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Using Competition Law to Promote Access

5/19/2014

Anti-Competitive Behaviours and the Remedies Available for Redress

Download here (Abbott - Chapter 3)

Download here (Full Text of Guidebook) - with Sean Flynn, Carlos Correa, Jonathan Berger & Natasha Nayak

IP-Watch Report on Guidebook Publication

in UNDP, Using Competition Law to Promote Access to Health Technologies: A guidebook for low- and middle-income countries 58-95 (ed. F. M. Abbott)(2014)

Abstract:

In this chapter, core doctrines of competition law generally applied by national authorities are reviewed. Most competition laws examine anti-competitive behavior in relation to agreements between enterprises, on the one hand, and monopolization or abuse of dominant position, on the other. Anti-competitive activity is further viewed as either ‘horizontal’ or ‘vertical’. Horizontal anti-competitive activity refers to conduct among independent enterprises that are suppliers of competitive (or potentially competitive) goods or services. Vertical anti-competitive activity refers to the supply chain controlled by a producer, beginning with inputs to production, into production, intermediate distribution and, ultimately, the retail sale of goods or services.

Some types of agreement between enterprises are so inherently anti-competitive that proof of the existence of the agreement is sufficient to establish a violation. Such agreements are referred to either as per se anti-competitive or hard-core competition law violations. Other types of conduct that may seem anti-competitive on their face may also have a pro-competitive justification, such that competition authorities assess the balance. This balancing is often referred to as assessment under the “rule of reason”. For a competition law violation to be found, the anti-competitive aspect of the arrangement should outweigh potential pro-competitive benefits.

Examples of horizontal anti-competitive behavior that are per se illegal in most jurisdictions include price-fixing among competitors, output restraints and allocation of geographic territories. Examples of vertical restraints that are per se illegal in many, but not all, jurisdictions are resale price maintenance (or fixing the minimum price at which retailers may sell) and “exclusive grantback” requirements in patent licenses.

There are some significant risks of anti-competitive conduct in pharmaceuticals markets that are fairly widespread and deserve close attention from competition authorities. These include bid manipulation in procurement of health technologies, whereby a group of potential competitors may agree not to submit bids below a set price and to allocate the ‘lowest set price’ bid to a particular firm. Such activity may also involve inappropriate payments to government officials who might otherwise report the anti-competitive practice. Anti-competitive conduct by patent-owning enterprises may include requiring a distributor or retailer of health technologies to purchase a complete line of products as a condition of purchasing a particular product or products (i.e. a tying arrangement). Perhaps the most widely discussed form of anti-competitive conduct involving patent owners involves ‘buying out’ generic challenges to patents that might otherwise result in generic products entering the market at an early date. Such buyouts upset the balance legislators strive to achieve between granting patents and authorizing their challenge to foster competition.

Mergers and acquisitions may adversely affect product markets by, for example, allowing combined companies to raise prices for therapies previously in competition with each other.

Anti-competitive conduct affects markets for innovation, such as when a patent is illegitimately used to prevent the development of new products not within the scope of the patent, or when patent-owning companies combine to control markets. Mergers and acquisitions can affect markets for innovation by reducing potential R&D targets and opportunities.

As noted earlier, competition law addresses dominant enterprises and monopolies as well as agreements between enterprises. A single enterprise (or a small group of enterprises) may alone exercise such significant power in a relevant market as to be able to raise prices above competitive market prices without concern that others will enter the market and undercut it. When an enterprise dominates a market, it does not need consensual agreements with potential competitors to control them; it may unilaterally dictate terms. One objective surrounding the control of mergers and acquisitions is to prevent an enterprise from combining with others precisely to take a dominant position in the market.

This chapter concludes with a discussion of the types of remedies that are available to national authorities and private parties as redress for anti-competitive conduct. It is not uncommon for the government to enter into some form of settlement agreement with an accused enterprise pursuant to which that enterprise agrees to cease its anti-competitive activities and may also make a payment either as damages or as a penalty. Such settlements may be approved and/or supervised by courts.

In some jurisdictions, particularly the United States, a good deal of competition enforcement is undertaken by private actors suing for damages. Anti-competitive conduct may also be subject to criminal penalties including substantial fines, and imprisonment for individuals. Specific types of remedies may be used to address anti-competitive conduct that is undertaken to block the introduction of generic products. This may include requiring pharmaceutical patent owners to compensate public procurement authorities, generic producers and others for damages occasioned by the unwarranted invocation of patents. Strong consideration should be given to prohibiting patent owners from “buying out” generic producers’ challenges to patent validity or assertions of non-infringement. Other types of specific remedies may be considered.

Number of Pages in PDF File: 170
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Emerging Markets

5/19/2014

Anti-Competitive Behaviours and the Remedies Available for Redress

Download here (Abbott - Chapter 3)

Download here (Full Text of Guidebook) - with Sean Flynn, Carlos Correa, Jonathan Berger & Natasha Nayak

IP-Watch Report on Guidebook Publication

in UNDP, Using Competition Law to Promote Access to Health Technologies: A guidebook for low- and middle-income countries 58-95 (ed. F. M. Abbott)(2014)

Abstract:

In this chapter, core doctrines of competition law generally applied by national authorities are reviewed. Most competition laws examine anti-competitive behavior in relation to agreements between enterprises, on the one hand, and monopolization or abuse of dominant position, on the other. Anti-competitive activity is further viewed as either ‘horizontal’ or ‘vertical’. Horizontal anti-competitive activity refers to conduct among independent enterprises that are suppliers of competitive (or potentially competitive) goods or services. Vertical anti-competitive activity refers to the supply chain controlled by a producer, beginning with inputs to production, into production, intermediate distribution and, ultimately, the retail sale of goods or services.

Some types of agreement between enterprises are so inherently anti-competitive that proof of the existence of the agreement is sufficient to establish a violation. Such agreements are referred to either as per se anti-competitive or hard-core competition law violations. Other types of conduct that may seem anti-competitive on their face may also have a pro-competitive justification, such that competition authorities assess the balance. This balancing is often referred to as assessment under the “rule of reason”. For a competition law violation to be found, the anti-competitive aspect of the arrangement should outweigh potential pro-competitive benefits.

Examples of horizontal anti-competitive behavior that are per se illegal in most jurisdictions include price-fixing among competitors, output restraints and allocation of geographic territories. Examples of vertical restraints that are per se illegal in many, but not all, jurisdictions are resale price maintenance (or fixing the minimum price at which retailers may sell) and “exclusive grantback” requirements in patent licenses.

There are some significant risks of anti-competitive conduct in pharmaceuticals markets that are fairly widespread and deserve close attention from competition authorities. These include bid manipulation in procurement of health technologies, whereby a group of potential competitors may agree not to submit bids below a set price and to allocate the ‘lowest set price’ bid to a particular firm. Such activity may also involve inappropriate payments to government officials who might otherwise report the anti-competitive practice. Anti-competitive conduct by patent-owning enterprises may include requiring a distributor or retailer of health technologies to purchase a complete line of products as a condition of purchasing a particular product or products (i.e. a tying arrangement). Perhaps the most widely discussed form of anti-competitive conduct involving patent owners involves ‘buying out’ generic challenges to patents that might otherwise result in generic products entering the market at an early date. Such buyouts upset the balance legislators strive to achieve between granting patents and authorizing their challenge to foster competition.

Mergers and acquisitions may adversely affect product markets by, for example, allowing combined companies to raise prices for therapies previously in competition with each other.

Anti-competitive conduct affects markets for innovation, such as when a patent is illegitimately used to prevent the development of new products not within the scope of the patent, or when patent-owning companies combine to control markets. Mergers and acquisitions can affect markets for innovation by reducing potential R&D targets and opportunities.

As noted earlier, competition law addresses dominant enterprises and monopolies as well as agreements between enterprises. A single enterprise (or a small group of enterprises) may alone exercise such significant power in a relevant market as to be able to raise prices above competitive market prices without concern that others will enter the market and undercut it. When an enterprise dominates a market, it does not need consensual agreements with potential competitors to control them; it may unilaterally dictate terms. One objective surrounding the control of mergers and acquisitions is to prevent an enterprise from combining with others precisely to take a dominant position in the market.

This chapter concludes with a discussion of the types of remedies that are available to national authorities and private parties as redress for anti-competitive conduct. It is not uncommon for the government to enter into some form of settlement agreement with an accused enterprise pursuant to which that enterprise agrees to cease its anti-competitive activities and may also make a payment either as damages or as a penalty. Such settlements may be approved and/or supervised by courts.

In some jurisdictions, particularly the United States, a good deal of competition enforcement is undertaken by private actors suing for damages. Anti-competitive conduct may also be subject to criminal penalties including substantial fines, and imprisonment for individuals. Specific types of remedies may be used to address anti-competitive conduct that is undertaken to block the introduction of generic products. This may include requiring pharmaceutical patent owners to compensate public procurement authorities, generic producers and others for damages occasioned by the unwarranted invocation of patents. Strong consideration should be given to prohibiting patent owners from “buying out” generic producers’ challenges to patent validity or assertions of non-infringement. Other types of specific remedies may be considered.

Number of Pages in PDF File: 170
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Review of Trilateral Study

5/19/2014

Anti-Competitive Behaviours and the Remedies Available for Redress

Download here (Abbott - Chapter 3)

Download here (Full Text of Guidebook) - with Sean Flynn, Carlos Correa, Jonathan Berger & Natasha Nayak

IP-Watch Report on Guidebook Publication

in UNDP, Using Competition Law to Promote Access to Health Technologies: A guidebook for low- and middle-income countries 58-95 (ed. F. M. Abbott)(2014)

Abstract:

In this chapter, core doctrines of competition law generally applied by national authorities are reviewed. Most competition laws examine anti-competitive behavior in relation to agreements between enterprises, on the one hand, and monopolization or abuse of dominant position, on the other. Anti-competitive activity is further viewed as either ‘horizontal’ or ‘vertical’. Horizontal anti-competitive activity refers to conduct among independent enterprises that are suppliers of competitive (or potentially competitive) goods or services. Vertical anti-competitive activity refers to the supply chain controlled by a producer, beginning with inputs to production, into production, intermediate distribution and, ultimately, the retail sale of goods or services.

Some types of agreement between enterprises are so inherently anti-competitive that proof of the existence of the agreement is sufficient to establish a violation. Such agreements are referred to either as per se anti-competitive or hard-core competition law violations. Other types of conduct that may seem anti-competitive on their face may also have a pro-competitive justification, such that competition authorities assess the balance. This balancing is often referred to as assessment under the “rule of reason”. For a competition law violation to be found, the anti-competitive aspect of the arrangement should outweigh potential pro-competitive benefits.

Examples of horizontal anti-competitive behavior that are per se illegal in most jurisdictions include price-fixing among competitors, output restraints and allocation of geographic territories. Examples of vertical restraints that are per se illegal in many, but not all, jurisdictions are resale price maintenance (or fixing the minimum price at which retailers may sell) and “exclusive grantback” requirements in patent licenses.

There are some significant risks of anti-competitive conduct in pharmaceuticals markets that are fairly widespread and deserve close attention from competition authorities. These include bid manipulation in procurement of health technologies, whereby a group of potential competitors may agree not to submit bids below a set price and to allocate the ‘lowest set price’ bid to a particular firm. Such activity may also involve inappropriate payments to government officials who might otherwise report the anti-competitive practice. Anti-competitive conduct by patent-owning enterprises may include requiring a distributor or retailer of health technologies to purchase a complete line of products as a condition of purchasing a particular product or products (i.e. a tying arrangement). Perhaps the most widely discussed form of anti-competitive conduct involving patent owners involves ‘buying out’ generic challenges to patents that might otherwise result in generic products entering the market at an early date. Such buyouts upset the balance legislators strive to achieve between granting patents and authorizing their challenge to foster competition.

Mergers and acquisitions may adversely affect product markets by, for example, allowing combined companies to raise prices for therapies previously in competition with each other.

Anti-competitive conduct affects markets for innovation, such as when a patent is illegitimately used to prevent the development of new products not within the scope of the patent, or when patent-owning companies combine to control markets. Mergers and acquisitions can affect markets for innovation by reducing potential R&D targets and opportunities.

As noted earlier, competition law addresses dominant enterprises and monopolies as well as agreements between enterprises. A single enterprise (or a small group of enterprises) may alone exercise such significant power in a relevant market as to be able to raise prices above competitive market prices without concern that others will enter the market and undercut it. When an enterprise dominates a market, it does not need consensual agreements with potential competitors to control them; it may unilaterally dictate terms. One objective surrounding the control of mergers and acquisitions is to prevent an enterprise from combining with others precisely to take a dominant position in the market.

This chapter concludes with a discussion of the types of remedies that are available to national authorities and private parties as redress for anti-competitive conduct. It is not uncommon for the government to enter into some form of settlement agreement with an accused enterprise pursuant to which that enterprise agrees to cease its anti-competitive activities and may also make a payment either as damages or as a penalty. Such settlements may be approved and/or supervised by courts.

In some jurisdictions, particularly the United States, a good deal of competition enforcement is undertaken by private actors suing for damages. Anti-competitive conduct may also be subject to criminal penalties including substantial fines, and imprisonment for individuals. Specific types of remedies may be used to address anti-competitive conduct that is undertaken to block the introduction of generic products. This may include requiring pharmaceutical patent owners to compensate public procurement authorities, generic producers and others for damages occasioned by the unwarranted invocation of patents. Strong consideration should be given to prohibiting patent owners from “buying out” generic producers’ challenges to patent validity or assertions of non-infringement. Other types of specific remedies may be considered.

Number of Pages in PDF File: 170
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Domain Names

5/19/2014

Anti-Competitive Behaviours and the Remedies Available for Redress

Download here (Abbott - Chapter 3)

Download here (Full Text of Guidebook) - with Sean Flynn, Carlos Correa, Jonathan Berger & Natasha Nayak

IP-Watch Report on Guidebook Publication

in UNDP, Using Competition Law to Promote Access to Health Technologies: A guidebook for low- and middle-income countries 58-95 (ed. F. M. Abbott)(2014)

Abstract:

In this chapter, core doctrines of competition law generally applied by national authorities are reviewed. Most competition laws examine anti-competitive behavior in relation to agreements between enterprises, on the one hand, and monopolization or abuse of dominant position, on the other. Anti-competitive activity is further viewed as either ‘horizontal’ or ‘vertical’. Horizontal anti-competitive activity refers to conduct among independent enterprises that are suppliers of competitive (or potentially competitive) goods or services. Vertical anti-competitive activity refers to the supply chain controlled by a producer, beginning with inputs to production, into production, intermediate distribution and, ultimately, the retail sale of goods or services.

Some types of agreement between enterprises are so inherently anti-competitive that proof of the existence of the agreement is sufficient to establish a violation. Such agreements are referred to either as per se anti-competitive or hard-core competition law violations. Other types of conduct that may seem anti-competitive on their face may also have a pro-competitive justification, such that competition authorities assess the balance. This balancing is often referred to as assessment under the “rule of reason”. For a competition law violation to be found, the anti-competitive aspect of the arrangement should outweigh potential pro-competitive benefits.

Examples of horizontal anti-competitive behavior that are per se illegal in most jurisdictions include price-fixing among competitors, output restraints and allocation of geographic territories. Examples of vertical restraints that are per se illegal in many, but not all, jurisdictions are resale price maintenance (or fixing the minimum price at which retailers may sell) and “exclusive grantback” requirements in patent licenses.

There are some significant risks of anti-competitive conduct in pharmaceuticals markets that are fairly widespread and deserve close attention from competition authorities. These include bid manipulation in procurement of health technologies, whereby a group of potential competitors may agree not to submit bids below a set price and to allocate the ‘lowest set price’ bid to a particular firm. Such activity may also involve inappropriate payments to government officials who might otherwise report the anti-competitive practice. Anti-competitive conduct by patent-owning enterprises may include requiring a distributor or retailer of health technologies to purchase a complete line of products as a condition of purchasing a particular product or products (i.e. a tying arrangement). Perhaps the most widely discussed form of anti-competitive conduct involving patent owners involves ‘buying out’ generic challenges to patents that might otherwise result in generic products entering the market at an early date. Such buyouts upset the balance legislators strive to achieve between granting patents and authorizing their challenge to foster competition.

Mergers and acquisitions may adversely affect product markets by, for example, allowing combined companies to raise prices for therapies previously in competition with each other.

Anti-competitive conduct affects markets for innovation, such as when a patent is illegitimately used to prevent the development of new products not within the scope of the patent, or when patent-owning companies combine to control markets. Mergers and acquisitions can affect markets for innovation by reducing potential R&D targets and opportunities.

As noted earlier, competition law addresses dominant enterprises and monopolies as well as agreements between enterprises. A single enterprise (or a small group of enterprises) may alone exercise such significant power in a relevant market as to be able to raise prices above competitive market prices without concern that others will enter the market and undercut it. When an enterprise dominates a market, it does not need consensual agreements with potential competitors to control them; it may unilaterally dictate terms. One objective surrounding the control of mergers and acquisitions is to prevent an enterprise from combining with others precisely to take a dominant position in the market.

This chapter concludes with a discussion of the types of remedies that are available to national authorities and private parties as redress for anti-competitive conduct. It is not uncommon for the government to enter into some form of settlement agreement with an accused enterprise pursuant to which that enterprise agrees to cease its anti-competitive activities and may also make a payment either as damages or as a penalty. Such settlements may be approved and/or supervised by courts.

In some jurisdictions, particularly the United States, a good deal of competition enforcement is undertaken by private actors suing for damages. Anti-competitive conduct may also be subject to criminal penalties including substantial fines, and imprisonment for individuals. Specific types of remedies may be used to address anti-competitive conduct that is undertaken to block the introduction of generic products. This may include requiring pharmaceutical patent owners to compensate public procurement authorities, generic producers and others for damages occasioned by the unwarranted invocation of patents. Strong consideration should be given to prohibiting patent owners from “buying out” generic producers’ challenges to patent validity or assertions of non-infringement. Other types of specific remedies may be considered.

Number of Pages in PDF File: 170
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EU Economic Partnership Agreements

5/19/2014

Anti-Competitive Behaviours and the Remedies Available for Redress

Download here (Abbott - Chapter 3)

Download here (Full Text of Guidebook) - with Sean Flynn, Carlos Correa, Jonathan Berger & Natasha Nayak

IP-Watch Report on Guidebook Publication

in UNDP, Using Competition Law to Promote Access to Health Technologies: A guidebook for low- and middle-income countries 58-95 (ed. F. M. Abbott)(2014)

Abstract:

In this chapter, core doctrines of competition law generally applied by national authorities are reviewed. Most competition laws examine anti-competitive behavior in relation to agreements between enterprises, on the one hand, and monopolization or abuse of dominant position, on the other. Anti-competitive activity is further viewed as either ‘horizontal’ or ‘vertical’. Horizontal anti-competitive activity refers to conduct among independent enterprises that are suppliers of competitive (or potentially competitive) goods or services. Vertical anti-competitive activity refers to the supply chain controlled by a producer, beginning with inputs to production, into production, intermediate distribution and, ultimately, the retail sale of goods or services.

Some types of agreement between enterprises are so inherently anti-competitive that proof of the existence of the agreement is sufficient to establish a violation. Such agreements are referred to either as per se anti-competitive or hard-core competition law violations. Other types of conduct that may seem anti-competitive on their face may also have a pro-competitive justification, such that competition authorities assess the balance. This balancing is often referred to as assessment under the “rule of reason”. For a competition law violation to be found, the anti-competitive aspect of the arrangement should outweigh potential pro-competitive benefits.

Examples of horizontal anti-competitive behavior that are per se illegal in most jurisdictions include price-fixing among competitors, output restraints and allocation of geographic territories. Examples of vertical restraints that are per se illegal in many, but not all, jurisdictions are resale price maintenance (or fixing the minimum price at which retailers may sell) and “exclusive grantback” requirements in patent licenses.

There are some significant risks of anti-competitive conduct in pharmaceuticals markets that are fairly widespread and deserve close attention from competition authorities. These include bid manipulation in procurement of health technologies, whereby a group of potential competitors may agree not to submit bids below a set price and to allocate the ‘lowest set price’ bid to a particular firm. Such activity may also involve inappropriate payments to government officials who might otherwise report the anti-competitive practice. Anti-competitive conduct by patent-owning enterprises may include requiring a distributor or retailer of health technologies to purchase a complete line of products as a condition of purchasing a particular product or products (i.e. a tying arrangement). Perhaps the most widely discussed form of anti-competitive conduct involving patent owners involves ‘buying out’ generic challenges to patents that might otherwise result in generic products entering the market at an early date. Such buyouts upset the balance legislators strive to achieve between granting patents and authorizing their challenge to foster competition.

Mergers and acquisitions may adversely affect product markets by, for example, allowing combined companies to raise prices for therapies previously in competition with each other.

Anti-competitive conduct affects markets for innovation, such as when a patent is illegitimately used to prevent the development of new products not within the scope of the patent, or when patent-owning companies combine to control markets. Mergers and acquisitions can affect markets for innovation by reducing potential R&D targets and opportunities.

As noted earlier, competition law addresses dominant enterprises and monopolies as well as agreements between enterprises. A single enterprise (or a small group of enterprises) may alone exercise such significant power in a relevant market as to be able to raise prices above competitive market prices without concern that others will enter the market and undercut it. When an enterprise dominates a market, it does not need consensual agreements with potential competitors to control them; it may unilaterally dictate terms. One objective surrounding the control of mergers and acquisitions is to prevent an enterprise from combining with others precisely to take a dominant position in the market.

This chapter concludes with a discussion of the types of remedies that are available to national authorities and private parties as redress for anti-competitive conduct. It is not uncommon for the government to enter into some form of settlement agreement with an accused enterprise pursuant to which that enterprise agrees to cease its anti-competitive activities and may also make a payment either as damages or as a penalty. Such settlements may be approved and/or supervised by courts.

In some jurisdictions, particularly the United States, a good deal of competition enforcement is undertaken by private actors suing for damages. Anti-competitive conduct may also be subject to criminal penalties including substantial fines, and imprisonment for individuals. Specific types of remedies may be used to address anti-competitive conduct that is undertaken to block the introduction of generic products. This may include requiring pharmaceutical patent owners to compensate public procurement authorities, generic producers and others for damages occasioned by the unwarranted invocation of patents. Strong consideration should be given to prohibiting patent owners from “buying out” generic producers’ challenges to patent validity or assertions of non-infringement. Other types of specific remedies may be considered.

Number of Pages in PDF File: 170
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ECJ Philips/Nokia Judgment

5/19/2014

Anti-Competitive Behaviours and the Remedies Available for Redress

Download here (Abbott - Chapter 3)

Download here (Full Text of Guidebook) - with Sean Flynn, Carlos Correa, Jonathan Berger & Natasha Nayak

IP-Watch Report on Guidebook Publication

in UNDP, Using Competition Law to Promote Access to Health Technologies: A guidebook for low- and middle-income countries 58-95 (ed. F. M. Abbott)(2014)

Abstract:

In this chapter, core doctrines of competition law generally applied by national authorities are reviewed. Most competition laws examine anti-competitive behavior in relation to agreements between enterprises, on the one hand, and monopolization or abuse of dominant position, on the other. Anti-competitive activity is further viewed as either ‘horizontal’ or ‘vertical’. Horizontal anti-competitive activity refers to conduct among independent enterprises that are suppliers of competitive (or potentially competitive) goods or services. Vertical anti-competitive activity refers to the supply chain controlled by a producer, beginning with inputs to production, into production, intermediate distribution and, ultimately, the retail sale of goods or services.

Some types of agreement between enterprises are so inherently anti-competitive that proof of the existence of the agreement is sufficient to establish a violation. Such agreements are referred to either as per se anti-competitive or hard-core competition law violations. Other types of conduct that may seem anti-competitive on their face may also have a pro-competitive justification, such that competition authorities assess the balance. This balancing is often referred to as assessment under the “rule of reason”. For a competition law violation to be found, the anti-competitive aspect of the arrangement should outweigh potential pro-competitive benefits.

Examples of horizontal anti-competitive behavior that are per se illegal in most jurisdictions include price-fixing among competitors, output restraints and allocation of geographic territories. Examples of vertical restraints that are per se illegal in many, but not all, jurisdictions are resale price maintenance (or fixing the minimum price at which retailers may sell) and “exclusive grantback” requirements in patent licenses.

There are some significant risks of anti-competitive conduct in pharmaceuticals markets that are fairly widespread and deserve close attention from competition authorities. These include bid manipulation in procurement of health technologies, whereby a group of potential competitors may agree not to submit bids below a set price and to allocate the ‘lowest set price’ bid to a particular firm. Such activity may also involve inappropriate payments to government officials who might otherwise report the anti-competitive practice. Anti-competitive conduct by patent-owning enterprises may include requiring a distributor or retailer of health technologies to purchase a complete line of products as a condition of purchasing a particular product or products (i.e. a tying arrangement). Perhaps the most widely discussed form of anti-competitive conduct involving patent owners involves ‘buying out’ generic challenges to patents that might otherwise result in generic products entering the market at an early date. Such buyouts upset the balance legislators strive to achieve between granting patents and authorizing their challenge to foster competition.

Mergers and acquisitions may adversely affect product markets by, for example, allowing combined companies to raise prices for therapies previously in competition with each other.

Anti-competitive conduct affects markets for innovation, such as when a patent is illegitimately used to prevent the development of new products not within the scope of the patent, or when patent-owning companies combine to control markets. Mergers and acquisitions can affect markets for innovation by reducing potential R&D targets and opportunities.

As noted earlier, competition law addresses dominant enterprises and monopolies as well as agreements between enterprises. A single enterprise (or a small group of enterprises) may alone exercise such significant power in a relevant market as to be able to raise prices above competitive market prices without concern that others will enter the market and undercut it. When an enterprise dominates a market, it does not need consensual agreements with potential competitors to control them; it may unilaterally dictate terms. One objective surrounding the control of mergers and acquisitions is to prevent an enterprise from combining with others precisely to take a dominant position in the market.

This chapter concludes with a discussion of the types of remedies that are available to national authorities and private parties as redress for anti-competitive conduct. It is not uncommon for the government to enter into some form of settlement agreement with an accused enterprise pursuant to which that enterprise agrees to cease its anti-competitive activities and may also make a payment either as damages or as a penalty. Such settlements may be approved and/or supervised by courts.

In some jurisdictions, particularly the United States, a good deal of competition enforcement is undertaken by private actors suing for damages. Anti-competitive conduct may also be subject to criminal penalties including substantial fines, and imprisonment for individuals. Specific types of remedies may be used to address anti-competitive conduct that is undertaken to block the introduction of generic products. This may include requiring pharmaceutical patent owners to compensate public procurement authorities, generic producers and others for damages occasioned by the unwarranted invocation of patents. Strong consideration should be given to prohibiting patent owners from “buying out” generic producers’ challenges to patent validity or assertions of non-infringement. Other types of specific remedies may be considered.

Number of Pages in PDF File: 170
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Local Production of Medicines

12/7/2011

Trends in Local Production of Medicines and Related Technology Transfer

Download here: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1971924

World Health Organization 2011

This report identifies and analyses trends in the local production of medicines in developing countries and related technology transfer. The objective is to assist the World Health Organization (WHO) in its support for Member States in implementing the global strategy and plan of action on public health innovation and intellectual property with particular reference to the promotion of capacity-building for local production in developing countries. The methodology of research included interviews with a range of stakeholders, including industry actors, operators of product development partnerships (PDPs), government officials and members of public health advocacy groups; review of literature and Internet resources; and participation in meetings with stakeholder groups in Africa, Asia and Latin America.

This report makes a number of recommendations. These are focused mainly on the role that WHO, working in partnership with others, can take with respect to transfer of technology and local production of medicines in developing countries.

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Meeting the Challenge

11/15/2011

Intellectual Property and Public Health: Meeting the Challenge of Sustainability

 

Download here: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1965458

Global Health Programme Working Paper No. 7/2011, November 15, 2011

In the decade since the Doha Declaration was adopted, significant progress has been made in addressing problems associated with innovation and access to medicines, including through expanded financial support for procurement and distribution of treatments and vaccines and the establishment of new research and development (R&D) mechanisms. There has been enhanced cooperation among WHO, WIPO and the WTO. Nevertheless, significant gaps remain in placing the development and supply of medicines to the world’s population on a sustainable footing; gaps that are exacerbated by the present trend toward restrained government spending. This paper reflects on the political and legal constellation making progress on global public health matters difficult, and on economic and scientific trends in the medicines sector that may affect policy over the next decade. A sustainable medicines supply system should proceed from “first principles”, encompassing financing mechanisms to assure that essential medicines are provided for all, while affording opportunity to countries at all levels of development to offer access to advanced treatments on a fair compensation basis. Improved mechanisms to incentive R&D are necessary and feasible. First principles should encompass rational prescribing based on the best interests of the patient, and should attend to regulation and enforcement adequate to assure quality, safety and efficacy. Development of a sustainable system could require some modification to the WTO TRIPS Agreement, but this should not be a determinative factor in considering an improved international framework. A new mechanism for global coordination of medicines strategy may be helpful.

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An International Legal Framework

10/1/2010

An International Legal Framework for the Sharing of Pathogens: Issues and Challenges

Download here:  http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1704522

ICTSD Programme on IPRs and Sustainable Development, No. 30, October 2010

Access to biological material with human pathogenic potential (pathogen materials) is important because research directed toward the development of new drugs and vaccines is dependent on scientific analysis of the underlying causes of disease. Member States of the World Health Organization (WHO) began to address problems associated with the sharing of pathogen materials when controversy arose in 2007 following Indonesia’s decision to withhold samples of biological material containing the H5N1 virus (avian flu) from WHO researchers. As a general proposition, states have sovereign rights of ownership and control over access to biological resources located within their territories and thus may determine the conditions of access to those resources. This includes ownership and control over access to pathogen materials. Sovereign control over pathogen materials and access to them is complicated by the fact that they have a tendency to spread geographically, and at some stage, to cross national borders in the absence of intentional human intervention. These sovereign rights, however, do not imply that the host state is not constrained by international legal obligations, such as the obligation to protect human rights related to life and health and the obligation to protect against harm to neighboring states. As a general proposition, states have sovereign rights of ownership and control over access to biological resources located within their territories and thus may determine the conditions of access to those resources. This includes ownership and control over access to pathogen materials. Sovereign control over pathogen materials and access to them is complicated by the fact that they have a tendency to spread geographically, and at some stage, to cross national borders in the absence of intentional human intervention. The ownership and control of pathogen materials are regulated at the international level by a set of norms involving: public international law, the Convention on Biological Diversity (CBD), the WHO Constitution and the International Health Regulations (IHR), the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and international human rights norms. Supplemental norms are under negotiation at the WHO (in the Intergovernmental Meeting on Pandemic Influenza Preparedness) under the CBD (in the Ad Hoc Open-Ended Working Group on Access and Benefit Sharing) and at the WTO (as part of the Doha Round). The reasons pathogen materials may, or may not, be subject to the regime established by the CBD are technically complex from a legal standpoint. Pathogen materials, as a general matter, probably are covered by the CBD, though this is not intended to suggest that the CBD is better equipped than the WHO to address the sharing of pathogen materials in the public health context, but rather addresses the existing or “default” legal situation. There is room for debate concerning whether the CBD, or at least its provisions on ABS, covers viruses, because of specific definitional language in the CBD. New rules related to pathogen materials sharing should most appropriately be negotiated at the WHO, because of the specific relationship to public health, which is most closely associated with the WHO charter. Protecting global health will require that countries share at least some categories of pathogen materials. An important element of the WHO negotiations is to define the availability of IPRs protection for the results of research and development. A negotiated framework must necessarily address the question of the extent to which recipients of such materials may apply for and obtain patents and/or the terms and conditions that will be applicable with respect to any patents obtained. Underlying the WHO negotiations is the question of affordable access to vaccines and treatments for developing countries, which is a presumed condition of a pathogen materials sharing obligation, at least among some WHO Member States. There is a real risk that the result will be a two-tiered system of access to pathogen materials: one addressing certain influenza viruses under the auspices of the WHO and another addressing pathogen materials more generally under the auspices of the ABS Protocol and/or the CBD. As a practical matter, subjecting states, economic operators and individuals to separate agreements covering the same subject matter may create confusion, particularly if the relationship between the agreements is not clearly specified and the rights and obligations are not in harmony. When public health interests are at stake, it is important to avoid a result that generates legal uncertainty and insecurity. Recognizing that negotiators at the WHO and the CBD are engaged in substantially independent and complex exercises each in their own right, greater attention should be focused on how the results of these exercises will relate to each other. Moreover, negotiators at the WHO should be cognizant of the fact that the current IGM-PIP negotiations are not taking place in a legal vacuum. This not only suggests that increased effort should be made to bring the current negotiations that address influenza viruses to a satisfactory conclusion, but also that these negotiations should be followed by a broadened effort to more generally address pathogen materials.
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NAFTA Encyclopedia Entries

5/19/2014

Anti-Competitive Behaviours and the Remedies Available for Redress

Download here (Abbott - Chapter 3)

Download here (Full Text of Guidebook) - with Sean Flynn, Carlos Correa, Jonathan Berger & Natasha Nayak

IP-Watch Report on Guidebook Publication

in UNDP, Using Competition Law to Promote Access to Health Technologies: A guidebook for low- and middle-income countries 58-95 (ed. F. M. Abbott)(2014)

Abstract:

In this chapter, core doctrines of competition law generally applied by national authorities are reviewed. Most competition laws examine anti-competitive behavior in relation to agreements between enterprises, on the one hand, and monopolization or abuse of dominant position, on the other. Anti-competitive activity is further viewed as either ‘horizontal’ or ‘vertical’. Horizontal anti-competitive activity refers to conduct among independent enterprises that are suppliers of competitive (or potentially competitive) goods or services. Vertical anti-competitive activity refers to the supply chain controlled by a producer, beginning with inputs to production, into production, intermediate distribution and, ultimately, the retail sale of goods or services.

Some types of agreement between enterprises are so inherently anti-competitive that proof of the existence of the agreement is sufficient to establish a violation. Such agreements are referred to either as per se anti-competitive or hard-core competition law violations. Other types of conduct that may seem anti-competitive on their face may also have a pro-competitive justification, such that competition authorities assess the balance. This balancing is often referred to as assessment under the “rule of reason”. For a competition law violation to be found, the anti-competitive aspect of the arrangement should outweigh potential pro-competitive benefits.

Examples of horizontal anti-competitive behavior that are per se illegal in most jurisdictions include price-fixing among competitors, output restraints and allocation of geographic territories. Examples of vertical restraints that are per se illegal in many, but not all, jurisdictions are resale price maintenance (or fixing the minimum price at which retailers may sell) and “exclusive grantback” requirements in patent licenses.

There are some significant risks of anti-competitive conduct in pharmaceuticals markets that are fairly widespread and deserve close attention from competition authorities. These include bid manipulation in procurement of health technologies, whereby a group of potential competitors may agree not to submit bids below a set price and to allocate the ‘lowest set price’ bid to a particular firm. Such activity may also involve inappropriate payments to government officials who might otherwise report the anti-competitive practice. Anti-competitive conduct by patent-owning enterprises may include requiring a distributor or retailer of health technologies to purchase a complete line of products as a condition of purchasing a particular product or products (i.e. a tying arrangement). Perhaps the most widely discussed form of anti-competitive conduct involving patent owners involves ‘buying out’ generic challenges to patents that might otherwise result in generic products entering the market at an early date. Such buyouts upset the balance legislators strive to achieve between granting patents and authorizing their challenge to foster competition.

Mergers and acquisitions may adversely affect product markets by, for example, allowing combined companies to raise prices for therapies previously in competition with each other.

Anti-competitive conduct affects markets for innovation, such as when a patent is illegitimately used to prevent the development of new products not within the scope of the patent, or when patent-owning companies combine to control markets. Mergers and acquisitions can affect markets for innovation by reducing potential R&D targets and opportunities.

As noted earlier, competition law addresses dominant enterprises and monopolies as well as agreements between enterprises. A single enterprise (or a small group of enterprises) may alone exercise such significant power in a relevant market as to be able to raise prices above competitive market prices without concern that others will enter the market and undercut it. When an enterprise dominates a market, it does not need consensual agreements with potential competitors to control them; it may unilaterally dictate terms. One objective surrounding the control of mergers and acquisitions is to prevent an enterprise from combining with others precisely to take a dominant position in the market.

This chapter concludes with a discussion of the types of remedies that are available to national authorities and private parties as redress for anti-competitive conduct. It is not uncommon for the government to enter into some form of settlement agreement with an accused enterprise pursuant to which that enterprise agrees to cease its anti-competitive activities and may also make a payment either as damages or as a penalty. Such settlements may be approved and/or supervised by courts.

In some jurisdictions, particularly the United States, a good deal of competition enforcement is undertaken by private actors suing for damages. Anti-competitive conduct may also be subject to criminal penalties including substantial fines, and imprisonment for individuals. Specific types of remedies may be used to address anti-competitive conduct that is undertaken to block the introduction of generic products. This may include requiring pharmaceutical patent owners to compensate public procurement authorities, generic producers and others for damages occasioned by the unwarranted invocation of patents. Strong consideration should be given to prohibiting patent owners from “buying out” generic producers’ challenges to patent validity or assertions of non-infringement. Other types of specific remedies may be considered.

Number of Pages in PDF File: 170
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International Intellectual Property in Max Planck Encyclopedia

5/19/2014

Anti-Competitive Behaviours and the Remedies Available for Redress

Download here (Abbott - Chapter 3)

Download here (Full Text of Guidebook) - with Sean Flynn, Carlos Correa, Jonathan Berger & Natasha Nayak

IP-Watch Report on Guidebook Publication

in UNDP, Using Competition Law to Promote Access to Health Technologies: A guidebook for low- and middle-income countries 58-95 (ed. F. M. Abbott)(2014)

Abstract:

In this chapter, core doctrines of competition law generally applied by national authorities are reviewed. Most competition laws examine anti-competitive behavior in relation to agreements between enterprises, on the one hand, and monopolization or abuse of dominant position, on the other. Anti-competitive activity is further viewed as either ‘horizontal’ or ‘vertical’. Horizontal anti-competitive activity refers to conduct among independent enterprises that are suppliers of competitive (or potentially competitive) goods or services. Vertical anti-competitive activity refers to the supply chain controlled by a producer, beginning with inputs to production, into production, intermediate distribution and, ultimately, the retail sale of goods or services.

Some types of agreement between enterprises are so inherently anti-competitive that proof of the existence of the agreement is sufficient to establish a violation. Such agreements are referred to either as per se anti-competitive or hard-core competition law violations. Other types of conduct that may seem anti-competitive on their face may also have a pro-competitive justification, such that competition authorities assess the balance. This balancing is often referred to as assessment under the “rule of reason”. For a competition law violation to be found, the anti-competitive aspect of the arrangement should outweigh potential pro-competitive benefits.

Examples of horizontal anti-competitive behavior that are per se illegal in most jurisdictions include price-fixing among competitors, output restraints and allocation of geographic territories. Examples of vertical restraints that are per se illegal in many, but not all, jurisdictions are resale price maintenance (or fixing the minimum price at which retailers may sell) and “exclusive grantback” requirements in patent licenses.

There are some significant risks of anti-competitive conduct in pharmaceuticals markets that are fairly widespread and deserve close attention from competition authorities. These include bid manipulation in procurement of health technologies, whereby a group of potential competitors may agree not to submit bids below a set price and to allocate the ‘lowest set price’ bid to a particular firm. Such activity may also involve inappropriate payments to government officials who might otherwise report the anti-competitive practice. Anti-competitive conduct by patent-owning enterprises may include requiring a distributor or retailer of health technologies to purchase a complete line of products as a condition of purchasing a particular product or products (i.e. a tying arrangement). Perhaps the most widely discussed form of anti-competitive conduct involving patent owners involves ‘buying out’ generic challenges to patents that might otherwise result in generic products entering the market at an early date. Such buyouts upset the balance legislators strive to achieve between granting patents and authorizing their challenge to foster competition.

Mergers and acquisitions may adversely affect product markets by, for example, allowing combined companies to raise prices for therapies previously in competition with each other.

Anti-competitive conduct affects markets for innovation, such as when a patent is illegitimately used to prevent the development of new products not within the scope of the patent, or when patent-owning companies combine to control markets. Mergers and acquisitions can affect markets for innovation by reducing potential R&D targets and opportunities.

As noted earlier, competition law addresses dominant enterprises and monopolies as well as agreements between enterprises. A single enterprise (or a small group of enterprises) may alone exercise such significant power in a relevant market as to be able to raise prices above competitive market prices without concern that others will enter the market and undercut it. When an enterprise dominates a market, it does not need consensual agreements with potential competitors to control them; it may unilaterally dictate terms. One objective surrounding the control of mergers and acquisitions is to prevent an enterprise from combining with others precisely to take a dominant position in the market.

This chapter concludes with a discussion of the types of remedies that are available to national authorities and private parties as redress for anti-competitive conduct. It is not uncommon for the government to enter into some form of settlement agreement with an accused enterprise pursuant to which that enterprise agrees to cease its anti-competitive activities and may also make a payment either as damages or as a penalty. Such settlements may be approved and/or supervised by courts.

In some jurisdictions, particularly the United States, a good deal of competition enforcement is undertaken by private actors suing for damages. Anti-competitive conduct may also be subject to criminal penalties including substantial fines, and imprisonment for individuals. Specific types of remedies may be used to address anti-competitive conduct that is undertaken to block the introduction of generic products. This may include requiring pharmaceutical patent owners to compensate public procurement authorities, generic producers and others for damages occasioned by the unwarranted invocation of patents. Strong consideration should be given to prohibiting patent owners from “buying out” generic producers’ challenges to patent validity or assertions of non-infringement. Other types of specific remedies may be considered.

Number of Pages in PDF File: 170
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Emerging Market Supply

5/19/2014

Anti-Competitive Behaviours and the Remedies Available for Redress

Download here (Abbott - Chapter 3)

Download here (Full Text of Guidebook) - with Sean Flynn, Carlos Correa, Jonathan Berger & Natasha Nayak

IP-Watch Report on Guidebook Publication

in UNDP, Using Competition Law to Promote Access to Health Technologies: A guidebook for low- and middle-income countries 58-95 (ed. F. M. Abbott)(2014)

Abstract:

In this chapter, core doctrines of competition law generally applied by national authorities are reviewed. Most competition laws examine anti-competitive behavior in relation to agreements between enterprises, on the one hand, and monopolization or abuse of dominant position, on the other. Anti-competitive activity is further viewed as either ‘horizontal’ or ‘vertical’. Horizontal anti-competitive activity refers to conduct among independent enterprises that are suppliers of competitive (or potentially competitive) goods or services. Vertical anti-competitive activity refers to the supply chain controlled by a producer, beginning with inputs to production, into production, intermediate distribution and, ultimately, the retail sale of goods or services.

Some types of agreement between enterprises are so inherently anti-competitive that proof of the existence of the agreement is sufficient to establish a violation. Such agreements are referred to either as per se anti-competitive or hard-core competition law violations. Other types of conduct that may seem anti-competitive on their face may also have a pro-competitive justification, such that competition authorities assess the balance. This balancing is often referred to as assessment under the “rule of reason”. For a competition law violation to be found, the anti-competitive aspect of the arrangement should outweigh potential pro-competitive benefits.

Examples of horizontal anti-competitive behavior that are per se illegal in most jurisdictions include price-fixing among competitors, output restraints and allocation of geographic territories. Examples of vertical restraints that are per se illegal in many, but not all, jurisdictions are resale price maintenance (or fixing the minimum price at which retailers may sell) and “exclusive grantback” requirements in patent licenses.

There are some significant risks of anti-competitive conduct in pharmaceuticals markets that are fairly widespread and deserve close attention from competition authorities. These include bid manipulation in procurement of health technologies, whereby a group of potential competitors may agree not to submit bids below a set price and to allocate the ‘lowest set price’ bid to a particular firm. Such activity may also involve inappropriate payments to government officials who might otherwise report the anti-competitive practice. Anti-competitive conduct by patent-owning enterprises may include requiring a distributor or retailer of health technologies to purchase a complete line of products as a condition of purchasing a particular product or products (i.e. a tying arrangement). Perhaps the most widely discussed form of anti-competitive conduct involving patent owners involves ‘buying out’ generic challenges to patents that might otherwise result in generic products entering the market at an early date. Such buyouts upset the balance legislators strive to achieve between granting patents and authorizing their challenge to foster competition.

Mergers and acquisitions may adversely affect product markets by, for example, allowing combined companies to raise prices for therapies previously in competition with each other.

Anti-competitive conduct affects markets for innovation, such as when a patent is illegitimately used to prevent the development of new products not within the scope of the patent, or when patent-owning companies combine to control markets. Mergers and acquisitions can affect markets for innovation by reducing potential R&D targets and opportunities.

As noted earlier, competition law addresses dominant enterprises and monopolies as well as agreements between enterprises. A single enterprise (or a small group of enterprises) may alone exercise such significant power in a relevant market as to be able to raise prices above competitive market prices without concern that others will enter the market and undercut it. When an enterprise dominates a market, it does not need consensual agreements with potential competitors to control them; it may unilaterally dictate terms. One objective surrounding the control of mergers and acquisitions is to prevent an enterprise from combining with others precisely to take a dominant position in the market.

This chapter concludes with a discussion of the types of remedies that are available to national authorities and private parties as redress for anti-competitive conduct. It is not uncommon for the government to enter into some form of settlement agreement with an accused enterprise pursuant to which that enterprise agrees to cease its anti-competitive activities and may also make a payment either as damages or as a penalty. Such settlements may be approved and/or supervised by courts.

In some jurisdictions, particularly the United States, a good deal of competition enforcement is undertaken by private actors suing for damages. Anti-competitive conduct may also be subject to criminal penalties including substantial fines, and imprisonment for individuals. Specific types of remedies may be used to address anti-competitive conduct that is undertaken to block the introduction of generic products. This may include requiring pharmaceutical patent owners to compensate public procurement authorities, generic producers and others for damages occasioned by the unwarranted invocation of patents. Strong consideration should be given to prohibiting patent owners from “buying out” generic producers’ challenges to patent validity or assertions of non-infringement. Other types of specific remedies may be considered.

Number of Pages in PDF File: 170
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Regional Assessment

5/19/2014

Anti-Competitive Behaviours and the Remedies Available for Redress

Download here (Abbott - Chapter 3)

Download here (Full Text of Guidebook) - with Sean Flynn, Carlos Correa, Jonathan Berger & Natasha Nayak

IP-Watch Report on Guidebook Publication

in UNDP, Using Competition Law to Promote Access to Health Technologies: A guidebook for low- and middle-income countries 58-95 (ed. F. M. Abbott)(2014)

Abstract:

In this chapter, core doctrines of competition law generally applied by national authorities are reviewed. Most competition laws examine anti-competitive behavior in relation to agreements between enterprises, on the one hand, and monopolization or abuse of dominant position, on the other. Anti-competitive activity is further viewed as either ‘horizontal’ or ‘vertical’. Horizontal anti-competitive activity refers to conduct among independent enterprises that are suppliers of competitive (or potentially competitive) goods or services. Vertical anti-competitive activity refers to the supply chain controlled by a producer, beginning with inputs to production, into production, intermediate distribution and, ultimately, the retail sale of goods or services.

Some types of agreement between enterprises are so inherently anti-competitive that proof of the existence of the agreement is sufficient to establish a violation. Such agreements are referred to either as per se anti-competitive or hard-core competition law violations. Other types of conduct that may seem anti-competitive on their face may also have a pro-competitive justification, such that competition authorities assess the balance. This balancing is often referred to as assessment under the “rule of reason”. For a competition law violation to be found, the anti-competitive aspect of the arrangement should outweigh potential pro-competitive benefits.

Examples of horizontal anti-competitive behavior that are per se illegal in most jurisdictions include price-fixing among competitors, output restraints and allocation of geographic territories. Examples of vertical restraints that are per se illegal in many, but not all, jurisdictions are resale price maintenance (or fixing the minimum price at which retailers may sell) and “exclusive grantback” requirements in patent licenses.

There are some significant risks of anti-competitive conduct in pharmaceuticals markets that are fairly widespread and deserve close attention from competition authorities. These include bid manipulation in procurement of health technologies, whereby a group of potential competitors may agree not to submit bids below a set price and to allocate the ‘lowest set price’ bid to a particular firm. Such activity may also involve inappropriate payments to government officials who might otherwise report the anti-competitive practice. Anti-competitive conduct by patent-owning enterprises may include requiring a distributor or retailer of health technologies to purchase a complete line of products as a condition of purchasing a particular product or products (i.e. a tying arrangement). Perhaps the most widely discussed form of anti-competitive conduct involving patent owners involves ‘buying out’ generic challenges to patents that might otherwise result in generic products entering the market at an early date. Such buyouts upset the balance legislators strive to achieve between granting patents and authorizing their challenge to foster competition.

Mergers and acquisitions may adversely affect product markets by, for example, allowing combined companies to raise prices for therapies previously in competition with each other.

Anti-competitive conduct affects markets for innovation, such as when a patent is illegitimately used to prevent the development of new products not within the scope of the patent, or when patent-owning companies combine to control markets. Mergers and acquisitions can affect markets for innovation by reducing potential R&D targets and opportunities.

As noted earlier, competition law addresses dominant enterprises and monopolies as well as agreements between enterprises. A single enterprise (or a small group of enterprises) may alone exercise such significant power in a relevant market as to be able to raise prices above competitive market prices without concern that others will enter the market and undercut it. When an enterprise dominates a market, it does not need consensual agreements with potential competitors to control them; it may unilaterally dictate terms. One objective surrounding the control of mergers and acquisitions is to prevent an enterprise from combining with others precisely to take a dominant position in the market.

This chapter concludes with a discussion of the types of remedies that are available to national authorities and private parties as redress for anti-competitive conduct. It is not uncommon for the government to enter into some form of settlement agreement with an accused enterprise pursuant to which that enterprise agrees to cease its anti-competitive activities and may also make a payment either as damages or as a penalty. Such settlements may be approved and/or supervised by courts.

In some jurisdictions, particularly the United States, a good deal of competition enforcement is undertaken by private actors suing for damages. Anti-competitive conduct may also be subject to criminal penalties including substantial fines, and imprisonment for individuals. Specific types of remedies may be used to address anti-competitive conduct that is undertaken to block the introduction of generic products. This may include requiring pharmaceutical patent owners to compensate public procurement authorities, generic producers and others for damages occasioned by the unwarranted invocation of patents. Strong consideration should be given to prohibiting patent owners from “buying out” generic producers’ challenges to patent validity or assertions of non-infringement. Other types of specific remedies may be considered.

Number of Pages in PDF File: 170
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Innovation and Technology Transfer

7/13/2009

Innovation and Technology Transfer to Address Climate Change

Lessons from the Global Debate on Intellectual Property and Public Health

Download Here:  http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1433579

ICTSD Programme on IPRs and Sustainable Development, Issue Paper No. 24

This paper examines issues surrounding the development and transfer of technologies for addressing the problem of climate change based on the experience of developing countries in addressing problems of innovation and access in the field of medicines.

It looks at alternative energy resources (AERs) and climate change mitigation technologies (MTs), at the forms of intellectual property rights (IPRs) used to promote and protect innovation, and at the ways these IPRs may have different effects and implications for AERs/MTs as compared with pharmaceutical technologies. It is generally assumed that the originator pharmaceutical sector is highly dependent on strong patent protection, mainly because of the high cost involved in developing novel drug therapies and the low cost of reverse engineering these new drugs. Preliminary research suggests that most AERs/MTs industries may be less dependent on strong patent protection, and/or that patents are less likely to cause significant bottlenecks in the development and transfer of AERs/MTs. While it is premature to come to a definitive conclusion because researchers are only now focusing on the evidence, there is some basis for anticipating that IPRs will present fewer risks for developing countries in the context of climate change than for public health.

Developing country negotiators understood that the GATT Uruguay Round negotiations on trade related aspects of intellectual property rights would affect access to medicines. The resulting WTO TRIPS Agreement did, in fact, present serious risks to public health. These risks were addressed through negotiation of the Doha Declaration on the TRIPS Agreement and Public Health, the Article 31b is amendment and the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property. The “Doha Declaration process” broadly speaking has resulted in some positive movement.

There are a number of lessons that can be drawn from the public health-related negotiations, at the WTO and other forums that may be useful to developing country negotiators addressing IPRs and climate change. Some of these lessons are relatively straightforward: economic and political power substantially influences the outcome of negotiations; the involvement of NGOs and other stakeholders is essential; it is important to shape public opinion through effective communication. Other lessons may be somewhat less evident.

Public health negotiations suggest that zero-sum bargaining is unlikely to be productive from the standpoint of developing countries, and that appeal to “equity” as the basis for demanding concessions is not enough. The private sector in the developed countries controls most pharmaceutical technology and AERs/MTs. Governments in developed countries are unlikely to “order” that technology be transferred by the private sector. Developing countries therefore might usefully focus on establishing frameworks for mutually beneficial joint venture economic arrangements between developed and developing country enterprises that will stimulate innovation and concrete transfers of technology to address climate change.

To the extent possible, technology transfer commitments resulting from climate change negotiations should be specific and concrete. “Soft” commitments on transfer of technology typically do not bear fruit.

A number of developing countries and NGOs have proposed that a declaration comparable to the Doha Declaration on the TRIPS Agreement and Public Health be adopted with respect to IPRs and Climate Change. Even if current multilateral IPRs rules incorporate flexibilities and exceptions adequate to address most foreseeable obstacles to technology transfer, a declaration may be useful in the progressive development of international law so that it properly balances the rights of innovators and access by the public to the benefi ts arising from new technologies.

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Global Pharmaceutical Policy

6/30/2009

The Challenges We Face

in Frederick M. Abbott and Graham Dukes, GLOBAL PHARMACEUTICAL POLICY: Ensuring Medicines for Tomorrow's World 1-15 (2009)(Edward Elgar Publishing)

Download here

Pharmaceutical products play a central role in the prevention and treatment of disease. Making safe and effective pharmaceutical products available and affordable to individuals around the world is a central challenge to the global governance system. There are however myriad obstacles to achieving and maintaining effective worldwide availability of medicines.

Despite the fact that people around the world face largely similar challenges from disease, the policy framework for promoting innovation and regulating pharmaceutical supply is remarkably disjointed. Innovation policy, insofar as it is implemented at all, is established on a country-to-country basis with minimal attention to coordination of research and development. Regulatory structures are almost equally fragmented. Each country has its own set of approval standards and regulatory procedures that must be dealt with, and only to a limited extent are there cooperative procedures or systems of mutual recognition. Corporate decisions concerning where to concentrate innovative efforts, what to produce, where to supply it and on what terms are based on the likely impact on profits and capital markets.

There are wide disparities in levels of income both among countries and within countries. Prices that are reasonably affordable for individuals covered by health insurance in developed countries are likely to be unaffordable for individuals without health insurance in developed and developing countries. There are compelling needs for new medicines to treat diseases affecting both the rich and poor, such as diabetes, cancer, heart disease and the degenerative disorders of old age. Innovation in these areas is costly, yet even with substantial sums invested in research and development rates of innovation are surprisingly low. There are equally compelling needs for new medicines to treat disease conditions predominantly afflicting tropical regions where poverty rates are typically high. Far less is invested in the diseases of the poor because of a lack of market demand.

Medicines must be safe and effective. Making and keeping them so is a challenge for both private and public sector suppliers, for the regulators charged with promoting and protecting public health and for the policy makers who determine the framework within which regulation operates. This book examines the state of play of the international system for the development and supply of pharmaceutical products, and offers insights into how some of its challenges might be addressed. This system is enormously complex, with many moving parts, and there is not likely to be a quick fix for the many challenges. There are quite a few good ideas circulating among individuals and groups involved in formulating and implementing public policy in the field of medicines.

Certainly new initiatives are needed in this field, and existing initiatives can and should be improved. We try to identify and explain those areas in which present policies are not working, and we offer suggestions regarding ways to improve them. We put forward our own proposals regarding directions that global public policy in the field of medicines should take. We do not claim a monopoly on promising ideas. We hope that this volume will succeed at least in moving the dialogue on these subjects forward.

Number of Pages in PDF File: 15



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Cross-Retaliation in TRIPS

4/1/2009

Cross-Retaliation in TRIPS: Options for Developing Countries

Download here:  http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1415802

ICTSD Programme on Dispute Settlement and Legal Aspects of International Trade, Issue Paper No. 8, April 2009

This paper addresses a World Trade Organization (WTO) dispute settlement remedy commonly known as 'cross-retaliation', and specifically the mechanism by which a WTO Member can suspend concessions in the field of trade-related intellectual property rights (TRIPS) to redress an injury suffered with respect to trade in goods or services. A WTO Member enforces compliance with a ruling by the Dispute Settlement Body (DSB) by suspending trade concessions enjoyed by the non-compliant Member. This might involve raising tariffs on products imported from the non-compliant Member. Economically powerful WTO Members are not likely to be harmed by the suspension of trade concessions in goods or services by substantially less powerful Members. The trade impact will be too small to 'induce compliance' and, equally important, the types of suspension that may be used in the fields of goods and services may cause economic harm to the less powerful Members using them. The WTO dispute settlement process strongly favors economically powerful countries, leaving most developing and least developed Members with few options for inducing compliance. Attention is increasingly being focused on the possibility for developing Members to suspend concessions relating to intellectual property rights (IPRs) as a means of inducing compliance by developed Members. Cross-retaliation is expressly contemplated by the WTO Dispute Settlement Understanding (DSU). WTO arbitrators have so far approved TRIPS cross-retaliation on two occasions: in favor of Ecuador (against the European Communities (EC)) and Antigua (against the United States (US)). Constructing and implementing a cross-retaliation program involving IPRs raises a substantial number of complex legal questions. The DSU establishes principles and procedures that must be respected. The various forms of IPR – copyright, patent, trademark, etc. – serve different social and industrial policy functions and have their own unique characteristics. There are multilateral and bilateral agreements and rules outside the WTO context that may influence the shaping of a cross-retaliation program. National constitutions and rules relating to property rights need to be addressed. This paper anticipates many legal questions raised by cross-retaliation in TRIPS and seeks to provide answers to them. It analyses the cross-cutting issues raised by external commitments and national IPRs-related rules, and looks at each major forms of IPR to suggest practical approaches to suspending (or not suspending) those forms. One of the difficult challenges less powerful WTO Members face in seeking to implement cross-retaliation in TRIPS is political pressure from industry groups as well as the governments of more powerful Members. While exporters of goods have not persuaded international media outlets that the suspension of tariff concessions is 'piracy of trade rights', IP-dependent industry groups use sophisticated and expensive propaganda campaigns that result in media portrayal of IPR suspension as 'piracy' and 'theft'. WTO Members must be prepared to deal with industry-induced media pressure.

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Seizure of Generic Pharmaceuticals in Transit Based on Allegations of Patent Infringement: A Threat to International Trade, Development and Public Welfare

1/1/2009

Seizure of Generic Pharmaceuticals in Transit Based on Allegations of Patent Infringement: A Threat to International Trade, Development and Public Welfare

Download here: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1535521

(1 W.I.P.O.J. 43 (2009)

This essay addresses the legitimacy of seizures by the customs authorities of some European Union member states of pharmaceutical products moving in transit through European ports and airports based on patents in force in the transit countries. Seizures have been directed to products off-patent in the countries of manufacture and destination. EU member state customs authorities have justified such seizures on the basis of a 2003 EU intellectual property border enforcement regulation. The seizures have generated intense controversy at the WTO and more widely among stakeholders interested in assuring affordable access to medicines. This essay argues that seizure of generic pharmaceutical products in transit contravenes GATT article V that obligates WTO Members to assure freedom of transit for goods passing through ports and airports, and obligates Members to refrain from imposing unreasonable regulations on such transit goods. It further argues that the seizures are fundamentally inconsistent with the Paris Convention principle of independence of patents that recognizes the sovereign right of states to adopt and implement patent protection as they consider appropriate, within the framework of a general set of rules. Rules permitting enforcement of transit country patents effectively deprives exporting and importing Paris Union and WTO Members of their right to make determinations regarding patents, and represents an overextension of patent jurisdiction by countries without a substantial interest in enforcement. Dutch court adoption of a manufacturing fiction to justify transit seizures – pretending that subject pharmaceuticals are manufactured in the Netherlands, when they clearly are not – represents a significant potential threat to the conduct of international trade. Each WTO Member might pretend that all manner of its domestic regulation – labor, environmental, social welfare – was violated in an exporting country when goods were manufactured, allowing the goods of that country to be seized in transit for a violation of transit country law. The international trading system could not function reasonably in such a fiction-laden environment. The seizure of generic pharmaceutical products in transit is inconsistent with the object and purpose of the Doha Declaration on the TRIPS Agreement and Public Health that promotes access to medicines for all.
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A New Dominant Trade Species Emerges: Is Bilateralism a Threat?

6/1/2007

A New Dominant Trade Species Emerges: Is Bilateralism a Threat?

download here:  http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1152151

Over the past decade, government trade and finance ministries have increasingly turned toward negotiating bilateral and regional trading arrangements, and away from negotiations in multilateral forums like the WTO. There are several reasons for this shift, including changes in the global political environment and negotiating obstacles encountered by the multinational business community at the multilateral level. This shift appears to be an embedded phenomenon. Positive and negative aspects of preferential trading arrangements (PTAs) are in evidence. Trade creation-trade diversion economic analysis suggests the results may be net global welfare enhancing, although such analysis does not readily assess distributional effects. The global economy is enjoying a period of sustained and widely distributed economic growth, suggesting that the PTA phenomenon is not an immediate economic threat. On the negative side, the PTAs lead to administrative complexity, and may be somewhat destabilizing as businesses are encouraged to relocate. Some countries may suffer if left out, but this risk is ameliorated by the wide availability of potential negotiating partners. The PTA negotiating environment strongly favors powerful economic actors like the United States and European Union, which are largely dictating terms to developing (and developed) countries. Developing countries, particularly the less economically powerful, are losing autonomous decision-making authority. The consequences of this are difficult to quantify, and may raise questions better attuned to moral philosophers than economists. The WTO continues on its way, relegated to a less central status. A return to the WTO might reinvigorate the role of less powerful actors, but such return does not appear an immediate prospect. The PTA phenomenon, on balance, does not appear aggressively threatening. We may, however, be underestimating the positive role of multilateralism.

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Parallel Importation

5/19/2014

Anti-Competitive Behaviours and the Remedies Available for Redress

Download here (Abbott - Chapter 3)

Download here (Full Text of Guidebook) - with Sean Flynn, Carlos Correa, Jonathan Berger & Natasha Nayak

IP-Watch Report on Guidebook Publication

in UNDP, Using Competition Law to Promote Access to Health Technologies: A guidebook for low- and middle-income countries 58-95 (ed. F. M. Abbott)(2014)

Abstract:

In this chapter, core doctrines of competition law generally applied by national authorities are reviewed. Most competition laws examine anti-competitive behavior in relation to agreements between enterprises, on the one hand, and monopolization or abuse of dominant position, on the other. Anti-competitive activity is further viewed as either ‘horizontal’ or ‘vertical’. Horizontal anti-competitive activity refers to conduct among independent enterprises that are suppliers of competitive (or potentially competitive) goods or services. Vertical anti-competitive activity refers to the supply chain controlled by a producer, beginning with inputs to production, into production, intermediate distribution and, ultimately, the retail sale of goods or services.

Some types of agreement between enterprises are so inherently anti-competitive that proof of the existence of the agreement is sufficient to establish a violation. Such agreements are referred to either as per se anti-competitive or hard-core competition law violations. Other types of conduct that may seem anti-competitive on their face may also have a pro-competitive justification, such that competition authorities assess the balance. This balancing is often referred to as assessment under the “rule of reason”. For a competition law violation to be found, the anti-competitive aspect of the arrangement should outweigh potential pro-competitive benefits.

Examples of horizontal anti-competitive behavior that are per se illegal in most jurisdictions include price-fixing among competitors, output restraints and allocation of geographic territories. Examples of vertical restraints that are per se illegal in many, but not all, jurisdictions are resale price maintenance (or fixing the minimum price at which retailers may sell) and “exclusive grantback” requirements in patent licenses.

There are some significant risks of anti-competitive conduct in pharmaceuticals markets that are fairly widespread and deserve close attention from competition authorities. These include bid manipulation in procurement of health technologies, whereby a group of potential competitors may agree not to submit bids below a set price and to allocate the ‘lowest set price’ bid to a particular firm. Such activity may also involve inappropriate payments to government officials who might otherwise report the anti-competitive practice. Anti-competitive conduct by patent-owning enterprises may include requiring a distributor or retailer of health technologies to purchase a complete line of products as a condition of purchasing a particular product or products (i.e. a tying arrangement). Perhaps the most widely discussed form of anti-competitive conduct involving patent owners involves ‘buying out’ generic challenges to patents that might otherwise result in generic products entering the market at an early date. Such buyouts upset the balance legislators strive to achieve between granting patents and authorizing their challenge to foster competition.

Mergers and acquisitions may adversely affect product markets by, for example, allowing combined companies to raise prices for therapies previously in competition with each other.

Anti-competitive conduct affects markets for innovation, such as when a patent is illegitimately used to prevent the development of new products not within the scope of the patent, or when patent-owning companies combine to control markets. Mergers and acquisitions can affect markets for innovation by reducing potential R&D targets and opportunities.

As noted earlier, competition law addresses dominant enterprises and monopolies as well as agreements between enterprises. A single enterprise (or a small group of enterprises) may alone exercise such significant power in a relevant market as to be able to raise prices above competitive market prices without concern that others will enter the market and undercut it. When an enterprise dominates a market, it does not need consensual agreements with potential competitors to control them; it may unilaterally dictate terms. One objective surrounding the control of mergers and acquisitions is to prevent an enterprise from combining with others precisely to take a dominant position in the market.

This chapter concludes with a discussion of the types of remedies that are available to national authorities and private parties as redress for anti-competitive conduct. It is not uncommon for the government to enter into some form of settlement agreement with an accused enterprise pursuant to which that enterprise agrees to cease its anti-competitive activities and may also make a payment either as damages or as a penalty. Such settlements may be approved and/or supervised by courts.

In some jurisdictions, particularly the United States, a good deal of competition enforcement is undertaken by private actors suing for damages. Anti-competitive conduct may also be subject to criminal penalties including substantial fines, and imprisonment for individuals. Specific types of remedies may be used to address anti-competitive conduct that is undertaken to block the introduction of generic products. This may include requiring pharmaceutical patent owners to compensate public procurement authorities, generic producers and others for damages occasioned by the unwarranted invocation of patents. Strong consideration should be given to prohibiting patent owners from “buying out” generic producers’ challenges to patent validity or assertions of non-infringement. Other types of specific remedies may be considered.

Number of Pages in PDF File: 170
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World Trade Organization Accession Agreements: Intellectual Property Issues

5/1/2007

World Trade Organization Accession Agreements: Intellectual Property Issues

download here:  http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1915338

This paper addresses intellectual property issues that arise in the context of the accession process with a view toward assisting prospective WTO Members involved in negotiations. The Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS Agreement”) is one of the Multilateral Trade Agreements or MTAs to which all WTO Members are party. As an ordinary consequence of joining the WTO, a state or autonomous customs territory would be expected to become party to the TRIPS Agreement and take on the obligations applicable to other Members at their respective levels of development. However, the terms of the WTO Agreement do not expressly limit the “entry fee” imposed on newly acceding Members to an equivalence of concessions with existing Members. As a consequence of this, accession negotiations have been used by certain Members as a mechanism for securing commitment to obligations in the field of intellectual property rights (IPRs) that are more extensive than those established by the TRIPS Agreement.

For any country which has not been a Member of the WTO, there is a strong possibility that the national regime governing IPRs in place prior to the commencement of accession negotiations will be inconsistent with the requirements of the TRIPS Agreement. In this regard, the process of joining the WTO even at the same level of obligation as existing Members may require a substantial adjustment in national law and corresponding industrial policy. The impact of bringing national law into baseline or “normal” TRIPS Agreement compliance should not be underestimated.

A fundamental characteristic of the TRIPS Agreement is that WTO Members have flexibility regarding the manner in which obligations are implemented. This flexibility has been recognized by the WTO Appellate Body in the India-Mailbox decision. Countries acceding to the WTO may have limited experience in drafting and implementing IPRs law. The way in which such law is drafted may substantially affect social welfare interests withi