The grant of a patent for a genuinely new chemical entity (NCE) provides for 20 to 25 years protection from generic competition, allowing the patent owner to set prices to recoup the cost of the invention. Evergreening is a strategy by which patent owners extend the life of a patent monopoly, surrounding an original inventive patent with numerous additional patents for modifications or variations to the original invention (secondary patents). The sub-set of secondary patents owned by the originator company are known as ‘evergreening patents’, that is, patents designed to further delay generic entry to the market. Only a small number of evergreening patents achieve this effect. Numerous articles on pharmaceutical marketing consider such patenting an important part of ‘lifecycle management’, ensuring continuing high profits from the original invention are kept ‘evergreen’.

Trade negotiations between the European Union (EU) and Australia and New Zealand (NZ) provide the opportunity to revisit the ongoing clash between EU and New World ( United States of America (USA), Canada, Australia, NZ etc.) countries over geographical indications (GIs). Since the EU-Canada negotiations, the EU has increased its GI demands and the Australia and NZ negotiations provide the first opportunity to assess these. NZ has agreed to privileges that exceed those in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and has fewer safeguards for NZ producers than were achieved in Canada. The EU's GI demands to Australia are scrutinized in terms of competition, rule of law and consumer information criteria, providing a basis for considering how Australia should respond. A particular focus is the problematic issues raised in the demand that specific GI names be listed in the treaty without proper review and opposition procedures. Questions are also raised about the accuracy of EU GI labels and the relative merit of EU GI policy compared to certification mark GIs to promote regional development. On this basis it is suggested that Australia should reject a number of the EU's GI demands as these lead to approving product labels which are deceptive for consumers.

Intellectual property (IP) privileges are one of the most contentious areas of international economic regulation. This chapter uses the example of pharmaceuticals to consider the question of balance in patent policy and how this is impacted by international trade negotiations. It reviews key provisions in TRIPS from the contrasting perspectives of inventors of new medicines and users of such medicines. A critical issue identified is the breadth of privilege granted to patent holders and the removal of prior social safeguards in TRIPS. Evidence from recent trade treaties and their negotiation shows how the interests of patent holders often prevail against the interests of patients and society. Closely related to patent privileges for pharmaceuticals are privileges regarding the use of clinical trial data to obtain marketing approval for medicines. Such privileges are also provided in TRIPS, and subsequent treaties, for agricultural chemicals. An interesting aspect emerging from the comparison of data protection privileges for these two product categories is that treaties embody protections to protect unnecessary testing on animals but not on humans.

BACKGROUND:It is widely accepted that intellectual property legal requirements such as patents and data exclusivity can affect access to medicines, but to date there has not been a comprehensive review of the empirical evidence on this topic. The World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) requires Member States to implement minimum standards of intellectual property protection including patents for pharmaceutical products, but also contains 'flexibilities' designed to address barriers to access to medicines. National intellectual property laws can also include TRIPS-plus rules that go beyond what is required by TRIPS. We aimed to systematically review literature that measures the impact of intellectual property rules on access to medicines, whether implemented as a result of TRIPS, TRIPS-plus provisions in other trade agreements, or unilateral policy decisions.METHODS:We searched Proquest, SCOPUS, Web of Science, PubMed, JSTOR, Westlaw and Lexis Nexis. Peer reviewed articles, government reports and other grey literature were included. Articles were eligible for inclusion if they were quantitative, in English, included a measure of cost, price, availability of or access to medicines, were about intellectual property or data exclusivity rules and published between January 1995 and October 2020. Ninety-one studies met our inclusion criteria. We systematically reviewed the studies' findings and evaluated their quality using a modified quality assessment template.RESULTS AND CONCLUSION:Five broad overarching themes and 11 subthemes were identified based on the articles' foci. They were: trade agreements (divided into EU FTAs and those that include the USA); use of TRIPS flexibilities (divided into compulsory licencing and parallel importation); patent expiry/generic entry/generic pathway (divided into comparative studies and single country studies); patent policies (also divided into comparative studies and single country studies) and TRIPS-plus rules (divided into data exclusivity, patent term extensions and secondary patenting). Most studies focused not on specific trade agreements, but on TRIPS-plus provisions, which can also be found within some trade agreements. The main finding of this review is that the stronger pharmaceutical monopolies created by TRIPs-plus intellectual property rules are generally associated with increased drug prices, delayed availability and increased costs to consumers and governments. There is evidence that TRIPS flexibilities can facilitate access to medicines although their use is limited to date. There were few studies that included resource poor settings, signalling a need for greater research in such settings where the impact on access to medicines is likely to be more damaging.

In our study, we tried to collect empirical studies focusing on the economic impact of Geographical Indications (GIs). Using a systematic literature review approach, we investigated three different aspects: market size, price premium and impacts on rural development. Based on the findings of studies both from the grey and academic literature, the results are quite mixed. Though the number of GI-related empirical studies has risen in recent years, there is a lack of economic data to support policies related to GIs, even in the European Union (EU), where the most important GI system exists. Overall, it is impossible to draw any general conclusions about the economic impact of GIs. Some countries have remarkable GI market size, and some GI products have a determinative role in both domestic and export markets; however, it is not general. Again, some particular GI products of some regions could gain significant price premiums, but due to the associated higher production costs and unequal distribution in the value chain, it might not result in higher producer incomes. The most conflicting empirical results were found in how GIs can contribute to regional prosperity, as evidences of the harmful effects of GIs on rural development were also identified.

Objectives The aim of the study was to estimate the potential savings to the Pharmaceutical Benefits Scheme (PBS) and the Repatriation Pharmaceutical Benefits Scheme (RPBS) in 2015-16 if biosimilar versions of selected biologic medicines (biologics) had been available and listed on the PBS. Methods The research involved retrospective analysis of Australian Medicare expenditure data and PBS price data from 2015-16 for biologics, for which biosimilar competition may be available in future, listed on the PBS. Results Australian Government expenditure on biologics on the PBS and RPBS was estimated at A$2.29 billion dollars in 2015-16. If biosimilar versions of these medicines had been listed on the PBS in 2015-16, at least A$367million dollars would have been saved in PBS and RPBS subsidies. Modelling based on price decreases following listing of biosimilars on the PBS suggests that annual PBS outlays on biologics could be reduced by as much as 24% through the timely introduction of biosimilars. Conclusions Biologic medicines represent a large proportion of government expenditure on pharmaceuticals. Reducing the length of monopoly protections on these medicines could generate savings of hundreds of millions of dollars per year. What is known about the topic? Biologics take up an increasing share of pharmaceutical expenditure, but no previous published studies have examined Australian Government expenditure on biologics or the potential savings from reducing the duration of monopoly protection. What does this paper add? This paper provides new evidence about Australian Government expenditure on biologics and potential savings for selected medicines that are still subject to monopoly protection and thus are not yet subject to biosimilar competition. In 2015-16 Australian Government expenditure on biologics through the PBS and RPBS was estimated at A$2.29 billion dollars. If biosimilar versions of these medicines had been listed on the PBS at that time, at least A$367million dollars would have been saved. What are the implications for practitioners? Reducing the duration of monopoly protection on biologic medicines could save hundreds of millions of dollars annually that could be redirected to other areas of the healthcare system.

In order to understand the global importance of foods with Geographical Indications (GIs), it is essential to get an overview of the market size for such products. In spite of the relative importance of GI policy in EU trade agreements, there are only very limited data available on the actual market size for GI labelled products. Against this background this paper collects all the available data that provides estimates of the market size for GI foods, analysing the available datasets and reports of the European Commission and conducting a systematic literature review on the academic papers related to this topic. Based on the results we can underline the high level of concentration of GI products in terms of origin and product category. The most important GI market is the domestic market of the European Union even though the share of GI production is only a minor part of total agri-food output. On the other hand, GI products with both significant market size (domestic and export) and remarkable market share also exist, but these are a small set of all registered GI products and are concentrated in only a few countries.

In the Trans Pacific Partnership (TPP) Agreement negotiations, the USA successfully pursued intellectual property (IP) provisions that will affect the affordability of medicines, including anti-retrovirals (ARV) for HIV. Vietnam has the lowest GDP per capita of the 12 TPP countries and in 2013 provided ARVs for only 68% of eligible people living with HIV. Using the current Vietnamese IP regime as our base case, we analysed the potential impact of a regime making full use of legal IP flexibilities, and one based on the IP provisions of the final, agreed TPP text. Results indicate that at current funding levels 82% of Vietnam's eligible people living with HIV would receive ARVs if legal flexibilities were fully utilised, while as few as 30% may have access to ARVs under the TPP Agreement - more than halving the proportion currently treated.

This article explores European Union (EU) policy on geographical indications (GIs) as expressed in the outcomes of EU trade negotiations. This empirical approach provides a factual basis about the GI deals which are acceptable to the EU. Across the EU’s six recent Global Europe treaties the EU has achieved a good degree of success in obtaining strong-form GI rights (no use of -like, -style qualifiers on labels) for a number of specific products. The article also identifies GI outcomes in recent treaties driven by US negotiating demands. While US-driven treaties prioritize a trademark approach to GIs, they also allow for coexistence with EU-style strong-form GIs. Comparing these two sets of outcomes provides useful insights for future EU trade negotiations, such as the proposed Transatlantic Trade and Investment Partnership (TTIP) with the US or the proposed Free Trade Agreement with Australia and New Zealand. In particular the Canada-EU Comprehensive Economic and Trade Agreement (CETA) shows how the interests of domestic cheese and meat producers can be protected while allowing for strong-form GI privileges for a reasonable number (163 in CETA) of listed product names.

This paper summarizes the empirical research on the patent system and on data protection. This is done in the context of the 2015-16 Australian Productivity Commission Inquiry into Intellectual Property Arrangements. The major focus is on whether the patent system is effective and efficient - that is, does it grant patents only for inventions that would not otherwise have occurred and which have net positive spillover benefits. These are the criteria for a parsimonious patent system - one that minimizes damage to consumers and follow-on inventors. In general patent systems are seen to fail this test largely because the inventiveness (non-obviousness) requirement is far too low. Beyond this, patent privileges are seen to be too extensive, now that the local working requirement has been removed. Further, penalties are one-sided encouraging applicants to apply for almost uninventive inventions. In regards to data protection questions are raised about both the economics and the ethics of providing data protection.

Litigated pharmaceutical patents are a valuable source of data on how much inventiveness is required for a patent grant and what are the costs of patents. Although innovation is central to economic growth and the competitiveness of firms, there are few data about either the cost of granted patents or the quantum of inventiveness required for a patent. Two cases of litigated pharmaceutical patents allow investigation of two types of secondary ‘evergreening’ patents—new formulations and closely related chemical variants. Both lead to higher Pharmaceutical Benefits Scheme outlays, and in some cases, these can be substantial. There are clear policy implications.

In the context of the initiative for Upgrading the Single Market, the Commission has put forward a re-evaluated approach to trade – Trade for All. The EU prioritises a return to global trade negotiations and puts forward a three-prong strategy for re-invigorating the World Trade Organisation’s role in trade negotiations. The first two prongs – the WTO to play a central role and single issue focused negotiations – are fairly straight-forward. However the third prong – letting subsets of nations advance particular agendas, with others to follow later – raises some concerns. While the Trade Facilitation Agreement appears to be a successful example of this, the ill-fated Anti-Counterfeiting Trade Agreement (ACTA) is another story. The European Commission was a strong advocate of this proposed treaty, but it was roundly rejected by the European Parliament. This paper reviews the experience of the ACTA negotiations to identify important lessons if the EU is to pursue limited membership treaties with greater success.

Litigated pharmaceutical patents are a valuable source of data on how much inventiveness is required for a patent grant and what are the costs of patents. Although innovation is central to economic growth and the competitiveness of firms, there are few data about either the cost of granted patents or the quantum of inventiveness required for a patent. Two cases of litigated pharmaceutical patents allow investigation of two types of ‘evergreening’ patents – new formulations and closely related chemical variants. Both lead to higher health costs, and in some cases these can be substantial. Both types of evergreening patent point to the very low standard of inventiveness required for patent grant. Although the data refer to Australia, there are implications for patent policy in other jurisdictions too.

The European Union (EU) has been the principal driver of policy on geographical indications (GIs). Classified as a form of "intellectual property", GIs have been highly contentious, creating considerable difficulties in international trade negotiations. This paper reviews how GI policy for foodstuffs is implemented within the EU and what are the key features the EU seeks in its trade treaties. Investigation of how EU GI policy is implemented allows assessment of GI policy against the alleged market failure in consumer information rationale. The limited data available on the operation of the EU GI scheme show that GIs cover only a small proportion of food output and an even smaller share of world trade. Despite this, the EU sees GI policy as a deal-breaker in international trade negotiations. The paper analyses the outcomes of recent EU trade treaties, with a particular focus on the agreement with Canada. Comparing EU demands and outcomes with the GI outcomes in the Trans Pacific Partnership Agreement (TPPA) provides some insights that might be useful for the foreshadowed agreement between the EU and Australia and New Zealand. There are also implication for the planned Transatlantic Trade and Investment Partnership (TTIP).

Intellectual property (IP) protections proposed by the United States for the Trans-Pacific Partnership Agreement (TPPA) have sparked widespread alarm about the potential negative impact on access to affordable medicines. The most recently leaked draft of the IP chapter shows some shifts in the US position, presumably in response to ongoing resistance from other countries. While some problematic provisions identified in earlier drafts have been removed or mitigated, major concerns remain unresolved. Three of the greatest concerns for Australia in the recent draft include provisions that would further entrench secondary patenting and evergreening, lock in extensions to patent terms and extend monopoly rights over clinical trial data for certain medicines. Data from the 2013 Pharmaceutical Patents Review, and from various submissions made to it, show that pharmaceutical monopoly protections already cost Australian taxpayers hundreds of millions of dollars each year. Provisions still being considered for the TPPA would further entrench and extend costly monopolies, with serious implications for the budget bottom line and the sustainability of the Pharmaceutical Benefits Scheme.

The major benefit from free trade is from domestic reform (Section 2A). Current preferential trade treaties have large sections concerning the wide range of domestic regulation that might impede trade in agriculture or services (Section 2B). These regulatory sections are highly detailed and prescriptive – the worst form of old-fashioned heavy-handed regulation (Section 2C). They need to be replaced by modern outcome-oriented objectives, with countries free to implement these as best fits other social, cultural and economic goals. As trade treaties receive little attention during elections a mandate cannot reasonably be claimed (Section 3A). These treaties tie the hands of both the current and future governments across a wide range of domestic regulation – open debate about these goals and the best means of achieving them is essential. Such an open agenda would re-build trust in government and better suit decision-making processes in a democracy. An important part of this would be independent evidence-based analysis by a trusted body (Section 3B). This would provide a factual basis for any consultations (Section 3C). The submission also considers what fair trade provisions might look like. The elements of a fair, balanced, patent policy are set out in Section 4A. These are assessed against our current treaties in Section 4B. There is a large gap. Many of our treaties fail the TRIPS Article 7 test of what a fair balanced patent policy should look like. The most essential first steps in ensuring that preferential trade treaties are democratic, procompetitive and balanced are to ensure that there is independent evidence-based assessment of the proposed content, and that the approval authority rests with parliament. Ideally there should be an active economic reform agenda, with full public debate of all the options likely to be included in trade treaties.