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Crosbie, Stephanie --- "The Limited Impact Of Evergreening Practices In Australia" [2015] JlLawInfoSci 5; (2014/2015) 23(2) Journal of Law, Information and Science 83


The Limited Impact Of Evergreening Practices In Australia

STEPHANIE CROSBIE [*]

Abstract
Concerns are often raised regarding the impact of strategies employed by originator pharmaceutical companies to expand patent protection with a view to maximising profits. It has been argued that such practices have a negative impact on competition and access to affordable pharmaceuticals for the public. This article focuses on ‘evergreening’ as one such strategy in an Australian context and argues that as a matter of practical reality, the impact of evergreening practices in Australia is not as detrimental as the concerns that have been raised regarding such strategies suggest. In support of this argument, this article examines: the ability of Australian patentability requirements to appropriately regulate the grant of follow-on patents, as demonstrated in cases of alleged evergreening including Merck & Co Inc v Arrow Pharmaceuticals Limited, Aktiebolaget Hassle v Alphapharm Pty Ltd and H Lundbeck A/S v Alphapharm Pty Ltd; the diverse generic and originator ownership of follow-on patents in Australia; the role of follow-on patent applications as part of legitimate and predictable business practices; the benefits potentially flowing from follow-on and cumulative innovation; and the limited scope and thus limited threat of follow-on patents in comparison to original patents. The findings of the Report of the 2013 Pharmaceutical Patents Review will also be considered.
Introduction

Pharmaceutical patents are temporary monopoly rights granted to exclude others from commercially exploiting an invention for or directly related to a medicine, including those for ‘active ingredients, new formulations and methods of use’.[1] They are granted in return for disclosure, in the patent specification, of sufficient information to allow an invention to be performed using the best method known to the applicant.[2] Patents over pharmaceutical inventions are pervasive in Australia, representing the third largest technology area for patent applications, with most applications filed by multi-national pharmaceutical companies.[3]

Concerns have been raised regarding the strategies utilised by such pharmaceutical companies to extend their patent monopolies, particularly surrounding the implications for patent policy, competition and affordable access to health care in our contemporary society that is highly reliant on pharmaceuticals.[4] ‘Evergreening’ is one such strategy that has resulted in criticism of originator pharmaceutical companies both in Australia and internationally. Evergreening is a colloquial term with no universally accepted definition. However, it is commonly used to describe the strategic utilisation of the patent system to extend the breadth and duration of patent protection for high-earning pharmaceuticals, by obtaining firstly an original patent for the API (Active Pharmaceutical Ingredient), and then multiple follow-on patents for different aspects of the same drug.[5]

Evergreening was discussed in the IP Australia’s Pharmaceutical Patents Review (the ‘Pharmaceutical Patents Review’).[6] The Pharmaceutical Patents Review endeavoured to evaluate the ability of the Australian patent system to balance access to competitively-priced pharmaceuticals with encouraging research and development by providing patent protection as an incentive for investing in innovation.[7] The Pharmaceutical Patents Review concluded that evergreening can have an unfortunate effect of ‘frustrating competitors’ efforts to enter the market’ and increasing ‘uncertainty for generics and others seeking to innovate’, by facilitating extended protection through ownership of multiple patents surrounding a single pharmaceutical.[8]

In this article, I will argue that in reality the impact of evergreening practices in Australia is not as ‘unfortunate’ or detrimental as has been claimed. By way of introduction, in Part 1, I will discuss the pharmaceutical industry and practices of evergreening. In Part 2, I will set the legal scene for evergreening in Australia by explaining the way current patentability requirements appropriately regulate the grant of follow-on patents. The concerns raised by others regarding evergreening will be outlined in Part 3, which will be rebutted in Part 4 where I will present four practical realities that suggest that evergreening is not of significant concern in Australia. In Part 41, I will discuss an empirical analysis revealing that follow-on pharmaceutical patents are owned by a variety of companies,[9] indicating that evergreening strategies are not exclusively utilised by allegedly unfair originator companies. In Part 4.2, I will argue that evergreening is generally a predictable and legitimate business practice that operates within the bounds of Australian patent law. The potential benefits flowing from the ability to seek follow-on patents and cumulative innovation will be highlighted in Part 4.3. Finally, in Part 4.4, I will argue that follow-on patents are necessarily more confined in scope than the original patent, and thus do not often pose a substantial threat to competition.

1 Pharmaceutical Patents And Evergreening In Australia

The pharmaceutical industry, which is comprised of companies that develop pharmaceuticals for use as medication,[10] is one of the most profitable in the world[11] and is experiencing growth in Australia.[12] The research and development of pharmaceuticals is challenging, risky and expensive,[13] requiring substantial upfront investment.[14] These problems are often the result of high failure rates; extensive delays between initial discovery and market entry of a drug; and the fact that pharmaceutical products are often relatively easy to ‘reverse engineer’, and are thus susceptible to ‘free riders’.[15] It has been noted by Medicines Australia that it takes approximately ‘$1.5 billion and 12 to 15 years to bring a new drug to market’.[16] While the impartiality of this estimation may be questioned due to the involvement of Medicines Australia in promoting the interests of originator pharmaceutical companies, this figure is substantially concordant with other suggestions. For example, another estimate puts the cost of releasing a new pharmaceutical at approximately US $800 million.[17] Despite the risk and initial outlay, the rewards are potentially high.[18] For example, Pfizer’s cholesterol lowering blockbuster atorvastatin, Australia’s biggest selling medicine, has generated $120 billion in cumulative global revenue since 2000.[19]

As a result of the initial risks and expense, pharmaceutical companies rely heavily on the patent system to enhance profitability through the exclusivity afforded by intellectual property protection.[20] Empirical findings show that patents play an important role in encouraging pharmaceutical innovation, which enhances the quality of public health care and advances our scientific knowledge.[21] These factors suggest that patents, by providing an assurance that there will be a period of market exclusivity in which the originator can recoup extensive research and development costs, have an important role for both the community and pharmaceutical companies.[22]

Further, the rising costs associated with developing pharmaceutical products,[23] the potential for high profitability and the increasing pressure on companies to increase returns on investments[24] have all created an incentive to stretch the boundaries of the patent system to maximise the scope and length of patent protection.[25] One strategy that has been employed by pharmaceutical companies in order to expand patent protection is evergreening. This practice involves seeking multiple follow-on patents for various features of an API over time in order to maximise patent protection.[26]

The most common evergreening paradigm involves an originator company lodging an initial patent claiming the API for a drug. Later, the company lodges so-called ‘follow-on’ patents, which are simply new standard or innovation patents that claim extraneous features of the drug.[27] These follow-on patents typically claim new variations, improvements, formulations, derivatives, packaging, dosing regimes, delivery systems, and new methods of use, production and manufacture.[28] As a result, this practice both broadens the scope of patent protection for a single drug and extends the length of protection, as follow-on patents expire later and thus have a greater ‘monopoly profit potential’.[29]

For example, there are various follow-on patents associated with lamotrigine, the API originally patented by GlaxoSmithKline in 1980, used to treat central nervous system disorders, including epilepsy.[30] The original drug was an oral tablet sold under the name Lamictal, and the original patent expired in 2000 in most countries.[31] GlaxoSmithKline applied for a follow-on patent in 1992 for a chewable and dispersible tablet formulation, which enhanced patient compliance and ease of use.[32] Prima facie, this could suggest that GlaxoSmithKline was able to extend their patent monopoly for lamotrigine.

However, in reality, when the original patent for the oral tablet expired, generic competitors were still able to enter the market and supply consumers with a generic alternative to Lamictal.[33] Importantly, the competitors were only precluded from manufacturing the new, chewable tablet formulation that was the subject of the follow-on patent.[34] Additionally, generic competitors were prompted to ‘design around’ GlaxoSmithKline’s follow-on patent and develop alternative chewable tablet formulations using different technology that had a similar effect.[35] Indeed there are numerous Australian follow-on patents associated with lamotrigine, claiming alternative tablet compositions and enhanced formulations, owned by more than ten originator and generic pharmaceutical companies.[36]

This initial example suggests that instances of ‘evergreening’ do not inevitably violate patent policy nor hinder competition to the extent that has been claimed. These concerns will be explored further in Part 3, following an analysis in Part 2 of the centrality of patentability requirements in appropriately regulating evergreening practices.

2 Patentability Requirements And Their Role In Appropriately Regulating Evergreening Strategies In Australia

The Australian patentability requirements play a fundamental role in ensuring that all patents, including follow-on patents, meet appropriate standards, as demonstrated through the cases discussed in this section.

2.1 Australian Patentability Requirements and Evergreening Strategies

In Australia, the Patents Act 1990 (Cth) (‘Patents Act) imposes a number of substantive patentability requirements and disclosure requirements, which must be met to obtain a standard patent.[37] The substantive requirements for both standard and innovation patents are specified in s 18 of the Patents Act.[38] A standard patent can only be granted over an invention that: is a manner of manufacture; is novel when compared with the prior art base as it existed before the priority date of the claim; involves an inventive step; is useful; and has not been secretly used before the priority date.[39] Of these requirements, manner of manufacture, novelty and inventive step are most contentious in cases of evergreening.

The ‘manner of manufacture’ requirement refers to a mode of achieving an end result that is an artificially created state of economic utility.[40] The manner of manufacture requirement should operate to limit inappropriate attempts to patent products or processes that are not legitimate inventions creating a new and useful state of affairs, but are instead better characterised as mere discoveries or scientific theories. This acts as a restraint on the grant of a follow-on patent in the context of evergreening.[41]

The novelty of the patent claims is measured against the prior art base, which includes information publicly disclosed in a document or made available through doing an act, as understood by a person skilled in the art.[42] Hence, it requires that the invention has not been previously disclosed in such a way that a skilled addressee would be able to apply and use the invention without needing to undertake further inventive work.[43] In the context of evergreening, the novelty requirement should operate to ensure that follow-on patents are not granted for what has already been disclosed, in either a previously filed patent specification or other publicly available information.[44]

The inventive step threshold requires that the product or process is an advance on prior knowledge, which means that follow-on patents must actually be inventive and non-obvious.[45] When compared with the prior art base, it must not have been an obvious step ‘to a person skilled in the relevant art in light of the common general knowledge’.[46] Following amendments to the Patents Act, contained in the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth), the inventive step requirement has been strengthened, and now more information can be considered in assessing inventiveness.[47] The Pharmaceutical Patents Review has stated that these amendments may make it more difficult to patent ‘trivial advances or obvious variations, thereby limiting the opportunities for patent portfolio-type evergreening’.[48] As these amendments only took force in April 2013,[49] their impact on evergreening practices is not yet known.

For pharmaceutical patents, the practical effect of these requirements is that monopolies cannot be granted for drugs or pharmaceutical processes that have already been invented, or are obvious given what has previously been done in the field. This means that to be granted a follow-on patent, incremental or cumulative improvements must be substantial enough to meet patentability thresholds. Christie and Pryor have insightfully highlighted that the patentee’s motives are irrelevant to patent validity.[50] Hence, patent applications for follow-on patents cannot be rejected merely on the basis of a patentee’s improper motives in attempting to gain an unfair advantage that could subvert patent policy or hinder competition.[51] Instead, recourse must be made to the patentability criteria to regulate patent quality in Australia. This makes the patentability requirements crucial in the case of evergreening.

2.2 Australian Cases Applying the Patentability Requirements in Situations Involving Evergreening

There have been relatively few evergreening cases in Australia.[52] The three cases that will be discussed in this section each demonstrate the adherence of Australian courts to the patentability requirements in ascertaining the validity of follow-on patents, and their role in appropriately regulating evergreening. Merck will be considered first as an example of an unsuccessful attempt to patent a dosage regime associated with a previously patented API, followed by Aktiebolaget and Lundbeck as instances where follow-on patents were found to be valid, having satisfied the patentability requirements.

2.2.1 Merck & Co Inc v Arrow Pharmaceuticals Limited (‘Merck’)[53]

Merck owned patents claiming alendronate, the API used in osteoporosis medication to inhibit bone resorption, filed in 1990, and a method for using alendronate using a one-per-day oral dosage regime.[54] A follow-on patent was claimed for an alternative one-per-week dosage regime, which reduced gastrointestinal side effects and raised patient compliance.[55] The follow-on patent claiming the weekly dosage regime was challenged in an action for revocation by a generic manufacturer, Arrow, under s 138 of the Patents Act.[56] At first instance, Justice Gyles held that the follow-on patent was invalid for two main reasons[57] and his decision was upheld on appeal to the Full Federal Court by Heerey, Kiefel and Dowsett JJ.[58]

First, Gyles J found that the claims failed to satisfy the requirements of a ‘patentable invention’ and ‘manner of new manufacture’ in s 18 of the Patents Act.[59] His Honour emphatically stated that ‘each of the so-called method claims was one way of utilising alendronate and its known quantities for the known purpose of preventing or treating osteoporosis by a known method of oral administration’.[60] In this way, Gyles J classified the claims of the follow-on patent as mere directions for use (and not an invention nor a manner of manufacture) as reduction in side effects produced no new technical effect or involved no discovery of new physical properties or results in the compound[61] beyond ‘standard mixing and formulation techniques’.[62] The decision reinforced the principle that the specification must disclose a new substance, new characteristic of a known substance, new use or new method to qualify as a manner of manufacture.[63] In this case, the specification did not disclose a new substance, nor a new property or use of a known substance.

Second, it was held that the subject matter of the follow-on patent lacked novelty.[64] Information surrounding the invention had been previously published in the Lunar News journal in 1996 and 1997.[65] While the publications were not well known,[66] they still formed part of the prior art base because 18 000 copies were circulated and they were published on the Lunar Corporation website.[67] Consequently, the contents were held to be ‘publicly available’ for the purpose of novelty.[68] The prior publications also sufficiently disclosed the invention to defeat novelty by anticipating each of the claims,[69] as the articles ‘clearly conveyed’ the benefits of a weekly dosing regime and the approximate quantity used.[70]

This decision emphasises that a follow-on patent claiming a dosage regime must still satisfy each of the patentability requirements. Justice Gyles stated that the case involved ‘what would now colloquially be called an attempt to “evergreen” a pharmaceutical patent’.[71] Interestingly, His Honour looked unfavourably on the fact that Merck attempted to claim a ‘particular dosing regime for a particular purpose that was contemplated at the time of the base patent, with no new properties of the compound having been discovered in an inventive fashion’.[72] It is this lack of further ingenuity that appears to make Merck distinguishable from other cases considering follow-on patents involving previously unknown properties that were not contemplated at the time of the original invention, as in Aktiebolaget and Lundbeck, discussed below.

2.2.2 Aktiebolaget Hassle v Alphapharm Pty Ltd (‘Aktiebolaget’)[73]

In Aktiebolaget, a follow-on patent directed towards a new formulation for coating omeprazole (sold as ‘Losec’), used in the treatment of gastrointestinal disorders, was challenged in the High Court.[74] Aktiebolaget’s follow-on patent claimed a method of formulating omeprazole in a way that enabled it to be delivered to the small intestine without degradation in the stomach by using a protective coating and with the addition of an alkaline material.[75] Omeprazole itself could not be commercially exploited without such a protective coating.[76] The patent for omeprazole, the API, was close to expiry, and, consequently, Alphapharm sought to import and sell a generic equivalent.[77] Aktiebolaget brought infringement proceedings against Alphapharm, and Alphapharm counterclaimed for revocation of the patent.[78] The primary judge in the Federal Court, Lehane J, held that the follow-on patent was obvious and, on that basis, made an order for revocation.[79] On appeal to the Full Federal Court, Justice Lehane’s findings were upheld.[80]

A 5–2 majority of the High Court, however, allowed an appeal against this finding. The majority, comprising of Gleeson CJ, Gaudron, Gummow and Hayne JJ (in a joint judgment) and Callinan J (in a separate judgment), found that the combination of elements used in the new tablet formulation and their interaction was inventive, even if some integers were previously known while others were new.[81]

Interestingly, the Pharmaceutical Patents Review described the Aktiebolaget follow-on patent as an example of the importance of the patent system extending protection to cumulative research and incremental developments.[82] Without the follow-on patent, the API could not be delivered to the correct site of action to achieve the intended medical effect,[83] and the High Court’s decision is consistent with patent policy in rewarding such an important invention. Here, the High Court is seen to condone evergreening practices provided follow-on inventions satisfy the patentability requirements.[84]

In contrast, both McHugh and Kirby JJ dissented, with Kirby J stating that ‘this Court should avoid creating fail-safe opportunities for unwarranted extensions of monopoly protection that are not clearly sustained by the law’.[85] However, despite His Honour’s concerns, where the patent meets the current patentability requirements, the grant of monopoly protection will be ‘sustained by the law’.

2.2.3 H Lundbeck A/S v Alphapharm Pty Ltd (‘Lundbeck’)[86]

This central issue in Lundbeck was whether Lundbeck’s follow-on patent claiming escitalopram satisfied the novelty requirement.[87] Escitalopram, which is used to treat depression, is an isolated enantiomer of citalopram, another antidepressant drug.[88] Lundbeck had already filed for a patent for citalopram in 1977, which was due to expire in 2009, before filing for escitalopram in 1989.[89] Alphapharm, a manufacturer who sought to produce a generic alternative, sought revocation of the later escitalopram patent.[90] On appeal to the Full Federal Court, Justice Lindgren’s findings at first instance[91] were upheld by a 2–1 majority, with Emmett J (in dissent) holding that the invention lacked novelty.[92] The majority of the Full Federal Court (consisting of Bennett and Middleton JJ) decided that because the initial citalopram patent specification described the racemate but not the isolated enantiomer, to the skilled addressee, there was no prior disclosure of the claimed enantiomer in the original patent nor in any other prior art information.[93] Hence, the follow-on patent did not disclose an invention which, if performed, would infringe the initial patent as prior disclosure did not contain ‘clear and unmistakable directions to obtain the enantiomers’ in their independent form.[94] The skilled addressee would not have been able to identify, separate and analyse the enantiomer from citalopram without further experimentation.[95] As such, the follow-on patent was deemed by the majority to be novel and thus valid.[96]

2.2.4 Summary

Each of the above cases demonstrate the willingness of Australian courts to strictly and appropriately apply the patentability standards to keep evergreening within its lawful bounds and to uphold the integrity of the patent system by filtering out invalid follow-on claims. In contrast to Aktiebolaget and Lundbeck, the follow-on patent in Merck attempted to claim a dosing regime that was not essential to the commercial exploitation of the pharmaceutical, involved no scientific ingenuity and was contemplated early in research and development. Conversely, the follow-on patent in Aktiebolaget was fundamental to the administration of omeprazole in treatment and involved an inventive combination of integers to achieve this purpose. Similarly, the escitalopram patent in Lundbeck involved inventiveness in its identification and isolation and had not been previously disclosed to the public.

3 Addressing The Concerns Regarding Evergreening Strategies

Despite the strict adherence of Australian courts to the patentability requirements demonstrated above, evergreening practices have been routinely criticised by various commentators for two main reasons. First, it has been argued that evergreening practices undermine patent policy, and second, that they reduce competition and consequently limit affordable access to the pharmaceuticals on which the health of modern society relies. However, as will be discussed in Part 4, these concerns ignore many of the practical realities surrounding evergreening, suggesting that these criticisms are often not warranted in an Australian context.

3.1 Evergreening Strategies Undermine Patent Policy

The foundation of the patent system is the grant of a temporary monopoly to exploit an invention in exchange for disclosure of the technical details of the invention to the public, which optimises public benefit by fostering the dissemination of information and incentivising investment in innovation.[97] Opponents of evergreening practices argue that by extending the patent-protected effective market life of a pharmaceutical, evergreening undermines this rationale and the patent bargain between patentees and the public.[98] Dwivedi et al have stated that evergreening practices are deceptive and undermine the ‘spirit’ and intended purpose of patent laws and, further, that they are utilised ‘in the quest of sustained profits and market exclusivity’.[99] Similarly, Collier has expressed concerns about evergreening practices that involve ‘[t]weaking something old and calling it new’ by slightly modifying aspects of existing drugs to obtain further patent protection,[100] which results in economic advantage for originator pharmaceutical companies without significant therapeutic advantage for consumers.[101] Many of these concerns appear to stem from a belief that follow-on patents are not original or true ‘inventions’ or that they are attempts to ‘bypass’ patent laws.[102]

The patentability requirements operate to uphold patent policy, by regulating the quality of patents granted in Australia. Follow-on patents are subject to the same patentability and disclosure requirements as ‘original’ patents and are equally exposed to the challenges of meeting these requirements. Hence, if the requirements specified in the Patents Act are applied correctly, the grant of follow-on patents should not undermine patent policy nor bypass patent laws. A patentee must disclose an actual invention meeting the patentability requirements to be granted an additional patent and, hence, be required to release further innovative information in exchange for the grant of the follow-on patent. This suggests that, in reality, evergreening practices are not ‘deceptive’ strategies that undermine patent laws and that a company cannot simply obtain a follow-on patent by ‘tweaking something old’.

As such, the Pharmaceutical Patents Review, together with other commentators,[103] have correctly identified the patentability requirements, and not originator pharmaceutical companies, as the gatekeepers of acceptable patenting behaviour in Australia.[104] Provided the patentability requirements are applied appropriately in examination by the Patent Office and enforced appropriately in court proceedings, it is difficult to sustain arguments that follow-on patents are not true inventions which deserve protection.[105] In this way, evergreening practices utilising follow-on patents do not undermine the fundamental policy rationale that monopolies should be granted for inventions in return for the exchange of information.

3.2 Evergreening Strategies Reduce Competition and Access to Health Care

When an originator company develops a ‘patent portfolio’ or ‘patent thicket’[106] containing numerous follow-on patents surrounding a single pharmaceutical, this can create a barrier for generic producers and competitors.[107] Generic pharmaceuticals are drugs that are equivalent to a ‘brand name’ drug, and are capable of being supplied after the patent for the brand name drug has expired.[108] They play an important role in assisting to secure affordable access to pharmaceuticals because they are less expensive than branded drugs given that the pharmaceutical has already been developed, tested and approved.[109] Consequently, evergreening has attracted criticism for allegedly undermining the patent system for the purpose of unfairly blocking competitors.[110] Bansal et al have stated that ‘evergreening promotes development of unfair means of competition and related abuse’ by creating a ‘roadblock for generic companies that are trying hard to provide safe and efficacious medicines to the masses at cost effective prices’.[111] Similarly, Glasgow has argued that layering patents to ensure blockbuster drugs remain under patent protection beyond a single patent term has undesirable costs for generic manufacturers and consumers.[112]

Even when a generic manufacturer could technically manufacture an API without infringing a follow-on patent, the need to navigate through a ‘maze’ of patents[113] and the resulting potential for litigation can act as a deterrent to enter the market.[114] It has been argued that the resulting lack of competition harms consumers[115] by reducing access to affordable pharmaceuticals. However, this assertion is not entirely accurate in Australia, due to the existence of the Pharmaceutical Benefits Scheme (PBS). The PBS is designed to provide equal access to affordable pharmaceuticals for all Australians through the provision of government subsidies on most pharmaceuticals.[116] As such, pharmaceutical prices for consumers are not as much of a concern in Australia, as they are in countries without such a system, even though the market entry of a generic version of a drug can produce a cost saving to the PBS[117] of over 25 per cent.[118] Indeed, the Generic Medicines Industry Association notes that generic medicines saved the PBS an estimated $1.4 billion from 2005–2009.[119] However, the existence of the PBS means that in Australia, evergreening practices would not impact on the public’s access to competitively priced pharmaceuticals.

4 Practical Realities Surrounding Evergreening In Australia

Prima facie, evergreening practices can run contrary to the ‘central tenets of the patent system’.[120] However, the reality in Australia is that concerns regarding ‘abuse’ by originator pharmaceutical companies discussed above are often overstated and ignore the positive aspects of follow-on innovation. These factors mitigating the negativity surrounding evergreening in Australia will be discussed in this Part.

4.1 Diverse Ownership of Follow-on Patents in Australia

There is a general presumption that evergreening is undertaken by originator companies who seek to create a patent thicket to maintain their market dominance.[121] In support of this belief, Gaudry has found that evergreening strategies are common in the US, with the existence of numerous patents per pharmaceutical.[122] A recent Australian empirical analysis undertaken by Christie et al found similar results, including the presence of multiple patents per drug.[123] However, the study went further and examined the ownership of these patents with surprising results. This suggested that the general presumption that evergreening is undertaken by originator companies is not the reality.[124]

In their study, Christie et al analysed the patents associated with 15 of the most expensive drugs in Australia.[125] The results showed that drug costs are concentrated around a small number of pharmaceuticals that represent approximately one third of total drug expenditures in the PBS.[126] Additionally, they found a mean of 49 patents associated with each drug.[127] For example, 22 patents were associated with ipratropium (a drug used for the treatment of pulmonary diseases including asthma) and 121 were associated with omeprazole.[128] Prima facie, these results may support the employment of extensive evergreening practices by originators in Australia to expand patent protection. However, examination of ownership of these patents revealed that three quarters of the patents were owned by companies other than the drug’s originator, with half of these patentees being non-originator companies.[129] Hence, the majority of the numerous patents associated with highly profitable blockbuster drugs in Australia were owned by non-originator companies.

These valuable empirical results suggest that the common perception of unscrupulous originator pharmaceutical companies manipulating the patent system through evergreening to gain an unfair advantage is misguided and ‘too simplistic’.[130] In reality, many companies seek to obtain monopolies over innovations surrounding blockbuster drugs by claiming follow-on inventions.[131] This suggests that non-originator companies are also investing in follow-on innovation related to highly profitable blockbuster drugs.[132] Additionally, many companies are seeking to hold part of the monopoly control of a blockbuster drug to produce pharmaceuticals on expiration of the original patent for an API.[133] The presence of dispersed ownership of follow-on patents also supports a conclusion that evergreening is not inhibiting competition on expiry of the original patent, as many companies are exploiting and seeking protection for their cumulative inventions in relation to the original API.

Similarly, Parker and Mooney note that evergreening practices are open to competitors, and that the phenomenon is not only limited to original companies claiming follow-on inventions.[134] Generic and competitor ownership of follow-on patents is also evidenced in the lamotrigine example discussed in Part 1. Additionally, IP Australia has found that later patent filings for pharmaceuticals are dominated by third parties with earlier patents mostly owned by originators.[135]

The study conducted by Christie et al demonstrates that the dichotomy between originator pharmaceutical companies who supposedly exploit the system and generics who seek to provide affordable access to pharmaceuticals is not as sharply delineated as is commonly perceived. All types of pharmaceutical companies utilise the patent system for business objectives in pursuit of the profits associated with a patent monopoly. Even where follow-on patents are sought by originator pharmaceutical companies, this is often a legitimate and predictable commercial strategy.

4.2 Commercial Strategies and Responsibilities

As noted in Part 3, there is a tendency to criticise originator pharmaceutical companies for trying to manipulate and circumvent the patent system in order to gain an unfair advantage.[136] However, where there is scope in the law to gain a commercial advantage, and a strong incentive to do so, it is to be expected that pharmaceutical companies will take every opportunity to extend their monopoly protection.[137] Indeed the Pharmaceutical Patents Review notes that high levels of profitability and risk for pharmaceutical companies will inevitably encourage business strategies to maximise exclusivity and protection through the patent system and its complexities.[138] Utilising the patent system as a ‘business tool’,[139] within the bounds of the law, constitutes a legitimate business practice[140] and pharmaceutical companies should not be expected to ‘observe some higher standard of patentability than in other industries’.[141] Rather, failure to use the boundaries of the patent system would constitute a failure to act in the best interests of the company, particularly given the risk and expenses associated with developing new pharmaceuticals.[142]

It is acknowledged that these legitimate business objectives of pharmaceutical companies may not always be congruent ‘with the social and medical needs of the public’.[143] However, it is the responsibility of Parliament and the Government to find the optimal balance between ‘providing incentives for future inventions of new drugs and ensuring affordable access to existing drugs’.[144] If evergreening is perceived to run contrary to patent policy, Parliament must enact clear laws to regulate such conduct, and, in the meantime, pharmaceutical companies should not be condemned for behaviour that is lawful.

4.3 The Benefits of Follow-on Patents

Investment in research and development by originator pharmaceutical companies makes a substantial contribution to health and welfare. Additionally, pharmaceutical innovation is often incremental and cumulative.[145] As such, Chesmond notes that it is both ‘common and appropriate’ for companies to develop improved formulations or new uses or methods of manufacture for their previously patented products and apply for new patents over those products.[146] In addition to the important medical advancements often resulting from development of API’s, follow-on patents can also offer substantial improvements in existing knowledge and health care. For example, the improved lamotrigine tablet formulation (that was the subject matter of the follow-on patent discussed in Part 1) offered significant practical benefits including enhanced patient compliance and the encouragement of further innovation by competitors.

It is consistent with patent policy to reward cumulative inventiveness and legitimate follow-on research and development with patent protection.[147] The ability to claim follow-on inventions enhances the incentive to continually improve existing pharmaceuticals[148] and this should be a goal of the patent system.[149] While this can occasionally inhibit generic competition, reduced competition is an acceptable consequence of the compromise between incentivising innovation and increasing access to cheaper pharmaceuticals.[150]

4.4 The Confined Scope of Follow-on Patents

Chalmers has described evergreening as a tool for the extension of monopoly exclusivity over a particular pharmaceutical which operates to ‘reset the clock’ on patent protection.[151] Similarly, Hemphill and Sampat have suggested that evergreening can extend the effective market life of a pharmaceutical beyond the standard 20-year term,[152] in addition to the potential for a five year maximum extension for patents relating to pharmaceutical substances.[153] However, these arguments seem to ignore the reality that it is only the subject matter of the follow-on patent that receives further protection, not the API. Indeed, Parker and Mooney insightfully note that ‘the patent system is inherently adapted to reflect how much innovation in fact takes place ... and to prevent “evergreening”’, meaning that patenting minor variations results in the grant of a narrow monopoly which will not significantly limit market competition.[154]

A follow-on patent cannot cover the same inventive material as the original patent because it would not satisfy the patentability requirements.[155] Follow-on patents are often more narrow, which limits the scope of the monopoly and leaves open the opportunity for competitors to ‘design around’ the original patent without infringement.[156] Consequently, in most cases, the presence of follow-on patents will not inhibit generic producers from exploiting the subject matter of the original patent on expiry without liability for infringement.[157]

The confined scope of follow-on patents (compared to the original API) means that they pose less of a threat to competition than has been claimed. This is demonstrated in the grant of follow-on patents for venlafaxine related medicines. In its submission to the Pharmaceutical Patents Review, Alphapharm proposed that venlafaxine related medicines have ‘undue market exclusivity of over 39 years’.[158] Venlafaxine is the API in the antidepressant Efexor.[159] The original patent was granted in 1988 and expired in 2008.[160] Two follow-on patents were granted, claiming an extended release formulation and an active metabolite, granted in 2001 and 2008 respectively.[161] While the presence of two additional follow-on patents could be perceived as inappropriate ‘evergreening’, the Pharmaceutical Patents Review noted that there is no evidence that the two follow-on patents have prevented competitors from entering the market once the original Efexor patent expired.[162] Rather, on expiry of the original patent generic, manufacturers have been able to use alternative release formulations and produce a competitor extended release venlafaxine.[163] Indeed there are numerous Australian venlafaxine related patents owned by a diverse range of companies, despite the fact that the follow-on patents will expire in 2017 and 2023 respectively.[164]

6 Conclusion

This article has illustrated that while the practice of evergreening is pervasive in Australia, its impact is less concerning and controversial than generally perceived. Evergreening through the grant of follow-on patents is permissible under Australian patent law (provided patent requirements are satisfied). Accordingly, evergreening is appropriately regulated by the patentability requirements, which distinguish legitimate inventions from frivolous attempts to undermine the system. To expect pharmaceutical companies to do more than the law requires by the adoption of patenting practices that promote the public interest while sacrificing their commercial interests is unrealistic.


* Stephanie Crosbie is a final year Science/Law student from the University of New South Wales. The author would like to thank Dr Catherine Bond for her helpful comments on drafts of this article.

1 Tony Harris, Dianne Nicol and Nicholas Gruen, Pharmaceutical Patents Review, Report (2013) 25; Gaurav Dwivedi, Sharanabasava Hallihosur and Latha Rangan, ‘Evergreening: A Deceptive Device in Patent Rights’ (2010) 32 Technology in Society 324, 324; Inderjit Singh Bansal, Deeptymaya Sahu, Gautam Bakshi and Sukhjeet Singh, ‘Evergreening – A Controversial Issue in Pharmaceutical Milieu’ (2009) 14 Journal of Intellectual Property Rights 299, 299.

[2] Patents Act 1990 (Cth) s 40 (Patents Act).

[3] Harris, Nicol and Gruen, above n 1, 29–30.

[4] See, eg, Dwivedi, Hallihosur and Rangan, above n 1; Andrew Christie and Sally Pryor, ‘Evergreen Dilemma: Law Blind to Patent’s Purpose’ (2004) On Line Opinion 1; Robert Chalmers, ‘Evergreen or Deciduous? Australian Trends in Relation to the “Evergreening” of Patents’ [2006] MelbULawRw 2; (2006) 30 Melbourne University Law Review 29.

[5] Rhonda Chesmond, ‘Patent Evergreening in Australia Under the Australia – United States Free Trade Agreement: Floodgates or Fallacy?’ [2006] FlinJlLawRfm 4; (2006) 9 Flinders Journal of Law Reform 51; Harris, Nicol and Gruen, above n 1, 7, 105; Bansal et al, above n 1, 299.

[6] Harris, Nicol and Gruen, above n 1. The Report was provided to the Government in May 2013. Initially it appeared that the Report would not be released, based on the response of Ian Macfarlane, the Minister for Industry, to a question posed by Western Australian MP Melissa Parke: Commonwealth, Questions in Writing: Question No 22, House of Representatives, 11 February 2014, 100. It was suggested that this hesitation was attributable to the recent changes in leadership in Australia: Mark Summerfield, Pharmaceutical Patents Review Buried by Successive Governments (16 February 2014) Patentology <http://blog.patentology.com.au/2014/02/pharmaceutical-patents-review-buried-by.html> . Ultimately, the Report was released to the public in 2014 as a response to ‘stakeholder interest’: IP Australia, Review of Pharmaceutical Patents in Australia (14 August 2014) <http://www.ipaustralia.gov.au/about-us/ip-legislation-changes/review-pharmaceutical-patents/> .

[7] Harris, Nicol and Gruen, above n 1, iv.

[8] Ibid 117.

[9] Originator pharmaceutical companies are those who originally invent a pharmaceutical, and are generally contrasted with generic companies who develop cheaper alternatives once the original patent has expired: Ibid viii, 121.

[10] Kim Sweeny, ‘The Pharmaceutical Industry in Australia’ (Working Paper No 34, Centre for Strategic Economic Studies, 2007) 1.

[11] Rhonda Chesmond, above n 5, 60.

[12] Department of Industry, Innovation, Science, Research and Tertiary Education, Australian Pharmaceutical Industry Data Card (2011) cited in IP Australia, Pharmaceutical Patents Review, Background and Suggested Issues Paper (2012).

[13] Roger Collier, ‘Drug Patents: The Evergreening Problem’ (2013) 185 Canadian Medical Association Journal 385, 386; Kate Gaudry, ‘Evergreening: A Common Practice to Protect New Drugs’ (2011) 29 Nature Biotechnology 876, 876; Harris, Nicol and Gruen, above n 1, 28.

[14] Bansal et al, above n 1, 301.

[15] Gaudry, above n 13, 876; Harris, Nicol and Gruen, above n 1, 28; Robert Weissman, ‘The Evergreen Patent System: Pharmaceutical Company Tactics to Extend Patent Protection’ (2002) Multinational Monitor 19, 19.

[16] Harris, Nicol and Gruen, above n 1, 33 citing the Medicines Australia Submission to the Pharmaceutical Patents Review, January 2013, 1.

[17] Joseph DiMasi, Ronald Hansen and Henry Grabowski, ‘The Price of Innovation: New Estimates of Drug Development Costs’ (2003) Journal of Health Economics 22, 151, 166 cited in David Cutler, ‘The Demise of the Blockbuster?’ (2007) 356 New England Journal of Medicine 1292, 1292.

[18] Harris, Nicol and Gruen, above n 1, 33.

[19] Reuters, ‘Update 2 – Pfizer Aims to Keep One-third of Lipitor Pie’ (30 November 2011); ‘Nature Reviews Drug Discovery’ (2011) 10 Nature Medicine 889.

[20] Henry Grabowski, ‘Patents, Innovation and Access to New Pharmaceuticals’ (2002) 5 Journal of International Economic Law 849, 850–2.

[21] Ibid 850–3; Edwin Mansfield, ‘Patents and Innovation: An Empirical Study’ (1986) 32 Management Science 173, 174.

[22] Harris, Nicol and Gruen, above n 1, 39–40.

[23] UK Office of Health Economics, The R&D Cost of a New Medicine (2012) cited in Harris, Nicol and Gruen, above n 1, 14.

[24] Michael Burdon and Kristie Sloper, ‘The Art of Using Secondary Patents to Improve Protection’ (2003) 3 International Journal of Medical Marketing 1, 1; Chalmers, above n 4, 33.

[25] Gaudry, above n 13, 877; Lara Glasgow, ‘Stretching the Limits of Intellectual Property Rights: Has the Pharmaceutical Industry Gone Too Far?’ 41 IDEA: The Intellectual Property Law Review 227, 227; Chalmers, above n 4, 31.

[26] Chesmond, above n 5, 51; Harris, Nicol and Gruen, above n 1, 105; Bansal et al, above n 1, 299.

[27] Harris, Nicol and Gruen, above n 1, 105. Other strategies involve marketing techniques and life-cycle management, where originator pharmaceutical companies employ strategies to extend their patent monopoly, including prescription switching from an old pharmaceutical coming to the end of its patent life to a new variety which does have patent protection: Harris, Nicol and Gruen, above n 1, 105–6. As these are not directly related to the patent system, they will not be discussed further in this article.

[28] Harris, Nicol and Gruen, above n 1, 105; IP Australia, above n 12, 25; Bansal et al, above n 1, 299.

[29] Gaudry, above n 13, 877.

[30] Bansal et al, above n 1, 301.

[31] GlaxoSmithKline, ‘Evergreening’ (2011) Global Public Policy Issues 2.

[32] Ibid.

[33] Ibid.

[34] Ibid.

[35] Ibid 2–3.

[36] Based on a search for ‘lamotrigine’ on the IP Australia ‘AusPat’ Patent Register on 31 January 2014.

[37] Patents Act.

[38] A standard patent affords 20 years of protection, while innovation patents expire after eight years and are subject to a lower threshold of inventiveness, as innovation patents only require an ‘innovative step’ as opposed to an ‘inventive step’: Ibid ss 67, 68.

[39] Ibid s 18(1).

[40] Ibid s 18(1)(a); National Research Development Corporation v Commissioner of Patents [1959] HCA 67; (1959) 102 CLR 252, [25] (Dixon CJ, Kitto and Windeyer JJ); CCOM Pty Ltd v Jiejing Pty Ltd [1994] FCA 396; (1994) 28 IPR 481, 513–14 (Spender, Gummow and Heerey JJ).

[41] See 2.2.1.

[42] Patents Act ss 18(1)(b)(i), 7(1), sch 1 (definition of ‘prior art base’).

[43] H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70, [174] (Bennett J) citing Hill v Evans [1862] EngR 365; (1862) 1A IPR 1, 6.

[44] Patents Act s 7(1), sch 1 (definition of ‘prior art base’).

[45] Ibid s 18(1)(b)(ii).

[46] Ibid s 7(2), sch 1 (definition of ‘prior art base’).

[47] Harris, Nicol and Gruen, above n 1, 118.

[48] Ibid 119.

[49] Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth) s 2.

[50] Christie and Pryor, above n 4, 2.

[51] Ibid.

[52] In contrast, it has been argued that evergreening has become ‘endemic’ in the United States and Canada (see, eg, Chesmond, above n 5, 54; Weissman, above n 15; Christie and Pryor, above n 4, 1). There are a greater number of cases surrounding evergreening in the United Kingdom, which take a similar approach to courts in Australia in assessing follow-on patents according to the patentability requirements (see, Burdon and Sloper, above n 24). Evergreening has attracted extensive criticism from Indian courts (see, eg, Novartis AG v Union of India & Others (2013) Civil Appeal No 2706–2716).

[53] [2006] FCAFC 91.

[54] Merck & Co Inc v Arrow Pharmaceuticals Ltd [2006] FCAFC 91, [4]–[5]; Arrow Pharmaceuticals Ltd v Merck & Co Inc [2004] FCA 1282, [9].

[55] Merck & Co Inc v Arrow Pharmaceuticals Ltd [2006] FCAFC 91, [10], [12].

[56] Arrow Pharmaceuticals Ltd v Merck & Co Inc [2004] FCA 1282, [1].

[57] Ibid.

[58] Merck & Co Inc v Arrow Pharmaceuticals Ltd [2006] FCAFC 91, [114].

[59] Arrow Pharmaceuticals Ltd v Merck & Co Inc [2004] FCA 1282, [80], [97].

[60] Ibid [87].

[61] Arrow Pharmaceuticals Ltd v Merck & Co Inc [2004] FCA 1282, [87], [95]; Merck & Co Inc v Arrow Pharmaceuticals Ltd [2006] FCAFC 91, [15]–[16].

[62] Arrow Pharmaceuticals Ltd v Merck & Co Inc [2004] FCA 1282, [80].

[63] Ibid [83]; National Research Development Corporation v Commissioner of Patents [1959] HCA 67; (1959) 102 CLR 252, [7]; Wellcome Foundation Ltd v Commissioner of Patents [1980] HCA 21; (1980) 145 CLR 520, [20]–[21]; Commissioner of Patents v Microcell Ltd [1959] HCA 71; (1959) 102 CLR 232, 249 (Dixon, McTiernan, Fullager, Taylor and Windeyer JJ).

[64] Merck & Co Inc v Arrow Pharmaceuticals Ltd [2006] FCAFC 91, [113].

[65] Arrow Pharmaceuticals Ltd v Merck & Co Inc [2004] FCA 1282, [37], [41].

[66] Ibid [98]; Merck & Co Inc v Arrow Pharmaceuticals Ltd [2006] FCAFC 91, [80]–[84], [89].

[67] Merck & Co Inc v Arrow Pharmaceuticals Ltd [2006] FCAFC 91, [98], [102]–[103].

[68] Ibid; Arrow Pharmaceuticals Ltd v Merck & Co Inc [2004] FCA 1282, [100]–[101].

[69] Merck & Co Inc v Arrow Pharmaceuticals Ltd [2006] FCAFC 91, [17], [89]; Arrow Pharmaceuticals Ltd v Merck & Co Inc [2004] FCA 1282, [98].

[70] Merck & Co Inc v Arrow Pharmaceuticals Ltd [2006] FCAFC 91, [79], [112], Arrow Pharmaceuticals Ltd v Merck & Co Inc [2004] FCA 1282, [30], [109], [116].

[71] Arrow Pharmaceuticals Ltd v Merck & Co Inc [2004] FCA 1282, [1].

[72] Ibid [88] (emphasis added).

[73] [2002] HCA 59; (2002) 194 ALR 485.

[74] Aktiebolaget Hassle v Alphapharm Pty Ltd [2002] HCA 59; (2002) 194 ALR 485, [3]–[6] (Gleeson CJ, Gaudron, Gummow and Hayne JJ).

[75] Ibid [3] (Gleeson CJ, Gaudron, Gummow and Hayne JJ).

[76] Ibid.

[77] Ibid [8] (Gleeson CJ, Gaudron, Gummow and Hayne JJ).

[78] Ibid [9] (Gleeson CJ, Gaudron, Gummow and Hayne JJ).

[79] Aktiebolaget Hassle v Alphapharm Pty Ltd [1999] FCA 628, [26]–[121], [234] (Lehane J).

[80] Aktiebolaget Hassle v Alphapharm Pty Ltd [2000] FCA 1303, [156] (Wilcox, Merkel and Emmett JJ).

[81] Aktiebolaget Hassle v Alphapharm Pty Ltd [2002] HCA 59; (2002) 194 ALR 485, [65] (Gleeson CJ, Gaudron, Gummow and Hayne JJ), [194] (Callinan J).

[82] Harris, Nicol and Gruen, above n 1, 114.

[83] Harris, Nicol and Gruen, above n 1, 113 quoting the Institute of Patent and Trade Mark Attorneys of Australia, Submission to the Pharmaceutical Patents Review, 20.

[84] Chesmond, above n 5, 61.

[85] Aktiebolaget Hassle v Alphapharm Pty Ltd [2002] HCA 59; (2002) 194 ALR 485, [101].

[86] [2009] FCAFC 70.

[87] H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70, [117] (Bennett J); Alphapharm Pty Ltd v H Lundbeck A/S [2008] FCA 559, [2] (Lindgren J).

[88] H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70, [37]–[38] (Emmett J).

[89] Alphapharm Pty Ltd v H Lundbeck A/S [2008] FCA 559, [6]–[7] (Lindgren J).

[90] H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70, [7] (Emmett J).

[91] Alphapharm Pty Ltd v H Lundbeck A/S [2008] FCA 559.

[92] H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70, [112] (Emmett J).

[93] Ibid [193] (Bennett J), [249] (Middleton J).

[94] Ibid [194] (Bennett J).

[95] Ibid [209] (Bennett J).

[96] Ibid [195] (Bennett J).

[97] Peter Drahos, ‘Six Minutes to Midnight: Can Intellectual Property Save the World?’ in Kathy Bowrey, Michael Handler and Dianne Nicol (eds), Emerging Challenges in Intellectual Property (Oxford University Press, 2011) 38.

[98] See, eg, EPO Economic and Scientific Advisory Board, Workshop on Patent Thickets (2013) 5 cited in Harris, Nicol and Gruen, above n 1, 115.

[99] Dwivedi, Hallihosur and Rangan, above n 1, 325, 329.

[100] Collier, above n 13, 385.

[101] Ibid.

[102] See, eg, Dwivedi, Hallihosur and Rangan, above n 1, 326.

[103] See, eg, Scott Parker and Kevin Mooney, ‘Is “Evergreening” a Cause for Concern? A Legal Perspective’ (2007) 13 Journal of Commercial Biotechnology 235, 241.

[104] Harris, Nicol and Gruen, above n 1, 119, 121.

[105] Dwivedi, Hallihosur and Rangan, above n 1, 324.

[106] IP Australia, above n 12, 26.

[107] Harris, Nicol and Gruen, above n 1, 105, 117.

[108] World Health Organization, Generic Drugs <http://www.who.int/trade/glossary/story034/en/> (1 November 2014).

[109] Bansal et al, above n 1, 301.

[110] See, eg, Collier, above n 13, 385.

[111] Bansal et al, above n 1, 306.

[112] Glasgow, above n 25, 228, 249.

[113] Mike Hutchins, ‘Extending the Monopoly – How “Secondary Patents” can be used to Delay or Prevent Generic Competition upon Expiry of the Basic Product Patent’ (2003) 1 Journal of Generic Medicines 57, 57.

[114] Gaudry, above n 13, 878; Burdon and Sloper, above n 24, 16.

[115] Dwivedi, Hallihosur and Rangan, above n 1, 329.

[116] Peter Drahos, Buddhima Lokuge, Tom Faunce, Martyn Goddard, ‘Pharmaceuticals, Intellectual property and Free Trade: The Case of the US-Australia Free Trade Agreement’ (2004) 22 Prometheus 243, 244.

[117] Harris, Nicol and Gruen, above n 1, 35.

[118] Department of Health and Aging, Price Reductions for Second Main Cycle (2013), cited in Harris, Nicol and Gruen, above n 1, 37.

[119] Harris, Nicol and Gruen, above n 1, 35.

[120] Chalmers, above n 4, 29.

[121] See, eg, Bansal et al, above n 1, 299, 306; Dwivedi, Hallihosur and Rangan, above n 1, 324, 329; Collier, above n 13, 385; Glasgow, above n 25.

[122] Gaudry, above n 13, 876.

[123] Andrew Christie, Chris Dent, Peter McIntyre, Lacklan Wilson and Davis Studdert, ‘Patents Associated with High-Cost Drugs in Australia’ (2013) 8 PLoS ONE 1.

[124] Ibid 1.

[125] Ibid.

[126] Ibid.

[127] Ibid 3.

[128] Ibid.

[129] Ibid.

[130] Ibid 6.

[131] Ibid 1.

[132] Ibid 4.

[133] Ibid 6.

[134] Parker and Mooney, above n 103, 239.

[135] IP Australia, Pharmaceutical Patents Review, Draft Report (2013) 137.

[136] See, eg, Bansal et al, above n 1; Collier, above n 13; Glasgow, above n 25.

[137] Harris, Nicol and Gruen, above n 1, 39.

[138] Ibid 33, 39.

[139] Chalmers, above n 4, 59.

[140] Harris, Nicol and Gruen, above n 1, 39–40.

[141] Parker and Mooney, above n 103, 239.

[142] Ibid.

[143] IP Australia, above n 12, 48.

[144] Ibid.

[145] Parker and Mooney, above n 103, 240.

[146] Chesmond, above n 5, 53.

[147] Harris, Nicol and Gruen, above n 1, 109.

[148] Parker and Mooney, above n 103, 240.

[149] Frederic Scherer, ‘The Link Between Gross Profitability and Pharmaceutical R&D Spending’ (2001) 20 Health Affairs 216 cited in Gaudry, above n 13, 878.

[150] Thomas Faunce and Joel Lexchin, ‘“Linkage” Pharmaceutical Evergreening in Canada and Australia’ (2007) 4 Australia and New Zealand Health Policy 1, 1.

[151] Robert Chalmers, above n 4, 31.

[152] Scott Hemphill and Bhaven Sampat, ‘Evergreening, Patent Challenges, and Effective Market Life in Pharmaceuticals’ (2012) 31 Journal of Health Economics 327, 327–8.

[153] Patents Act ss 67, 7079A.

[154] Parker and Mooney, above n 103, 239.

[155] Ibid 238.

[156] Ibid 239.

[157] Ibid 235.

[158] Harris, Nicol and Gruen, above n 1, 110 citing the Alphapharm, Submission to the Pharmaceutical Patents Review, 14.

[159] Harris, Nicol and Gruen, above n 1, 110.

[160] Ibid.

[161] Ibid 110.

[162] Ibid 111.

[163] Ibid.

[164] Based on a search for ‘venlafaxine’ on the IP Australia ‘AusPat’ Patent Register on 31 January 2014.


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