1 Name: E.P.W. (Erwin) Feenstra
Mastertrack: Informatierecht UvA, Masterthesis Supervisor: Dr. Sven J.R. Bostyn
Number of words: 12.983
Second medical use: a breeding ground for patents or an escape
to affordable healthcare?
2 List of abbreviations
1. Patentee Pharmaceutical company with a
SMI patent
2. Generic Generic pharmaceutical company
3. SMI Second Medical Indication
4. EPC European Patent Convention
5. CPC Community Patent Convention
6. DPA Dutch Patent Act
7. UKPA UK Patent Act
8. GPA German Patent Act
9. A.o. Among other things
10. E.g. For example
11. BGH Bundesgerichtshof
12. Ff. And further
13. NPO Netherlands Patent Office
3 Abstract
This master thesis, Second medical use: a breeding ground for patents or an escape to affordable healthcare?, assesses a problem in contemporary practice concerning second medical indications. The problem being dealt with is that there is a tension among the interests of affordable healthcare, the patentee and the generic. Case law in the relevant jurisdictions, including the Netherlands; Germany and the UK, has led to much uncertainty about the question to be answered: What measures should a generic pharmaceutical producer in Europe take to avoid liability concerning Second Medical Indication patents to ensure a fair balance among the interests of generic pharmaceutical producers, patentees and affordable healthcare, comparing the Dutch, the German and the UK regimes? This contribution is normative as well as descriptive and is based on a review of the available literature. In addition, the jurisdictions are compared by means of a comparative research method.
This master thesis compares the various considerations in case law and forms of policy in the three jurisdictions involved. By analyzing the doctrines in the aforementioned jurisdictions it is possible to conclude that only entrusting the generic with additional responsibilities, to prevent infringement of the second medical indication patent, does not strike a fair balance among the interests of affordable healthcare, the patentee and the generic. The solution lies in the creation of a database or modification of an existing database, thereby ensuring legal certainty; legal protection and efficiency to strike a fair balance among the interests involved.
4 Table of Contents 1 Introduction ... 6 2 Elements of interest ... 10 2.1 Swiss-type claim ... 10 2.2 EPC2000 claim ... 11 2.3 Skinny labelling ... 12
2.4 Prescribing generic drugs and substitution ... 12
2.5 Off-label use ... 13
2.6 Preference policy ... 13
3 Which parties and what kind of interests play a role in formulating what requirements must be imposed on the generic to prevent a breach of the SMI? ... 14
3.1 Patentees ... 14 3.2 Generics ... 14 3.3 Government... 15 3.4 Insurance companies ... 16 3.5 Physicians ... 16 3.6 Pharmacists ... 16
4 What is the current doctrine concerning (in)direct infringement of Swiss-type claims in the Netherlands, the UK and Germany? ... 17
4.1 The concepts of (in)direct infringements ... 17
4.1.1 Direct infringement ... 17
4.1.2 Indirect infringement ... 17
4.2 Direct infringement Swiss-Type claims ... 18
4.2.1 Foreseeability test ... 18
4.2.2 Subjective and objective intent ... 21
4.2.3 Outward presentation test ... 23
4.3 Indirect infringement Swiss-Type claims ... 26
4.3.1 General remarks concerning indirect infringement Swiss-Type claims 26 4.3.2 Applicable doctrines within the jurisdictions ... 26
5 What is the current doctrine concerning the (in)direct infringement of the EPC2000-claims in the Netherlands, the UK and Germany? ... 30
5.1 Direct infringement ... 31
5.2 Indirect infringement ... 32
6 A critical formulation concerning the obligations, to be accepted by the generic drug manufacturers, that bring a reasonable balance among the interests of the: patentees, the generics and affordable healthcare. ... 34
6.1 Skinny label ... 34
5 7 Conclusion ... 39 8 Acknowledgements ... 42 9 Bibliography: ... 43 9.1 Literature ... 43 9.1.1 Articles... 43 9.1.2 Online sources ... 44 9.1.3 Books ... 48 9.2 Legislation ... 48 9.2.1 European ... 49 9.2.2 Netherlands ... 49 9.2.3 Germany ... 49 9.2.4 UK ... 50 9.3 Case law ... 50 9.3.1 European ... 50
9.3.1.1 Court of Justice European Union ... 50
9.3.1.2 Enlarged Board of Appeal (EBA) ... 50
9.3.1.3 Technical Board of Appeal (TBA) ... 50
9.3.2 United Kingdom ... 50 9.3.3 Germany ... 51 9.3.4 The Nederlands ... 51 9.3.4.1 Conclusions Advocate-General ... 52 9.4 Miscellaneous ... 52 9.4.1 European ... 52 9.4.2 The Netherlands ... 53 9.4.3 Germany ... 53 9.4.4 The UK ... 53
6 1 Introduction
The last decennium, series of judicial proceedings have occupied the administration of justice. These series include the Warner-Lambert/ Mylan & Actavis, Sun/Novartis and the MSD/Teva cases. Judges all over the world have thought and given their opinion concerning possible answers on these matters. This attention has resulted in some clarity, but above all in more questions.
The aforementioned cases have one element in common, because the subject of these cases is the Second Medical Indication (SMI). The inventor who invents that it is possible to use a known compound in any way to treat a disease, in another way than it was originally intended for, is entitled to a SMI patent.1 The purpose behind the allowance of SMI patents is the encouragement of research to other suitable effects of the known compound.2 The SMI’s are of increasing importance in an era of personalised medicine. Personalised medicine is a model, in which molecular profiling is used to find the appropriate treatment for an individual patient based on his characteristics. This can also include imaging techniques and other technologies. The modelling will often result in stratified medicine, in which the patents are treated on the basis of their genetic composition. This implies that certain drugs are used for different diseases and that dosages differ per patient group. For this, the deviating use of the drugs allows the justification of patentability as SMI.3
The use of sildenafil, the pharmaceutical compound of Viagra, is an example of a SMI. The original indication of sildenafil is the treatment of angina pectoris, a disease of the coronary arteries. The invention of the use of this pharmaceutical compound for the treatment of this disease is called the first medical indication. During the 90’s, research revealed that sildenafil was also a suitable pharmaceutical compound in order to combat erectile dysfunctions.4 So, in addition to the already existing protection of the pharmaceutical compound sildenafil for the use of the first medical indication angina pectoris, research has led to the SMI protection of the pharmaceutical compound in relation to erectile dysfunctions.5
1
Kleemans & Drok, IER 2017/3, p. 9
2
Castellano IDEA 2005/46, p. 284-285
3
European Alliance for Personalised Medicine 2013, p.8 Bostyn, I.P.Q 2016/02, p. 152
4
Zorginstituut Nederland 2019 1/2
5
7 Now that it is clear what SMI means, it is possible to determine the central problem being dealt with in this thesis. On the one hand, inventors in Europe are entitled to an European patent on a SMI. Patentees have the exclusive right to produce the pharmaceutical compound intended for the patented indication. On the other hand, a generic pharmaceutical producer (generic) is able to produce this pharmaceutical compound, which in itself is not protected by a patent (anymore), at the service of off-patent indications. The generic is in this way in the position to make profits.6 Besides that, the practice of generics producing generic medicines has the positive side effect of supporting affordable healthcare.7 As long as the medicaments of both the patentee and the generic are prescribed for their respective indications there will be no problem. However, problems arise when the generic medicament is prescribed or used for the treatment of the patented indication. On the one hand it is plausible that this confusion leads to cheaper healthcare in favor of the patient. On the other hand this could lead to detriment of the protection of the patentee. In the Netherlands, the United Kingdom (UK) and Germany, three well-respected patent litigation jurisdictions in Europe, the SMI is treated differently. For European market participants, who are active and specialized in the field of medical product patents, there is uncertainty concerning the obligations of the generics to avoid liability. Measures that are necessary to be taken by generics, to strike a fair balance among the interests of patentees; the generics and affordable healthcare, are unharmonized within the European Union (EU). Besides the, for this thesis relevant, question of which measures a generic producer has to take in order to avoid liability, a controversial question is whether there is an infringement by the generic producer on the SMI at all. This concerns the issue whether measures should be taken, because it is doubtful whether there is an infringement in the first place. The latter, although interesting, is beyond the scope of this thesis.
The approaches of the EPC-2000 claims as well as the Swiss-type claims are discussed in this thesis. The prevailing doctrine in the jurisdiction of the Netherlands is compared with the approaches in the jurisdictions of the UK and Germany.
Castellano IDEA 2005/46, p. 284-285
6
Simoens & De Coster 2006, p.268
8 The aforementioned problem and scope has led to the following central question to be answered in this thesis:
What measures should a generic pharmaceutical producer in Europe take to avoid liability concerning Second Medical Indication patents to ensure a fair balance among the interests of generic pharmaceutical producers, patentees and affordable healthcare, comparing the Dutch, the German and the UK regimes?
In order to formulate an answer to the central research question, the following sub-questions need to be answered:
What parties and what kind of their interests play a role in formulating what requirements must be imposed on the generic to prevent a breach of the SMI? What is the current doctrine concerning the (in)direct infringement of the
Swiss-type claims in the Netherlands, the UK and Germany?
What is the current doctrine concerning the (in)direct infringement of the EPC2000 claims in the Netherlands, the UK and Germany?
A critical formulation concerning the obligations, to be accepted by the generic drug manufacturers that bring a reasonable balance among the interests of the patentees, the generics and affordable healthcare.
The relevance of answering the aforementioned questions consists of solving the uncertainty regarding the application of SMI. The three jurisdictions apply the SMI’S in different ways, which can lead to many lawsuits and an impairment of the patent system. It is necessary to establish a clear framework with the requirements to be imposed on the generic. With these requirements the uncertainty can be resolved and a fair balance can be found among the interests of the patentee, the generic and affordable healthcare.
Literature research has been carried out for this contribution. Firstly, literature research has been done on the general legal framework concerning Swiss-Type claims and the EPC2000 claims in Dutch, German and English literature, legislation and case law. Secondly, literature research has been done into the direct and indirect infringement of these two types of claims. Thirdly, attention has been paid to the extent to which there is a different opinion in the jurisdictions about the position of affordable healthcare, the protection of generics and the protection of the patentee.
9 Finally, research was carried out and consideration was given to any recommendations for improving the practice regarding the obligations to be imposed on those involved in second medical indications. The legal-scientific paradigm in this master thesis is comparative law research in the form of a micro-comparison of the isolated doctrine of the ways in which jurisdictions deal with possible infringements of the second medical indication claims. This research revolves around the "law in action". This contribution is normative as well as descriptive and is based on a review of the available literature. The literature study shows that in the different jurisdictions a different weight is assigned to the protection of the patentee and the generic. The research objective is to identify differences and similarities in the Dutch, German and English jurisdictions in order to be able to formulate a harmonized solution to the uncertainty that exists for the patentee and the generic with regard to the obligations they have to prevent liability through the infringement of second medical indication claims. This solution has to strike a fair balance among the interests of generics, patentees and affordable healthcare. Insights from the European Patent Convention, national patent laws, case law of the three jurisdictions and European case law are all relevant for the analysis. Finally, books, research reports, European legislation and policy documents were consulted.
10 2 Elements of interest
A number of basic concepts deserve clarification before a more thorough research into the issue of SMI’s is possible.
2.1 Swiss-type claim
The allowance of a SMI constitutes a contradiction with the general patent system. There are two non-patentability concerns.8 First of all, one of the requirements, to be fulfilled to patent an invention, is novelty. Patent law requires that an invention is patentable if a.o. it is not yet part of the state of the art. This would mean that there is no protection for molecules or chemical entities under patent law if they are part of the state of the art. The legislators of the EPC considered this as an undesirable situation and therefore codified the ‘’first medical use of a known substance’’ as an exception to the novelty requirement.9
The introduction of the aforementioned exception turned out to be insufficient to halt the discussion about the protection of medical indications, because subsequent questions arose concerning the position of the inventors who invented further use of the same medicine. Under the EPC 1973 regime it was not possible to provide protection to the inventor of the SMI for the known compound. The SMI is not protected as a compound in itself (regardless of the application as a medicament) nor as a medicament (it was already known that the compound is suitable as a medicament, more specifically, for the treatment of the first medical use).10 Secondly, according to art. 53(c) of the European Patent Convention (EPC), medical treatment methods on the human or animal body are excluded from patentability.11 The EBA explained the reason for this exclusion with the fact that physicians need the freedom to act during an operation and they should not be concerned with the risk of infringing patents.12 To attach sufficient importance to the interest of patentability of new applications for existing medicaments and to offer a solution for the two aforementioned non-patentability concerns, the EBA came to a sustainable approach.
8
Dutch Supreme Court September 30, 2016, no. 15/01813, Opinion A-G Van Peursem, (Novartis/Sun), footnote 1, p. 1
9 EPO Guidelines Art. 54 (5) EPC 1973 Bostyn, I.P.Q 2016/02, p. 156 10 Bostyn, I.P.Q 2016/02, p. 156 11
Kleemans & Drok, IER 2017/3, p. 9-21 Ibid.
12
11 It decided that the so-called ‘’Swiss-type claims’’ were allowed, which are formulated as: ‘’use of compound X in the preparation of a medicament for the treatment of Y’’.13
These claims are classified as “purpose-limited process claims”.14
The formulation of the Swiss-type claim requires attention. After all, it is not about the preparation of a medicament. The medicament and the preparation thereof were already known. However, what matters is the invention that the medicament can be used for a formerly unknown indication. The words ‘’preparation of a medicament for’’ are only included in the formulation of the Swiss-type claims to circumvent art. 53(c) of the original EPC that excludes treatment methods.15
2.2 EPC2000 claim
The practice of granting patents in the Swiss-type form came to an end with the introduction of the current EPC2000. As a result, the legitimacy of the SMI patents is no longer solely based on case law of the EBA.16 Art. 54 section 5 EPC2000 states explicitly that SMI’s are allowed. It forms the codified basis for the protection concerning substances and compounds which were already known as medicaments, if those are used in a specific way in a method as meant in art. 53(c) EPC2000. More specifically, it is about the words ‘’for a specific use’’.17
With regard to patents of which the priority date is from January 29, 2011 onwards, the EPO merely allows claims in the form of ‘’compound X for use in the treatment of Y’’.18
This type of claim is indicated as an EPC2000-claim. These claims are classified as purpose-limited product claims. 19 As a consequence of the introduction of art. 54 section 5 of the EPC2000 the words ‘’in the preparation of a medicament’’ of Swiss-type claims have lost their importance. However, according to
13
G 0005/83, ¶21-23
Kleemans & Drok, IER 2017/3, p. 9-21
14
G 0005/83, ¶21-23
Kleemans & Drok, IER 2017/3, p. 12 Bostyn, I.P.Q 2016/02, p. 156 - 157
15
Bostyn, I.P.Q 2016/02, p. 157
16
Kleemans & Drok, IER 2017/3, p. 10
17
In a method referred to in art. 53(c) EPC2000
18
Notice OJ EPO 2010, 514 G 2/08
19
12 the G2/08 judgement of the EBA the obligation of formulating the patent in an EPC2000 format has no retroactive effect.20
2.3 Skinny labelling
In order to launch a drug on the European market, all indications and details must be described in the Summary of Product Characteristics (SmPC) and the Patient Information Leaflet (PIL). For generics who want to introduce their medicinal product on the market, of which the substance is still protected by a patent for a certain indication and/or dosage, an exception exists. The generic has an obligation to exclude the components, still protected by a patent, from the SmPC and PIL.21 This exclusion is called a ‘’carve-out’’ or a ‘’skinny label’’.22
The generic is obliged to prevent the generic medicine from being prescribed for a patented indication, because that would result in a patent infringement. The Warner-Lambert/State of the Netherlands judgement has resulted in an important addition to this skinny label doctrine. As a starting point, the generic receives a license for the same indications as the patentee. The generic can simply deliver for the patented indication on the basis of his marketing authorization. From an administrative point of view there is therefore no obligation to implement a skinny label. If the generic wants to prevent the supply of the generic drugs for the patented indication, he could apply a skinny label. From the ruling of the court it now follows that this means that, after applying a skinny label for a certain indication, the generic no longer has a license to supply for that indication. The skinny label is therefore voluntary to prevent infringement. In theory, the application of a skinny label is not mandatory or necessary if infringement can also be prevented otherwise.23
2.4 Prescribing generic drugs and substitution
Despite the use of skinny labels (2.3), generic drugs are nevertheless commonly infringing medical patents. This is partly due to the fact that physicians are stimulated to prescribe the International Non-proprietary Name (INN) of the substance and the
20
G 2/08, 7.1.3 – 7.1.4
21
Art. 11, Directive 2001/83/EC
22
Bostyn, I.P.Q 2016/02, p. 160
23 CJEU February 14, 2019, C-423/17 (The Netherlands/Warner-Lambert) ¶ 47
Art. 40 DMA
13 dosage, to limit the use of the expensive (often patented) drugs.24 There is an emphasis for pharmacists to provide generic drugs when a certain substance is prescribed by brand name, unless prescribing this brand is necessary from a medical point of view.25 The reason behind this policy is keeping the healthcare affordable. Pharmacists are often not aware of the indication on the basis of which the medication is prescribed by a physician. The pharmacist only knows the substance name. For that reason, the pharmacist will opt for the cheapest, often generic, drug that contains the same substance as the patented drug. However, this could result into an infringement of the patentee’s right.26
2.5 Off-label use
A drug is characterized by the fact that it is intended and allowed for treatment of certain conditions, as the disease and patient characteristics. Nonetheless, it regularly occurs in practice that medications are prescribed to certain patients for whom it was not originally intended. This is referred to as off-label use.27
2.6 Preference policy
The preference policy in the Netherlands entails that insurers can decide to consider a label of a medicine, often the cheapest, for a certain period of time, as a preferred drug and to only allow this medicine to be reimbursed under the basic insurance. 28 This can lead to an undesirable situation for the pharmacist, because in some situations the preferential policy forces the pharmacist to prescribe a generic drug instead of a patented drug. If the pharmacist nevertheless opts for the patented medicine, it may be that the health insurer does not reimburse this medicine.29
24 KNMP 2018, p. 6 Dutfield 2017, p. 466 25 Ibid.
Art. 129 German Code of Social Law V
26
Dutfield 2017, p. 466
UKSC November 14, 2018 (Warner-Lambert v Generics) ¶ 65-66 Duncan & Willoughby 2016, p. 137-139
27
Fugh-Berman & Melnick 2008, p. 1432 Aronson & Ferner 2017, p. 2615
Zorginstituut Nederland 2019 2/2
28
KNMP 2019
29
14 3 Which parties and what kind of interests play a role in formulating what requirements must be imposed on the generic to prevent a breach of the SMI?
This chapter discusses the parties and their interests in the question to what extent and what measures should be imposed on the generic to avoid patent infringement. Successively, the following parties are discussed: the patentees, the generics, the government, insurance companies, the physicians and pharmacists.
3.1 Patentees
The patentees argue that their research, into new applications of existing medicines, entails high costs. To encourage these companies to conduct research, SMI’s would be justified.30 The growing importance of personalised healthcare adds two more arguments in favor of the patentees. First of all, the costs to treat the smaller patient populations are relatively higher than the conventional treatment due to a.o. the ‘’economy of scale’’.31
However, the second argument includes the observation that the segmentation of the population is beneficial to the patentees. This is due to the fact that an optimal profit can be made from these smaller markets.32 Based on these reasons, the patentees argue that they have a major interest in protecting the SMI’s. 3.2 Generics
The generics need clarity in law in order to know what they are allowed to do. In their view, a non-rigid enforcement of SMI’s is necessary, because it has to be avoided that the patentees abuse their dominant position. In practice, patentees can pursue a predominantly aggressive strategy of banning the generics from the market, abusing the lack of clarity concerning SMI’s for this purpose.33
Besides the fact that generics have an interest of their own to generate sufficient revenue, the generics are also necessary to decrease the costs of healthcare. On the current European market, the prices of generic medicines are on average 50% lower than the matching original medicines, in the first fifteen months after the introduction of the generic medicine on the market.34 For these reasons, it is in the 30 Domeij 2000, p. 181-182. 31 IRGC 2018, p. 13 32 Eppinger et al. 2011, p. 33-37 33 Bostyn, I.P.Q 2016/02, p. 152 34
Simoens & De Coster 2006, p. 268 Copenhagen Economics 2018, p. 14
15 interest of the generics as well as the affordable healthcare to enforce the SMI’s not too strictly.
3.3 Government
Due to the fact that the European population is aging, the emergence of diseases and disorders among the elderly and the increasing importance of personalised healthcare, the pharmaceutical costs will rise in Europe. Governments are aware that prices have to be kept low, because the budget for national healthcare must be used as efficiently as possible.35 Involving generics to produce generic drugs proves to be a good solution, because the generics are capable of producing affordable, effective, safe and high-quality drugs.36 The use of generic drugs in the Netherlands, through the preferential policy of insurers (see 2.6), will save 600 million euros in the Netherlands each year.37 Besides this, the generics also contribute to the innovation of drugs due to their low prices. Competitors have to act strategically to become cost-effectively and have to continue innovating in order to stay ahead of the rest of the stakeholders.38
On the other hand, governments are aware that patentees are needed to develop drugs. Patentees contribute and invest in the development of new medicines. No politician wants to explain to his constituents that there are no medicines for a certain disease, due to the fact that the politician has omitted the support in the benefit of the patentees. For this reason, the government does not want to hinder the patentees too much and it has to provide sufficient protection for the SMI’s.39
In short, governments benefit from the fact that drug prices remain as low as possible in order to make affordable healthcare possible. Therefore they strive to less enforcement of SMI’s. However, governments are aware that patentees make important inventions that benefit healthcare and are therefore forced to enforce SMI’s. In other words, governments need to find the right balance.
35 Bruins 2018, p.1 36 EGA 2009, p.10 Simoens 2012, p. 11 37 SFK 2013 38 Simoens 2012, p. 9 EGA 2009, p. 11 39 Bostyn, I.P.Q 2016/02, p. 191-192
16 3.4 Insurance companies
Health insurers strive to minimize their costs and to maximize their profits by creating a practice in which the use of the cheapest medicines is eligible for reimbursement. Under 3.2, the author concludes that generic drugs are cheaper than the patented ones. For the insurer in general, it is therefore most advantageous to encourage the use of generic medicines instead of expensive patented drugs. In the Netherlands this is a.o. realized through the aforementioned preference policies.40 In short, for reasons of cost saving, it is clear that insurers have a direct interest in the less enforcement of SMI’s.
3.5 Physicians
The physician’s interest lies in offering the best treatment for the benefit of the patient. Dutch physicians and physicians from the UK are operating on the basis of guidelines and electronic prescribing systems,while physicians in Germany still make use of a prescribing system on paper.41 The electronic systems do not take the existence of patents into account. Physicians can easily contribute to an infringement, since they can prescribe cross-label on the basis of the INN without mentioning the name of the brand. Besides that, physicians do not provide the indication on the prescription, so that the pharmacist only pays attention to the substance name.42 Nevertheless, it is uncommon to hold the physician liable for any infringements. 3.6 Pharmacists
The interest of the pharmacist is to offer medicines as cheap as possible in order to gain a maximum profit from what they have declared. The pharmacist must take the policy of the health insurer into account. If the health insurer applies a preference policy then the pharmacist must prescribe certain, possibly generic, medicines even if this is contrary to the patentee’s right.43
40
Art. 2.8 Health Insurance Decree
41
Ahmed et al. 2016, p. 1-2 General Medical Council 2013 KNMG 2014
Klein & Schellhammer 2017, p. 151-152
42
Royal Dutch Pharmacist Assocation 2012, p.1.
43
17 4 What is the current doctrine concerning (in)direct infringement of
Swiss-type claims in the Netherlands, the UK and Germany?
This chapter discusses the current doctrines in the three jurisdictions concerning the (in)direct infringement of Swiss-Type claims. 4.1 explains the concepts of (in)direct infringements. 4.2 discusses the direct infringement of Swiss-Type claims, while 4.3 examines the indirect infringement of Swiss-Type claims.
4.1 The concepts of (in)direct infringements
The Netherlands, the UK and Germany all ratified the Community Patent Convention (CPC).44 Nevertheless, it never came into force. However, the legal definitions of direct and indirect infringement in these jurisdictions are more or less the same.45 If there are essential differences between these three jurisdictions, regarding the meanings of (in)direct infringement, they will be discussed. The current state of the doctrines, concerning the (in)direct infringement of Swiss-type claims in the three jurisdictions, will be explained from paragraph 4.2.
4.1.1 Direct infringement
There is a direct infringement of a patented product if a person performs an act that is exclusively reserved for the patentee. These acts include a.o. the manufacture, the use, the rental and the import of the patented products. Secondly, in the case of a patented process, there is a direct infringement if the process is applied for or in the company of the generic. Lastly, the generic will infringe the patentee’s patent if the generic a.o. uses, rents and trades the product, obtained directly by applying the process. 46 4.1.2 Indirect infringement
There may be an indirect (contributory) infringement if the generic, in or for his company, offers or supplies means relating to an ‘’essential element’’ of the invention to those who are not authorized for the application of the patented invention. Benyamini argues that the generic must know or it must be clear, in view of the circumstances, that these means are suitable and intended for that application. The 44 Agreement 89/695/EEC 45 Art. 25-26 CPC 1989 46 Art. 25 CPC 1989 Art. 53 DPA 1995 Art. 60(1) UKPA 1977 Art. 9 GPA 1981 Bostyn, I.P.Q 2016/02, p. 162
18 concept of the essential element is not limited to an element that is new and inventive.47 What is meant by ‘’means relating to an essential element of the invention’’ requires explanation of the patent and is strongly intertwined with valuations of a factual nature. A clear description in general terms of what is meant by this is not given in Dutch or foreign case law and literature. From case law of the BGH and from Benyamini it can be deduced that the means must serve the concept of the invention and have to contribute to the realization of the patent. In each individual case, the court has to ask itself, on the basis of its interpretation of the patent, whether this is the case.48 An example of an indirect infringement would be the situation in which a generic provides drugs (resources relating to a substantial component of the invention) to a third party, e.g. the pharmacist of the physician, to possibly infringe the patent.49
4.2 Direct infringement Swiss-Type claims
Now that 4.1 makes clear what (in)direct infringement means, this section continues to display the various doctrines in the jurisdictions concerning direct infringement of Swiss-Type claims.
4.2.1 Foreseeability test
If the purpose of the manufacturing and marketing of generic drugs is to use the drugs for the patented indication, this could result in a direct infringement. The purpose of the manufacture and marketing of the generic drugs could be deduced from a.o. the lack of a carve-out, entering into an agreement with a health insurer in the context of its preference policy, without distinguishing between indications or, at last, from the
47 Benyamini 1993, p. 199 48
Benyamini 1993, p. 199-201
BGH May 4, 2004, X ZR 48/03 BGHZ 159, 7
Dutch Supreme Court, October 31, 2003, ECLI:NL:HR:2003:AI0346, NJ 2006/600 (Senseo)
Art. 73(1) DPA 1995
Dutch Supreme Court, November 3, 2017, ECLI:NL:HR:2017:2807 (MSD/Teva), §3.6.6 49 Art. 26 CPC 1989 Art. 73(1) DPA 1995 Art. 60(2) UKPA 1977 Art. 10 GPA 1981 Bostyn, I.P.Q 2016/02, p. 162-163
19 actions of the generic. 50 The Supreme Court of the Netherlands and the Oberlandesgericht Düsseldorf have acknowledged the so-called ‘’foreseeability test’’ in 2017.51 This meant a major shift for German case law. In Germany a different regime applied in the past, which was more patentee-unfriendly in contrast to this foreseeability test. The German regime from the past will be discussed later in 4.2.3.
The foreseeability test concerns the question whether a manufacturer or trader directly infringes a Swiss-type claim patent when he ‘’knows or should have known’’ that the generic drug is used for the patented indication. In order to prevent direct infringement of the Swiss-type claim, the generic must take ‘’all effective steps that may reasonably required of him to prevent his product from being delivered for the patented medical indication.’’ The mere presence of a carve-out, in the SmPC and package leaflet of the generic drug, is generally insufficient.52 The foreseeability requires that the average person skilled in the art, on the basis of the SmPC or other circumstances, believes that the product is intended or suitable for that treatment. 53 There is, however, a minimum threshold that the drug is regularly used for the patented indication and the generic must have bad faith in some way. Besides this, it is also ruled that it is justified to hold the generic liable for direct infringement if he was aware or should have been aware of the practice of prescribing and substitution and he nevertheless chose to favor himself by providing his medicine.54
A problem with this test is that it often seems reasonably foreseeable that the drug is (also) intended for the application of the patented invention, considering e.g.
50
Conclusion A-G Wissink, June 9, 2017 ECLI:NL:PHR:2017:488 (MSD/TEVA) §4.8.2, 4.12.1-4.12.3
Dutch Supreme Court, April 14, 2017, ECLI:NL:HR:2017:692 (Sun/Novartis) §3.5.1-3.5.2
51
Dutch Supreme Court, April 14, 2017, ECLI:NL:HR:2017:692, (Sun/Novartis) OLG Düsseldorf, May 5, 2017, GRUR 2017, 1107 (Östrogenblocker)
52
Dutch Supreme Court, November 3, 2017 ECLI:NL:HR:2017:2807 (MSD/TEVA), §3.4.4-3.5.
Dutch Supreme Court, April 14, 2017, ECLI:NL:HR:2017:692, (Sun/Novartis), §3.5.2.
OLG Düsseldorf, May 5, 2017, GRUR 2017, 1107 (Östrogenblocker)
OLG Düsseldorf, March 1, 2018, I-2 U 30/17, 2 U 30/17, Rn. 72. 73 (Dexmedetomidin)
53
Dutch Supreme Court, November 3, 2017, ECLI:NL:HR:2017:2807, (MSD/Teva), §3.4.4-3.5.
54
20 the current preference, prescription and substitution policies in the Netherlands.55 This implies that a generic, despite his good intentions, may directly infringe the Swiss-type claim quickly.
In contrast to Germany and the Netherlands, four of the five lords in the UK came to the conclusion that the foreseeability test should not be applied.56 They considered it an objective test, but holding someone responsible for the undesirable consequences of his actions, regardless of whether he foresaw them or not, was considered arbitrary. In addition, the Lords judged that the protection of the patentee is extended too far in this way.57 In their view, the foregoing does not change with a flexible approach of the measures to be imposed. Nor is it a good solution to oblige the generic company to take all reasonable steps to prevent the generic drugs from ending up with patients suffering from the patented indication. As a generic it is possible to reduce the usage of the generic drug for the patented indication, but there are no reasonable steps to completely prevent leakage of the generic drug for the patented indication.58 The Court of Appeal considered that the acts of the generic were sufficient to undo the intention of using the generic drug for the patented indication.59 However, this will not be the case with the foreseeability test. This is due to the fact that the generic will take into account the foreseeable leakage, despite the steps that have been taken to reduce this. According to the judgement of the Court of Appeal, it is about a non-statutory defence to infringement. It is not the role of the judiciary to
55 Art. 11 2001/83/EC Bostyn, I.P.Q 2016/02, p. 160 KNMP 2018, p. 6 Dutfield 2017, p. 466
UK Supreme Court November 14, 2018 UKSC 56 (Warner-Lambert v Generics) ¶ 65-66
KNMP 2019
Medicines for Europe 2018, p. 22
56 UK Supreme Court, November 14, 2018, UKSC 56 (Warner-Lambert v Generics)
¶79
57
Ibid.
60(1(c)) UKPA 1977
58 UK Supreme Court, November 14, 2018, UKSC 56 (Warner-Lambert v Generics)
¶81
59 UK Court of Appeal, October 13, 2016, EWCA Civ 1006 (Warner-Lambert v
21 develop a non-statutory defence here, because this is up to the legislator. It is undesirable to maintain the foreseeability test, because it preserves legal uncertainty.60 4.2.2 Subjective and objective intent
In the Warner-Lambert/Generics judgement of November 2018, the objective and the subjective intent tests were recognized. These tests are not adhered to in the Dutch and German jurisdictions, so this section only deals with the UK ruling. Lord Sumption is a.o. of the opinion that the question whether there is a direct infringement of a patent concerns the finding that the drug is deliberately intended for the patented indication. In other words, there has to be an ‘’intent’’.61 Following this, there are two tests discussed in the Warner-Lambert/Generics ruling that can be treated together due to their similarity. These are the ‘’subjective intent’- and the ‘’objective intent’’-tests.
Firstly, the ‘’subjective intent’’-test includes the assessment of the infringement on the basis of a research into whether the generic produces the generic drug (also) for the treatment of the patented indication. This research is aimed at determining the subjective ‘’mindset’’ of the generic when he produces the drug.62
Secondly, the ‘objective intent’-test also involves determining whether the generic produces the generic drug for the patented indication. However, this mindset is determined based on objective – internal, but also external – facts and circumstances.63
It is possible to assume that a part of the generic drugs will be used for the patented indication as a consequence of the (subjective or objective) intention of the generic. In the case that the generic’s intention is proven, it has an effect on the complete sales of the production of the generic drug, including the drugs that are prescribed for the non-patented indications. It is all produced with a certain ‘’wrong’’ intention of the generic. The distributor and the pharmacist could both trade with a generic product that is created by a patented method.64 Even if this is prescribed for a
60 UK Supreme Court, November 14, 2018, UKSC 56 (Warner-Lambert v Generics)
¶81
61 UK Supreme Court, November 14, 2018, UKSC 56 (Warner-Lambert v Generics),
¶73
62 UK Supreme Court, November 14, 2018, UKSC 56 (Warner-Lambert v Generics)
¶72
63 Ibid.
22 non-patented indication, this still creates liability. The only thing that the pharmacist and the distributor could do in the future is the complete refusal of these generic drugs. This has major consequences for the generics, because they can no longer sell their drugs for non-patented indications. 65
Besides the foregoing, the subjective intention is a selection, for example the choice of the market for patent-protected indications. Physicians and pharmacists have to provide these drugs to the patient for the patented indication and in this way the intention of the generic can be realized. The problem that occurs is that the generic is not in control of the practice of pharmacists and physicians. The generic only produces the drug, but he does not prescribe it or provides the drugs directly to the patient. In this case, it can of course be judged that there is indeed a desire with the generic that pharmacists and physicians provide the generic drug to the patient of the patented indication, but it goes too far to regard this as an intention.66
Besides that, there are some practical objections. What would the judgement be if the generic intends to provide the generic drug for the patented indication, but ultimately it is only used for the indication that is not protected by a patent? Does this intention nevertheless ensure that this complete production, which does not contradict the patent protection, leads to an infringement? In the law there is a lack of rational considerations that could depend on issues like this. Moreover, this example would only come up if the intention of the manufacturer can already be proven, which in the vast part of the cases will not be possible.
Lord Briggs and Lord Hodge have a view contrary to that of Lord Reed and Lord Sumption. They are of the opinion that the subject intent test is workable, at least that, insofar as the test is less workable, this does not outweigh that this test does more justice to the word ‘’for’’ in the Swiss-type conclusions and, in particular, a better balance is found between the fair protection of the patentee and a reasonable degree of legal certainty for third parties. They also believe that this subjective intent should be proven in all possible ways, including the use of words; the behavior and the negligent behavior of the generic. In particular, labeling; packaging and the PIL
65 UK Supreme Court, November 14, 2018, UKSC 56 (Warner-Lambert v Generics)
¶73
66 UK Supreme Court, November 14, 2018, UKSC 56 (Warner-Lambert v Generics)
23 will provide the best proof of the intention of the producer.67 This is confirmed by the views of Benyamini and Justice Jacob, according to whom a man can deduce the intention of the producer from the situation that the way of labeling and packaging indicates the use for the patented indication.68
Based on the foregoing considerations, it appears that there is no clear and unanimous opinion about the intent tests.69
4.2.3 Outward presentation test
The ‘’outward presentation test’’ is introduced by Lord Sumption in the Warner-Lambert/Generics case.70 In addition, a similar test was generally applied in German case law in the past. Prior to the previously discussed and currently valid patentee-friendly foreseeability test, there was the sinnfällige Herrichtung test in German case law. 71 For the sake of comparability, the sinnfällige Herrichtung and the outward presentation test are discussed together in this section.
In the two tests, the direct infringement of the Swiss type claim is determined by the way in which the drug is presented. This concerns the dosage, the wording, the labelling, the packaging and the PIL, which in the countries of the EU ensure that it is clear what indication the drug should be used for.72 This could mean that it has to be developed for the intended application or that it is sold with a carve-out in the SmPC and the PIL, concerning the patented indication.73 In the relevant case law it was not sufficient that the group of patients, to which the SMI applied, was that large that the application of the drug for a patented indication was in principle unavoidable.74 Besides that it was not considered sufficient to constitute an infringement if, by
67
UK Supreme Court, November 14, 2018, UKSC 56 (Warner-Lambert v Generics) ¶172-174
68
Benyamini 1993, p. 94
UK Court of Appeal May 21, 2008, EWCA Civ 444 (Merck v Actavis) ¶10
69
UK Supreme Court, November 14, 2018, UKSC 56 (Warner-Lambert v Generics) ¶78
70 UK Supreme Court, November 14, 2018, UKSC 56 (Warner-Lambert v Generics)
¶84
71 BGH, June 16, 1987, GRUR 1987, 794 (Antivirusmittel)
BGH, March 20, 2001, X ZR 177/98 (Trigonellin)
72
UK Supreme Court, November 14, 2018, UKSC 56 (Warner-Lambert v Generics) ¶84
BGH, June 16, 1987, GRUR 1987, 794 (Antivirusmittel) BGH, March 20, 2001, X ZR 177/98 (Trigonellin)
73
OLG Düsseldorf, February 24, 2004, GRUR-RR 2004, 193 (Ribavirin)
74
24 substitution, it was likely that the drug would be used for the patented indication.75 Finally, it was not enough that, although there was a carve-out in the PIL, the product was marketed differently.76 All in all, these tests ensure that the use of a carve-out, in the PIL as well as in the SmPC, prevents the generic from infringing a patented indication.77
The arguments in favor of this test will be explained. Firstly, the outward presentation and the sinnfällige Herrichtung tests are objective, because they do not depend on what the intention of the generic has been. Lord Sumption believes that the outward presentation test offers legal certainty.78 The PIL is not only a public explanation, concerning the use for which the drug is produced. It informs users, including distributors; importers; patients and pharmacists. It is about the practice and what the outward presentation of the drug is when viewed from the market it is sold on. It is not about the internal thoughts that the generic has had. Secondly, the outward presentation test is in line with the purpose-limited process conclusion, of which the purpose is an essential element of the invention. An intention-based test is not. Thirdly, the test honors the fact that a purpose-limited process claim is about the process of production, not the use made of the drug. Taking care of the creation and appearance of a drug is part of the production. Following activities, including the marketing, are not part of the production. Fourthly, it offers legal certainty, especially for downstream traders or users. This test ensures a right balance between the protection of the patentee and the free use of the invention for therapeutic applications that deserves no (longer) protection.79
However, there are also disadvantages to this test, as Lord Justice Floyd explained. This test does not take sufficient account of the patentee’s interests. The danger of this test lies in the fact that the generic can pretend to exclude the drug for a patented indication by means of a carve-out. In this way the generic is protected under the outward-presentation test. The generic could misuse this protection under this test
75
OLG Düsseldorf, March 14, 2013, 4a O 145/12 (Chronische Hepatitis C)
76
OLG Düsseldorf, January 31, 2013, I-2 U 54/11 (Cistus Incanus)
77
Art. 11a (1)GDA 2005 Art. 11 (2) 2001/83/EC
78 UK Supreme Court, November 14, 2018, UKSC 56 (Warner-Lambert v Generics)
¶84
79
Ibid.
UK Supreme Court, November 14, 2018, UKSC 56 (Warner-Lambert v Generics) ¶213-216
25 by simultaneously stimulating the participants of the supply chain to prescribe the drug for the patented indication.80 Lord Briggs also acknowledges this problem.81
Lord Sumption accepts these shortcomings of the test, but responds with two arguments. First of all, he states that the interests of the patentees are important, but that they are not the only ones. Lord Sumption believes that finding the right balance is about the interplay of many more interests, including the protection of the patentee; legal certainty for third parties and more general policy purposes (such as the free use of a product once the patent has expired). In addition, Lord Sumption indicates that it may be considered strange that the generic does not have to be liable if he introduces a drug on the market for a protected indication, but that it is even more strange that the generic’s intention is subjected to liability. This would namely mean that not only the generic is exposed to liability, but also any pharmacist who markets this drug.82 Lord Sumption’s second argument is that the incomplete functioning of the outward presentation test results from an inherent restriction regarding the Swiss-type claim. The question whether someone is liable for the infringement of a Swiss-type claim must be answered on the basis of the purpose of the production of the patent-protected product. For this reason, the protection of the patentee is always incomplete. If a test also takes the process into account after it has appeared on the market, including disclosing and promoting the use of the drug, this limitation is not included in the consideration. Lord Sumption ends his opinion with the following consideration: ‘’I consider that the outward presentation test is less imperfect than any other.[…] The legislation was not drafted with purpose-limited products in mind, and if it proves to be serious it must be for the legislature to address it.’’83
80
UK Court of Appeal, October 13, 2016, EWCA Civ 1006 (Warner-Lambert v Mylan and Actavis)
81
UK Supreme Court, November 14, 2018, UKSC 56 (Warner-Lambert v Generics) ¶188
82
UK Supreme Court, November 14, 2018, UKSC 56 (Warner-Lambert v Generics) ¶86
83
UK Supreme Court, November 14, 2018, UKSC 56 (Warner-Lambert v Generics) ¶86
26 4.3 Indirect infringement Swiss-Type claims
4.3.1 General remarks concerning indirect infringement Swiss-Type claims
If the use of the generic drug for the patented indication is not the purpose (as opposed to direct infringement), but the result of the manufacturing or marketing then establishing the infringement is more problematic.84 After all, there is no active involvement of the generic and more extensive research needs to be conducted into the consequences of manufacturer’s actions for dealing with medicines in the medicine chain.85
In case of close scrutiny of the literal text, it can be argued that no indirect infringement of Swiss-Type claims (purpose-limited product claims) can be committed by e.g. an intermediary. This is due to the fact that the intermediary does not offer or deliver means that serve the process, consisting of the use of the substance mentioned in the claim, for the preparation of a pharmaceutical product. Literal reading of the Swiss-Type claim implies that the patented invention is the application of the process. 86 Subsequently, offering or supplying an essential means is offering or supplying for application of the process. The process relates to the manufacturing of the drug. The drug itself is not an essential means for applying that process, but the result thereof. Another reading would mean equating the purpose-limited process conclusion and the purpose-purpose-limited product conclusion.87 Opponents therefore consider it not possible to indirectly infringe a Swiss-Type claim.88
4.3.2 Applicable doctrines within the jurisdictions
However, the MSD/TEVA and the Sun/Novartis cases in the Netherlands had the opposite outcome.89 Against the background that led to the recognition of the Swiss-Type claims and the possibility to attach a product-related product claim to a patent for the protection of a SMI, the acceptance that indirect infringement can be made on a Swiss-type claim, on the same basis as on a claim according to the current art. 54 (5)
84
Conclusion A-G Wissink, June 9, 2017 ECLI:NL:PHR:2017:488 (MSD/TEVA), 4.8.2, 4.9 85 Theuws 2017, p. 5 86 Art. 73(1) DPA 1995 87 T 1780/12, ¶ 22 88
District Court of The Hague November 25, 2015, ECLI:NL:RBDHA:2015:14337, (Sun/Novartis), 4.47-4.56
89 Dutch Supreme Court, November 3, 2017 ECLI:NL:HR:2017:2807 (MSD/TEVA),
§3.6.4
Dutch Supreme Court, April 14, 2017, ECLI:NL:HR:2017:692, (Sun/Novartis), §3.5.2.
27 EPC, is justified. 90 This is due to the fact that the aim of the revision of the EPC was to preserve the patentability of substances or mixtures, developed in case law.91 For this reason, the protection of the patentee, on the basis of art. 1 of the Protocol, justifies the acceptance that indirect infringement can be made on a Swiss-type claim on the same basis as on a claim according to the current art. 54 lid 5 EPC.92 The underlying idea is that certain steps, during manufacturing, occur downstream. An example of this is the pharmacist who applies the label on the package and delivers the drug to the patient. Besides this, the invention, which lies in the specific use, is only applied within the meaning of art. 73 DPA, because it is the pharmacist who, with the delivery to the patient, determines for which indication the drug is used.93
In addition to the recognition in the Netherlands, German courts also recognized the indirect infringement of Swiss-Type claims.94 German case law on this topic has been subject to major changes in recent years. Finally, with the Pemetrexed ruling in 2016, an answer was given to the question whether an indirect infringement of a Swiss-Type claim was possible.95 In the old situation, it was possible in Germany to indirectly infringe a SMI if there was a sinnfällige Herrichtung.96 The foregoing must be accompanied by the situation that the generic has the knowledge or if it is clear in the current state that: the product is eligible to the SMI and that the buyer has the intention to prepare the product for the SMI on purpose.97 After all, when the rebate agreement with the pharmacist is not restricted to non-patented indications, there may be an indirect infringement. Besides this, even if there is a possible provision in social law that obliges the providing of a substitute instead of the patented drug, infringing a patent is not justified.98 The Pemetrexed case has led to
90
Since EPC2000
Art. 54 (5) EPC 2000 & art. 4(6) DPA 1995
91
OJ EPO 4/2007
92
G 2/08, §5.10.1-4
Dutch Supreme Court, November 3, 2017 ECLI:NL:HR:2017:2807 (MSD/TEVA), §3.6.3
93
Dutch Supreme Court, November 3, 2017, ECLI:NL:HR:2017:2807, (MSD/Teva), §3.6.3
94
BGH June 14, 2016, nr. X ZR 29/15, GRUR 2016/921 (Eli Lilly/Actavis)§83-85
95
BGH June 14, 2016, no. X ZR 29/15, GRUR 2016/921 (Eli Lilly v Actavis)§83-85
96
See 4.2.3. for an explanation of the sinnfällige Herrichtung
97
Zigann 2018, p. 5
98
LG Hamburg, April 2, 2015, 327 O 143/15 (Pregabalin) Zigann 2018, p. 7-9
28 a major change in the German doctrine. As a consequence of this case, there is an indirect infringement if the generic drug is supplied and when it is clear that the buyer will use this substance for the SMI. Before this takes place, there does not have to be a sinnfällige Herrichtung.99
The foregoing equates the scope of protection of the purpose-limited process claims and the purpose-limited product claims and allows the possibility of an indirect infringement of a Swiss-type claim in the Netherlands and Germany.100
In the Netherlands it is possible, as part of the foreseeability test, that the generic indirectly infringes a patent by not taking all reasonable measures to prevent infringing downstream actions.101 This could include taking measures to make it clear to the pharmacist that a generic medicine should not be prescribed for the patented indication. The court does not determine what measures a generic must take to prevent an infringement. It is the job of the generic to prove that he has done enough to prevent the infringement of the SMI.102 The Supreme Court of the Netherlands has judged that applying a carve-out in the SmPC and sending e-mails to wholesalers and hospital pharmacies, to prevent the generic drug from being used for the patented indication, is insufficient.103
In conformity with the aforementioned doctrines, the indirect infringement of Swiss-Type claims has been accepted in previous case law of a.o. the Court of Appeal in the UK for a while. The indirect infringement of Swiss-Type claims was accepted by Court of Appeal’s Lord Justice Floyd as opposed to Justice Arnold of the High Court of the UK.104 In fact, Justice Arnold had ruled that, as that case involved the
99
Zigann 2018, p. 16
BGH 14 June 2016, no. X ZR 29/15, GRUR 2016/921 (Eli Lilly v Actavis), §83-85
100
Dutch Supreme Court, November 3, 2017 ECLI:NL:HR:2017:2807 (MSD/TEVA), §3.6.3
101
Dutch Supreme Court, November 3, 2017 ECLI:NL:HR:2017:2807 (MSD/TEVA), §3.6.4
Dutch Supreme Court, April 14, 2017, ECLI:NL:HR:2017:692, (Sun/Novartis), §3.5.2.
Art. 73 (1) DPA 1995
102
Dutch Supreme Court, April 14, 2017, ECLI:NL:HR:2017:692, (Sun/Novartis), §3.5.2.
103
Dutch Supreme Court, April 14, 2017, ECLI:NL:HR:2017:692, (Sun/Novartis), §3.5.2.
Court of Appeal, January 27, 2015, ECLI:NL:GHDHA:2015:1769, (Sun/Novartis), 4.35
104
29 preparation of a medicine, an indirect infringement by the producer could not be assumed. According to Justice Arnold, after the marketing of the medicine by the producer (downstream) it is no longer the preparation phase of the medicine.105 Lord Justice Floyd disagreed with this. In the first place, the placement of a label, which links the indication to the medicine, can fall under the preparation process as claimed.106 The importance of placing the label is that it indicates the intention. Taking this into account, Lord Justice Floyd came to the conclusion that there is no reason:
‘’ Why other acts of the pharmacist in preparing the composition for delivery to the patient cannot also be regarded as relevant acts of preparation, if done with the necessary intention’’.107
Justice Arnold’s judgement, that pharmacists do not carry out relevant preparation operations, or that they could not do this, was undermined after this judgement of the Court of Appeal. That indirect infringement of Swiss-Type claims is possible, was later also confirmed by the UK Supreme Court in the Actavis/Eli Lily case of July 12, 2017.108
The acceptance of this indirect infringement of Swiss-Type claims came to an end by the unanimous ruling on this point by the Lords in the Warner-Lambert/Generics case of November 2018.109 Lord Sumption concluded in this judgement that the possibility of indirectly infringing a Swiss-Type claim is not accepted, in contrast to the Dutch and German doctrine. Lord Sumption regards this form of infringement of a Swiss-Type claim as an artificial extension of the scope of the Swiss-Type SMI’s, which has to be interpreted in a limited way by their
Court of Appeal, October 13, 2016, EWCA Civ 1006, (Warner-Lambert v Actavis) ¶ 218 ff.
105 High Court, September 10, 2015, EWHC 2548, (Warner-Lambert) ¶ 684
106 Court of Appeal, October 13, 2016, EWCA Civ 1006, (Warner-Lambert v Actavis)
¶224
107 Court of Appeal, October 13, 2016, EWCA Civ 1006, (Warner-Lambert v Actavis)
¶225
108 Dutch Supreme Court, November 3, 2017 ECLI:NL:HR:2017:2807 (MSD/TEVA),
§3.6.3
UK Supreme Court, July 12, 2017, UKSC 48 (Actavis/Eli Lilly), ¶ 103-112
109 UK Supreme Court, November 14, 2018, UKSC 56 (Warner-Lambert v Generics)
30 nature.110A Swiss-type claim protects the production of the SMI drug for the intended purpose, but does not protect the subsequent use of the drug for the patients. The purpose of the Swiss-type claim is only to prevent obstacles due to the lack of novelty, in connection with the product claims, and the legal provision that ensures that a method of treatment will not be patentable. These Swiss-type purpose-limited process claims must be interpreted in a more limited way than the protection of standard product claims and it should not be extended to acts of the pharmacist.111
The other Lords agree with Lord Sumption. Lord Briggs adds to the theory of Sumption that paragraph 60(2) UKPA does not treat the inventions, concerning a product or a process, differently. However, the fact that an ‘’invention’’ is limited by the scope of the claim entails that ‘’putting the invention into effect’’ is also limited. When the claim protects the production process, the invention is implemented after the production process has been completed. Briggs also states that paragraph 60(2), with regard to process claims, is aimed at the upstream of the production process, while paragraph 60 (1) (c) focuses on the downstream of the production process.112 In short, according to the Lords in de UK, and unlike the German and Dutch case law, there can be no indirect infringement of a Swiss-Type SMI. This judgement of the Lords is closely related to a different, more limited, scope of protection than the ‘’purpose-limited product claims’’ of the EPC2000.
5 What is the current doctrine concerning the (in)direct infringement of the EPC2000-claims in the Netherlands, the UK and Germany?
Due to the fact that there is a limited amount of literature and case law available on the EPC2000, the regime concerning the (in)direct infringement of the EPC2000 claims is discussed without dividing the chapter into paragraphs based on jurisdictions.
When the EPC-2000 claim was introduced, some scholars expected that the EPC-2000 would have the same or a wider scope of protection than the Swiss-type
110
Ibid.
111
UK Court of Appeal, November 28, 2002 1 WLR 1462 (Menashe Business Mercantile Ltd v William Hill Organisation Ltd ) ¶24
Ibid.
112
UK Supreme Court, November 14, 2018, UKSC 56 (Warner-Lambert v Generics) ¶135
31 claim. That is why the Swiss-type claims became superfluous. 113 After the introduction, other doctrines emerged in the three jurisdictions.
5.1 Direct infringement
In the Netherlands and Germany there is a similar view on direct and indirect infringement of EPC-2000 claims. In these doctrines there is a direct infringement if a person, not entitled to do so, performs an act that belongs to the patentee’s exclusive right.114 Before there is a direct infringement of an EPC-2000 claim, the action has to be performed ‘’for’’ the SMI. Scholars have argued that the element ‘’for’’, in EPC-2000 claims, has the same meaning as the word in the Swiss-type claims. There is the same scope of protection.115 In the MSD / Teva case, it is judged that no distinction should be made between different types of SMI patents.116 The case law of the Dutch Supreme Court and the German BGH explain the element of the EPC-2000 formula ‘’for use’’ by analogy. The test takes the average person skilled in the art, examining whether he believes that the generic drugs are intended or suitable for the treatment of the SMI. In addition, this test attaches importance to the question whether the generic or trader foresees or has to foresee that the generic drug will deliberately used for the treatment and finally the reasonable measures, to prevent this use, will be omitted.117
In contrast, the element ‘’for use’’ in the formula of an EPC-2000 claim remains a reason for division in English case law, in which it is judged that Swiss-type claims and EPC-2000 claims do not have the same scope of protection. To find out whether there is a direct infringement of an EPC-2000 claim, there are three different tests in the UK following the Warner-Lambert/Generics case. Justice Arnold’s test is supported by Lord Hodge and Lord Briggs. This is because this test is about the mental property of the generic to provide the generic drug instead of the 113 G 2/08,¶5.9 Ibid,¶5.10.7 Ibid,¶6.5 T 1780/12,¶ 22
Kleemans & Drok, IER 2017/3, p.14
114
Article 53(1)(a) DPA 1995
115
Bostyn, I.P.Q 2016/02, p. 174
OLG Düsseldorf, May 5, 2017, GRUR 2017, 1107 (Östrogenblocker)
116
Dutch Supreme Court, November 3, 2017, ECLI:NL:HR:2017:2807, (MSD/Teva), §3.4.4-3.5
117
Dutch Supreme Court, November 3, 2017, ECLI:NL:HR:2017:2807, (MSD/Teva), §3.4.4-3.5
32 patented SMI.118 Lord Justice Floyd’s theory, namely the foreseeability test, was followed by Lord Mance. This concerns the question whether it was foreseeable that the generic drug would be used instead of the SMI drug.119 Finally, the other two lords, Sumption and Reed, introduced the theory of the ‘’outward presentation’’ This is not focused on the intention of the infringer, but about the way the product is presented.120
5.2 Indirect infringement
As described, it has been ruled that indirect infringement of Swiss-type claims is not permissible in the UK. On the other hand, in Germany and in the Netherlands it was judged that it is possible.121 In the UK, the Lords were of the opinion that the Swiss-type claims should not be given such a scope of protection that the downstream acts were also covered, as discussed in 3.3.2.122 On the other hand, the downstream acts in case of an EPC-2000 claim are possible, even in the UK, because this concerns product claims.123 Therefore, there is a similar doctrine in all three jurisdictions with regard to the indirect infringement of EPC-2000 claims. There is an indirect infringement of an EPC-2000 claim if someone delivers or offers to deliver means
118
UK Court of Appeal May 28, 2015, EHF [2015] EWHC 72 (Warner-Lambert Co LLC v. Actavis Group), §111
UK Supreme Court, November 14, 2018, UKSC 56 (Warner-Lambert v Generics) ¶172-174
119
UK Court of Appeal May 28, 2015, EHF [2015] EWHC 72 (Warner-Lambert Co LLC v. Actavis Group), §127
UK Supreme Court, November 14, 2018, UKSC 56 (Warner-Lambert v Generics) ¶213-216
120
UK Supreme Court, November 14, 2018, UKSC 56 (Warner-Lambert v Generics) ¶84-86
121
Zigann 2018, p. 16
BGH 14 June 2016, no. X ZR 29/15, GRUR 2016/921 (Eli Lilly v Actavis), §83-85 Dutch Supreme Court, November 3, 2017, ECLI:NL:HR:2017:2807, (MSD/Teva), §3.6
122
UK Supreme Court, November 14, 2018, UKSC 56 (Warner-Lambert v Generics) ¶88
UK Court of Appeal, November 28, 2002 1 WLR 1462 (Menashe Business Mercantile Ltd v William Hill Organisation Ltd ) ¶24
UK Supreme Court, November 14, 2018, UKSC 56 (Warner-Lambert v Generics) ¶135
123
UK Supreme Court, November 14, 2018, UKSC 56 (Warner-Lambert v Generics) ¶88&135
