THESIS – MASTER INFORMATION LAW FACULTY OF LAW
Second medical use claims: a bitter pill to swallow?
A comparative and solution-oriented analysis of second medical use patents in healthcare systems of the Netherlands and the United Kingdom.
AUTHOR: Berber van der Wansem
DATE: 2 January 2017
STUDENT NO.: 10107002
ABSTRACT
This thesis discusses second medical use claims in both the Netherlands and the United Kingdom. The main question to be addressed is which solutions provide a more socially desirable equilibrium between the rights of patentees of second medical use claims and the interest of an accessible and affordable provision of healthcare. After an analysis of the national regulatory schemes on healthcare and the legal frameworks on the scope and infringement of second medical use patents, this thesis turns to the risk of liability of involved parties (i.e. the generic drug manufacturer, the physician, the pharmacist and the patient) and lack of enforceability in both countries. This thesis will conclude that all involved parties have a credible risk of infringement or are at least affected by second medical use claims in some way, and as such, patent infringement through cross- and off-label use has a negative effect upon the access to and affordability of drugs for the public. This situation is undesirable and should be remedied in the interest of society and public health. Finally, this thesis discusses a number of solutions aimed at restoring the social contract of patent law, wherein public and private interests are fairly balanced. Not every proposed solution is feasible, but some, if necessary combined, solutions could be viable. One proposition is a coordinated approach between patent law and regulatory healthcare schemes, another proposal suggests harmonisation regard to infringement of second medical use claims at a European level, through the UPC. Other proposed solutions are discussed as well, such as self-regulation through patent pools, if possible, or clearinghouses, proportionate relief (i.e. the production of generic drugs in proportion with the market size of the unpatented indications) and by means of competition law.
ACKNOWLEDGEMENT
I would first like to thank my thesis advisor, dr. mr. Bostyn, attached to the Institute for Information Law. For his supervision and contributing remarks as an expert on this area of law, specifically on the topic of this thesis.
I would also like to thank the law firm “Brinkhof” in Amsterdam, where their legal resources were at my disposal, and where I could discuss my topic with experts in the patent litigation area.
Finally, I must express my very profound gratitude to my parents, brother and sisters, and boyfriend for providing me with unfailing support and continuous encouragement throughout my years of study and through the process of researching and writing this thesis. This accomplishment could not have been possible without them. Thank you.
Berber van der Wansem January 2017
TABLE OF CONTENTS
INTRODUCTION... 7
RESEARCH FRAMEWORK... 9
RESEARCH QUESTION AND METHODOLOGY...9
HYPOTHESIS... 10
1 CONCEPTUAL OVERVIEW... 12
2 HEALTHCARE SYSTEM REGULATIONS... 16
2.1 REGULATORY SYSTEM...16
2.1.1 Prescribing and dispensing... 16
2.1.2 The preference policy in the Netherlands...18
3 LEGAL FRAMEWORK... 20
3.1 LEGAL FRAMEWORK ON EUROPEAN LEVEL...20
3.1.1 Legislation... 20
3.1.2 Direct and indirect infringement...21
3.2 THE NETHERLANDS...24
3.2.1 Legislation... 24
3.2.2 Scope and infringement... 24
3.2.3 Interim conclusion... 30
3.3 THE UNITED KINGDOM...31
3.3.1 Legislation... 31 3.3.2 Warner-Lambert v Actavis... 31 3.3.3 Interim conclusion... 34 4 LEGAL UNCERTAINTY... 36 4.1 INTRODUCTION...36 4.2 LIABILITY...36
4.3 THE EFFECT ON THE PROVISION OF HEALTHCARE...38
4.5 THE PUBLIC'S RIGHT TO HEALTH...39
4.6 RESPONSIBILITIES OF HEALTHCARE PROVIDERS...41
4.7 INTERIM CONCLUSION...42
5 POTENTIAL SOLUTIONS AND REMEDIES... 43
5.1 INTRODUCTION...43
5.3 ADJUSTING THE RESTRICTIVE LICENSING POLICY...48
5.4 THE ROLE OF EUROPE – UNIFIED PATENT COURT...49
5.5 SELF-REGULATION AND OPEN INNOVATION...50
5.6 PROPORTIONATE RELIEF...54
5.7 COMPETITION LAW...54
5.8 INTERIM CONCLUSION...56
CONCLUSION... 58
BIBLIOGRAPHY... 60
APPENDIX 1 – RELEVANT ARTICLES OF EPC 1973 AND EPC 2000...70
APPENDIX 2 – TYPES OF CLAIMS... 71
LIST OF ABBREVIATIONS
AIPPI Association Internationale pour la Protection de la Propriété Intellectuelle API Active pharmaceutical ingredient
Art. Article
BoA Board of Appeal
DPA Dutch Patent Act
EBA Enlarged Board of Appeal of the EPO ECHR European Conventions on Human Rights EMA European Medicines Agency of the EPO EPO European Patent Office
EU European Union
FDA Food and Drug Administration of the US
ICESCR International Covenant on Economic, Social and Cultural Rights INN International Non-proprietary Name
MA Market Authorisation
MEB Medicines Evaluation Board of the Netherlands (in Dutch: CBG) NHS National Health Service of the UK
NCE New Chemical Entity
PIL Patient Information Leaflet R&D Research and development
SmPC Summary of Product Characteristics TBA Technical Board of Appeal of the EPO
TRIPs Agreement on Trade-Related Aspects of Intellectual Property Rights
UK United Kingdom
US United States of America
Introduction
The pharmaceutical industry is an important force of patent activity. Amongst the protections sought are second medical indications: new therapeutic uses for known substances. Second medical use patents are a relevant component of potential second-line patent protection: As a result of patent cliffs, branded drugs have either lost or will lose their patent protection. Originator companies try to protect their market in order to extend the patent life of their drug by creating variations of the existing patented invention, and thus, keep generic manufacturers off the market.1 This practice is known as evergreening.2 However, evergreening may come at
a very high cost to the healthcare system. Patent strategies such as evergreening combined with a growing demand for personalised medicine – the tailoring of medical treatment to the individual3 – have renewed the interest in medical indication patents.
Moreover, it is important to consider whether these second medical use patents provide the originator the effective protection that is granted on the basis of Article 52(1) European Patent Convention (EPC), which is a topic currently open to debate. While generic drug manufacturers can enter the market for the first medical use, they still have to be aware of the originators’ second-generation patent. Indeed, there is currently legal uncertainty regarding if and how an originator can enforce his second medical use patent when a case of infringement occurs. It is unclear whether the physician, patient, generic drug manufacturer or patient can, indeed, infringe a second medical use patent or even how to determine when a case of infringement occurs and moreover, what is necessary in order to not infringe such patents. While second medical use claims have been patentable in Europe for three decades and there is a substantive amount of literature on the issue, European case law concerning second medical use patents has been scant thus far; case law is expected to increase with the expiry of first line of protection patents.
The difficulty in enforcing second medical use patents arises from a collision between the policy of incentivising important medical research by granting second medical use patents on one hand, and other policies and practices regarding an affordable healthcare systems on the
1 European Commission 2009; Bostyn 2016a, p. 151. 2 Collier 2013, p. 385.
3 In practice, rather than having a unique treatment for each individual person, patients are sub-divided into groups based on their genes (see European Alliance for Personalised Medicine, Innovation and Patient Access to Personalised Medicine 2013, p.8).
other hand.4 Examples of the latter include: rules concerning the prescribing and dispensing of
medicines and the policies of health insurers which deal with the reimbursement of medical costs. This collision – patent law against ‘other policies and practices’ – makes the enforceability of second medical use patents difficult, since both systems are working independently of each other.
Since it is assumed that personalised medicine will increase the relevance of second medical uses in the future, originators consider it necessary having their second medical indication patents effectively enforced. Otherwise, the incentive for further research and development (R&D) of known drugs, which is important for public health, might decrease.5 However, all
players in the chain (i.e. generic drug manufacturers, drug wholesalers, physicians and pharmacists) run the plausible risk of committing infringement as a result of their daily activities.6 This uncertainty can withheld the access of competing generic drugs entering the
market for a price usually at a fraction of the price the patented drug was sold for.7 Thus,
potentially resulting in a negative effect on public health.
This thesis formulates a number of proposals for resolving the current problems concerning the enforcement of second medical use patents. These proposals attempt to shift the solution forward, from actual occurrence of infringement to the prevention of the problems in an earlier phase. The overall goal is trying to find a more socially desirable equilibrium between the rights of patentees of second medical use claims and the desire for an accessible and affordable provision of healthcare.
4 [2015] EWHC 72 (Pat) 21 January 2015 (Warner-Lambert v Actavis), para. 1
5 AIPPI Q238 2014 UK, p. 21; [2003] EWHC 5 (Pat) 6 November 2003 (Teva v Instituto Gentili Spa), para. 80. 6 Bostyn 2016a, p. 152.
RESEARCH FRAMEWORK
Research question and methodologyThe research question that is addressed and answered within this thesis is as follows:
“Which solutions provide a more socially desirable equilibrium between the rights of patentees of second medical use claims and the interest of an accessible and affordable provision of healthcare?”
This question is addressed through a comparison of the Netherlands and the United Kingdom (UK). To answer the research question, it is relevant to first explain what constitutes second medical use patents and related key concepts (Chapter 1). Thus, relevant literature, reports and case laws are consulted to clarify the key concepts related to second medical use patents.
I consider, as part of my research question, the healthcare systems in both the Netherlands and the UK (Chapter 2). A comprehensive understanding of the practice of providing healthcare, i.e. the regulatory law on the practice of prescribing and dispensing medicines by medical professionals, in both countries is indispensable. And as such, I consult relevant reports, regulatory legislation and literature.
The second element of the research question consists of mapping the legal framework of second medical use patents (Chapter 3). The (non-)patentability of second medical use patents has experienced numerous developments, and recent case law has drawn attention to the difficulties that have arisen with regard to this topic. This chapter also outlines the patentability of second medical uses in Europe (in light of the European Patent Office (EPO)), in particular in the Netherlands and the UK. Subsequently, this chapter also addresses how the national courts handle problematic situations regarding the enforcement of second medical use patents, including how the national Dutch and UK courts interpret and judge second medical use patents on their scope and infringement.
It is crucial to provide an overview of the responsibilities of all involved parties, as well as who can be liable for infringing second medical use patents, in order to discover possible
solutions that (try to) encompass all related rights and interests. The third element of the research question, thus, examines whether second medical use patents can potentially be problematic, and if so, what are the consequences – or effects – upon the provision of healthcare in both the Netherlands and the UK (Chapter 4). Furthermore, this chapter discusses the practical realisation of the fundamental right to health. This chapter is a literature review.
Chapter 5 proposes and discusses several solutions, not solely within the boundaries of patent law, for determining the most reasonable balance, i.e. socially desirable equilibrium, between the rights of patentees of second medical use claims and the desire for a good provision of healthcare. As a result, a normative judgment must be made by identifying, describing, assessing and comparing all of the solutions to the relevant national legal frameworks in case of an adverse effect of second medical use patents on a good provision of healthcare in the Netherlands or the UK.
The focus is placed upon the Netherlands and the UK because they have extensive case law – which do not always comply with each other or use the same approach - on second medical use patents, providing an interesting perspective for comparison. Additionally, both countries have a different basis of law: the Netherlands have a civil law background and the UK has a common law system.
Outside the scope of this thesis is the ethic discussion concerning whether the patentability of second medical use claims is, in fact, desirable.
Hypothesis
There is currently a serious issue of legal uncertainty on the enforceability of second medical use claims in Europe. Germany, Spain, the UK and the Netherlands all approach these types of patents differently, taking various aspects into account.8 As a consequence of this legal
uncertainty, important parties within the medical field are unsure whether they can be held liable for an infringement of second medical use patents. This uncertainty extends to situations when the infringing use is out of their control to stop (i.e. it happens in the downstream practice) or when they are unaware of the infringement.
A party that can be held liable for actions which may be inevitable or are executed by third parties could negatively affect the delivery of healthcare. For example, if generic companies risk liability for infringing activities executed by pharmacists, they may refrain from manufacturing medicinal products that are within the public domain9 for a certain indication,
because the products also have patented indications. This risk could possibly result in a market with fewer cheap medicines and less competition for originator manufacturers. Another possibility is that physicians may change the way in which they provide healthcare to their patients so that they are not held liable for patent infringement and the associated high costs. Moreover, when patentees’ patents are not protected and they do not receive the proper reimbursement, this could result in a lack of incentive to further develop existing medicines which are already found to be safe for patients and may contribute to the practice of personalised medicine.
Considering the above, this study concludes that second medical use patents have an adverse effect upon the proper provision of healthcare and proposes to find solutions creating a balance between the rights and interests of all relevant actors. For example, changing the regulatory law within the context of prescribing and dispensing.
1
CONCEPTUAL OVERVIEW
In order to comprehend the issue that is central to this thesis (i.e. second medical use patents) and give the reader a proper understanding of second medical use patents, it is necessary to clarify a number of key concepts that are related to the topic.
First medical use patent
The first medical use patent for a known product is laid down in Article 54(4) EPC, which introduces the patentability of any known chemical entity for a new use in a medical method. This is an addition – or rather an exception – to the standard concept of novelty, and introduces the so-called first medical use protection for a known product. 10 A first medical use
patent is typically construed as a product claim of "Substance X for use as a medicament for Y". The claim protects product X, which is suitable for the purpose Y.11 Thus, it is possible
for the inventor to obtain purpose-limited product protection for the first medical use of a known drug, “without having to restrict himself to the substance or composition when in a form technically adapted to a specified therapeutic purpose”.12
Second medical use patent
The EPC of 197313 contained no reference for second medical use patents,14 e.g. novel
medical uses of the same drug, whereby it was unknown if such patents were even patentable. Article 54(5) EPC 1973 only addressed the patentability of first medical indications. It was, therefore, the task of the EPO judges to fill in the gap as regards to the patentability of second medical use claims.15 As such, in 1984 the Enlarged Board of Appeal (EBA) ruled in G5/8316
that, in principle, obtaining patent protection for specified new and inventive uses of known drugs is allowed,17 as long as the patent is in the format of a “Swiss-type claim”. 18 When EPC
10 Bostyn 2016a, p. 155; Yasui 2014, p. 327-328. 11 Ibidem; See also England 2015.
12 G5/83, at 15.
13 Convention on the Grant of European Patent (European Patent Convention) of 5 October 1973 as revised by the Act revising Article 63 EPC of 17 December 1991 and the Act revising the EPC of 29 November 2000.
14 In this thesis is also understood that ‘second medical use’ covers any subsequent new therapeutic application of a known compound or substance.
15 Bostyn 2016a, p. 155
16 Second medical indication/EISAI, G5/83 (1984).
17 Assuming that the invention fulfils the other general criteria for patent protection, Art. 52 EPC. See G5/83, at 19,20 and 23; Bostyn 2015, p. 750-751.
2000 replaced EPC 1973, it introduced a new article that concerns the possibility of protecting the second medical uses of a known product; whereby, every subsequent new and inventive medical use of a chemical entity already comprised in the state of the art can be protected.19
Thus, the concept of second medical use refers to a new and inventive therapeutic application of already existing compounds and substances.20 The AIPPI Q238 duly noted that patent
eligible second medical uses “should not be limited to uses that treat diseases, but should also include applications directed at alleviating or preventing illness or otherwise improving health.”21 Each jurisdiction should, therefore, offer the possibility to patent at least one type of
claim of second medical uses.22 Although second medical use patents are not everywhere
patentable, these type of patents are allowed under the ‘old’ and the ‘new’ legal regime in both the UK and the Netherlands .23 24 The most common types of second medical uses lie in the
innovative application for new diseases,25 new patient sub-groups,26 new technical effects,27
new mechanisms,28 new administration modes or routes29 and new dosage regimes.3031
Second medical use patents can occur in two formats: the so-called Swiss-type claim or the EPC2000 claim. First, the Swiss-type claim – first introduced in G5/83 – refers to the "use of a substance X for the manufacture of a medicament for treatment of Z".32 This constitutes a
purpose-limited process claim. In order to prevent the claim from being interpreted as a method of treatment, which is not patentable on the basis of Article 53 EPC, the “manufacture” requirement was included so as not to affect the work of physicians.33
However, due to the legal uncertainty of the Swiss-type claim, the EBA ruled in G2/08 that this type of claim was no longer allowed for future patent applications. And furthermore, they ruled that it should be replaced by the new EPC2000 claim.34
19 Yasui 2014, p. 327-328.
20 AIPPI Q238 2014 Resolution, p. 2. 21 Ibidem, p. 3.
22 Ibidem.
23 With the old regime referring to Swiss-type claims and the new regime to EPC2000 claims. 24 Bostyn 2015, p. 750; AIPPI Q238 2014 Netherlands, p. 2; AIPPI Q238 2014 UK, p. 1. 25 G5/83.
26 T19/86, T893/90, T233/96 and T734/12. 27 T290/86, T254/93 and T1020/03 28 T254/93, T189/95 and T486/01 29 T51/93 and T138/95.
30 This is an issue not without any discussion, as to whether this was within the category of a medical treatment method or a medical indication. At first, it was the latter that had the upper hand in case law (e.g. T317/95 and T1319/04), but this was later overruled in Dosage regime/Abbott Respiratory, G2/08 (2010) where the court came to the conclusion that dosage regimes fall within the medical indication category. See also T51/93 and T1020/03.
31 Following the judgment in G2/08 second medical uses are not restricted to the use in the treatment of new diseases. See also Bostyn 2016a, p. 155.; Yasui 2014, p. 328.
32 G5/83, at 19 and 23.
33 G2/08 (2010), at 7.1.3; England 2016, p. 1; Bostyn 2016a, p. 155; Conclusion A-G van Peursem, footnote 1. 34 Yasui 2014, p. 327-328.
The second form of a second medical use patent is an EPC2000 claim,35 and it is only
applicable to patents for which the patent’s grant date was decided on or after the date that the new EPC2000 legislation entered into force, i.e. 13 December 2007. The EPC2000 claim can typically be construed as: "substance X for use in the treatment of condition Z".36 Hence, this
claim is known as a purpose-limited product claim; the scope of protection of the product is restricted to the particular application of the product which is claimed within the patent. This type of claim does not cover all applications of the product, and is therefore not absolute, but only protects the application which is new and inventive.37
Skinny label or carve-out indication
Skinny labelling is the practice whereby a generic company obtains a market authorisation (MA) for a drug limited to the medical indications which are no longer protected under patent law by carving out the still patented medical indication(s). Thus, skinny labelling or a carve-out indication of generic drugs occurs by removing the still-patent-protected medical indications from the product information (e.g. the Summary of Product Characteristics (SmPC) and the patient information leaflet (PIL)).38 This practice is recognised and allowed in
European medicine legislation.39
Off-label and cross-label use
When a medicine, either patented or generic, is used for an unauthorised indication which does not appear on the product label, it is off-label use.40 Thus, for example, a generic
medicine is used for the patented medical indication, while the generic company has received no authorization for this use.41 However, this definition could also mean cross-label use,
which is when a branded medicine (X) has a label for a non-patented indication (Y) and a patented indication (Z) and a generic company obtains an MA for a generic version of X for indication Y and carves out the indication Z from its product label (e.g. skinny label). If the
35 Laid down in Article 54(5) EPC. 36 Bostyn 2016a, p. 155. 37 Ibidem.
38 Ibidem, p. 157. [2015]; EWHC 72 (Pat) 21 January 2015 (Warner-Lambert v Actavis), par. 17.
39 See for example Art. 11 of Directive 2001/83/EC of the European Parliament and the Council of 6 November 2001 on the Community code relating to medicinal products for human use; Bostyn 2016a, p. 157.
40 AIPPI Q238 2014 UK, p. 9. 41 Bostyn 2016a, p. 156.
generic version of X is used for the patented indication Z, then this is so-called cross-label use.42
Personalised medicine
Personalised medicine is an approach that emphasises “tailor-made” medical treatment for a patient; a targeted therapy instead of a "one-size-fits-all" treatment. In practice, personalised medicine does not per se relate to the individual treatment of a patient but mostly implies technological strategies that aim at categorising patients into a variety of patient groups.43 This
personalised approach aims at treating groups of patients according to their specific needs. Indeed, the human genome provides information that can lead to more informed decisions about health and healthcare, since every individual’s genes react differently to different medicine and treatments. It is believed that personalised medicine is a more efficient way of treating patients.
42 The example is derived from the AIPPI Q238 2014 UK, p. 9. 43 Bostyn 2016a, p. 152.
2
HEALTHCARE SYSTEM REGULATIONS
Before the difficulties of enforcing second medical use claims can be understood, with regard to their scope and infringement, it is important to grasp how healthcare is provided in practice. This chapter analyses the regulatory scheme by which the public gains access to medicine and medical treatment within the healthcare systems of the Netherlands and the UK; addressing the prescribing and dispensing practices and the preference policy.
2.1 Regulatory system
The patent law framework and the regulatory scheme on healthcare are entirely separate, which is a problem in numerous situations. For example, physicians and pharmacists, who work accordingly regulatory law, could still infringe patents during their daily activities. It is difficult to determine which law has priority. The following section illustrates how, in various jurisdictions, the regulatory system obliges health professionals to act a certain way, which does not correspond with the rights of protection granted to a patentee.
An important aspect to emphasise is that healthcare systems around the world are exceedingly diverse; the healthcare system in the Netherlands relies on private insurers,44 while the UK’s
system, led by the National Health System (NHS), is led and financed by the government.45
2.1.1 Prescribing and dispensing
Prescribing refers to one of a doctor’s many daily activities, whereby the daily concern of the physician excludes the rules of patent law. Dispensing happens in relation to the professional practice of a pharmacist. For both the Netherlands and the UK, the situation can generally be described as follows: After the patient receives his diagnosis, the doctor prescribes the needed pharmaceutical(s) on the basis of the international non-proprietary name (INN) of the active pharmaceutical ingredient (API). The INN does not identify the medicine.46 Consequently,
44 Nevertheless, the government still plays a vital role in assuring healthcare services to its citizens by introducing legislation that regulates the role of health insurers.
45 Bostyn 2015, p. 780.
46 NHS Guide to Healthcare system England; [2015] EWHC 72 (Pat) 21 January 2015 (Warner-Lambert v Actavis), par. 28; [2015] EWHC Civ 556 28 May 2015 (Warner-Lambert v Actavis), par. 376.
doctors do not consider possible patented indications which have been carved out of the SmPC of the generic drug. If the doctor prescribes drugs on the basis of their INN, then the pharmacist can choose freely whether to dispense the patented drug or the generic option. Thus, if a pharmacist possesses various medicines for the same API, he or she can choose which option to dispense, since the drugs are effectively the same and based on the same API. Moreover, for what the prescription will be used is not typically, specifically mentioned,47 and
thus, the pharmacist has, in general, no knowledge for which indication they are dispensing the medicine.48 However, the pharmacist can become knowledgeable about the indication due
to previous medical records or by querying the patient or the doctor directly.
In the UK, doctors are encouraged to prescribe drugs in the generic form, unless certain circumstances (e.g. the Selected List Scheme49), oblige them to prescribe the patented drug
and the pharmacist can choose freely which product will be dispensed.50 This encouragement
stems from the rationale that generic medicines are equally effective as the branded versions, but cost up to 80% less. Since the healthcare system is publicly funded, the reduction in medication cost frees up NHS resources to be able to pay for other treatments. Furthermore, when a particular drug comes short in stock, the pharmacist can easily choose another.51
Nevertheless, if a doctor makes a reference to a particular brand of medicine, then the pharmacist is obliged to dispense only that brand,52 because generic substitution53 is prohibited
in the UK.54
In the Netherlands, however, the situation is somewhat different as to the allowance of generic substitutions by the pharmacist. Dutch pharmacists are required to substitute a branded substance by a generic version when they partake in a rebate contract. If the pharmacist substitutes a drug, he or she must ensure that the physician and the patient agree with the generic substitution. The pharmacist is not allowed to personally deviate from the prescription; the pharmacist must prove that the patient who needs the drug and the prescribing physician consented to the substitution.55
47 In the Netherlands this does not apply to 23 specific medicines, whereby the physician is obligated to enumerate the indication on the prescription as well, see ‘Reden van voorschrijven op recept en labwaarden uitwisselen’ 2013.
48 Carter 2014; [2015] EWHC 72 (Pat) 21 January 2015 (Warner-Lambert v Actavis), para. 28 and 34. 49 Medicinal products – PSNC; NHS England – Standard General Medical Services Contract, May 2014. 50 [2015] EWHC 72 (Pat) 21 January 2015 (Warner-Lambert v Actavis), par. 28; Bostyn 2016a, footnote 49. 51 NHS – Medicines information Brand names and generics
52 Carter 2014; [2015] EWHC 72 (Pat) 21 January 2015 (Warner-Lambert v Actavis), par. 28 and 34;
53 Generic substitution is the mutual substitution of medicinal products having the same active ingredient, the same dose, and the same pharmaceutical form (see Handleiding Geneesmiddelsubsitutie June 2013, p. 11).
54 Bostyn 2016a, footnote 49; NHS England – Standard General Medical Services Contract 2014. 55 Handleiding Geneesmiddelsubstitutie June 2013, p. 31.
2.1.2 The preference policy in the Netherlands
The Netherlands has a different position from many other countries, including the UK, with regard to their policies for health insurers. In an effort to achieve lower costs for medicine by increasing market competition, health insurers utilize the preference policy method56: The
health insurer chooses which type of medicine out of a variety of medicines (with the same API) will be reimbursed. Thus, per API, or a combination thereof, at least one medicine shall be refunded – except in cases of medical necessity.57 This medicine is called the preferred
medicine. This policy influences the pharmacist’s dispensing choices and does not take patent law into account, as health insurers do not have to consider strength, mode of administration or brand.58
There are two models of drug reimbursement that a health insurer can use to determine which medicines will be reimbursed. First, health insurers can use the tender method to determine what will be the preferred medicine. In this method, manufacturers, originators59 or generics
are given the chance to sell their medicines, for a particular API, in a tender. The manufacturer who offers the lowest price for his drug wins the tender and is named the preferred medicine, and this is the only medicine that will be reimbursed for that API.60
Hence, pharmacists dispensing choices of the preferred medicine is based on economic motivation.
Second, the health insurer can choose what medicine will receive compensation on the basis of a public price list, such as the G-Standard. Contrary to the tender model, there are more factors than just price which are relevant when choosing the preferred medicine, e.g. whether the manufacturer can provide the medicine in the market the entire time that it has the preferred status.61
An alternative to the preference policy is the price preference policy, whereby the pharmacist receives a fixed, average price for all of the preferred medicines, irrespective of the actual 56 Kanavos, Seeley, Vandoros 2009, p. 7.
57 See Article 2.8 of the Dutch Health Insurance Decree. If this is applicable, a doctor must make this clear by writing ‘MN’ on the prescription. It is mandatory for the health insurer to reimburse the non-preferred medicine.
58 Preferency policy – KNMP; Kanavos, Seeley, Vandoros 2009, p. 17.
59 Although they can apply for reimbursement through a tender, originator companies are in general priced higher than generic ones, which leads to that only generic manufactured will have the preferred status.
60 Kanavos, Seeley, Vandoros 2009, p. 7. 61 Preferency policy – KNMP
price. The pharmacist determines which (brand of) medicine he will dispense. If the pharmacist obtains his drugs at a lower price than the reimbursement from the health insurer, the difference between the two prices is his profit. If the pharmacist stocks the medicine for a higher price than the compensation he receives, that disadvantage cannot be recovered from the patient.62
In practice, price will always be the most important factor for the pharmacist in deciding what medicine will be dispensed. For this reason, generic medicines are more commonly used because both the branded – if present – and the similar generic version are considered effective for treatment.
3
LEGAL FRAMEWORK
The previous chapter shows that national regulatory law has been drafted to facilitate access to generic drugs through the option of carving out any references to the patented indications within the SmPC and patient information leaflet PIL. This chapter maps the legal framework regarding second medical use inventions and discusses the scope of protection afforded to these inventions and their infringement. It is important to first understand the law that relates to second medical use patents before beginning to discuss the possible problems and effects these patents have on the provision of healthcare.
3.1 Legal framework on European level
A granted European patent splits into separate national patents, with each patent in compliance with their national patent law.63 Hence, national patent law plays a significant role
in the enforcements of patents.64 65 In order to seek uniformity among the member states, the
jurisprudence of the EPO66 and case law of other contracting states are relevant to the
assessment of a national court. Obtaining uniformity is particularly pertinent to second medical use patents, where national courts take different approaches concerning the enforcement of second medical use for a variety of factors.6768
3.1.1 Legislation
Following the principles set down in Article 52(1) EPC, the requirement of ‘novelty’69 for the
patentability of second medical uses can cause issues. Initially, this appears to be a straightforward rule: anything that forms part of the state of the art is not new. As such, a second medical use patent is not novel within the traditional application of Article 54(1) EPC.
63 Van Engelen §11.1.
64 Article 2(2) EPC; Gielen et al. 2014.
65 As opposed to other jurisdictions, patent law only has – for now – one European Directive on harmonising the patentability of Biotechnical Inventions within the EU.
66 http://www.epo.org/about-us/boards-of-appeal.html
67 Such as whether or not second medical use patents are patentable, and the patentability of various specific therapeutic applications (i.e. dosage regimes).
68 Broes et al. 2016, p. 23; AIPPI Q238 2014 Resolution, p. 2-3. 69 Article 52(1) EPC jo. Article 54 EPC.
However, second medical use patents contain a ‘virtue of legal fiction’70: novelty lies in the
newly discovered specific application of the invention.7172
Second medical use patents are codified within the EPC as follows:
“(5) Paragraph 2 and 3 shall also not exclude the patentability of any substance or composition referred to in paragraph 4 for any specific use in a method referred to in Article 53(c), provided that such use is not comprised in the state of the art.”73
(Emphasis added).
Nevertheless, there is thin line between patenting a supposedly new therapeutic application of a substance and the so-called method of treatment exclusion.7475 The rationale for this
exclusion is threefold: ethical, societal and with respect to public health, which should ensure that medical professionals experience no difficulties in carrying out their daily activities.76
Dosage regimes are an example of an act that could both be patentable through a second medical use patent, and non-patentable because of the method of treatment exclusion. It depends on how the dosage regime is provided. While medical procedures with new dosage regimes given by the physician are un-patentable under this article, a second medical use patent could be granted for a drug product that states such dosage regimes in its instructions77.78
3.1.2 Direct and indirect infringement
It is further interesting to discuss whether the two types of second medical use claims, which are both valid patents and therefore enforceable, are covered by the same scope of protection. As previously mentioned, the Swiss-type claim is a process claim, i.e. a use or a method claim, whilst the EPC2000 claim is a product claim. As such, each claim is different and could be afforded a different scope of protection.79 In T1780/12,80 the TBA concluded that the
70 This "novelty-exception" is only allowed under the EPC for inventions in the medical field.
71 The EPC lacks a definition of “invention”, but did, however, defined it negatively in Article 52(2) EPC. 72 Yasui 2014, p. 324; AIPPI Q238 2014 Netherlands, p. 3.
73 Art. 54(5) EPC.
74 Article 53(c) EPC; Article 3(1)(f) DPA; Section 4A(1) UK PA.
75 Article 53(c) EPC reads: "methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body; this provision shall not apply to products, in particular substances or compositions, for the use in any of these methods".
76 Bostyn 2016a, p. 154. 77 PIL and SmPC.
78 The example is derived from Yasui 2014, p. 330. 79 Bostyn 2015, p. 750; Bostyn 2016a, p. 6.
two types of claims, in fact, differ in their claimed subject-matter – with the Swiss-type claim requiring the manufacturing of a drug, a prerequisite which the EPC2000 does not contain – and thus, the scopes of protection are not equivalent. The Swiss-type claim confers less protection than the EPC2000 claim,81 even though the EPC legislator's intention was to
closely match the scopes of protection of the two claims.82 While this theoretical difference in
the protection under the two types of claims could be relevant with regard to infringement, case law reveals that, in practice, the scopes of protection do not greatly differ.83 As discussed
below, one needs to be informed about the distinction between direct and indirect infringement, particularly when there is no harmonised approach84 between countries
concerning the principles which determine infringement of second medical use patents.85
Direct infringement
When a third party commits one of the exclusive acts of the patentee – without the consent of the patentee – this is called direct infringement, whether it involves the product itself or the use of the patented process.86 Regarding direct infringement of the manufacturing process, the
generic pharmaceutical company is considered infringing the second medical use patent if they commit any of the exclusive acts – without consent – belonging to the originator company by disposing of, offering, using or importing the patented product obtained directly by the patented process.87 In other words, the third party that commits any of the patentee's
reserved acts related to the drug for the patented indication88 is directly infringing the patent,
and is thereby (directly) liable.89
The intentional element
The key aspect of determining direct infringement lies in the meaning of the word “for” in Swiss-type claims, which denotes some kind of purpose or intention.90 The author follows the
opinion of Bostyn in the matter that the intention behind “for use” should be equally applicable to EPC2000 claims, as it is relevant for both types of claims to construe the
81 Ibidem, at 19, 22 and 23. 82 MR/18/00 2000, at. 4. 83 Bostyn 2016a, p. 156.
84 The enforcement of patents is an issue of national patent law. 85 Article 64(3) EPC; Bostyn 2016a, p. 159; C-539/03, para. 31. 86 Bostyn 2016a, p. 159.
87 Ibidem.
88 A party does not, in principle, directly infringe a patent when they make or supply the generic version of the drug and use it for everything but the patented indication.
89 Bostyn 2016a, p. 161.
meaning of the “for use” claim limitation.91 Citing Benyamini92 on the infringement of
Swiss-type claims:
“The requirement that the medicament be specifically manufactured for the novel indication means no more than that it should be packaged and labelled with directions designating it for the indication.”93
If one should accept that the wording “for” includes an intentional element, then the follow-up question concerns how the courts should, or have, interpret(ed) this intentional element.94 In
the following parts (§3.2.2 & 3.3.2), the intentional element and its interpretation are analysed.
Indirect infringement
Indirect infringement95 entails that the patentee holds the right to prevent that the alleged
infringer:
(i) supplies or offers to supply, without the patentee's consent, that a person, other than a party entitled to use the patented invention with any of the means, in respect of an essential part of that invention;
(ii) puts the invention into effect
(iii) when the third party knows, or it is obvious to a reasonable person in the circumstances, that these means are suitable for putting, and are intended to put, the invention into effect in the territory of a Contracting State. 96
Within the scope of this thesis, a generic pharmaceutical company could be indirectly infringing the patent if they have supplied the drugs to a third party97, who in their place,
directly infringe the patent by using the drugs for the patented medical indication.98
91 Bostyn 2016a, p. 169. 92 Benyamini 1993. 93 Ibidem, p. 94. 94 Bostyn 2016a, p. 165.
95 A precise statutory wording varies from country to country, but in general, does contain the follow-up criteria.
96 Article 30 of the Convention for the European Patent for the Common Market. This Convention never entered into force, but the provision in European countries on indirect infringement is based on this article.
97 Meaning the parties further down the chain (i.e. “downstream”). 98 Bostyn 2016a, p. 156.
3.2 The Netherlands
A cornerstone of the Dutch legal system, including the Dutch patent system, concerns creating a fair balance between the interests of all relevant parties. In order to strike an equitable balance within Dutch patent law, it is accepted that second medical use patents are permissible. In particular, for a better harmonisation on second medical use patents, the national court ruled in line with the EPC legislation and case law of the EPO.99
3.2.1 Legislation
Patents that are applicable in the Netherlands are covered under the Dutch Patent Act 1995 (“DPA”), EPC2000 claims are stated in Article 4(6) DPA100 and Swiss-type claims are
regarded on the basis of the G5/83 decision, which is adopted in Dutch case law.101
Direct infringement is laid down in Article 70 DPA, and extend to the product or process102
(as subject matter). Article 73 DPA concerns indirect infringement. For indirect infringement are the above-mentioned criteria relevant.103 The wording of Article 73(1) DPA clarifies that it
is not relevant for a successful appeal for indirect infringement it is that the third party receiving the essential element, in fact infringes the patent.104 The limited aspect of
determining indirect infringement is that it should be offered or supplied within the Dutch territory.105
3.2.2 Scope and infringement
Currently, (national) case law on the subject of infringing second medical use patents is limited, and the little case law that exists only concerns Swiss-type claims.
The Dutch view on direct infringement
99 AIPPI Q238 2014 Netherlands, p. 2; Conclusion A-G van Peursem, footnote 1; Bostyn 2016a, p. 155-156. 100 For first medical indication patents, Article 4(5) DPA is applicable and in line with Article 54(4) EPC.
101 See for example District Court The Hague 25 September 2009 (Sanofi v Ratiopharm), para 4.9; Court of Appeal The Hague 1 November 2011 (Sanofi v Ratiopharm ), para. 5.1; District Court The Hague 6 July 2011 (Sandoz & Stada v Astrazeneca), para 2.11; District Court The Hague 13 November 2013 (Sanofi v Amylin), para. 5.27.
102 The protection is extended to products that are directly obtained from such process, see Article 53(1)(b) DPA. 103 Van Engelen 2016, §11.6.2; AIPPI Q238 2014 Netherlands, p. 5-7.
104 Kort Begrip 2014, nr. 65. 105 Article 73(1) DPA.
The case Schering/Teva106 is considered one of the leading cases on direct infringement of
Swiss-type claims.107 In this case, Schering possessed a second medical use patent for the use
of the compound ribavirin for manufacturing a drug for treating Hepatitis C within a particular patient subgroup. The court decided that Teva ensured, through the use of a skinny label,108 that the patent was only aimed at the non-patented indications. Given the precise
nature of the type of patents (Swiss-type claim), the court held that primary consideration should be given to the SmPC so as to discover what the purpose of the related drug entails.109
Hence, the specific step of carving out the SmPC was sufficient for Teva to avoid liability and, thus, Teva did not infringe Schering’s patent. This decision was confirmed in appeal.110
The court, however, did leave the possibility open that even with the use of a skinny label other parts in the SmPC (e.g. stating the chemical entities) could, in certain circumstances, encourage the utility of the generic drug for the patented indication.111 The court may, in
certain circumstances, consider the practical reality, such as the practice of the Dutch regulatory scheme (Chapter 2). Furthermore, the court also pointed out that infringement could occur if Schering submitted evidence112 that the patent was indeed used for the patented
indication (i.e. the patient subpopulation).113
Another relevant case in the Netherlands is the Warner Lambert (WLC) 114 case. In short, WLC
has a second medical indication patent for the use of pregabalin for treating neuropathic pain.115 One of the tasks of the Medicines Evaluation Board (MEB) in the Netherlands is to
online register the SmPC, PIL and evaluation report of the permitted drugs. The MEB publishes the full label of the SmPC and PIL of the medicine online regardless of whether or not the generic company uses a skinny label. In this case, direct infringement was not adopted, because the MEB’s online published information was not considered to be an exclusive act of the patentee: the MEB does not sell or offer pregabalin for treating pain.116
However, the court did find that the MEB acted unlawfully. The notion of the court was that
106 District Court of The Hague, 10 November 2010 (Schering v Teva). 107 McCulloch, Paul and Bhattacharya 2015
108 District court of The Hague, 10 November 2010 (Schering v Teva), para. 4.6. 109 Ibidem, para. 4.4.
110 Court of Appeal of The Hague, 14 July 2015 (Schering v Teva II). This decision is again on appeal by the Dutch Supreme Court (oral pleadings were on 30 September 2016) and pending trial.
111 For example, if physicians prescribe the drug for the patented indication on the basis of information in the SmPC that does not relate to the chapter with the therapeutic indications listed.
112 Such as specific references to the patented indication in the SmPC, PIL, bulk packaging or label. 113 District court of The Hague, 10 November 2010 (Schering v Teva), para. 4.11.
114 District Court The Hague 15 January 2016 (Warner-Lambert/CBG). 115 Ibidem, para. 2.2.
the SmPC is aimed at the healthcare professional and not at the patient. Given that the full-label version of the SmPC is published on MEB’s website, MEB actively informs the doctors and pharmacists that the generic drug could be prescribed and dispensed for the patented indication, regardless of other informative sources for healthcare professionals. Subsequently, with publishing all information online, healthcare professionals are easier persuaded to prescribe and dispense a generic version for a patented indication.117
Comments
With regards to the threshold of knowledge and intention, the Dutch court in the Schering/Teva118 case remains unclear in its judgment. In this case, the court rather modestly
approached determining the intention element: Teva used a skinny label for its generic drug, which appears to be enough for the court to decide a lack of intention on Teva’s side.
The author wonders why the court did not give (more) notice to certain other relevant facts indicating that the generic manufacturer took at least all possible steps within its power to prevent infringements situations, rather than merely carving out the SmPC. Such as, the marketing of the product, market information regarding the drugs, or a letter notifying the involved people or a warning on the wholesale package that the generic version should not be sold, delivered or used for the patented indication. Merely using a skinny label sets a high threshold for infringement liability, and is not significant to demonstrate that there is a lack of intention. If a skinny label is sufficient to avoid liability, no generic manufacturer shall purposely refer to the patented use.
The regulatory scheme should also be taken into consideration when determining infringement, especially when skinny labelling has been adopted within the regulatory legislation framework in order to prevent automatic infringement. A wrongly a contrario reasoning is that by complying with the regulatory scheme, no patent infringement can occur.119 Within other European countries,120 the regulatory system was relevant for the
assessment of reasonable foreseeability on the side of the generic manufacturer. Thereby, it seems reasonable that a generic manufacturer should elaborate upon its intention. On the other hand, it should be taken into account that knowledge is not a requirement for determining
117 Ibidem, para. 4.14 & 4.15.
118 District Court of The Hague, 10 November 2010 (Schering v Teva). 119 AIPPI Q238 2014 Netherlands, p. 14.
patent infringement.121 In the case of second medical use claims – where claims have a
purpose limitation – the patentee should, however, at least make it sufficiently plausible that the third party knows, or reasonably had to know, that the drug was going to be used for the patented indication. 122 Thus, making the difference between direct and indirect infringement,
in practice, less significant under Dutch law.123
An additional comment on the reasoning of the Court of Appeal in the Schering/Teva case124
-on whether direct infringement can be adopted in this case – is that the court took the perspective of the person skilled in the art for deciding on the infringement question. Following the court’s reasoning it is required that in order to determine infringement, the person skilled in the art should read in the SmPC of the PIL that the generic version is specifically destined for the patented use.125 While determining infringement, the Court of
Appeal takes the wrong test; It should not be the person skilled in the art (i.e. which is relevant for questioning the validity of the patent which was not at stake here), but the third party who knows, or reasonably had to know, that the drug was used for the exclusive acts of the patentee.
The atypical case on indirect infringement
Indirect infringement was dealt with in the summary proceeding case of Novartis v Sun I126.
Although this case is currently one of the leading precedents127 on this type of infringement,
one must consider that this case had particular facts which make it difficult to generalise this decision.128 The facts of the case are as follows: Novartis has a Swiss form patent on the use
of zoledronic acid in a specific dosage range, form and regime for the treatment of osteoporosis. The original patent had expired on the indication of treating Paget’s disease.129
Sun had a generic product for this latter indication with a skinny label.130 There is a significant
difference between osteoporosis and Paget’s disease with regard to the patient population:
121 AIPPI Q238 2014 Netherlands, p. 7. This is different for indirect infringement. 122 AIPPI Q238 2014 Netherlands, p. 6.
123 McCulloch, Paul and Bhattacharya 2015; Blomme 2015, p. 94. 124 Court of Appeal of The Hague, 14 July 2015 (Schering v Teva II) 125 Ibidem, para. 5.2.
126 Court of Appeal of The Hague, 27 January 2015 (Novartis v Sun). The case is pending trial before the Supreme Court of the Netherlands and awaiting decision early 2017.
127 It is leading because it is the only case where the Dutch court has judged positively on indirect infringement.
128 Furthermore, the District court in final relief proceedings ruled that indirect infringement of a Swiss form claim is, in fact, not legally possible. Nevertheless, this interesting topic was not raised in the PI proceedings. Thus we should assume that indirect infringement of a Swiss-type claim is possible. See A-G van Peursem 2016, p.2.
129 Court of Appeal of The Hague, 27 January 2015 (Novartis v Sun), para. 2.4. 130 The patented indication ‘the use for osteoporosis’ was carved out.
97% of the utility of zoledronic acid was for the treatment of osteoporosis, while the remaining 3% was used for treating Paget’s disease.131 Another important fact in this case
concerned the participation of Sun in a tender of a Dutch insurance company whose stated policy was to use the preferred product – the generic drug – for all indications, regardless of the legitimate patents.132 Sun won the tender.
The court held Sun liable for indirect infringement133 despite the fact that Sun marketed its
product under a skinny label. In this case, it was evident that the generic version was used for the patented indication. The following reasons led to the court’s decision:
The sales of Sun’s generic drug were too high compared to the numbers of patients with the non-indication.134 This supported the court's opinion that it was inevitable that
the generic drug was dispensed for the patented indication.135
As to winning the tender, it was clear beforehand that the conduct of the health insurer led to patent infringement; the pharmacists are obliged to dispense Sun’s generic drug irrespective of the indication.136
Sun knows or should have known that the medicine would be used for the patented indication. It was, therefore, required of Sun to do everything in its power to prevent patent infringement (i.e. the use of generic zoledronic acid for treating osteoporosis). Writing to the relevant medical insurer as well as the wholesalers (including the joined pharmacists) was not enough to dismiss Sun of indirect infringement.137
However, when the case was decided on its merits, the District Court of The Hague138 ruled
contrary to the Court of Appeal on indirect infringement in this case for a similar reasoning that Arnold J had in Warner Lambert (see 3.3.2). This led to a visible non-uniformity on enforcing second medical use claims within the Netherlands. The district court provided two important reasons for its decision: (i) the patent concerns a Swiss-type claims, which has the distinctive element of the “manufacture of a product” and (ii) the third party does not put the invention into effect.139 The latter should be understood as the preparation of the drug
131 Court of Appeal of The Hague, 27 January 2015 (Novartis v Sun), para. 4.29.
132 Leading to the generic zoledronic acid of Sun to be used both for osteoporosis and disease of Paget. 133 Novartis did not allegate Sun on direct infringement.
134 In the period between January and February 2014 alone, 142 units of Sun’s generic drug were being sold, while 135 units were the expected to be sold in one year. See Court of Appeal of The Hague, 27 January 2015 ( Novartis v Sun), para. 4.29 and 4.33.
135 Ibidem, para. 4.34. 136 Ibidem, para. 4.34.
137 Ibidem, para. 4.32, 4.34 and 4.35.
138 District court of The Hague, 25 November 2015 (Sun v Novartis). 139 Article 73(1) DPA.
zoledronic acid for the treatment of osteoporosis. Without the invention being put into effect, there is no indirect infringement. After Sun’s delivery of the medicine, no one downstream applied the claimed process because the manufacturing process occurred when the product was placed on the market.140 The drug is a so-called ready product, and thus, not an essential
part of the invention.141 In the famous Senseo142 decision, the Dutch Supreme Court held that
an essential element must be one which distinguishes the invention from the prior art.143 With
the second medical use patent at present, the novelty is based on the application: for treating osteoporosis.
In the earlier mentioned case of Warner Lambert,144 indirect infringement was not adopted
because the knowledge that the generic drug could be used for the patented indication was not to be considered as “a means relating to an essential element of the invention”.145 This latter
requirement is applicable for physical things (i.e. not the knowledge of the invention) and WLC did not make it plausible that the substance (i.e. pregabalin) was used downstream for the manufacture of treating the patented indication (i.e. neuropathic pain).146 This last part
makes it clear (again) that the patentee should substantiate its presumptions that the generic drug is likely to be used for the patented indication, despite skinny labels.147
Comments
It is interesting to note that the Court of Appeal in the Sun/Novartis148 derives the mens rea
element from the fact that it is inevitable that the generic drug will be used for the patented use. Therefore, indirect infringement was found. Not in dispute and not further elaborated upon by the court, is the assumption of the court that the pharmaceutical formulation in question is “an essential element of the invention”149.150 While this is not apparent per se, or an
essential codified requirement, the author thinks it would have been proper for the court to
140 District court of The Hague, 25 November 2015 (Sun v Novartis), para. 4.54.
141 If Article 64(2) EPC was applicable, concerning the directly obtained product from the patented method, then it falls under direct infringement. SeeIbidem, para. 4.54.
142 Supreme Court of the Netherlands, 31 October 2003 (Sara Lee v Integro). 143 Ibidem, para. 3.4.2.
144 District Court The Hague 15 January 2016 (Warner-Lambert/CBG). 145 Pallard & Killan 2016, p. 5.
146 Ibidem, para. 4.6.
147 By providing internal documents of the generic company revealing their intention; the relative market size for the different indication in relation to the number of sales of a medicine; the likelihood of cross-labelling and the steps taken by the alleged infringer to prevent patented use.
148 Court of Appeal of The Hague, 27 January 2015 (Novartis v Sun). 149 Article 73(1) DPA.
elaborate on this issue with regards to, inter alia, legal certainty. As such, the decision was in my opinion poorly and shallowly argued.
Furthermore, the Court of Appeal case made certain assumptions that still need to be proven, such as the assumption that indirect infringement of Swiss-type claims is possible, while this has not yet been established. The same is true for the conclusion of Van Peursem:
“De - interessante - vraag of indirecte inbreuk op een Swiss-type claim juridisch wel mogelijk is, is in deze procedure (anders dan in de bodemzaak) als zodanig niet aan de orde gesteld, zodat ervan moet worden uitgegaan in dit kort geding dat dat type inbreuk octrooirechtelijk voorhanden is.” 151 (Emphasis added)
This reasoning is dubious: The matter is not treated, and thus, he assumes that it is possible. The author follows Justice Floyd in the Warner Lambert case152 (see 3.2.2) and Bostyn that it
is disputable if indirect infringement could occur with Swiss-type claims.153 It is, in view of
future cases regarding (indirect) infringement of second medical use patents (in Swiss form), necessary to prepare a judgment on this matter.154 Indirect infringement would be easier to
decide upon with EPC2000 claims due to the lack of the term “manufacture” within the claims.
3.2.3 Interim conclusion
In light of the above, the SmPC is in the Netherlands an important factor in deciding whether a second medical use claim is directly infringed. Full labelling by the generic company is likely to result in direct infringement. This is, however, not a straightforward situation regarding skinny labelling. In these cases, it is more difficult for a patentee to prove direct infringement by a generic company. It is, therefore, necessary to provide evidence of intention that the infringing product was manufactured for the patented use specifically. This could be substantiated by the steps taken to prevent that the generic version was used for the patented indication.
For indirect infringement, knowledge of the use of the generic drug for the patented use should be made plausible. Indirect infringement does not require an obvious intention of the 151 Conclusion A-G van Peursem, p. 2.
152 [2015] EWHC Civ 556 28 May 2015 (Warner-Lambert v Actavis), para. 135. 153 Bostyn 2016a, p. 177-179.
generic company that infringement would occur. However, it is necessary for the generic manufacturer to do everything in its power to prevent patent infringement.
3.3 The United Kingdom
In the UK, patentability of second medical uses was confirmed by the Court of Appeal decision in Actavis v Merck.155 Decisions of the EPO were also at issue under the principle of
stare decisis.156 As can be seen in Ranbaxy v Astrazenec,157 the Swiss-type claim is not limited
to a particular method of manufacture, thereby, recognising the artificial nature of these types of claims. The court held that a skilled person in the art would, with his common general knowledge and specification in mind, understand that the “medicament” in the claim meant to include the API for which the new specified therapeutic application had been found.158
3.3.1 Legislation
The UK Patent Act (PA) sets out the requirements for patent applications, the process of granting a patent and the law related to disputes concerning patents. Direct and indirect infringement can respectively be found in S.60(1) and (2) UK PA, which more or less contain the same formulation and content as the EPC and the DPA (see 3.1 & 3.2). Finding infringement is also limited to the territory of the UK.159
3.3.2 Warner-Lambert v Actavis
The facts of the case
In the UK, the issue of second medical uses is the subject of a heated debate in the ongoing dispute between Warner-Lambert (WL) and Actavis. In short, the facts of the case are as follows:160 WL has a patent (product name is Lyrica) for pregabalin for three different
indications: epilepsy, generalised anxiety disorder (GAD) and neuropathic pain. The original patent expired and WL received a second medical use patent in the form of a Swiss-type claiming “the use of pregabalin or a pharmaceutically acceptable salt of it for the preparation of a pharmaceutical composition for treating neuropathic pain”161.162 Actavis had applied for a
155 [2008] EWCA Civ 444 21 May 2008 (Actavis v Merck) 156 Such as the case G5/83 (1984)
157 [2011] EWHC 1831 (Pat) 15 July 2011 (Ranbaxy v Astrazeneca) 158 Ibidem, para. 67.
159 s.60(1) and (2) UK PA.
160 [2015] EWHC 72 (Pat) 21 January 2015 (Warner-Lambert v Actavis). 161 Ibidem, para. 15.
marketing authorisation for a generic pregabalin limited to epilepsy and GAD (skinny label) under the name Leceant.163 The dispute between the two parties concerns whether the
manufacturer of pregabalin by Actavis would fall within WL's patent claims as the generic product is directly obtained from the means of the patented process. The issue, in this case, is the interpretation of the words "for treating (neuropathic) pain". 164
Direct infringement
Justice Arnold gave the first detailed consideration of interpretation of a Swiss-type claim in the UK in the preliminary decision165. As previously mentioned, a Swiss-form claim is
construed as "use of a substance A in the manufacture of a medicament for the treatment of B". The term “for” has traditionally been interpreted under UK law as “suitable and intended for”.166 As Arnold J has also stated: it is common ground that Leceant is suitable for treating
pain.167 This follows from the WL’s patent and its market authorisation. Furthermore, the
word “for” means that, in order to infringe, the manufacturer of a generic drug must have a subjective intention that the drug is used for the patented indication. 168 A Swiss-type claim is
aimed neither at the manufacturer and not the doctor nor, in general, the pharmacist.169 The
manufacturer carries out the process, and thus, his intention is relevant.170
The Court of Appeal171 disagreed on this preliminary issue and introduced a wider test for the
infringement. Lord Justice Floyd ruled that when assessing direct infringement, the word “for” is understood by the skilled person to require that the manufacturer knows or can reasonably foresee that the drug will be ultimately intended for use for the treatment of the patented indication, not that the manufacturer had the specific intention or desire for this.172
“For”, paraphrasing Floyd LJ, aims at a more objective intention on the part of the manufacturer and the test resembles that for indirect infringement (see below).173
163 [2015] EWHC 72 (Pat) 21 January 2015 (Warner-Lambert v Actavis), para. 5. 164 Ibidem, para. 95.
165 Ibidem
166 [2014] EWHC 1094 (Pat) 27 July 2016 (Hospira UK Ltd v Genentech), para. 58. 167 Pain means (neuropathic) pain.
168 [2015] EWHC 72 (Pat) 21 January 2015 (Warner-Lambert v Actavis), para. 101 & 111.
169 Arnold J confirmed what was decided in [2008] EWCA Civ 444 21 May 2008 (Actavis v Merck), para. 75. 170 [2015] EWHC 72 (Pat) 21 January 2015 (Warner-Lambert v Actavis), para. 96 + 99.
171 [2015] EWHC Civ 556 28 May 2015 (Warner-Lambert v Actavis) 172 Ibidem, para. 127.
