TRIPS Flashcards

Question

what is the criteria who is the beneficiaries

Answer 1

1. Industrial property Pursuant to Articles 2 and 3 of the Paris Convention, protection is granted in the case of industrial property to natural or legal persons who:  are nationals of a Member;  are domiciled in a Member; or  have real and effective industrial or commercial establishments in a Member. Pursuant to Article 5 of the IPIC Treaty, similar criteria for determining eligible beneficiaries are applied in relation to layout-designs or integrated circuits. 2. Copyright and related rights a) Copyright Pursuant to Articles 3 and 4 of the Berne Convention, protection is granted to authors of literary or artistic works who:  are nationals of a Member;  have their habitual residence in a Member;  have their works first (or simultaneously) published in a Member;  are authors of cinematographic works the maker of which has his headquarters or habitual residence in a Member; or  are authors of works of architecture erected in a Member or of other artistic works incorporated in a building or other structure located in a Member. b) Performers Pursuant to Article 4 of the Rome Convention, protection is granted to performers whose:  performance takes place in another Member;  performance is incorporated in a phonogram as defined below; or  performance is covered by a broadcast as defined below. c) Producers of phonograms Pursuant to Article 5 of the Rome Convention, protection is granted to producers of phonograms:  if the producer is a national of another Member;  if the first fixation of sound (i.e. recording) was made in another  Member; or  if the phonogram was first published in another Member. In accordance with the provisions of Article 5(3) of the Rome Convention as incorporated into the TRIPS Agreement, a Member may declare that it does not apply either the criterion of fixation or that of publication. The criterion of nationality, however, may not be excluded. d) Broadcasting organizations Pursuant to Article 6 of the Rome Convention, protection is granted to broadcasting organizations:  whose headquarters are situated in another Member; or  when the broadcast was transmitted from a transmitter in another Member. In accordance with the provisions of Article 6(2) of the Rome Convention as incorporated into the TRIPS Agreement, a Member may declare that it will protect broadcasts only if both relevant conditions are met, i.e. that the headquarters of the broadcasting organization are situated in another Member and the broadcast was transmitted from a transmitter situated in the same Member.

Answer 2

Non-discrimination is a fundamental principle of the WTO. The principle of non-discrimination has two components: (i) the national treatment principle; and (ii) the most-favoured nation (MFN) principle. Under the GATT 1994, the subject of the MFN and national treatment is “goods”, while under the GATS the subjects are “services and services suppliers”. Instead, in the context of TRIPS, the subject of protection is “nationals”, which as mentioned before, include natural and legal persons – who are the owners of the IPRs. While the national treatment clause forbids discrimination between a Member’s own nationals and the nationals of other Members; the MFN treatment clause forbids discrimination among the nationals of WTO Members. The MFN principle requires to accord to nations of WTO Members any advantage given to nationals of any other country - Member or not of the WTO.

Answer 3

Under the TRIPS Agreement, the national treatment obligation contained in Article 3 requires each Member to accord to the nationals of other Members treatment no less favourable than that it accords to its own nationals with regard to the protection of IP.

Answer 4

The exceptions allowed under the four pre- existing WIPO treaties (Paris, Berne, Rome and IPIC) are also allowed under TRIPS. An important exception to national treatment is the so-called “comparison of terms” for copyright. Pursuant to this exception, allowed under Article 7(8) of the Berne Convention as incorporated into the TRIPS Agreement, if a Member provides a term of protection in excess of the minimum term required by the TRIPS Agreement, it does not need to protect a work for a duration that exceeds the term fixed in the country of origin of that work. In other words, the additional term can be made available to foreigners on the basis of “material reciprocity”.

Answer 5

Article 4 on MFN treatment requires that, with regard to the protection of IP, any advantage, favour, privilege or immunity granted by a Member to the nationals of any other country shall be accorded immediately and unconditionally to the nationals of all other Members. EXAMPLE: if Member A decides to recognize and enforce the patents granted to medicines in Member B from the date of filing in Member B, irrespective of whether the inventions covered meet the novelty criterion or not in A. Then, Member A must extend the same advantage to nationals of other Members.

Answer 6

article 4 (a) and (d)

Answer 7

This exception does not apply in respect of the substantive standards of protection themselves. It is not limited to pre-existing WIPO agreements. Examples of such agreements are the Patent Cooperation Treaty, the Madrid Agreement Concerning the International Registration of Marks and the Protocol to that Agreement, and the Hague Agreement Concerning the International Registration of Industrial Des

Answer 8

The term ‘exhaustion’ refers to the generally accepted principle in IP law that a right owner’s exclusive right to control the distribution of a protected item lapses after the first act of distribution. In many countries, once the item has been put on the market by or with the consent of the right owner, the exclusive distribution right is ‘exhausted’ (which is why the principle is referred to in some jurisdictions as the ‘first-sale doctrine’) and further circulation of that item can no longer be controlled by the right holder. This doctrine of exhaustion does not, of course, affect any other exclusive rights the right holder may enjoy, for example, the right to authorize activities such as reproduction or communication to the public. In other words, the entitlement to distribute a legitimately purchased CD does not in itself extend to an entitlement to make reproductions or public performances of the recorded music.

Answer 9

The answer depends on whether a country applies a regime of national or international exhaustion and thereby prevents or allows so-called “parallel importation”.

Answer 10

The right owners’ distribution rights are only considered exhausted once they put the protected item on the market in that country. Distribution rights would not be exhausted with regard to protected items that were put on the market in another country, so that right holders can still control the sale or import of those items into the first country. Parallel imports of products first sold on other markets are illegal

Answer 11

The right owner’s distribution right in that country is exhausted regardless of where the first act of distribution took place. In the example, right holders cannot use IPRs to prevent the importation and sale of DVDs that they have sold in another country. Parallel imports of products first sold on other markets are legal

Answer 12

International Exhaustion Products imported as parallel imports are NOT counterfeit or pirated goods, but genuine original products that have been sold in other countries with the authorization of the right holder; they do not infringe IPRs in the country of origin. A country may adopt different exhaustion regimes (national or international exhaustion) for different ! categories of IPRs.

Answer 13

An alternative approach is taken in some free trade areas (FTAs) or customs unions, namely regional exhaustion. In this case, the right holder’s IPRs are exhausted once the first sale takes place anywhere within the specified region.

Answer 14

The TRIPS Agreement leaves Members considerable discretion as to how to regulate the question of exhaustion. Article 6 provides that, for the purposes of dispute settlement under the TRIPS Agreement, nothing in the Agreement shall be used to address the issue of the exhaustion of IPRs, provided that the national and MFN treatment obligations are complied with. It is generally understood that national exhaustion favours market segmentation as well as differential pricing, product differentiation and differing release dates, whereas international exhaustion facilitates parallel importation of the same product sold at lower prices in other countries.

Answer 15

This provision was confirmed in the Doha Declaration on the TRIPS Agreement and Public Health. It stated that the effect of the TRIPS provisions relevant to exhaustion of IPRs was to leave each Member free to establish its own regime for exhaustion without challenge, subject to the MFN and national treatment obligations

Answer 16

The TRIPS Agreement:  is a comprehensive multilateral agreement on IP which establishes minimum standards of protection for each of the main categories of IPRs.  it incorporates most provisions of the main WIPO Conventions (mainly Berne and Paris Conventions), while adding a number of obligations.  includes the national treatment and MFN obligations, which apply to nationals owners of IPRs.  leaves policy space for each Member to choose its own regime of exhaustion for IPRs according to its policy objectives.

Answer 17

Relevant WIPO Convention | Berne Convention

Answer 18

Copyright protects “literary and artistic works”, that is, every production in the literary, scientific and artistic domain, whatever may be the mode or form of its expression. Such works include computer programmes and databases.

Answer 19

The TRIPS Agreement incorporates most of the provisions of the Berne Convention (except the moral rights). The economic rights of an author of a work include the reproduction right, rental right, rights of public performance, broadcasting and communication to the public and right of translation and adaptation.

Answer 20

The Berne Convention allows free uses for certain specified purposes, such as quotation, illustration for teaching purposes, and reporting of current events. They also allow limitations to the reproduction right. Minor exceptions can be made to the public performance right. Non-voluntary licences (allowing use of protected work without authorization but with the obligation to pay equitable remuneration) can be applied to broadcasting and communication to the public of works broadcasts, as well as to the recording of musical works. Developing countries may provide compulsory licences, subject to certain conditions, in respect of reproduction and translation of works for educational purposes. In addition, according to Article 13 of the TRIPS Agreement, limitations and exceptions are allowed if three conditions are met (known as "three step test"):

Answer 21

Step 1 The limitations or exceptions are confined to certain special cases Step 2 They do not conflict with a normal exploitation of the work Step 3 They do not unreasonably prejudice the legitimate interests of the right holder

Answer 22

In general, the minimum term of copyright protection is the life of the author and 50 years after his death.

Answer 23

Performers have the possibility of preventing certain unauthorized acts, such as fixation of their performance on a sound recording (e.g. CD) and its unauthorized broadcasting. Producers of phonograms have an exclusive reproduction right and rental right. Broadcasting organizations have the right to prohibit certain acts in respect of their broadcasts, such as rebroadcasting.

Answer 24

Members may provide certain specific limitations such as private use. In general, Members may also provide for the same kinds of limitations as they provide for in respect of literary and artistic works.

Answer 25

The term of protection is at least 50 years for performers and producers of phonograms, and 20 years for broadcasting organizations.

Answer 26

Signs that are capable of distinguishing the goods and services of one undertaking from those of others are eligible for trademark protection. There are no constraints on the types of signs that can be protected as a trademark (such as words, numbers, figurative elements or combinations of colours or signs), but Members may make registration of signs dependent on visual perceptibility. Members may allow distinctiveness to be acquired by use. While the conditions for the registering of a trademark are in principle determined by the domestic law of each Member, there are some common rules that have to be observed by all Members.

Answer 27

The owner of a registered trademark must at least be able to prevent the unauthorized use of an identical or similar sign on identical or similar goods or services in the course of trade, which would create a likelihood of confusion among consumers. For well-known trademarks, such protection would apply even if the trademark is not registered in the country where protection is claimed or, in some cases, extends to products which are not similar to those in respect of which the trademark is registered.

Answer 28

Members are allowed to provide for limited exceptions to trademark rights if these take into account the legitimate interests of the right owner and those of third parties. This is a variation of the “three-step test” referred to in the section on copyright.

Answer 29

The initial term of protection for trademarks must be 7 years, which must be renewable indefinitely. This means that protection of a trademark, provided that certain conditions are met, may last for an indefinite period of time.

Answer 30

Geographical indications (GI) identify a good as originating in the territory of a Member, or a region or locality in that territory, where a given quality, reputation or other characteristic of the good is essentially attributable to its geographical origin (e.g. "Champagne" from France or "Tequila" from Mexico). The definition is limited to goods. The main requirement is that there is a linkage between the quality, reputation or other characteristics of the good and its geographical origin. The Agreement does not specify the legal form that the protection should take. In practice, GIs are protected, for example, by laws on business practices (e.g. on unfair competition or consumer protection), trademark law or sui generis (i.e. a system created specifically for this purpose) GI laws.

Answer 31

The TRIPS Agreement requires protection to be available for all GIs against use in a manner that would mislead the public as to the true origin of the product; and, against use that would constitute an act of unfair competition. GIs for wines and spirits enjoy an additional, higher level of protection. It is not dependent on meeting tests of misleading the consumer or unfair competition and applies even if the true place of origin is indicated or the use is accompanied by certain qualifying terms such as 'type' or 'kind', or the use is in translation. The right to take action must be available to any interested party, that is, not only the right holder but also, for example distributors.

Answer 32

The Agreement provides for a range of exceptions to the protection that would otherwise have to be given, notably in respect of terms that have become generic in the local language, certain prior trademark rights and certain other forms of prior use that pre- date the TRIPS Agreement. The exceptions are accompanied by a commitment on the part of Members to be willing to enter into negotiations, bilaterally or multilaterally, including about the continued applicability of the exceptions. A specific role is also given to the Council for TRIPS to review the application of the TRIPS rules in this area and consult about compliance issues.

Answer 33

The TRIPS Agreement requires Members to make patents be available for any inventions, whether products or processes, in all fields of technology without discrimination, subject to the invention meeting the tests of novelty, inventiveness and industrial applicability. It also requires that patents be available and patent rights enjoyable without discrimination as to the place of the invention, the field of technology and whether products are imported or locally produced. Members shall require that an applicant for a patent disclose the invention in a manner sufficiently clear and complete for the invention to be carried out by a person skilled in the art. They may also require the applicant to indicate the best mode for carrying out the invention.

Answer 34

There are three permissible exclusions to patentability: 1. Inventions contrary to ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment. The use of this exception is subject to the condition that it must be necessary to prevent the commercial exploitation of the invention for the protection of ordre public or morality. 2. Diagnostic, therapeutic and surgical methods for the treatment of humans or animals. 3. Plants and animals and essentially biological processes for their production. Members are required to give protection for micro-organisms and non-biological and microbiological processes for the production of plants and animals. Members must also protect plant varieties by patents or by an effective sui generis system or by a combination of both. This provision (Article 27.3(b)) was made subject to review four years after the entry into force of the Agreement. The review started in 1999 and is continuing. The Council for TRIPS has examined also the relationship between the TRIPS Agreement and the Convention on Biological Diversity (CBD) as well as the protection of traditional knowledge and folklore. The relationship between the TRIPS Agreement and the CBD has also been addressed as an outstanding implementation issue pursuant to paragraph 12 of the Doha Ministerial Declaration.

Answer 35

The exclusive rights that must be conferred are mainly the ones of making, using, offering for sale, selling, and importing for these purposes. Process patent protection must be given not only over use of the process but also over products obtained directly by the process. Patent owners shall also have the right to assign, or transfer by succession, the patent and to conclude licensing contracts. If the subject matter of a patent is a process for obtaining a product, the judicial authorities shall have the authority to order the defendant to prove that the process to obtain an identical products is different from the patented process, where certain conditions indicating a likelihood that the protected process was used are met.

Answer 36

Exceptions to patent rights can be placed into two categories: limited exceptions and other uses without the authorization of the right holder which cover compulsory licences and government use. 1. Limited exceptions Members may provide for limited exceptions provided that they do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties. This is a variation of the “three-step test” discussed in the copyright section. 2. Compulsory licences Key Provisions Articles 27 to 34 Compulsory licensing, including government use without the authorization of the right holder, are allowed without limitation as to the grounds or underlying reasons but subject to conditions aimed at protecting the legitimate interests of the right holder. The conditions are contained in Article 31. These conditions include the obligation, as a general rule, to grant such licences only if an unsuccessful attempt has been made to acquire a voluntary licence on reasonable terms and conditions within a reasonable period of time; to pay adequate remuneration in the circumstances of each case, taking into account the economic value of the licence; and that decisions be subject to judicial or other independent review by a distinct higher authority. Members may relax certain of these conditions in cases of emergency and public non- commercial use and where compulsory licences are employed to remedy practices that have been established as anticompetitive by a legal process.

Answer 37

The minimum term of protection for patents is 20 years counted from the filling date of the patent application.

Answer 38

Protection must be available for designs that are new or original and independently created. Members may provide that design protection shall not extend to designs dictated essentially by technical or functional considerations. Textile designs, which typically have a short life cycle and particularly liable to copying, are given special attention. Requirements for obtaining protection should not unreasonably impair the possibility of gaining that protection.

Answer 39

Owners of protected designs must be able to prevent the unauthorized manufacture, sale or importation for commercial purposes of articles bearing or embodying a design which is a copy of the protected design.

Answer 40

WTO Members are allowed to provide for limited exceptions (another variation of the “three-step test” also available for copyright, trademarks and patents).

Answer 41

The minimum term of protection is 10 years.

Answer 42

An integrated circuit (or ‘chip’) is a three-dimensional layout of an integrated circuit.

Answer 43

Protection extends to layout-designs that are: original and not commonplace among creators of layout-designs and manufacturers of integrated circuits at the time of their creation.

Answer 44

IPIC Treaty

Answer 45

Right holders have the right to prevent unauthorized reproduction and importation, sale or other distribution for commercial purposes of protected layout-designs. These prohibitions extent to integrated circuits incorporating such a design or articles which contain such integrated circuits.

Answer 46

There are a number of limitations and exceptions including compulsory licenses. As to compulsory licenses, the same conditions applicable in the patent area apply to layout-design of integrated circuits.

Answer 47

The minimum term of protection is 10 years counted either from the date of filing or date of first commercialization.

Answer 48

a) Trade secrets Protection must be provided to information that is secret, has commercial value and has been subject to reasonable steps to keep it secret. A person lawfully in control of such information must have the possibility of preventing it from being disclosed to, acquired by, or used by others without his consent in a manner contrary to honest commercial practices. b) Undisclosed test and other data The Agreement also requires Members to protect undisclosed test or other data, whose submission is required by governments as a condition of approving the marketing of pharmaceutical or agricultural chemical products which use new chemical entities. There are two forms of protection to be accorded to such test and other data. First, Members are required to protect such data against unfair commercial use. Second, they must protect it against disclosure, except where necessary to protect the public, or where steps are taken to ensure that the data are protected against unfair commercial use.

Answer 49

An important element of the overall balance embodied in the TRIPS Agreement is a recognition of the legitimate role of competition law and policy (laws and related policies that address anticompetitive practices of enterprises) vis-a-vis IPRs and licensing practices. Anti-competitive practices are practices or conditions that may constitute an abuse of IPRs having an adverse effect on competition on the relevant market. The TRIPS Agreement recognizes the right of Members to take measures to prevent or control anti-competitive abuses of IPRs as long as these measures are consistent with the Agreement. It contains a short illustrative list of practices that may be treated as abuses. The Agreement establishes a consultation procedure for mutual acceptance between Members in such cases.

Answer 50

Enforcement refers to the procedures that have to be made available by Members to permit prompt and effective action against any act of infringement of IPRs covered by the TRIPS Agreement. As you have seen in this course, IPRs grant exclusive rights to their owners, which enable them to prevent others from undertaking certain acts without their authorization. Those rights may be infringed in several ways, either accidentally or deliberately. Infringement occurs when an act, which is inconsistent with the rights of the owner of the IPR and is not subject to an admissible exception, is undertaken. Typical examples are: - Unauthorized reproduction of copyright-protected material for commercial gain. - Unauthorized reproduction of trademarks with the intention of passing off the good as a genuine product of the trademark owner - Unauthorized manufacture, use or sale of a patent protected invention.

Answer 51

There is little value in developing substantive standards of IP protection if the right holder is not in a position to enforce them effectively through fair and expeditious procedures, in particular in an environment in which modern technologies have significantly facilitated the infringement of IPRs. Part III of the TRIPS Agreement specifies the procedures and remedies that must be available so that right holders can effectively enforce their rights. The Agreement also provides for safeguards against the abuse of such procedures and remedies as barriers to legitimate trade. The basic principles of the TRIPS Agreement apply to the provisions on enforcement of IPRs along with other aspects of IP protection. The TRIPS Agreement is the first multilateral treaty with detailed rules on the enforcement of IPRs, although earlier IP treaties, notably the Paris and Berne Conventions, do have some provisions specifically on enforcement. The Agreement provides general obligations and specifies the civil and administrative procedures and remedies, including provisional measures, which must be available in respect of acts of infringement of any covered intellectual property right. In addition, as regards trademark counterfeiting and copyright piracy, Members are required to make available border measures and, when counterfeiting or piracy is wilful and on a commercial scale, criminal procedures.

Answer 52

all infringements : - general obligations - civil and administrative procedures and remedies - provisional measures Trademarks counterfeiting and copyright piracy: - Border measures - Criminal procedures

Answer 53

The WTO dispute settlement system is one of the major results of the Uruguay Round. The system underscores the rule of law and makes the trading system more secure and predictable through the impartial an effective resolution of disputes between Members. The DSU sets out in considerable detail the procedures and the timetable for the various stages of a WTO dispute. The first formal stage is consultations. If no agreement is reached, the next stage is adjudication before the panels and, in case of appeal, before the Appellate Body. The rulings of panels and the Appellate Body have to be adopted by the Dispute Settlement Body (DSB) - the General Council - composed of all Members-, which is responsible for overseeing the entire dispute settlement process. A solution mutually acceptable to the parties to a dispute, and consistent with the covered Agreements, is to be preferred.

Answer 54

1. Enforcement: procedures and remedies that Member governments must make available so that IPR owners can enforce their rights.  For all IPRs covered under TRIPS: general obligations, civil and administrative procedures and remedies, and provisional measures must be available.  For trademark counterfeiting and copyright piracy only: also border measures and, when counterfeiting or piracy is wilful and on a commercial scale, criminal procedures. 2. The WTO dispute settlement mechanism (DSM): compulsory inter-governmental mechanism for the resolution of international trade disputes, including over TRIPS   There have been more than 30 disputes in the area of TRIPS. Members have agreed on a “moratorium” on the use of non-violation and situation complaints in the area of TRIPS.

Answer 55

The TRIPS Agreement recognizes the special needs of LDCs. It originally provided LDC Members a transition period until 1 January 2006, with an extension upon duly motivated request. With respect to certain obligations concerning pharmaceutical products, the TRIPS Council decided in 2002 to extend the transition period until 1 January 2016. In this connection, a waiver was also adopted concerning so-called “exclusive marketing rights” The general transition period for LDCs (except non- discrimination) has been extended twice. First, it was extended until 1 July 2013, and then, until 1 July 2021 or when a country ceases to be in the LDC category. A process has also been set up to help LDCs implement TRIPS within their national IP regimes

Answer 56

Article 18 of the Berne Convention includes the so-called ‘rule of retroactivity’, which applies not only in respect of the rights of authors but also of the rights of performers and producers of phonograms in phonograms. According to the rule of retroactivity, the Agreement applies to all works which have not fallen into the public domain either in the country of origin or the country where protection is claimed through the expiry of a term of protection. The provisions of Article 18 allow some transitional flexibility where a country is, as a result, taking subject matter out of the public domain and putting it under protection, to safeguard the interests of persons who have in good faith already taken steps on the basis of the material in the public domain (for example: a film producer that has already invested in the making of a film using a work that is brought under copyright).

Answer 57

The TRIPS Agreement includes special and differential treatment provisions in favour of developing and LDC Members:  Transitional arrangements: TRIPS gave developing and LDC Members longer transition periods to meet their obligations. At present, only LDCs still benefit from transitional arrangements.  Technology transfer: developed Members are required to provide incentives to enterprises and institutions in their territories for the purpose of promoting and encouraging technology transfer to LDC Members.  Technical cooperation: developed Members are required to provide, on request and on mutually agreed conditions, technical and financial cooperation in favour of developing and LDC Members to facilitate the implementation of the Agreement.

Answer 58

The TRIPS Council is the WTO body in charge of overseeing the functioning of the TRIPS Agreement. It has the following main functions:  Notification and review of national laws and regulations  Forum for consultations among Members on any concern relating to the Agreement  Forum for further negotiations and review:      Negotiations of a multilateral system of notification and registration of GIs for wines and spirits Review of Article 27.3(b) which concerns the option to exclude from patentability certain plant and animal inventions Examination of the applicability to TRIPS of non-violation and situation complaints under the WTO DSM Work on the relationship between the TRIPS Agreement and the CBD and the protection of traditional knowledge and folklore Extension of the higher level of protection required for GIs for wines and spirits to other products

Answer 59

The Declaration emphasized that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health and reaffirmed the right of Members to fully use the flexibilities available in the Agreement for that purpose. It made clear that the Agreement should be interpreted and implemented in a manner supportive of Members’ right to protect public health and, in particular, to promote access to medicines for all. It highlighted the importance of the objectives and principles of the Agreement regarding the interpretation of its provisions.

Answer 60

With respect to compulsory licences, each Member has the right to grant compulsory licences and is free to determine the grounds upon which such licences are granted. Each Member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency. (Public health crisis including those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics can represent such circumstances. It is made clear that the Declaration is not limited to these diseases, but is broader in its application.)  Regarding the exhaustion of IPRs, the Declaration clarifies that the TRIPS Agreement leaves each Member free to establish its own regime without challenge under the WTO DSM. This is subject to the TRIPS obligations on non- discrimination. Least-developedcountries Members agreed to provide LDC Members with an extended transitional period to comply with certain obligations concerning pharmaceutical products until 1 January 2016. Exporting under compulsory licences (paragraph6) In its paragraph 6, the Declaration recognized the problem of countries with insufficient or no manufacturing capacity in the pharmaceutical sector in making effective use of compulsory licensing when they need to call upon sources of supply from generic producers in third countries where the medicines needed are patent-protected. In order to solve this problem, the General Council adopted a Decision which established the so-called “Paragraph 6 system” (WT/L/540).

Answer 61

``` It provides an additional pathway for countries with limited resources to import cheaper generics made under compulsory licensing if they are unable to manufacture the medicines themselves. Under the TRIPS Agreement, Members can issue compulsory licences for importation and for domestic production. However, a potential problem may arise when the sources of supply from generic producers are in third countries where the medicine is patent-protected. The TRIPS Agreement (Article 31(f)) limits the amount that such third countries can export under a compulsory licence. Thus, a problem could arise if the product is patent protected in the third country from where the medicines needed will be imported and a compulsory licence has to be granted in that country. Additional Resources (2) In order to solve this problem, the General Council adopted a Decision on 30 August 2003, which waives under certain circumstances: 1) 2) the obligation on exporting Members to ensure that compulsory licences are only granted for the purpose of predominantly supplying its domestic market (Article 31(f)) - subject to certain transparency requirements; and, the obligation on importing Members to pay adequate remuneration to the right holder subject to a compulsory licence in order to avoid double remuneration (Article 31(h)). (If a compulsory licence has to be granted in both the importing and exporting country for the same products, remuneration need only to be paid in the exporting country based on the value of the licence in the importing country); a further derogation enables export and re- export of products manufactured under a compulsory licence more easily amongst parties to a regional trade agreement at least half of whom are LDCs. ```

Answer 62

The TRIPS Agreement aims at balancing the interest of providing incentives for research and development of new drugs, while making them as widely accessible as possible. In that sense, the Doha Declaration on TRIPS and Public Health clarified some of the flexibilities provided under the Agreement:  Members are free to determine the grounds upon which compulsory licences are granted  Members are free to establish their own regime of exhaustion for IPRs The Declaration also lead to the adoption of the “paragraph 6 system” which provides an additional pathway for countries with limited capacity in the pharmaceutical sector in order to import cheaper generics made in other countries under compulsory licences.

TRIPS Flashcards

(110 cards)