mandate for public health by encouraging European governments not to block
generic imports to developing countries.“
HAI Global, Tim Reed, (+31 20 683 3684, [email protected]).
"As an NGO who has worked collaboratively with the World health Organisation
(WHO) for many years on delivering increased access to essential medicines and the
rational use of medicines in low and middle income countries, Health Action
International is dismayed that WHO has remained quiet for so long about the recent
spate of generic medicine seizures in Europe. This is an opportunity for WHO to show
strong leadership and promote its own principle of universal access to essential
medicines, with a clear message that the actions in European ports are unacceptable.
Instead, we have a deafening silence."
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Contd…

HAI Europe, Teresa Alves, (+31 20 683 3684, [email protected]).
"The public health dimension of the European seizures of generics cannot be ignored.
Yet, the clock is ticking while the international health community awaits WHO's
reaction. WHO must act decisively to drive global health advocacy and represent the
interests of those who do not have access to the medicines they need.“

Knowledge Ecology, James Love, (office +1 202-332-2670, mobile +1 202-361-3040,
[email protected]).
"The WHO should protect the poor, and champion access to medicine. There is a
campaign by a handful of giant pharmaceutical companies and trade associations to
undermine legitimate trade in generic medicines. As noted by the Director General of
the World Trade Organization (WTO), the seizures of medicines in transit to developing
country markets is a serious issue. There are many resolutions and declarations that
speak to the need to promote access to medicines, and the WHO clearly has a
mandate in this area. The WHO needs to find its voice, and act."
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Contd…

TransAtlantic Consumer Dialogue, Anne-Catherine Lorrain (+32 473 99 97 92,
[email protected]).
"The silence of the World Health Organisation (WHO) sends the wrong signal on the
crucial issue of the supply of legitimate generic medicines to developing countries.
Consumers are looking to the WHO to provide leadership and expertise in resolving this
issue, which is critical for our life and health.“

Third World Network, Sangeeta Shashikant (office: +41 22 908 3550,mobile: +41
78 757 2331, [email protected]).
"The lack of a prompt response by WHO on an issue that affects access to medicines in
developing countries is extremely disappointing.It suggest a lack of commitment and
leadership in WHO. As an organisation tasked with the attainment by all peoples of the
highest possible level of health, WHO must without any further delay push the EU to
amend its Directive. WHO should also assess and speak out against the anticounterfeiting initiatives such as IMPACT, WCO's SECURE, ACTA that could have
serious consequences for the availability of generics and access to medicines."
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To achieve a principled solution to the problem facing the generic pharmaceutical trade, one
can proceed with the following:
i) a court will have to ask the European Court of Justice (ECJ) for guidance.
ii) file a petition at the WTO Dispute Settlement Body.




Below is a time and cost estimate to obtain ECJ guidance.
Time estimate
In a proceedings on the merits the relevant questions can be put to the ECJ in six months to a
year's time. Procedures before the ECJ vary (greatly) in length, but will generally take at least
another year and a half. After the ECJ has given guidance the Dutch proceedings will continue.
From an European perspective, this would be, in fact, a quick result, given that only the
highest national courts are obliged to ask guidance on EU law, and courts of first instance are not.
Costs
Costs of patent litigation before the Dutch courts of first instance range from EUR 35,000,- to
EUR 250,000,-. However, the cost of patent litigation is in a large part due to the costs of expert
evidence and involvement of patent attorneys. To minimize costs and exposure, one can (1) avoid
(postpone) claiming a specific sum as damage, (2) avoid making patent-related claims, and (3) ask
the court to merely declare that a Dutch (EU) patent is not sufficient for infringement in transit,
according to national and EU law.
In this way, for instance, the costs involved with claiming and substantiating non-infringement will
be postponed, to wait and see if it is worthwhile to make these costs. A demand for release of the
consignment and demands for payment can be added later, after the ECJ has given guidance.
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
A dispute arises when one country adopts a trade policy measure or takes some
action that one or more fellow-WTO members considers to be breaking the WTO
agreements, or to be a failure to live up to obligations. A third group of countries
can declare that they have an interest in the case and enjoy some rights.

The Dispute Settlement Body
Made up of all member governments, usually represented by ambassadors or
equivalent

A procedure for settling disputes existed under the old GATT, but it had no fixed
timetables, rulings were easier to block, and many cases dragged on for a long time
inconclusively. The Uruguay Round agreement introduced a more structured
process with more clearly defined stages in the procedure.
 If a case runs its full course to a first ruling, it should not normally take more than
about one year — 15 months if the case is appealed. The agreed time limits are
flexible, and if the case is considered urgent (e.g. if perishable goods are involved),
it is accelerated as much as possible.
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How long to settle a dispute?
These approximate periods for each stage of a dispute settlement procedure are target
figures — the agreement is flexible. In addition, the countries can settle their dispute
themselves at any stage. Totals are also approximate.
60 days
Consultations, mediation, etc
45 days
Panel set up and panellists appointed
6 months
Final panel report to parties
3 weeks
Final panel report to WTO members
60 days
Dispute Settlement Body adopts report (if no appeal)
Total = 1 year
(without appeal)
60-90 days
Appeals report
30 days
Dispute Settlement Body adopts appeals report
Total = 1y 3m
(with appeal)
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WTO Dispute Settlement Body: Panel Process
60 days Consultations (Art. 4)
By 2nd DSB
meeting
0-20 days
20 days (+10 if
Director –General
asked to pick panel)
Panel established
by Dispute Settlement Body (DSB) (Art. 6)
Terms of Reference (Art. 7)
Composition (Art. 8)
Panel examination
Normally 2 meetings with parties (Art. 12),
1 meeting with third parties (Art. 10)
Interim review stage
Descriptive part of report
sent to parties for comment (Art. 15.1)
Interim report sent to parties for comment (Art. 15.2)
6 months from panel’s
composition,
3 months
if urgent
August
2009
During all stages
good offices, conciliation,
or mediation (Art. 5)
Panel report issued to parties
(Art. 12.8, Appendix 3 par 12 (j))
Expert review group
(Art. 13; Appendix 4)
Review meeting
with panel
upon request
….30 days for
appellate report
(Art. 15.2)
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Up to 9 months
Panel report issued to DSB
from panel’s
establishment (Art. 12.9; Appendix 3 par 12 (k))
DSB adopts panel / appellate report (s)
60 days for panel Including any changes to panel report
report unless
made by appellate report
appealed….
(Art. 16.1, 16.4 and 17.14)
REASONABLE
Implementation
PERIOD OF
report by losing party of proposed
determined by Implementation within reasonable period
member proposes,
of time (Art. 21.3)
DSB agrees; or
parties in dispute
agree; or arbitrator
In cases of non-implementation
(approx 15 months,
if by arbitrator)
parties negotiate compensation
pending full non-implementation (Art. 22.2)
Retaliation
If no agreement on compensation, DSB authorizes
retaliation pending full non-implementation.
30 days after
(Art. 22)
reasonable
period expires
Cross-Retaliation:
same sector, other sectors, other agreements
August 2009
(Art. 22.3)
Appellate review
(Art. 16.4 and 17)
max 90 days
Dispute over
Implementation:
Proceedings possible,
including referral to initial
panel on implementation
(Art. 21.5)
TOTAL FOR
REPORT
ADOPTION:
Usually up to 9
months (no
appeal), 12
months (with
appeal) from
establishment
of panel to
adoption of
report (Art. 20)
90 days
Possibility of arbitration
on level of suspension
procedures and principles
of retaliation
(Art. 22.6 and 22.7)
Cipla
India may move WTO to protest drug seizures

After voicing its concerns with EU and WHO separately, India is now considering legal options as
the issue is a trade dispute between governments.

India plans to sue the European Union at the World Trade Organization for allowing big
pharmaceutical companies to use the bloc's tough patent laws to detain generic drugs in transit to
developing countries, according to India's commerce secretary, Mr. Rajeev Kher. He further said,
it’s an attack on the Indian Generis Industry, adding that he’s preparing a complaint that India
would soon file at WTO.
(Ref: The Wall Street Journal Asia, Aug 6, 2009)

While the seizures were carried out on charges of alleged violation of intellectual property rights
(IPR), India’s attempt will be to prove that the consignments were not meant for European
markets, but were on transit towards its final destinations in Africa and South America and hence
involve no IPR violation.
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India warned on moving WTO over drug seizures
(Ref: Business Standard: New Delhi Aug 11, 2009)

Even as India considers the European Union (EU) directive that allows seizure of goods-intransit by its member countries as violative of the World Trade Organization’s TRIPS agreement,
legal experts caution against the central government’s plans to approach the dispute settlement
body of WTO.

What has triggered the change of mind among Indian experts is a recent decision of the UK High
Court to refuse Nokia’s plea to seize counterfeit cell phones (bearing Noika name) that had
reached London’s Heathrow airport from Hong Kong en route to Colombia.
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Nokia Corporation v Her Majesty’s Commissioners of Revenue & Customs
(HMRC) [2009] EWHC 1903 (Ch)

Nokia petitioned the UK customs authorities (HMRC) to seize counterfeit cell phones (bearing
the Nokia trademark) that had reached London's Heathrow airport from Hong Kong en route to
Colombia.

HMRC refused and Nokia challenged the said refusal before the UK High Court.

Mr. Justice Kitchin held that since the said counterfeit goods were mere "in transit" goods that
were never meant for the UK market, it fell outside the ambit of the relevant EC Customs
Regulation (Council Regulation No 1383/2003 of 22 July 2003).

In particular, he held that in order for alleged counterfeits to be susceptible to seizure or detention
under the above mentioned regulation, the said goods must have been "used in the course of
trade" within the UK. Transit goods do not satisfy this condition, unless and until there is a
serious risk that they are likely to be diverted to the local market (the so called "Montex"
exception).
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Applying Nokia Decision to Indian Drug Seizures

It bears noting that one cannot readily assume that Kitchin J's ruling in the context of "in transit"
counterfeit phones would apply on all fours to the Indian drug seizure cases.

Kitchin's decision was limited to counterfeit goods (where identical trademarks have been used)
and not patented goods. In pertinent part, Kitchin J held that customs seizures are defensible only
when the entry of the allegedly infringing goods into the local border amounts to an
"infringement" under the laws of the country whose borders have been breached. A mere "in
transit" good that is never meant for trade within the UK cannot be said to infringe, merely
because it had crossed the UK border.

The UK Patents Act (based on the EPC 1973, as revised by EPC 2000) does not contain any such
"use in the course of trade" limitation. However, this by itself is not sufficient to conclude that any
and all "in transit" goods that happen to infringe a UK patent could be detained by UK customs
authorities. Rather, on the wordings of the UK Patents Act (1977), the allegedly infringing goods
have to be "imported" into the UK in order for it to amount to an infringement.

In line with Kitchin J's reasoning in the Nokia case, it could be argued that an in-transit entry is not
really an "import", as these goods were never meant for the UK market and were unlikely to harm
the market of a patent owner within this territory. It also bears noting that drugs violating patent
rights (which have been properly authorized by a drug regulator) cannot be equated with
counterfeit goods. In fact, public health considerations dictate that such goods must be placed on a
much higher and deferential pedestal than counterfeit goods.
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UK vs. Dutch Courts

One may argue that the judgment, at best, reflects a UK understanding of the EC customs
regulation and this may not necessarily tally with courts of other jurisdictions, most notably the
Dutch courts themselves...who have been known to be more partial to IP owners (with a higher
number of "infringement" findings and a lower number of "revocations") than their English
counterparts.

In the case at hand, Nokia cited a judgment contending that in an earlier decision (Sisvel v
Sosecal, Case No 311378 of 18 July 2008), a Dutch court found in favour of a patent owner
seeking to detain "in transit" goods that were being transhipped from China to Brazil.

However Kitchin J cleverly distinguished the Sisvel decision on the ground that it was based
upon the particular wordings of Article 6 of Regulation (EC) No 3295/94, a regulation that was
subsequently replaced by the 2003 EC customs regulations.
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Challenging the Drug Seizures before Local Dutch Courts

Should an Indian company challenge the drug seizures before a Dutch court, it is unclear as to
how they would rule.

Would they examine TRIPS provisions on this count and interpret their local laws in such a way
that they remain TRIPS compliant?
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Vote of thanks

My sincere thanks to Pharmaexil for Pharmaexil's efforts and to
Government of India and also to The Brussels and The Hague embassies
to support the Indian companies, especially Cipla in fighting this unjust
seizure in the name of Intellectual property violation when Netherlands
was used merely as a transit for goods intended for Peru.

My sincere thanks to my colleagues Ms. Patsy Jeffery and Ms. Bhakti
Vajratkar in preparing this presentation

My sincere thanks to Spicy IP colleagues for allowing me to reproduce
some of the information.
August 2009
Cipla
THANK YOU FOR YOUR TIME AND PATIENCE
August 2009
Cipla