On the debate of abuse of patents it can be said that assignment of patents/IPRs
in itself is not the problem, the problem arises due to non-enforcement of
patent rights and lack of sufficient knowledge regarding patents. There are many
myths surrounding patents in India which when discussed highlighted that patent
abuse in India is largely due to the myths surrounding it.
The conclusion on the
choice whether patents should be made competitive or should they continue to be
an exception to the Competition Act, 2002 is that the patents should continue to
be as an exception to the Act because the benefits from assigning patents and
giving monopoly rights to the patentee exceeds the benefits of charging a market
price to the consumers by making patents competitive.
Therefore for the overall welfare to increase it is essential that the patents
regime in India is modified regularly and general awareness regarding patents
and their proper use is increased by launching awareness oriented programmes, in
addition to this proper management of patent right application should be ensured
to avoid patent abuse.
Compulsory License (S.84)
The provisions of compulsory license are made to prevent the abuse of patents as
a monopoly and to make way for commercial exploitation of the invention by the
interested person. Any interested person can make an application for the grand
of compulsory license for the grand of patent after three years from the date of
grand of that patent on any of the following grounds;
- the reasonable requirements of the public with respect to the patented
intention have not been satisfied.
- the patented invention is not available to the public domain at a
reasonably affordable price
- the patented invention is not worked within the territory of India. The
request for the grant of compulsory license can be made by the licensee of
Abuse Of Rights
Generally speaking, abuse of the rights as a legal concept is well-known. It
means that although as per the theory, someone might be acting within the scope
of what is legally permitted (as a ‘right’), as the law is infringed nonetheless
because a specific situation turns out to render the chosen action to be legally
unacceptable. A right is used, but in an illegitimate (‘abusive’) way. Without
the application of the abuse of rights theory, said behaviour could not or only
with great difficulty be challenged. Abuse of rights thus frames the general
‘substance over form’ debate. It can be considered a counterweight of
flexibility to/in positivistic legal systems.
In most legal systems, the notion roots in the more general notion of ‘good
faith’. In common law systems, it has been linked to ‘equity14’. We concentrate
on the classical and narrow ‘abuse of rights’ doctrine. To this purpose, how the
abuse of rights is being applied in the civil law of a number of countries is
highlighted here. Countries are addressed as such;
- The Belgian legal system – the authors’ native country
- The French - where the notion of ‘l’abus social’ appears particularly
interesting in light of instances going against a given rights’ rationale
- The German - a country with a strong positivistic legal system
- The Swiss - a country with a clear as well as specific provisions on the
In Belgium, the notion (‘Rechtsmisbruik’) in civil law roots in the general
obligation to good faith: “Alle overeenkomsten, …, moeten te goeder trouw worden ten
As we will see below, this is the case in most jurisdictions. The narrower
notion of abuse of rights does not however have a particularly long history in
Belgium. Although it first appeared in the early 20th century, ‘modern’ abuse of
rights was only established in the 1980s. It is nonetheless considered to be a
general principle of law today.
Abuse of rights has been interpreted by Belgium’s highest court in several
cases. It has most recently been defined as the exercise of one’s right(s)
obviously/evidently going beyond the normal exercise of that right by a careful
and concerned person. On this basis, numerous applications of it can be
In international law
In the public actors’ relationship, abuse of rights is exclusively based upon
the principle of good faith. Good faith is one of the most important principles
of the International law. Treaties must be executed and interpreted as well
with pacta sunt servanda - in good faith - bona fides. We read it in of the
Vienna Convention on the Law of Treaties:
“Every treaty in force is binding upon the parties to it and must
be performed by them in good faith
“A treaty shall be interpreted in good faith"
The TRIPs Agreement mentions ‘abuse
’ at several occasions.
First, "it says that its member states may take ‘appropriate measures’
(cryptically however: ‘consistent with the Agreement’) to prevent the abuse of
intellectual property rights by right holders. This could be interpreted as
allowing countries to work with the notion of abuse of rights, but may then also
be interpreted as establishing a limitation thereto: ‘consistency with the
Second, members may specify licensing practices or conditions that may
constitute an abuse of intellectual property rights. The abuse here is limited
to the constellation of licensing practices having an adverse impact on
competition. It is thus similar to the US Patent Misuse notion. The provision
however does not exclude a broader use. It only - explicitly but exemplary -
mentions exclusive grant-back conditions, conditions preventing challenges to
validity and coercive package licensing in this context. Further, in Article 41
TRIPs we read as mentioned above that enforcement procedures must be applied in
such a manner as to provide for safeguard against their abuse and that adequate
compensations for defendants who were victim of abused enforcement procedures
are allowed (yet not imposed).
Abuse Of Rights In Patent Law
A classical subject of abuse of rights cases are ownership rights. The notion is
classically applied to limit the way one can use one’s garden in relation to the
neighbours. Much case law on the matter in fact developed from such cases.
Patent rights being (intangible) ownership rights, the application of the notion
in patent law should occur predictably smooth. In Germany for instance, patent
rights are considered to be a form of personal property as guaranteed under
Article 14 of the constitution.
Surprisingly, however, cases in patent law involving abuse of rights arguments
are not known of so far. Only concepts similar to those being used in the US
patent system can be found: patent misuse and inequitable conduct. The
investigation on how abuse of rights would function in patent law therefore has
to start from scratch, yet may rely on a strong potential for analogical
applications from US doctrines. We therefore start off with these.
Patent misuse in the United States cannot be used to start a case. It is merely
an affirmative defence and unlike abuse of rights, it is linked to competition
effects of patents. It is a type of tool internal to patent law to tackle
anticompetitive behaviour. Although a breach of competition law is not enough to
invoke patent misuse, neither is it a requirement.
Patent misuse can be used to “show that the patentee has impermissibly broadened
the ‘physical or temporal scope’ of the patent grant with anticompetitive
Patent misuse is there to ; “prevent a patentee from using the patent to obtain
market benefit beyond that which inheres in the statutory patent right”.
It has been recently confirmed in Federal Circuit jurisprudence that this should
be interpreted narrowly, yet the notion of “obtaining market benefit beyond that
which inheres the statutory patent right” does seem to leave some leeway to
address more than pure competition issues. Even then, however, it remains a mere
defensive tool, and appears to be limited to “a handful of specific practices by
which the patentee seemed to be trying to 'extend' his patent grant beyond its
A general application of the concept seems to have been excluded from the
notion, while a number of cases are explicitly excluded from patent misuse under
35 U.S.C. 271 (D). Patent misuse will be sanctioned by the unenforceability of
the patent until the misuse has stopped.
The US notion of ‘inequitable conduct’ can be inspiring to our study as well.
Inequitable conduct in general means the failure of an applicant to exercise his
duty of candour and good faith to the patent office; the USPTO.70 This notion is
thus closely linked to the idea of tackling abusive pre-grant behaviour. If a
patent applicant has failed to provide certain prior art information or
submitted false information to the patent office, the patent will be declared
The patent cannot be declared invalid on this basis and it has in fact
been infringed, yet inequitable conduct in the course of the procedure will make
it unenforceable. Unlike with patent misuse, this will be permanent. Like with
patent misuse, it is however only a defence mechanism. This means that the
deterring effect on third-parties of the patent obtained in an abusive manner
will to a large extent remain. Proof of inequitable conduct, finally, has been
set quite strictly. A “mere showing that art or information having some
degree of materiality was not disclosed”, is not enough71.72
Abuse of patent rights
After having seen what is being used already, we now move to investigating our
proposal: introducing the notion of abuse of patent rights. Going back to the
categorisation we made in the introduction, and linking this to the country
studies above, it is now indeed have to check whether or not the notion of abuse
of rights is usually broad enough to cover all the said cases:
- Can abuse of rights be used to tackle uses of a patent that are abusive
towards a specific third-party?
- Can abuse of rights be used to address instances where a patent is being
used against the rationale of the system?
- Can abuse of rights be used when a patent is being used against higher
ends, i.e. the benefit of society as a whole?
The answers to all three questions a priori appears to be in the affirmative.
The above discussed notions of abuse of rights in civil law slightly differ
amongst the studied countries. Yet, it can be noted that whether it is derived
from the provisions of good faith or from extra-contractual liability, abuse of
rights covers cases where:
- third-parties are affected with or without an intention to cause damage;
as well as
- cases where a right is being used against its rationale or its social
Whereas the notion may thus appear broad enough to cover the three groupings in
most systems, it is however not clear whether it offers an adequate relief to
each of them. Also, it may often appear difficult to prove when, for instance, a
patent is being used in a way that goes against the rationale of the patent
system, which aims at incentivising innovation.
A specific issue of patent law finally shows in distinguishing the cases (and
their effect) amongst whether the ‘abuses’ root in the pre-grant phase – before
the actual grant of the right – whether they originate post-grant; or whether
they are mixed.
Consequently, three questions will be addressed in the discussion:
- Can the notion – in relation to abuse of the system’s rationale or
‘higher ends’ – really be used in practice or would one stumble on the
difficulty to bring evidence that is more than anecdotal or equivocal?
- For which cases is the usual remedy of abuse of rights – the
curtailment/limitation of the use of the right – adequate and for which is
it not? Or, alternatively, could the abuse of rights also lead to the
revocation of the patent?
- Can the notion apply to both pre- and post-grant issues; and if so,
which of both types of cases would it be able to tackle efficiently (in
light of the above)?
Secondly, post-grant issues are the ‘natural habitat’ of the abuse of rights
notion. Before being able to abuse a right, one must have acquired it. Following
the usual application of abuse of rights as discussed above, one could not count
on the notion to be applicable to pre-grant abuses. However, the specific
context of patent law, the emphasis on third-parties appeal and the lack of
strong pre-grant checks by the institution granting the rights may require a
broad interpretation of the notion to include such cases. Abuse of rights is
applied differently in the field of law. It is essentially a flexible notion,
and in patent law no prior jurisprudential guidance exists.
Abuse Of Patent Rights Applied: Evergreening Of Patents
A situation often referred to as an abuse of the patent system is the so-called
evergreening of patents. It can be described as follows: shortly before a patent
expires, one re-applies a slightly different version of the invention to restart
another 20 years of protection for what is in fact the same subject matter.
Mostly, this scenario is encountered in the medicinal field:
“the evident commercial strategy of innovative drug companies to evergreen their
products by adding bells and whistles to a pioneering product even after the
original patent for that pioneering product has expired”.
The evergreening of patents is not limited to this field, yet is particularly
present here due to the increasing number of patentable drug properties.
In the evergreening scenario, competitors will thus not be able to place a
generic version of the product on the market even after twenty years - as should
be the case. The compromise that has lead to rewarding innovation with a
time-limited monopoly is disregarded. The duration of a patent is extended by
another 20 years, although innovation did not occur:
“In particular, strategy documents of originator companies confirm that some of
them aimed at developing strategies to extend the breadth and duration of their
patent protection. Filing numerous patent applications for the same medicine
(forming so called "patent clusters" or "patent thickets") is a common practice.
Documents gathered in the course of the inquiry confirm that an important
objective of this approach is to delay or block the market entry of generic
Issues of evergreening exist on various levels. The first level covers
non-legal, practical analysis and impact assessment issues. The second is about
the legal basis to address the matter. The first level goes beyond the scope of
this article, but is nonetheless worth mentioning. It brings about questions on
how to distinguish real cases of evergreening from genuine innovation (a matter
of case-to-case, non-legal analysis) and on the concrete realm and impact of the
phenomenon (a matter of quantitative and qualitative patent data analysis). We
only address the second level of issues here: legal matters.
The evergreening of patents essentially calls for pre-grant intervention: it
should simply not happen. Patent officers must be able to assure the quality of
the patents they grant.
Third parties faced with patents suspected of evergreening have several options.
Either they do not enter the field protected by the evergreened patent – the
worst scenario – or they simply ignore the patent at stake and do enter the
Two possibilities can be outlined:
- The patent holder may only have been speculating on the deterrent effect
of his patent. In the knowledge that it would not stand in an invalidity
procedure, the patent holder would then simply not initiate an infringement
- Or, an uncertain procedure starts. The patent holder will challenge the
competitors or other third parties which ignored the patent. Here:
- A patent law-internal challenge will most likely bring an invalidity
counterclaim. This may however not necessarily bring the patent owner to the
losing camp. We will see below that the patentability requirements will not
necessarily lead to invalidation. Inventiveness could be invoked, but this
will depend on how this notion is applied in the given jurisdiction.
- Rather, competition law elements may in fact appear the most ready. Both
unfair competition and the abuse of monopoly positions could be used to
tackle the effects of an evergreening patent.
Yet, one must then first fulfil their internal criteria of application (e.g. the
proof of a dominant position), and it remains unclear to which extent the use of
unfair competition is in fact allowed in relation to IP issues.
- Finally, the abuse of rights notion or – in the United States – the
patent misuse or inequitable conduct doctrines could be used.
Inventors intending to evergreen their patent rights make use of the fact that,
for patent law, inventions can be novel, inventive and industrially applicable
(and hence patentable) without achieving substantial progress. Inventions must
in fact not solve an existing problem or improve a given invention.
There is no ‘solving an unsolved problem’ requirement. This allows, for
instance, for the patenting of different processes leading to the same result.
It is therefore in fact a legitimate feature of the patent system. Although not
solving an unsolved problem a priori, these processes and methods nonetheless
bring about progress. If used strategically however, the said mechanism can lead
to situations such as the evergreening of patents.
For this reason, India decided to explicitly exclude new dosages and different
forms of the same medicine such as capsules, tablets, syrups, and suspensions
from patentability, as well as more generally every known substance which does
not result in the enhancement of the known efficacy thereof. Salts, esters,
ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of
isomers, complexes, combinations and other derivatives of known substances will
be considered to be the same substance, unless they differ significantly in
properties regarding efficacy. This is a purely pre-grant intervention, however
also allowing later invalidity (counter) claims to be successful post-grant.
Perhaps this is the most recommendable approach, yet as we’ll see later, doubts
as to the TRIPs compatibility of the measures arise.
In the post-grant phase, classical elements to redress an abusive use of certain
patents are to be found outside of patent, in competition law. We discuss below
the European example to see whether abuse of dominant position and/or unfair
competition is suited to address the matter of evergreening.
- Abuse of dominant position
Under EU law, a dominant position is reached when
“a position of economic strength enjoyed by an undertaking which enables it to
prevent effective competition being maintained in the relevant market by giving
it the power to behave to an appreciable extent independently of its
competitors, customers and ultimately of consumers”.
The main factors here appear to be the size of market shares, economic weakness
of competitors, and the control of resources and technologies. Abuses of
dominant positions are ruled by the European Court of Justice (ECJ) as being
objective concepts; the “recourse to methods different from those which
condition normal competition in products and services on the basis of the
transactions of commercial operators”, resulting in the reduction of competition
in a market already weakened by the company concerned.
Examples here include imposing unfair prices or other unfair trading conditions;
limiting production, markets or technical development to the prejudice of
consumers; applying dissimilar conditions to equivalent transactions with other
trading parties; and imposing supplementary obligations which have no connection
with the purpose of the contract.
Depending on what is considered to be the ‘relevant market’, a patent holder may
be deemed to have a dominant position. However, a patent alone cannot lead to a
presumption of a monopoly or dominant position. It is an ownership right. It is
still the market deciding on whether or not there is a monopoly, and not the
eventuality of patents. Patents in fact do not decide on markets per se. Yet,
they do help shaping them.
- Unfair competition
The notion of unfair competition primarily aims at ensuring fairness in business
operations and is meant to fulfil the need that all market participants should
play in accordance with the same rules. Unfair competition is one the few
competition law features to have entered into international law. Under Article
2.1 of the WTO TRIPS Agreement, which incorporates Article 10bis of the 1883
Paris Convention, unfair competition forms part of WTO law.
Although under Article 10bis of the Paris Convention, the concept seems limited
to direct and indirect (potential and future) competitive relationships, unfair
competition notions essentially protect against unfair business practices and
therefore not compulsorily call for a competitive relationship. The concept
could equally be invoked to protect consumer’s interests and those of the public
or the economy at large. In the EU, unfair business-to-consumer practices can
for instance be found in acts that are contrary to the behaviour of
professional diligence and in behaviour that has an adverse impact on the
economic activities of the average consumer (especially when this practice is
misleading and aggressive).
Again, the evergreening of patents appears to fit the description, perhaps even
more easily than that of abuse of monopoly rights. However, it is debated to
what extent unfair competition can be invoked in patent law cases, since patent
law would be the lex specialis. Both would be mutually exclusive.
Abuse of patent rights
Evergreening patents slip through the mazes of the legal net. They are hard to
challenge since they move along the borderline between the legal and the
illegal, yet, they are definitely illegitimate. This is exactly the type of case
for which the notion of abuse of rights has been designed in other fields of
The evergreening of patents constitutes a case-study which could fit into each
of the three groupings of our previously established typology of patent misuses,
and thus upon each of the three elements that could constitute or border the
abuse of patent rights notion:
- an abuse in relation to specific third-parties (e.g. competitors,
- an abuse in view of the rationale of the patent right and the patent
system (by re-claiming 20 years of protection without having innovated); and
- an abuse possibly also against higher ends, because the society as whole
would not benefit from that patent anymore. We think in particular of access
to medicines and the human right to health. Both are reportedly favoured and
hindered by the grant of patents, yet this balance may shift the wrong way if
patent protection goes up to 40 years.
The abuse of rights thus provides a fundamental tool to actively challenge
evergreening patents outside of the validity angle and outside of the
competition law realm. Since both are often hard to impose, abuse of rights may
have a potential here. Evergreening is however not the issue which most
obviously calls for the introduction of abuse of rights, since it should ideally
have been tackled by the patent office itself, by not granting evergreening
patents. Despite their often dubious strength in eventual invalidity procedures,
the mere existence of ‘evergreening’ patents will first discourage generic
competitors from entering the market.
At the very least, it will delay entry. In the United States, for instance,
manufacturers of generic pharmaceutical products must notify the holder of the
expiring patent that they will launch a certain product onto the market.
Automatically and obligatorily informed, patent holders will then threaten
eventual competitors with (and may even file a case on the basis of) the newly
acquired ‘evergreening’ patents. This creates costs, uncertainty and has an
unjustified deterring effect. Avoiding this, means avoiding that the patent is
Abuse Of Patent Rights Applied: Transit Of Generic Medicines
The year is 2009. Dutch border authorities stop, seize and destroy or send back
shipments of medicines in transit in The Netherlands. The shipments are on the
way from India to Brazil, Venezuela, Colombia, Peru or Nigeria. Neither in the
producing country, nor in the receiving county, the medicines were subject to
patent protection. In the Netherlands – the transit country – they were.
Pharmaceutical giant Merck, one of the patent holders at stake, first requested
the seizure of a shipment of the drug Losartan on the way from India to Brazil.
This started a cascade of 19 similar cases. Whereas in the first case, the drugs
were reshipped to India, in later cases the drugs were sometimes destroyed. It
was also not always a mere private initiative. Although GlaxoSmithkline, for
instance, first claimed its patent rights, the Dutch customs proceeded against
its later withdrawal and sent to the criminal prosecutor in charge a case
involving a shipment of Abacavir on route on behalf of UNITAID.
The matter of the drugs in transit caught quite some attention in the past two
years. From a patent law perspective – unless one challenges the very idea of
granting patents for medicines in developed countries – this is a purely
postgrant case. It is not rooted in the way the patent has been granted, but in
the way it is being enforced. We are faced with a case where the patent is
legal, the enforcement is within the legal framework; but the result appears
illegitimate. At first glance, this seems to be another classical setting where
the abuse of right notion could be useful.
Laws and issues
The legal basis for these decisions was the Council Regulation (EC) n°
1383/2003, as incorporated into the Dutch Patent Act. This Regulation addresses
customs actions against goods suspected of infringing certain intellectual
property rights. It aims in particular at keeping off the market counterfeit and
pirated goods, “because of the considerable damage to law-abiding manufacturers
and traders and to right-holders, as well as the deceiving and in some cases
endangering effect to the health and safety of consumers”. It is explicitly
mentioned that this should however be done without impeding legitimate trade. In
general, the Regulation applies to goods which are entered for release for free
circulation, export or re-export.
In Article 2 of the Regulation ‘goods infringing an intellectual property right’
means goods which infringe a patent under that Member States’ law. If - goods
are suspected of infringing an intellectual property right, the Regulation
allows customs authorities to suspend the release of the goods or detain them
for a period of three working days from the moment of receiving the notification
by the right-holder.
This is done in order to enable the latter to submit an application for action
in relation to such goods. Authorities shall suspend the release of the goods or
detain them when an application for action has then been initiated, while a
number of deterrents have been set in place to avoid a frivolous use of said
custom measures. The claimant can be held liable and bear all costs if the goods
in question are subsequently found not to infringe intellectual property right.
Abuse of patent rights
From an abuse of rights point of view, the matter appears to offer a good case
study. It also introduces a new angle to the debate: the application of abuse of
rights amongst treaty parties. Whereas indeed the enforcement of patents on
goods in transit may be abusive amongst private actors, the above discussed
obligations of international law involving EU Regulation, the Dutch judgement,
and the active engagement of Dutch custom authorities may point - at an abusive
use of the TRIPs enforcement provisions amongst WTO member countries as well.
This conclusion leads us to analyse the application of the principle of good
faith in international law, which will be discussed in the section below.
The abuse of rights notion could have been an argument to tackle the procedures
in the Netherlands. The request to seize and destroy goods in transit only –
medicines on the way between countries where no patent protection was granted –
may well be construed as an abuse of patent rights.
As with the evergreening of patents, the case here could be based upon each of
the three elements which we have identified to constitute the border of the
abuse of patent rights notion:
- an abuse in relation to specific third-parties (e.g. producers of
generic medicines, consumers);
- an abuse in view of the rationale of the patent right and the patent
- an abuse also against higher ends; access to medicines and the right to
The notion of abuse of rights can be a useful tool to tackle a number of cases
reported to be undesired in patent literature. Its flexible nature perfectly
matches that of the patent system itself. Not all issues can however be
addressed by this notion and not all issues – although in theory challengeable
from this angle – need the abuse of rights notion. Cases rooting in post-grant
issues which can satisfactorily be addressed by competition law, for instance,
do not need the notion. Abuse of rights is thus only aimed at filling a gap of
lacking means for legal challenge.
Abuse of rights does not usually lead to the revocation of the right at stake.
This would however be necessary in the case of evergreening patents. Whereas the
notion could be used for abuses rooting in the pre-grant phase, the usual remedy
would thus not be appropriate in these cases. Additionally, it would come too
late. Abuse of rights therefore mainly is a tool to address post-grant abuses,
in cases where competition law does not intervene. Nonetheless, a patent law
specific tailoring of the notion and its sanction
seems to be possible.
The transit of medicines case exemplifies a theoretically legal but
illegitimate enforcement - the classical subject matter of abuse of rights. The
study on the evergreening of patents shows that this in fact must be tackled
pre-grant, but that in practice it amounts to post-grant action. Here, abuse of
rights is useful. For international law, the case studies can serve as
background information to the ceilings debate. Abuse of rights can be used a
mechanism used to screening for the necessity for changes in the positive law.
The case study on medicines in transit in fact showed the need for a ceiling in
this respect specifically.
The possibility to use the notion of abuse of rights also brings a further tool
to deal with a number of cases in a TRIPs compliant manner - it offers an
additional and underused flexibility. Finally and most importantly, an
interpretation of the TRIPs Agreement in good faith, may mean that
certain interpretations leading to a ever higher level of protection constitute
an abuse of rights. It may mean that ceilings are silently present in the
Agreement already; that abuse of rights – as a substantive rule – is a ceiling
to the TRIPs Agreement.
- Indian Patents Act 1970.
- Hoffman La Roche Ltd V Cipla decided in I.A 642/2008 IN CS (OS) 89/2008F
- Roche vs. CIPLA is another such case where a Court in India has heavily
considered ‘public interest’ while granting temporary injunction.
- Memorandum of Understanding between Ministry of Commerce and Industry of
India and The Federal Department of Economic Affairs of Switzerland on
Intellectual Property 7th August 2007.
- Article 1 of MOU between Ministry of Commerce and Industry of India and
The Federal Department of Economic Affairs of Switzerland on Intellectual
Property 7th August 2007.
- Patent Cooperation Treaty done at Washington on June 19 1970 amended on
September 28,1979,modified on February 3 1984 and on October 3 2001.
- WTO, Agreement on Trade Related Aspects of Intellectual Property Rights,
Annex C available at http://www.wto.org/english/docs_e/legal_e/27-trips.doc,
visited on May 26, 2008.
- Biswajit Dhar, Post 2005 TRIPS Scenario in patent protection in the
pharmaceutical sector: the case of generic pharmaceutical industry in India
available at http://www.iprsonline.org/unctadictsd/docs/Dhar%20Indian%20 Pharma%20November06.pdf.
- Article 8 specifically states that member countries may adopt measures
necessary to protect their public health and nutrition and to promote public
interest in sectors of vital importance to their socio-economic and