SECOND
MEDICAL
CONFUSION
The enforceability of second medical use patents in
the Netherlands: problems and solutions
Name: Akiva Friedmann Student no: 10181296
Master Track: Information Law Supervisor: Dr S.J.R Bostyn LL.M Date: 29 July 2016
1 INTRODUCTION... 4
-1.1 FIRST MEDICAL USE CLAIMS... 4
-1.2 SWISS TYPE CLAIMS... 4
-1.3 EPC-2000 CLAIMS... 5
-1.4 MAIN QUESTION... 5
-1.5 IMPORTANTCONCEPTS... 6
-1.5.1 The use of a carveout... 6
-1.5.2 Generic prescribing and substitution... 7
-1.5.3 Off label use... 7
-1.5.4 Other policies... 7
-1.6 APPROACH... 8
-1.7 SCOPE... 8
-2 THE RESPECTIVE INTERESTS OF PARTIES INVOLVED IN THE PHARMACEUTICAL SUPPLY CHAIN... 8
-2.1 PATENTEES... 8
-2.2 GENERIC COMPANIES... 9
-2.3 HEALTH INSURERS... 9
-2.4 DOCTORS... 9
-2.5 PHARMACISTS... 9
-3 DIRECT INFRINGEMENT OF SWISS TYPE CLAIMS... 10
-3.1.1 The actions reserved for the patentee... 10
-3.1.2 Scope of protection... 10
-3.1.3 Direct infringement... 11
-3.1.4 “For use” and the intentional element... 11
-3.1.5 The problem with skinnylabelling... 12
-3.1.6 Directly obtained product... 13
-3.2 INTERPRETATION OF SWISS TYPE CLAIMS IN PRACTICE: WL V ACTAVIS... 14
-3.2.1 Justice Arnold’s interpretation of the word for in interim proceedings... 14
-3.2.2 Court of Appeal... 15
-3.2.3 Full trial... 17
-3.2.4 The intentional element... 19
-3.3 DIRECT INFRINGEMENT IN THE NETHERLANDS... 24
-3.4 CONCLUSION ON THE APPROPRIATE TEST... 24
-3.5 WHOCANINFRINGEA SWISSTYPECLAIM?... 25
-4 INDIRECT INFRINGEMENT OF SWISS TYPE CLAIMS... 26
-4.1.1 Means relating to an essential element of the invention... 26
-4.1.2 The knowledge requirement... 27
-4.2 CASE LAW ON INDIRECT INFRINGEMENT... 27
-4.2.1 Novartis v. Sun –facts of the case... 27
-4.2.2 Court of Appeal – Novartis v. Sun... 29
-4.3 UK WARNER LAMBERT V ACTAVIS CASES... 31
-4.3.1 Preliminary decisions... 31
-4.3.2 Court of Appeal and Full trial... 32
-4.3.3 Full trial judgement... 33
-4.4 PROCEEDINGSONTHEMERITSIN NOVARTISV. SUN... 35
-4.5 CONCLUSION... 36
-5 INFRINGEMENT OF EPC2000 CLAIMS... 37
-5.2 INDIRECT INFRINGEMENT... 40
-5.2.1 Means relating to an essential element of the invention... 40
-5.2.2 The knowledge requirement... 41
-5.2.3 When does indirect infringement occur in practice... 42
-5.2.4 Conclusion... 43
-6 INFRINGEMENT OF PATIENT SUBPOPULATION PATENTS IN THE NETHERLANDS... 43
-6.1 MSD V TEVA – DIRECT INFRINGEMENT OF PATIENT SUBPOPULATION PATENTS... 43
-6.1.1 Conclusion... 44
-6.2 MSD V. TEVA –INDIRECT INFRINGEMENT OF PATIENT SUBPOPULATION PATENTS... 45
-6.3 CONCLUSIONONTHEINFRINGEMENTOFPATIENTSUBPOPULATIONPATENTS... 47
-7 WARNER LAMBERT V. STATE OF THE NETHERLANDS - UNLAWFUL ACTS DUE TO THE INDUCEMENT OF INFRINGEMENT... 48
-7.1 BACKGROUND... 48
-7.2 FACTS... 49
-7.3 WARNER LAMBERT’S ARGUMENTS... 49
-7.4 DIRECT INFRINGEMENT... 50
-7.5 INDIRECT INFRINGEMENT... 50
-7.6 UNLAWFUL CONDUCT BY THE MEB... 51
-7.7 CONCLUSION... 52
-8 PROBLEMS AND SOLUTIONS... 53
-8.1 INFRINGEMENT... 53
-8.1.1 Liability risk for doctors... 54
-8.2 PRESCRIBINGANDDISPENSING... 54
-8.3 POSSIBLESOLUTIONS... 54
-8.3.1 Ending preferential policies... 55
-8.3.2 Therapeutic treatment exception... 55
-8.3.3 Prescription by brand name as proposed by Justice Arnold... 56
-8.3.4 Prescription with indication... 57
-8.3.5 Informing pharmacists about patented indications... 58
-8.3.6 Injunctions in the form of royalty payments... 59
-8.3.7 The Ideal situation... 61
-9 SUMMARY OF CONCLUSIONS... 61 BIBLIOGRAPHY... 63 -LITERATURE... 63 Articles... 63 Books... 68 Legislation... 68 CASE LAW... 69 EPO... 69 United Kingdom... 69 Germany... 70 The Netherlands... 71 MISCELLANEOUS... 71
-1 Introduction
1.1 First medical use claims
In order for an invention to be patentable, it must among other requirements be novel. This means that the claimed subject matter has not been known in the prior art. However, some known compounds are later found to be useful for their therapeutic effects. Because the European Patent Convention excludes methods for the treatment of the human or animal body from patentability, patent claims claiming the use of a compound for medical treatment are invalid according to the EPO.1
Because it is believed that the discovery of new medical uses for known compounds must be incentivised using patents, the problem was solved by allowing a known substance or composition to be claimed for use as a medicine if it was not known in the prior art for any therapeutic purpose.2 This exception was provided in art. 54 (5) EPC 1973.3 A patent claim
claiming a known compound for therapeutic purposes is known as a first medical use claim.4
Such claims are “purpose limited product claims”, because they are claims to a product limited to general therapeutic use.5
1.2 Swiss type claims
When a novel application for a known pharmaceutical compound, such as a new indication, dosing regime, mode of application or a new technical effect is patented, this is known as a second medical indication (SMI) patent. Possibly the best known example of a novel application of a known pharmaceutical compound is the use of Bayer’s Aspirin: first known as a pain killer, it was later found to be useful, in small doses, as an anti-coagulant. To provide an incentive for pharmaceutical companies to do research into new uses for known drugs, SMI patents are believed to be justified.6
However, the EPC-1973 did not provide an exception to the rule of absolute novelty for second and further medical uses. With the Enlarged Board’s G5/83 decision, so-called Swiss type claims became the claim format the EPO accepted for second and further medical 1 Article 52(4) of the old EPC 1973 forbids methods of treatment for the human or animal body; G 0005/83, points 12-13 of the decision.
2 Domeij 2000, p. 127-128.
3 Article 54 (5) EPC 1973 corresponds to the current article 54 (4) EPC. 4 Benyamini 1993, p 90.
5 Benyamini 1993, p. 90; G0005/83 points 15 and 21 of the decision. 6 See e.g. Castellano 2005, p. 284, 285
indication patents. Swiss type claims are claims in the format of: “use of compound X in the preparation of a medicament for the treatment of Y”. This format was deemed appropriate since it was impossible to patent a known therapeutic compound for a new use because it would lack novelty, and as mentioned above, methods for treating the human body are excluded from patentability.7 The claims have been characterised as “purpose bound
manufacturing process claims”.8 The subject matter is the process of manufacturing a
medicine for a new therapeutic use.9
1.3 EPC-2000 claims
Following the EPC-2000, article 54(5) EPC enablespatenting a substance or composition for second and further medical uses. Because of this, Swiss type claims are now no longer necessary and for patents with a priority date of 29 January 2011, the EPO only accepts claims in the form of “compound X for use in the treatment of Y”.10 A claim in this format is
known as an EPC-2000 claim. Such claims are purpose related product claims and according to the EPO have a broader scope of protection than Swiss type claims.11 However, although
Swiss type claims are no longer being drafted, patents with Swiss type claims will remain in force for many years to come.
1.4 Main question
As we shall see the enforceability of SMI patents is not straightforward for a number of reasons. The main problem lies in the fact that SMI patents relate to the use of a therapeutic compound that itself is often no longer protected by a patent. Therefore, the compound can be manufactured and used for any off-patent indication. In order to keep the costs of health care down it is considered to be essential that generic drug manufacturers can supply generic drugs for off-patent indications. Patentees on the other hand, have the exclusive right to manufacture and use exactly the same active ingredient for the treatment of patented indications. One basic assumption in this thesis is that affording innovator companies patents on new uses for known medicines is indeed necessary for advancing the progress of health care. Therefore, the main question addressed in this thesis is:
7 G 0005/83, points 21-23 of the decision. 8 Benyamini 1993, p. 94.
9 Ibid., p. 95.
10 Notice from the EPO in OJ EPO 2010, 514.
How can the rights of holders of second medical indication patents be protected, without limiting the legitimate production and use of generic drugs for off-patent indications?
A part of this thesis will focus on the question of when Swiss type and EPC-2000 patents are respectively infringed in the Netherlands. To answer this question, relevant case law from both the Netherlands and the UK concerning the interpretation of SMI claims will be analysed. If such claims must be interpreted in a way that they are too easily infringed, the danger exists that generic manufacturers will be kept off the market. If, however the test of infringement is too hard to meet, SMI patents become impossible to enforce. Although it is still too early for case law concerning the interpretation of EPC-2000 claims, the case law concerning Swiss type claims is highly relevant for the interpretation of EPC-2000 claims.
1.5 Important concepts
In order to better understand the topics discussed in this thesis, some key regulatory and practical concepts relating to the regulation and supply of pharmaceuticals must be explained. 1.5.1 The use of a carve-out
To gain market authorisation for a drug in the EU, the Summary of Product Characteristics (SmPC) and the Patient Information Leaflet (PIL) must contain all indications and particulars of a drug. However, article 11 of Directive 2001/83/EC provides an exception to this rule for generic companies which are filing for market authorisation for a drug, in cases where one or more indications or dosage forms are still protected by a patent.12 When this is the case a
generic company can apply for a so-called “carved out” version of the SmPC and PIL that leaves out the patented elements, in order to avoid infringing a patent. This is also referred to as a “skinny label”.
1.5.2 Generic prescribing and substitution
In practice the use of carve-outs is not an effective way of stopping the use of generic drugs for patented patented indications. To minimize the use of expensive innovator products, doctors are encouraged to prescribe generically, i.e. by writing only the International Non-proprietary Name (INN) of the active ingredient and the dosage on the prescription.13
Moreover, in the Netherlands pharmacists are encouraged to substitute medicines that have 12 Article 11, Directive 2001/83/EC
been prescribed by brand name with generic equivalents.14 In many cases the pharmacist, not
knowing for which indication a drug has been prescribed, will issue the generic (cheaper) version of the drug, even for a patented indication.
1.5.3 Off label use
When a new medicine is put on the market it receives market authorization for the treatment of specific diseases, modes of treatment, and population groups. In many cases however, medicines are prescribed for indications and for population groups for which they are not authorized. This practice is known as off label use. For example, a large amount of medicines prescribed to children are prescribed off label, because children have only recently become subjects of clinical trials.15 Also, pregnant women are usually not included in clinical trials. Because of this most
medicines prescribed to pregnant woman are prescribed off label. 1.5.4 Other policies
Other practices have made the enforcement of second medical indication patents problematic in the Netherlands. Some health insurance providers practice a so-called “preferential policy” for reimbursing drugs. This means that a health insurance agency makes pharmaceutical companies compete for the exclusive reimbursement of a specific drug. The health insurer signs a contract with the manufacturer offering his product at the lowest price; this will be the only product to be reimbursed, even when some uses for the drug fall under a patent owned by a third party. This can put pharmacists in an impossible position: even if they know a drug is being prescribed for a patented indication, they cannot dispense the patentee’s drug because it will not be reimbursed by the patient’s health insurer.
1.6 Approach
In order to answer the main question, the following sub questions must be answered. When is a Swiss-type claim infringed?
When is a EPC-2000 claim infringed?
Are there problems with the enforcement of second medical indication patents? Which solutions are there to the problem of enforcement of second medical indication
patents within patent law?
Which solutions are there to the problem of enforcement of second medical indication patents outside of patent law?
14 Ibid.
My research is based mainly on case law and legal literature. However, some references are made to scientific sources from other disciplines.
1.7 Scope
Because of the relatively large differences in both patent and pharmaceutical regulatory laws and policies within the EU, the main focus in this thesis is on the Dutch jurisdiction. However, because the legal situation in the UK is in my opinion relatively similar to the Dutch situation, comparisons are drawn with the UK.
2 The respective interests of parties involved in the pharmaceutical
supply chain
In this chapter I will discuss the different positions of the parties involved in the pharmaceutical supply chain. Because some of the parties have conflicting interests, understanding how these parties relate to each other is essential for understanding how they influence the enforcement of SMI patents. The following parties will be discussed: patentees, generic manufacturers, health insurers, doctors, pharmacists and patients.
2.1 Patentees
Innovator pharmaceutical companies claim to have high research costs for finding new applications for known substances. To maintain an incentive for pharmaceutical companies to do research and develop new uses for known drugs, SMI patents are believed to be justified.16
However, innovator companies employ a number of strategies to keep generic companies off the market for as long as possible and it is claimed that SMI patents are used for this purpose.17
2.2 Generic companies
Generic pharmaceutical companies are essential in keeping health care affordable, especially because of the rising costs of health care in recent years.18 Generic companies are interested in
supplying as much generic drugs as possible and therefore it can be assumed that they would like SMI patents to be unenforceable.
2.3 Health insurers
16 Domeij 2000, p. 181-182.
17 Bostyn 2016, p. 152; see also Whitehead et.al. 2008, p. 229-230 18 Simoens & De Coster 2006, 257-268
Health insurers want to minimize the costs of medicines they are required to reimburse and apply a.o. preferential policies to achieve this.19 They have a direct interest in the dispensing
of generic drugs by pharmacists for patented indications, and therefore it can be assumed that they would like SMI patents to be unenforceable.
2.4 Doctors
Doctors want to deliver the best quality health care for the lowest price possible. They are generally unaware of and uninterested in patents, and have never been held accountable for patent infringement. In the Netherlands doctors decide which medicine to prescribe on the basis of professional guidelines20 and use electronic prescription systems21, which make no reference to
patents. Doctors often prescribe medicines generically, i.e. by making reference to the International Non-proprietary Name (INN) without mentioning the brand name. Usually they do not mention the reason for prescribing on the prescription.22
2.5 Pharmacists
Pharmacists are often interested in dispensing the cheapest possible medication so that they can make a maximum profit over the amount they are reimbursed.23 If a patient’s health insurer has a
preferential policy in place, the pharmacist is required to dispense a specific manufacturer’s product, even if it is for a patented indication.
3 Direct infringement of Swiss type claims
To answer the question when infringement of a Swiss type claim occurs, the scope of a patentee’s rights must be determined. For this, two questions must be answered: (i) which actions does the patent reserve for the patentee, and (ii) what is the scope of protection of the patent.24
3.1.1 The actions reserved for the patentee
The actions reserved for the patentee are determined by national law, even for European patents.25
These actions are for example the acts that constitute infringement, and which remedies are
19 https://www.knmp.nl/praktijkvoering/bekostiging/preferentiebeleid 20Van den Berg 2011, p.124
21 Richtlijn Elektronisch Voorschrijven 2013 22 Guideline for generic substitution 2012, p.1. 23Leendertse Et al. 2014, 41.
24 Geerts 2014 p. 57. 25 Article 64 EPC.
available in respect of an infringement.26 The article providing for direct infringement in the
Netherlands is based on article 25 of the Community Patent Convention, and is therefore more or less identical to the provisions regulating direct infringement in other EU countries. Swiss type claims are purpose limited manufacturing process claims.27 Article 53(1)(b) Dutch Patent Act
(DPA) provides that holder of a Dutch process patent, or the Dutch part of a European patent in the form of a process patent, has the exclusive right to apply the process, to use, sell, rent, deliver, trade in any other way, offer for sale, import, or to hold in stock, the product directly obtained by said process.28
3.1.2 Scope of protection
The EPC determines the scope of protection of a European patent. Article 69 EPC provides:
“the extent of the protection conferred by a European patent or a European patent application shall be determined by the claims.”29
Because of this provision only the claims are relevant for determining the scope of protection.30 In the G 2/88 decision the Enlarged Board was confronted with the interpretation
and effect of a patent claim.31 The Enlarged Board considered that:
“(…) the subject-matter of a claimed invention involves two aspects: first the category or type of the claim, and second, the technical features, which constitute its technical subject matter.”32
Swiss type claims have the format “use of compound X for preparation of a medicament for the treatment of Y”. The subject matter of such claims is therefore the process of manufacturing a medicament for the new therapeutic use.33 In short, Swiss type claims prohibit the use of the active
ingredient in the manufacture of a known drug, when the drug has been manufactured for the second indication.34
26 EBA G 2/88, 3.3 of the reasons.
27Benyamini 1993, p. 94; T 1780/12, 16 of the reasons. 28 Article 53 Dutch Patent Act.
29 Article 69 EPC. 30 Brinkhof 2005, p. 407.
31 EBA G 2/88, point 2 of the reasons. 32 Ibid., point 2 of the reasons
33 Benyamini 1993, p. 95 (emphasis added); G 5/83, n.1 paras. 21 and 22. 34 Benyamini 1993, p. 94
3.1.3 Direct infringement
With limited literature and until recently no case law on the topic, it has long been unclear when exactly Swiss type claims are directly infringed. In the Netherlands no final decision has yet been given on this issue.35 Furthermore, it was also unclear which parties could infringe a
Swiss type patent.
3.1.4 “For use” and the intentional element
The most important question concerning the interpretation of Swiss type claims is: when has a drug been manufactured for use in the treatment of a patented indication? The word for indicates that a drug must have been manufactured with a certain purpose or intention. Until recently this question had not been answered by a court and it seemed as if the answer was quite straightforward. In his influential treatise on patent infringement Benyamini wrote about 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 be packaged and labelled with directions designating it for the indication. In practice, it should be no problem to prove this condition in view of the legal requirements to register medicaments, state their field of application and sell them with use directions”36
In Actavis v Merck Lord Justice Jacob of the England and Wales Court of Appeal seemed to agree with Benyamini’s view that proving infringement of Swiss type claims would not be problematic in practice:
“But in many cases the difficulty may be more theoretical than real. This is because manufacturers, particularly for prescription medicines and probably many others, have to provide detailed instructions and information about the use(s) and dosage(s) of their products. So in practice you can tell whether someone has used X for the manufacture of a medicament for the treatment of Y. He will have to say that his product is for the treatment of Y on his product information leaflet.”37
It seems clear that both Benyamini and Justice Jacob believed that in practice a drug has been manufactured “for use” in the treatment of the patented indication when it is obvious from the 35 In the at the time of this writing pending Novartis v Sun case the court has given parties an opportunity to submit arguments, but the judgement has not yet been handed down.
36 Benyamini 1993, p. 94
packaging or e.g. the specific amount of active ingredient in a pill or the patient information leaflet that a drug is intended for the patented indication.
3.1.5 The problem with skinny-labelling
However, because of the practice of skinny-labelling by generic manufacturers, the generic version of a pharmaceutical covered by a second medical indication patent will only rarely be packaged and labelled with directions designating it for the patented indication. Moreover, off label use of generic drugs for patented indications is common practice38, and doctors often
prescribe generically, with reference to the INN. When a drug has been prescribed generically pharmacists will dispense the cheapest version of the drug, which will usually be a generic one.39
In the Netherlands, it is the case that even when a medicine has been prescribed by the brand name, a generic product can be dispensed unless there is a medical necessity for that specific product.40 Considering the practice of skinny labelling Benyamini’s view does not seem to fit the
current reality. Benyamini wrote the above fragment before skinny labelling was common practice and it seems that he did not anticipate problems with proving that a pharmaceutical has been manufactured for the novel indication. In my opinion the mere fact that a pharmaceutical has a skinny label should not always absolve a generic manufacturer from liability. As we shall see it can be the case that it is known to a generic manufacturer that a large portion of the pharmaceuticals he produces are used for the patented indication, even though the drug is marketed with a skinny label. If a skinny label would absolve all third parties from infringing, the patent Swiss type claims would be largely unenforceable in practice. Recital 3 of the enforcement directive highlights the importance of enforceability of IP rights.
“[..]without effective means of enforcing intellectual property rights, innovation and creativity are discouraged and investment diminished. It is therefore necessary to ensure that the substantive law on intellectual property, which is nowadays largely part of the acquis communautaire, is applied effectively in the Community. In this respect, the means of enforcing intellectual property rights are of paramount importance for the success of the internal market.”41
3.1.6 Directly obtained product
An important concept for understanding how Swiss type claims can be infringed is the protection 38 Berman & Melnick 2008, Off-Label Promotion, On-Target Sales, PloS Medicine 10 2008, p.1432.
39 Guideline for generic substitution, p.1. 40 Ibid.
of the direct product of a patented process. Article 25(C) of the CPC reads as follows:
“A Community patent shall confer on its proprietor the right to prevent all third parties not having his consent:
(c) from offering, putting on the market, using, or importing or stocking for these purposes the product obtained directly by a process which is the subject-matter of the patent.”
Article 64 (2) EPC contains a similar provision:
64 (2) “If the subject-matter of the European patent is a process, the protection conferred by the patent shall extend to the products directly obtained by such process.”
A “product directly obtained” must be understood as everything that can be considered the direct result of the process.42 To establish infringement one must first establish whether the process that
has been used to manufacture a product falls under the invoked patent’s scope of protection.43
Secondly, it must be established that the attacked product is in fact the direct result of the process.44
The protection for the directly obtained product is essential for the enforceability of Swiss type SMI patents. Most legal scholars agree that when a medicine has been manufactured for the claimed indication, it is protected as a direct product of the manufacturing or customizing process.45 Without direct product protection only generic manufacturers could be held liable for
infringement and even they could only be held liable in the country where the manufacturing process takes place.46 If a pharmaceutical has not been manufactured for use in the treatment of the
patented indication, it can never infringe a Swiss type claim downstream. Therefore, only the moment of manufacturing is relevant for determining if a drug is the direct product of the patented process.47 Considering the fact that Swiss type claims are purpose bound process claims, I believe
that the protection of the direct product of a Swiss type claim should be limited to protection against use of the direct product for the treatment of the patented indication. If this were not the case any use of the direct product would constitute infringement. E.g., a pharmacist dispensing a generic drug for an off-patent indication could become an infringer if the drug had been 42 Gielen 2014, p. 58
43 Ibid. 44 Ibid.
45 Benyamini 1993, p. 95; Jaenichen et al, p. 272; Blomme, p. 93; Bostyn 2016, p. 170. 46 Benyamini 1993, p. 95; Bostyn 2016, p. 170.
manufactured according to the patented process.
3.2 Interpretation of Swiss type claims in practice: WL v Actavis
In the United Kingdom there has been a series of judgements relating to Warner Lambert’s (WL) Swiss type SMI patent for the use of pregabalin for the preparation of a medicament for the treatment of pain. The dispute arose after Actavis had brought a generic pregabalin product (Lecaent) on the UK market under a skinny label. Most importantly, the judgements address the question of when a drug has been manufactured for the patented indication and which intentional element is necessary for proving infringement. Moreover, the judgements shed light on the question of who can be held liable for the infringement of a Swiss type claim. The decisions have provided valuable guidance as to how Dutch courts may interpret Swiss type claims.
3.2.1 Justice Arnold’s interpretation of the word for in interim proceedings
In first instance WL’s direct infringement claim was based on the sale in the UK by Actavis of generic pregabalin as the direct product of the manufacturing process (the use of pregabalin for the preparation of a medicament for the treatment of pain). Justice Arnold accepted Actavis’ argument that the correct interpretation of the word “for” in Swiss type claims is “suitable and (subjectively) intended for”, and therefore held that the word “for”
“imports a requirement of subjective intention on the part of the manufacturer that the medicament or pharmaceutical composition will be used for treating the specified condition.”48
3.2.2 Court of Appeal
At the Court of Appeal Lord Justice Floyd acknowledged the problems skinny labels can cause patentees.
“It is not in practice the case that a manufacturer “will have to say that his product is for the treatment of Y on his product information leaflet” in order to benefit from the patentee’s market for the novel use. By the means of a “skinny label” he can say nothing at all about the novel indication, and leave it to the market to ensure that it is in fact dispensed for pain. The court [in Actavis v Merck] was not addressing the problem which confronts the court on this appeal, where the PIL is silent as to an indication for which there is a large market, in
circumstances where doctors and pharmacists are encouraged and incentivised towards generic prescribing, dispensing and cross-dispensing.”49
Floyd considered that there had not yet emerged a universal formulation of a principle which can be applied to determine whether a medicament is for a therapeutic purpose.50 According
to Floyd it is not sufficient to construe the word “for” in the conventional, objective sense of “suitable for”, because pregabalin as used in the prior art would also be “suitable” for the treatment of pain. 51
The court referred to the G 2/8852 case for determining the protection conferred by the patent,
and noted that the skilled person would understand that the technical features of the claim extend beyond the making of pregabalin, yet fall short of including the step of actually using pregabalin for treating pain.53 Floyd concluded that the claim includes a feature concerned
with the ultimate purpose of the product manufactured, namely the intentional treatment of pain. Therefore, the judge determined that the subject matter of the claim is “making pregabalin for patients to whom it will be intentionally administered for treating pain.”54
Floyd went on to determine that the invention owes its novelty to the discovery of the new therapeutic use of the medicament55, and that the skilled person would understand that the
technical subject matter of the claim was concerned with the ultimate end use of the medicament.56 Because of this he concluded that the intention for which the compound is
administered is at the heart of the invention.57 He went on to consider that the
“skilled person would understand the word “for” in the claim to be providing a link between the act of manufacture using pregabalin and the ultimate intentional use of the drug by the end user to treat pain.”58
According to Floyd there were two realistic candidates for what could constitute such a link: 49 Warner Lambert v Actavis, [2015] EWCA Civ 556, para. 66.
50 Ibid., para. 98. 51 Ibid., para. 113.
52 Enlarged Board G 2/88, para. 3.3.
53 Warner Lambert v Actavis, [2015] EWCA Civ 556, para. 113.
54 Warner Lambert v Actavis, [2015] EWCA Civ 556, para. 118, emphasis added. 55 Ibid., para120; this is in line with EBA G 5/83, para. 21.
56 Ibid., para. 121. 57 Ibid.
“(a) foreseeability that the drug will intentionally be used for the patented indication and (b) a subjective intention to that effect.”59
Floyd subsequently considered that the word “for” could not mean subjective intent. If that were the case, WL would have to prove that it was Actavis’ wish or desire that they sell some generic pregabalin for pain, and according to him this would “rob Swiss claims of much of their enforceability”.60 He further concluded that the skilled person would understand that the
manufacturer who knows (constructive knowledge is enough) or could reasonably foresee that some of his drug will intentionally be used for pain is making use of the patentee’s inventive contribution in the same way as a manufacturer who actually desires that result.61 Therefore,
Floyd concluded that the word for in Swiss type claims means that the ultimate intentional use of the drug for the patented indication was reasonably foreseeable by the manufacturer. He further clarified that it is the end user that must intentionally use the drug for infringement to occur.62 In other words: when a manufacturer produces a generic drug and he knows or
foresees that users will intentionally administer it for the patented indication, he infringes the claim by using the patented process.
It was clear to Floyd that his proposed test for infringement would easily be met by generic manufacturers. Nevertheless, he stated that liability for infringement due to using a process is strict and has no mental requirement.63 However, he recognised that unfair situations could
occur if an injunction prohibiting the sale of a generic product altogether would be granted, however he was of the opinion that
“the answer to any potential unfairness in such a case may lie in the relief to be granted. A general injunction prohibiting sale of the product itself is plainly not justifiable, and it may be unjust and inconvenient [..] to grant an injunction at all.”64
Although Floyd concluded that Warner-Lambert had an arguable case of direct infringement he did not grant an injunction because he was of the opinion that whether or not to grant an relief was an issue for the trial.65
59 Ibid., para. 122. 60 Ibid., para. 126-127. 61 Ibid., para. 127.
62 Warner Lambert v Actavis, [2015] EWCA Civ 556, para. 127-128. 63 Ibid., para. 129.
64 Ibid., para. 131. 65 Ibid., para. 133.
3.2.3 Full trial
In full trial before the Patents Court66, Mr Justice Arnold expressed “considerable doubts”
about the correctness of Floyd’s interpretation of the word “for” in Swiss type claims.67
627 “[..],Counsel submitted that Floyd LJ’s construction apparently had the consequence that, if it was foreseeable to an unlicensed manufacturer of pregabalin that “some of his drug” [..] would be intentionally administered for the treatment of pain, then all of that manufacturer’s acts of manufacture of pregabalin would be infringing acts even though it was foreseeable that the remainder of its pregabalin would be administered for the treatment of non-patented indications. [..]Furthermore, this would be so even if it was foreseeable that the majority (possibly even the vast majority, depending on what was meant by “some”) of the pregabalin made by that manufacturer would be administered for the treatment of the non-patented indications and even if the majority (possibly the vast majority) was in fact administered for the treatment of those indications. Still further, all of the pregabalin would be infringing product, and thus anyone who subsequently dealt in it would also infringe on a strict liability basis. Counsel for Actavis submitted that this outcome would be worse for the manufacturer than the “extreme view” which Floyd LJ rejected at [122], because at least the “extreme view” meant that only the proportion of pregabalin which was in fact administered for the treatment of pain would be infringing.”68
Arnold stated that as a result of Floyd’s test all of the product produced would infringe, and that therefore any use of a product manufactured according to a Swiss type claim by anyone constitutes an infringement. In my opinion the prohibition of the unauthorised use of such a product should be purpose bound, and limited to the use in the treatment of the patented indication. If this were not the case, the consequences would be unfair even if Arnold’s test of subjective intent would be applied. A pharmacist dispensing a generic medicine for an off-patent indication could under circumstances infringe a off-patent merely because the medicine was produced by an infringing manufacturer. Furthermore, if the use of the direct product was not purpose bound this would in many cases mean that a Swiss type claim can offer more protection that an EPC-2000 claim. As we shall see this is not the case according to the EPO.69
66 Warner-Lambert v Actavis & others: EWHC 2548 (2015).
67 Warner-Lambert v Actavis & others: EWHC 2548 (2015), para. 632. 68 Warner-Lambert v Actavis & others: EWHC 2548 (2015), para. 627. 69 TBA 1780/12, point 24 of the reasons; EBA G 0002/08, point 5.5.
Arnold then went on to note that he found it to be “reasonably clear” that Floyd did not intend his interpretation to have the consequence that all of the pregabalin produced would infringe, and referred to Floyd’s opinion that any potential unfairness must be limited by tailoring the injunctive relief given.70 According to Arnold:
“This suggests that he considered that the injunction might somehow be tailored so as only to prohibit manufacture of pregabalin which it was foreseeable would be intentionally administered to treat pain, and not pregabalin which it was foreseeable would be administered for non-patented indications, although his statement that it might be unjust to grant an injunction at all indicates that he appreciated that this could be very difficult. Similarly, it appears that he envisaged that the financial remedy would only apply to pregabalin which it was foreseeable would be intentionally administered to treat pain, presumably on a statistical basis.”71
However, Arnold did not see a principled basis for such a statistical approach.72 Despite his
doubts Arnold followed the Court of Appeal’s interpretation.73
3.2.4 The intentional element
Next Arnold went on to consider how the Court of Appeal’s interpretation of the word “for” must be applied.
634. “There are two main aspects of the dispute. First, counsel for Pfizer submitted that there was no real difference between Floyd LJ's interpretation of the word "for" and a pure test of foreseeability on the part of the manufacturer that its pregabalin would in fact be used for the treatment of pain. I do not accept this submission. Floyd LJ made it clear at [121] that intentional administration was at the heart of the invention, at [122] that the word "for" provided the link between the manufacture of pregabalin and the intentional use of the drug, at [127] that the word "for" required knowledge or foresight of the ultimate intentional use, at [128] that there were two mental states involved and at [129] that a manufacturer infringes when he knows or foresees that users will intentionally administer pregabalin for the treatment of pain. Thus the requirement of intention is central to his interpretation. It is plainly not a pure test of foreseeability. Furthermore, I agree with counsel for Actavis that a pure test of foreseeability would not be enough to confer novelty on the claim. It is the element of intention which ensures novelty.”
70 Warner-Lambert v Actavis & others: EWHC 2548 (2015), para. 628. 71 Ibid.
72 Warner-Lambert v Actavis & others: EWHC 2548 (2015), para. 629. 73 Ibid., para. 632.
Next Arnold considered whether it was the doctor’s, the pharmacist’s or the patient’s intention that was relevant for determining if it is foreseeable that pregabalin will be intentionally administered for pain. First he discussed the doctor’s intention:
636. “[.]I agree that the intention of the doctor is highly relevant, if not exclusively so. Floyd LJ expressly referred to "the doctor" at [119], and at [121] he made the point that the novelty of the claim derives from "the intention of producing the new therapeutic effect". It is the prescribing doctor who intends to produce the new therapeutic effect (here treating pain) because it is the doctor who has the requisite medical knowledge.74
637. Counsel for Actavis also submitted that it was not sufficient that the prescribing doctor intended pregabalin from any source to be administered for the treatment of pain. I agree with this. Floyd LJ expressly referred at [127] to the manufacturer foreseeing that "some of his drug will intentionally be used for pain [emphasis added]". Furthermore, it would make no sense for it to be sufficient that the doctor intended pregabalin from any source to be administered for pain. Infringement must depend on what the manufacturer can foresee happening with the pregabalin it manufactures, not pregabalin made by others. Moreover, statistically, it would be probable that pregabalin from any source would be made by Pfizer and hence non-infringing on any view.”
It may be true that a prescribing doctor intends to use pregabalin to treat pain, but in my opinion this does not mean that patients and pharmacists cannot also intend to treat pain using pregabalin. For example, it could well be the case that a patient has heard about pregabalin on the internet or from a friend and specifically asks his/her doctor for a prescription for pregabalin. In my opinion Arnold has misinterpreted the Court of Appeal’s test for infringement. In the Court of Appeal’s ruling, Floyd wrote the following about the relevant intention:
“It is, I think, important to bear in mind that there are two mental elements involved: the question is what the manufacturer knows or foresees about the intentional use of the drug by the end user which counts.”75
129. Turning to the second question, section 60(1)(b) makes it an infringement to use the process. Unlike “offering a process for use” and indirect infringement under section 60(2), liability under this part of section 60(1)(b) has no mental requirement: liability is strict. How
74 Warner-Lambert v Actavis & others: EWHC 2548 (2015), para. 636
does one tell whether a manufacturer is using the manufacturing process of the claim, and therefore rendering himself liable for patent infringement? The answer must be when he manufactures pregabalin when he knows or foresees that users will intentionally administer it for pain.”76
Floyd expressly refers to the intentional use of the drug by the end user. Because pregabalin is manufactured in the form of a pill it is not administered by the doctor or the pharmacist, therefore Floyd could have only meant that the patient is the user. It is not clear to me how Floyd could have meant the doctor with the term “the end user”. In my opinion, with the words “intentional use” the Court of Appeal means nothing more then that pregabalin is used for the specific purpose of treating pain. This, as opposed to the situation that pregabalin is used for the treatment of an off-patent indication with the additional or unintended effect that pain is relieved, which would have also happened before the priority date of the patent. This becomes clear in the following paragraph from the Court of Appeal’s ruling:
121. “Thus the skilled person would understand that the technical subject matter of the claim was concerned with the ultimate end use of the medicament, from which it derived its novelty. The therapeutic treatment is of course new because, and only because, it is carried out with the intention of producing the new therapeutic effect. The prior use of the compound may have in fact produced the effect, for example if a patient taking it for GAD or epilepsy was at the time experiencing pain as well. This demonstrates, to my mind, that it is the intention for which the compound is administered which is at the heart of the invention.”77
In my opinion a generic manufacturer is “using the patentee’s inventive contribution” when a patient takes that manufacturer’s pregabalin pill and knows that he is taking it to relieve pain.78 The patient himself is not an infringer, but the manufacturer is profiting from the new
market which has been created thanks to the information provided by the patent.79
Next Arnold considered whether pharmacists can bring about the relevant intention.
76 Ibid., para. 129 (emphasis added).
77 Warner Lambert v Actavis, [2015] EWCA Civ 556, para. 121 (emphasis added). 78 Compare Warner Lambert v Actavis, [2015] EWCA Civ 556, para. 127.
79 When a patient uses a drug for himself he is not using it commercially and therefore does not infringe the patent.
638. “What about the pharmacist? Floyd LJ does not expressly refer to the pharmacist in his analysis, but as counsel for Pfizer pointed out, his language in [122]-[129] is quite general, referring, for example, to "intentional use for pain". After considerable hesitation, I have concluded that, on Floyd LJ's reasoning, the intention of the pharmacist is also relevant. In general, of course, the pharmacist will simply intend to dispense the drug which the doctor has prescribed for the purpose of treating whatever indication the doctor has prescribed that drug for. Moreover, in general, the pharmacist will not know what that indication is. In those circumstances the pharmacist's intention adds nothing to that of the doctor. Even if the doctor prescribes generic pregabalin for treating pain and the pharmacist dispenses the generic manufacturer's product, neither the doctor nor the pharmacist nor the two in combination will have intended that that product be administered for the treatment of pain. But what if the pharmacist knows that the doctor has prescribed generic pregabalin for treating pain and the pharmacist dispenses the generic manufacturer's product? In those circumstances it seems to me that it can be said that the result is intentional administration of the generic manufacturer's product to treat pain.”80
I agree with Arnold that the intention of the pharmacist can also be relevant, and it is true that in many cases the pharmacist will not know for which indication he is dispensing a drug. However, a pharmacist will in practice often be able to know for which indication he is dispensing a drug.81 It seems to me that Arnold has decided that the doctor’s intention is the
most relevant precisely because the doctor will almost never intend “that that product”, i.e. generic pregabalin from a specific manufacturer, will be administered for the treatment of pain, so that infringement will be rare. Bostyn is of the opinion that infringement will never occur when Arnold’s approach is followed.
“I think this is a very semantic approach to the requirement of intention. If I understand the judgment correctly, the intentional element would only be proven and hence there could only be infringement if the physician had prescribed a specific generic drug from a specific manufacturer and/or the pharmacist had dispensed as a consequence of that prescription also a generic drug from that specific manufacturer. As that is unlikely to ever happen, I think it shuts the door quite firmly on infringement. This can or cannot be an equitable solution, but I think it is questionable on legal grounds.”82
80 Warner-Lambert v Actavis & others: EWHC 2548 (2015), para. 638.
81 In many cases it will be clear from the prescription for which indication a drug has been prescribed even though the indication has not been mentioned, e.g. by looking at the prescribed dose. In the Netherlands there is a list of 23 compounds which must be prescribed with the indication written on the prescription. This list will be expanded to about 80 compounds (Netherlands State Gazette 2013, no. 18918 10 July 2013).
I agree with Bostyn that infringement will be rare when one follows Arnolds approach, but the door is not shut on infringement. In my view Arnold does not mean that there can only be infringement if a doctor has prescribed a specific generic drug from a specific manufacturer. With the words “if a doctor prescribes generic pregabalin” in paragraph 638 of his ruling quoted above, Arnold means pregabalin prescribed generically, i.e. with reference to the INN, as apposed to prescription with reference to the brand name. I believe Arnold means that when a doctor prescribes pregabalin for pain without referring to the brand name, and the pharmacist knows that the pregabalin has been prescribed for pain and he/she dispenses a generic manufacturer’s product, the drug has been intentionally administered for pain. Paragraph 666 of Arnold’s ruling clarifies this:
666. “Was it foreseeable that Lecaent would be intentionally administered for the treatment of pain? For the reasons explained above, I do not consider that there is intentional administration of Lecaent for the treatment of pain if Lecaent is dispensed in circumstances where the doctor has prescribed generic pregabalin for pain and the pharmacist does not know the indication for which it has been prescribed, but I consider that there is intentional administration of Lecaent for pain if the pharmacist dispenses Lecaent when he or she knows that pregabalin has been prescribed for pain.”83
Finally, Arnold considered whether the intention of patients is relevant:
639. “As for the patient, notwithstanding Floyd LJ’s reference in [128] to “the end user”, I cannot see that the patient’s intention is relevant. The patient is the one who is being treated. In general, the patient intends to take whatever drug the doctor has prescribed for whatever condition the doctor has prescribed it for. Usually the patient will not have any medical knowledge about the efficacy of that drug for that condition. Moreover, the patient will rely on the pharmacist to dispense the correct drug, and in general the patient will not have any choice as to the source of that drug. Indeed, many patients will be oblivious to the source of the drug.”84
In my opinion it should be the patient’s intention that is the most relevant from a practical point of view.85 It is true that “the patient intends to take whatever drug the doctor has
prescribed for whatever condition the doctor has prescribed it for.” However, I believe that patients usually do know for what indication they are taking a drug, and for example, in the 83 Warner-Lambert v Actavis & others: EWHC 2548 (2015), para. 666.
84 Warner-Lambert v Actavis & others: EWHC 2548 (2015), para. 639. 85 See also Warner Lambert v Actavis, [2015] EWCA Civ 556, paras. 128-129.
case of pain a patient will even be able to tell how effective a pill for pain relief is. Besides, the fact that the patient is “oblivious to the source of the drug” is in my opinion not relevant for the question of whether the drug is being used intentionally. Surely, Floyd did not mean that the user must have knowledge of the patent in order for the drug to be “intentionally administered”.
Arnold went on to conclude that at the time of production of Actavis’ product it was not foreseeable to Actavis that more than a de minimis amount of generic pregabalin would be intentionally administered.86 Arnold also concluded that Actavis had not had the subjective
intention that Laecent would be used for the treatment of pain.
3.3 Direct infringement in the Netherlands
As we shall see, in the proceedings on the merits in the Novartis v Sun case dicussed below in chapter 4 the District Court of The Hague agreed with Justice Arnold that Swiss type claims cannot be indirectly infringed after the final product has been manufactured. However, the court gave parties the opportunity to present arguments on the question of direct infringement.87 It is yet to be seen which test for direct infringement the court will apply. In
the MSD v Teva case the Court of Appeal of The Hague confirmed that direct infringement of a Swiss type claim, due to the sale of the product directly obtained by the patented process, is possible in the Netherlands.88 One can only speculate that the court will either apply Arnold’s
test of subjective intention or Floyd’s test of foreseeability. As stated above, my preference goes out to Lord Justice Floyd’s test of foreseeability, because the test of subjective intent is too difficult to prove.
3.4 Conclusion on the appropriate test
In my opinion Floyd’s test for infringement is the more favourable of the two. Subjective intention is too difficult to prove, even where it is very clear that a generic manufacturer is profiting from the patentee’s contribution to the art. However, I do not agree with Arnold’s application Floyd’s test. I believe that Arnold’s application of the requirement of intention is based on a misinterpretation of the Court of Appeal’s decision. It will usually be the patient or the pharmacist who intends that a specific manufacturer’s drug is used for a certain indication. 86 Warner-Lambert v Actavis & others: EWHC 2548 (2015), paras. 676, 671
87 District Court of the Hague, 25 November 2015, IEF 15450, 6.62-6.66 88 Court of Appeal of The Hague, 14 July 2015, IEF 15109, para. 5.1
Moreover, I find Arnold’s view that it must be foreseeable to the manufacturer that more than a de minimis amount of a drug intentionally administered in order for there to be a finding of infringement, inconsistent with Floyd’s test for infringement. In the Netherlands, there does not seem to be room for the possibility of a quantitative de minimis defence against patent infringement.89 Floyd LJ’s view, that any unfairness from a finding of infringement should be
evened out with tailored remedies, seems to be a better solution. This issue will be discussed in greater depth in chapter 8.
3.5 Who can infringe a Swiss type claim? Generic manufacturers
When a generic manufacturer produces a medicine and he can reasonably foresee that some of the medicine will be intentionally administered for the treatment of the patented indication, he is applying the patented process and thus infringing the Swiss type claim. In my opinion it should be either the doctor’s, the pharmacist’s or the patient’s intention that is relevant. When a generic medicine has been produced according to the patented process, anyone selling, dispensing or administering it for the treatment of patented indication will infringe, except the patient.90
Doctors
It is not clear whether a Swiss type claim can affect a doctor. Schutjens believes the exercise of the medical profession falls outside the realm of patent law per se, and that therefore doctors are excluded from liability.91 She contends that this would be in line with the fact that
medical treatments are excluded from patentability.92 I find these arguments convincing.
Regardless, in most cases, doctors do not prescribe a specific manufacturer’s product, because they usually prescribe generically, i.e. with reference to the INN. In such cases doctors cannot 89 Maas & Santman 2007, p. 224-229
90 Arnold seems to be of the opinion that any dealing with the product so produced will infringe. See 3.2.3 above.
91 Schutjens 2015; See however Zimmer and Zeman 2006, p.5 who claim the prescription of a medicine by a doctor constitutes a commercial act and that therefore doctors can directly infringe in Germany.
infringe. It is unclear whether a doctor or a nurse who directly administers the direct product of a patented process for the treatment of a patented indication can infringe. With Schutjens, in my opinion this should not be the case.
Pharmacists
Pharmacists can directly infringe Swiss type SMI patents. When a generic manufacturer’s drug has been manufactured according to a patented process and a pharmacist dispenses it for the patented indication, the pharmacist would be using the direct product of a patented process and would therefore infringe the patent.93 However in cases of the individual preparation of
medicines pharmacists are exempt from patent infringement.94
4 Indirect infringement of Swiss type claims
The article regulating indirect or contributory infringement in the Netherlands is article 73 of the Dutch Patent Act (DPA). Although the respective provisions on indirect infringement in different EU countries correspond with article 26 of the Community Patent Convention (which never entered into force), the test for indirect infringement has been approached in differing ways by courts throughout the EU.
Article 73 (1) DPA reads as follows:
“The patent holder may institute the claims at his disposal in enforcing his patent against any party who offers or supplies in the Netherlands or Netherlands Antilles, in or for his business, to parties other than those who by virtue of Articles 55 to 60 are empowered to use the patented invention, the means for putting the patent invention into effect in the Netherlands or Netherlands Antilles relating to an essential element of the invention, provided that that person knows, or it is obvious in view of the circumstances, that those means are suitable and intended for that application.”95
4.1.1 Means relating to an essential element of the invention
Indirect infringement occurs when someone supplies or offers to supply “a means relating to an essential element of the invention, for putting the invention into effect.” In the Netherlands, 93 See e.g. Blomme, p. 93; Benyamini, p. 95; Bostyn, p. 21, 22; see however Jaenichen et al, para 3.2, who contend that a prescribed product can only be protected as a direct product if a medicine has been manifestly customized for the claimed use, within the meaning of German patent jurisprudence.
94 Benyamini 1993, p. 92.
what exactly can constitute such a means has been the object of much debate. According to the Dutch Supreme Court such a means is “that with which the teaching of the patent is distinguished from the prior art”.96 However, in the opinion of many Dutch legal scholars this
interpretation is incorrect. A more commonly accepted interpretation is that every element of the patent claim is a means relating to an essential element of the invention.97
4.1.2 The knowledge requirement
For indirect infringement to occur it is further needed that the person supplying the means has knowledge or it is clear from the circumstances that the means are suitable and intended for putting the invention into effect. This means that the “supplier knows or it is obvious in the circumstances, that ultimate users will intend to put the invention into effect.”98
As we shall see indirect infringement of Swiss type claims is in many cases impossible in the Netherlands. For this reason, the requirements of indirect infringement are discussed in greater detail in the context of EPC-2000 claims.99
4.2 Case law on indirect infringement
The most important case for the interpretation of Swiss type claims in the Netherlands has been the Novartis v Sun case. In a preliminary decision, The Hague Court of Appeal decided that Sun was indirectly infringing Novartis’ Swiss type SMI patent. However, in the decision on the merits the District Court of The Hague ruled differently and followed Justice Arnold’s opinion that there could be no indirect infringement of a Swiss type claim. For reasons of clarity the rulings in the Novartis v Sun and the Warner Lambert v Actavis cases are discussed in chronological order.
4.2.1 Novartis v. Sun –facts of the case
The facts of the case are highly relevant for understanding the reasoning behind the Court of Appeal’s preliminary ruling, and in my opinion they illustrate the importance of the enforceability of Swiss type claims.
96 Supreme Court of The Netherlands, 31 October 2003, BIE 2004, 37 (Sara Lee/Integro).
97 See e.g. De Hullu 2003; Blomme 2015, p. 258, Blomme states that this interpretation is also followed by British and German courts.; Geerts, p. 53.
98 Grimme Maschinenfabrik v. Scott [2010] EWCA Civ 2220; [2011] F.S.R. 7., para. 115.; this interpretation is consistent with Benyamini, p. 192.
In the 1980’s Novartis discovered zoledronic acid and developed a medicine for use in the treatment and prevention of tumour related bone diseases.100 In 2001 Novartis applied for a
Swiss type SMI patent for use of zoledronic acid for the preparation of a medicament for the treatment of osteoporosis.101 Novartis currently manufactures a zoledronic acid solution which
is administered once a year for the treatment of osteoporosis, and marketed as Aclasta.102
Aclasta is also approved as medicine for the treatment of Paget’s disease, a rare disorder that can lead to enlarged or malformed bones. Shortly after the basic compound patent expired Sun obtained a market licence from the Medicines Evaluation Board (MEB) for a zoledronic acid solution which corresponds to Aclasta.103 The market approval was granted for the
treatment of both osteoporosis and Paget’s disease. Sun requested the MEB to remove the indication osteoporosis by means of a carve-out from the SmPC and the PIL.104 However, at
the time the MEB had the policy to publish the full version of carved out SmPCs and patient information leaflets on its website.105
VGZ, a health insurance provider, has implemented a so-called preferential policy.106 This means
that VGZ selects which pharmaceuticals it will reimburse by a so-called tender procedure. The company that offers a specific drug for the lowest price wins the tender and ensures that the health insurer will only reimburse the winner’s version of a medicine. Sun had registered its zoledronic acid product for VGZ’s tender and won.107 As a result of this, Sun’s zoledronic acid solution is the
only zoledronic acid solution that VGZ reimburses for any indication, irrespective of Novartis’ patent.
After winning the tender Sun sent an email to wholesalers and hospital pharmacies stating that its generic medicine was as of yet only meant for the treatment of Paget’s disease, that the osteoporosis indication was protected by a patent owned by Novartis, and that osteoporosis was therefore not mentioned in the PIL.108 The email was headed by the sentence: “This information
concerns a formality.”109 However, because of the proportion of patients who suffer from Paget’s
100 District Court of The Hague, preliminary decision, 12 May 2014, IEF 13841, r.o. 2.2. 101 Ibid., para. 2.5. 102 Ibid., para. 2.4. 103 Ibid., para. 2.8. 104 Ibid., para. 2.9. 105 Ibid. 106 Ibid., para. 2.11. 107 Ibid.
108 Court of Appeal of The Hague 27 January 2015, IEF 14599, para. 4.32. 109 Ibid., para. 4.35.
disease (2.7%) in relationship to the proportion of patients that suffer from osteoporosis (97.3%) it was almost certain that Sun’s generic medicine would be dispensed and used for the treatment of osteoporosis.
In first instance in summary proceedings Novartis was denied an injunction because the judge deemed the patent to be invalid due to lack of novelty.110
4.2.2 Court of Appeal – Novartis v. Sun
Novartis appealed the summary judgement at the Court of Appeal of The Hague. The Court deemed the patent valid and went on to the question of infringement.111 Interestingly, Novartis
based its infringement claim solely on article 73 DPA, which regulates indirect infringement. The Court of Appeal accepted Novartis’ estimation that 97.3% of zoledronic acid sold will be used for osteoporosis. Novartis based this estimate on the sale of Aclasta in the years before a generic equivalent came on the market. The court pointed out that all patients who are insured with VGZ and are prescribed zoledronic acid will receive Sun’s generic product, irrespective of the indication.112 Moreover, the court concluded that the vast majority of the generic product would be
prescribed and dispensed for the patented indication, assuming that the patients insured with VGZ are a representative sample of the Dutch population.113
Means and knowledge
Interestingly, there was no dispute between parties that the zoledronic acid supplied by Sun constitutes a means relating to an essential element of the invention.114 Because Sun had
committed itself to supply unlimited amounts of generic zoledronic acid, the court concluded that the supply was not limited to that for the treatment of Paget’s disease, but was also for the treatment of osteoporosis.115 Sun had however sent VGZ an email which stated that the generic
zoledronic acid was only for the treatment of Paget’s disease and that osteoporosis was an 110 District Court of The Hague, 12 May 2014, C/09/460540 / KG ZA 14-185.
111 Court of Appeal of The Hague, preliminary decision, 27 January 2015 (Novartis v Sun), IEF 14599, para. 4.31.
112 Ibid., para. 4.30. 113 Ibid.
114 Ibid., para. 4.31. 115 Ibid.
indication still covered by a patent held by Novartis. However, the court did not find that this made any difference, because Sun had not attached any consequences regarding the obligation to supply unlimited amounts of the generic product, to the notification.116
The court of appeal concluded that the generic product would unavoidably be dispensed and administered for the treatment of osteoporosis.117 Doctors almost exclusively prescribe generically
and pharmacists are obliged to dispense the preferential product, even if Aclasta had been prescribed by brand name. The court concluded that Sun must have known that at the end of the distribution chain its product would also be dispensed for the patented indication.118 Because of
this the court came to the preliminary opinion that the necessary requirement of knowledge of the infringing use of the generic product for indirect infringement had been met.119
Moreover, the court considered that the fact that Sun could only sell its product under the conditions of the tender for all indications, did not relieve it from its duty to do everything possible to prevent that its product would be dispensed for the treatment of osteoporosis.120 The
court also considered that the email Sun had sent to wholesalers and hospital pharmacies was not sufficient. Sun should have at least made clear that the generic product should not have been prescribed or dispensed for the treatment of osteoporosis, because this would infringe Novartis’ patent rights.121 By heading the email with “This notification is a mere formality”, Sun had given
the suggestion that it is unimportant that the generic product is only intended for the treatment of Paget’s disease and that the treatment of osteoporosis is still protected by Novartis’ patent, and that no measures need be taken.122 The court concluded provisionally that Sun was indirectly
infringing Novartis’ patent.123
The outcome of the “realistic approach” by the Court of Appeal has been welcomed in the literature.124 I agree that the court’s reasoning is understandable considering the facts of the case,
in particular the fact that 97% of the generic drug was being used for the patented indication. 116 Ibid., para. 4.32. 117 Ibid., para. 4.33. 118 Ibid. 119 Ibid. 120 Ibid., r.o. 4.34. 121 Ibid., r.o. 4.35. 122 Ibid., r.o. 4.35.
123 Ibid., r.o. 4.37; indirect infringement is provided for by article 73 in conjunction with article 70 of the Dutch Patent Act.
However, it is unclear why the court did not look into the manufacturing element of Swiss type claims. As we shall see, The Hague District Court ruled differently in the decision on the merits after Justice Arnold’s ruling in the Warner Lambert case.
4.3 UK Warner Lambert v Actavis cases
4.3.1 Preliminary decisions
In interim proceedings in the Warner Lambert (WL) case discussed above under 4.2.1, Justice Arnold dismissed WL’s indirect infringement claim under section 60(2) of the 1977 Patent Act (which corresponds to article 26 CPC). His reasoning was as follows:
“There can only be infringement under section 60(2) if there can be infringement by the person supplied or by a user further down the chain of supply (although it is not necessary for there actually to be an infringing act). This is not the case here, since no wholesaler or pharmacist will use Lecaent to prepare a pharmaceutical composition.”125
In a second judgement126 Arnold considered The Hague Court of Appeal’s preliminary finding
of indirect infringement in the Novartis v. Sun case discussed above at 5.2.1. and noted that in that case the Court had in his opinion assumed that the claim in question was a product claim.127 He pointed out that Swiss type claims have a different scope than EPC-2000 claims
and that therefore the reasoning that Swiss type claims should be seen as product claims could not be justified.128
In a third judgement, the judge struck out WL’s claim to indirect infringement. According to Arnold the claim of indirect infringement was “simply hopeless”.129 Arnold considered that
interpreting a Swiss-type claim in the same way as an EPC-2000 claim, and in particular as a product claim, was “wholly unsustainable” in view of UK case law and the T 1780/12 case of the EPO’s Technical Board of Appeal.130 The judge further noted that the Court of Appeal’s
125 Warner Lambert v. Actavis [2015] EWHC 72 (Pat) (21 January 2015), para. 113. 126 Warner Lambert v. Actavis [2015] EWHC 223 (Pat) (6 February 2015).
127 Ibid., para. 55. 128 Ibid., para. 56.
129 Warner Lambert v. Actavis [2015] EWHC 249 (Pat) (06 February 2015), para. 2.
130 Arnold referred cases: John Wyeth & Brother Ltd’s Application [1985] RPC 545, 563; Monsanto & Co. v Merck & Co. Inc. [2000] RPC 77, 92-93; Actavis UK Ltd v Merck & Co. Inc. [2008] EWCA Civ 444, [2009] 1 WLR 1186.
