Decision of the Swiss Federal Court of 4 March 2011 (4A_437/2010), 1st civil division
Articles:
SPL (Swiss patent law) Articles 2(2)(a), 7d; EPC Articles 52(1), 52(4) EPC 1973, 53(c) EPC, 54(4), 54(5)
Keyword:
Dosage regime for known medicament – decisions of EPO and national courts considered – "Swiss-type" claim – uniform law – freedom of medical treatment
Editorial office headnote:
1. Patentability is not necessarily excluded if the only feature claimed which is not in the state of the art is a dosage regime for a known medicament. That regime must however be new and inventive. So merely defining it differently in the claim is not enough; it must contain a technical teaching divergent from the state of the art.
2. In Article 52(4) EPC 1973 and Article 53(c) EPC the contracting states adopted unitary rules on patentability, whereas infringement of European patents is governed by national patent law (see Article 64(3) EPC). Therefore, the unitary patentability rules and the exceptions thereto are not to be interpreted in terms of national law: the lack of a specific national provision to the effect that doctors treating their patients will not normally be regarded as infringing a patent cannot justify a divergent interpretation of the EPC and a widening of the patentability exclusions under its harmonised rules. If this means that action to protect the freedom of medical treatment is required, lawmakers should provide for exemptions from the patent's effect accordingly.
Summary of facts and submissions
The appeal is against the decision of 14 April 2009 given by Zurich commercial court.
Facts:
A.
On 28 March 2007 the European Patent Office granted EP 1 175 904 (the patent in suit), for the use of "alendronic acid" to treat osteoporosis.
Claim 1 of the patent in suit reads as follows:
"Use of alendronate in the manufacture of a medicament for treating osteoporosis in a human in need of such treatment, where said medicament is orally administered to said human as a unit dosage comprising about 70 mg of the alendronate compound, on an alendronic acid active weight basis, according to a continuous schedule having a once-weekly dosing interval."
Treatment of osteoporosis using alendronic acid was already known.
B.
B(a) On 28 January 2008 the respondents filed a suit with the Zurich commercial court seeking revocation of the patent in suit for Switzerland ...
By decision of 14 April 2009, that court found in their favour, essentially on the basis that the dosage claimed was non-patentable under Article 2(2)(a) SPL and Article 52(4) EPC 1973.
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C.
The proprietor appealed to the Federal Court, petitioning it to set aside the decision of 14 April 2009 and to dismiss the suit of 28 January 2008, or – as an auxiliary request – to send the case back to the lower court for review.
The respondents requested that the appeal be dismissed ...
The appeal succeeded; Zurich commercial court's decision was set aside, and the case sent back to it for review.
Extract from the reasons
1.
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2.
The appellant argues that the lower court's view of the "dosage regime" feature was mistaken.
2.1 The lower court left open whether the patent in suit fulfilled the requirements for a "patentable invention" within the meaning of Article 52 EPC 1973 ...., and in particular failed to consider whether the claimed dosage regime was new and inventive (Article 52(1) EPC 1973). Instead it held that the patent's independent claim 1 was in any case non-patentable in view of Article 52(4) EPC 1973, which reads as follows:
"(4) Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body shall not be regarded as inventions which are susceptible of industrial application within the meaning of paragraph 1. This provision shall not apply to products, in particular substances or compositions, for use in any of these methods."
2.1.1 The lower court reasoned that the patent's claim 1 was directed to the use of a known substance (alendronic acid) in manufacturing a medicament for a known medical indication (treatment of osteoporosis), differing from the previous use only in the dosage regime (70 mg once weekly). It therefore deemed it necessary to decide whether the patent involved an allowed second medical use ("Swiss-type claim"), or a "method for treatment by therapy" which was non-patentable under Article 2(2)(a) SPL (not amended in the revision of 22 June 2007) or Article 53(c) EPC 2000 (which corresponds to Article 52(4) EPC 1973).
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2.2
2.2.1 The EPC 1973 (as since amended on 29 November 2000 by the EPC 2000) established a system of law common to the contracting states for the grant of patents for invention (see Article 1 EPC 1973/EPC 2000). Under Article 52 et seq., European patents granted under the EPC are subject to uniform rules governing the substantive patentability criteria. True, the EPC does not provide that the decisions of EPO bodies are binding on courts in the contracting states. However, given its objective of establishing legal uniformity – which is also not challenged by the parties - account must be taken of the case law of the EPO's boards of appeal (decision of the Swiss Federal Court, BGE 133 III 229 E. 3, 231 et seq.), interpreted where applicable in the light of relevant decisions by foreign courts, especially by higher instances but also, if convincingly argued, by lower ones (see decision of the Swiss Federal Court, BGE 121 III 336 E. 5c, 338; 117 II 480 E. 2b, 486 et seq.; re judicial co-operation in the field of patent law, see Stefan Luginbühl, Die neuen Wege zur einheitlichen Auslegung des Europäischen Patentrechts, GRUR 2/2010, 99 et seq.).
2.2.2 The EPO's Enlarged Board of Appeal has now ruled on the referred matters (mentioned by the lower court) relating to the patentability of dosage regimes. In decision G 2/08 of 19 February 2010 (OJ EPO 10/2010, 456 et seq.), it held that Article 54(5) EPC 2000 did not exclude a medicament already known to treat an illness from being patented for use in a different treatment by therapy of the same illness (Question 1). Patentability was also not excluded where a dosage regime was the only feature claimed which was not comprised in the state of the art (Question 2). Lastly, where the subject-matter of a claim was rendered novel only by a new therapeutic use of a medicament, such claim could no longer have the format of a so-called Swiss-type claim as instituted by decision G 1/83 (Question 3).
The appellant argued that G 2/08 – for which the lower court had not waited – had clarified the situation also for the present litigation, there being also no apparent reason for departing from the case law already developed in T 1020/03 of 29 October 2004 (OJ EPO 4/2007, 204 et seq.) for the EPC 1973, and now confirmed for the EPC 2000. The respondents however maintained that the Enlarged Board's decision was based solely on revised Article 54(5) EPC 2000, which did not apply to the patent in suit; G 2/08 therefore did not apply in the present dispute.
2.2.3 As the respondents correctly point out, the EPC 2000 did not enter into force until 13 December 2007. Under Article 1.1 of the EPO Administrative Council's decision of 28 June 2001 on the transitional provisions under Article 7(1), second sentence, of the Act revising the EPC 1973, Articles 52, 53, 54(3) and (4) EPC 2000 on patentability apply also to European patents already granted at the time of their entry into force, whereas, under that decision's Article 1.3, Article 54(5) EPC 2000 applies to European patent applications pending at the time of its entry into force, in so far as a decision on the grant of the patent has not yet been taken.
The patent in suit was granted on 28 March 2007. So the patentability issue in the present litigation is to be judged under revised Articles 53(c) and 54(4) EPC 2000. Article 54(5) EPC 2000 does not apply, because on 13 December 2007 the patent in suit had already been granted.
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2.2.4 On Article 52(4) EPC 1973 the Enlarged Board had already noted that this exclusion from patentability was based on socio-ethical and public-health considerations, although the lawmaker had chosen the legal fiction of lack of industrial applicability. Physicians had to be able to take any action they considered suitable to prevent or cure a disease, without being inhibited by patents. The reason Article 52(4) EPC 1973 had gone into the revised EPC as Article 53(c) was thus that it was no longer justified to base these methods' non-patentability on lack of industrial application (G 2/08, loc. cit., points 5.3-5.5, 474 et seq.; G 1/04 of 16 December 2005, OJ EPO 5/2006, point 3, 347, point 10, 359; see also G 1/83 of 5 December 1984, OJ EPO 3/1985, point 22, 63). The amendments in Article 53(c) 2000 are purely editorial and not intended to change the legal situation (see the explanatory remarks on the transitional provisions of the revised EPC 2000, OJ EPO 2001, special edition No. 4, p. 135, point 6; for background to the new text, see G 2/08, loc. cit., point 5.5, 475 et seq.). Nor, clearly, did revised Article 54(4) EPC substantively change the legal situation compared with the earlier Article 54(5) EPC 1973 (see the explanatory remarks on the transitional provisions of the revised EPC 2000, loc. cit., p. 135 et seq., points 6 and 8; G 2/08, loc. cit., point 5.8, 477 et seq.).
Therefore, EPO board of appeal decisions issued under the EPC 1973 remain significant. Secondly, pace the respondents, Enlarged Board decision G 2/08 is indeed relevant for the present litigation, particularly since it concerns itself with not only Articles 53(c) and 54(4) EPC 2000 but also the case law on Articles 52(4) and 54(5) EPC 1973.
2.2.5 Like the old Article 52(4) EPC 1973, Article 53(c) EPC 2000 distinguishes between unallowable method claims directed to a therapeutic treatment (first half-sentence) and allowable claims to products for use in such methods (second half-sentence). The two concepts of a method for treatment by therapy and of a product to be used in such a method must each be confined to its own domain as allocated to it by the law. It would be improper to consider Article 53(c), second half-sentence, EPC 2000 as lex specialis vis-à-vis the first half-sentence, to be interpreted narrowly. Both in fact must be given the same weight, which means that method claims directed to treatment by therapy are absolutely prohibited, whereas claims directed to products for use in such methods are allowable provided their subject-matter is new and inventive (G 2/08 of 19 February 2010, loc. cit., p. 477, point 5.7). Thus Article 53(c), second half-sentence, and Article 54(4) EPC 2000 do not constitute exceptions, to be interpreted narrowly, to the absolute prohibition on patenting methods of therapy (Article 53(c), first half-sentence, EPC 2000), but constitute provisions enjoying an identical ranking and aiming at allowing patent protection for medicaments as a matter of principle. Accordingly, the exception to patentability under Article 53(c), first half-sentence, EPC 2000, under which methods for treatment by therapy are excluded from patent protection, must be interpreted in conjunction with the provisions of Article 53(c), second half-sentence, and Article 54(4) EPC 2000, which enjoy identical ranking and are not mutually exclusive but in fact complementary (G 2/08 of 19 February 2010, loc. cit., p. 480, point 5.9.1.2, and p. 486, point 5.10.9).
2.2.6 Like the old Article 54(5) EPC 1973, Article 54(4) EPC does not prohibit the patenting of any substance or composition, even if comprised in the state of the art, provided that it is intended for use in a method referred to in Article 53(c) EPC 2000 and that its use for any such method is not comprised in the state of the art. Hence a product for use in a method for treatment by therapy may be granted patent protection not only if it is new per se and can therefore constitute the subject-matter of a product claim, but as a substance or composition under Article 54(4) EPC 2000 it is patentable even if it is already known per se but has not yet been used in a method for treatment by therapy. This first medical indication is in general the object of broad generic claims in the form of use-related product claims (G 2/08 of 19 February 2010, loc. cit., p. 477 et seq., Reasons 5.8; see Christoph Bertschinger, Patentfähige Erfindung, in: Schweizerisches und europäisches Patentrecht, 2002, section 4, point 71).
2.2.7 Under the EPC 1973 there was no provision comparable to Article 54(5) EPC 2000 expressly extending patent protection to products (substances or compositions) already known as medicaments. This lacuna had however been filled "in a praetorian way" by the Enlarged Board with G 5/83 of 5 December 1984 (loc. cit., p. 64 et seq.) and the case law based on that decision (G 2/08 of 19 February 2010, loc. cit., p. 478, Reasons 5.9), whereby "Swiss-type" claims may be granted for a second or further medical indication provided that they are directed to the use of a substance or composition for the manufacture of a medicament for a "specified new and inventive therapeutic application" (G 5/83 of 5 December 1984, loc. cit., p. 66, Reasons 23 and Order 2; see also Bertschinger, loc. cit., Section 4, point 72). This applies even if the process of manufacture as such does not differ from known processes using the same active ingredient, i.e. if the medicament resulting from the claimed use is not in any way different from a known medicament (G 5/83 of 5 December 1984, loc. cit., p. 66, Reasons 20, 23).
The respondents are wrong to argue that "in the manufacture of a medicament" is an irrelevant feature of claim 1, especially as this type of claim is actually enshrined in law in Switzerland under Article 7d SPL (see also Peter Heinrich, Kommentar zu PatG/EPÜ, 2nd ed. 2010, No. 1 re Article 7d SPL). Furthermore, the Enlarged Board's ruling that Swiss-type claims would in future no longer be allowed is based on the new claim category of purpose-related product protection that was created by Article 54(5) EPC 2000 and does not apply to patents that have already been granted (G 2/08 of 19 February 2010, loc. cit., p. 491 et seq., Reasons 7).
In such cases, novelty for patentability purposes and hence also inventive step, if any (see Article 52(1) EPC 2000), are derived not from the substance or composition as such but from its intended therapeutic use.
2.2.8 On the basis of the case law on Article 54(5) EPC 1973 (equivalent to present Article 54(4) EPC 2000), initially arising from Enlarged Board decision G 1/83 and subsequently developed, patent protection in the form of Swiss-type claims may also be granted for a specific therapeutic use as a further medical indication provided that the claim is directed to the use of a substance or composition for the manufacture of a medicament. Article 52(4), first sentence, EPC 1973 (now Article 53(c), first half-sentence, EPC 2000) does not prohibit the granting of such a claim; in fact, patent protection for medicaments is specifically supported by Article 52(4), second sentence, EPC 1973 (Article 53(c), second half-sentence, EPC 2000) and Article 54(5) EPC 1973 (Article 54(4) EPC 2000) or their application mutatis mutandis (G 2/08 of 19 February 2010, loc. cit., p. 486 et seq., Reasons 5.10.9; G 5/83 of 5 December 1984, loc. cit., p. 66 et seq., Reasons 21 f; see also Mario M. Pedrazzini/Christian Hilti, Europäisches und schweizerisches Patent- und Patentprozessrecht, 3rd ed. 2008, p. 129, according to which Article 53(c) EPC 2000 and Article 2(2)(a) SPL do not exclude patentability if a method of treatment takes the form of a product or use claim).
Moreover, in keeping with the Enlarged Board, the assumption must be that the described arrangement is not confined to a new indication in the sense of a new illness, but applies even if the use of a known medicament is directed to the treatment of an illness that has already been treated with the same composition, provided that the said treatment is new and inventive. That already reflected established EPO appeal board case law under EPC 1973, typically in cases relating to a novel group of subjects treated (T 19/86 of 15 October 1987, OJ EPO 1-2/1989, 28, Reasons 8; T 893/90 of 22 July 1993, Reasons 4.1 and 4.2; T 233/96 of 4 May 2000, Reasons 8.7), to a new route or mode of administration (T 51/93 of 8 June 1994, Reasons 3.1.2; T 138/95 of 12 October 1999, Reasons 4 et seq.; see also T 120/03 of 29 October 2004, Reasons 51) or to a different technical effect (T 290/86 of 13 November 1990, OJ EPO 8/1992, 425, Reasons 6.1; T 254/93 of 14 May 1997, OJ EPO 6/1998, 291, Reasons 3; see also G 2/08 of 19 February 2010, loc. cit., 485 et seq., Reasons 5.10.5-7, with further references; Benkard/Klaus-Jürgen Melullis, in: Europäisches Patentübereinkommen, 2002, No. 231 et seq. re Article 54 EPC 1973; Bertschinger, loc. cit., Section 4, point 87 et seq.; Heinrich, loc. cit., No. 55 re Article 2 SPL/Article 53 EPC 2000). The Federal Court sees no reason to depart from these principles.
2.2.9 Consequently, in due application of Article 54(5) EPC 1973 (now Article 54(4) EPC 2000) claims are allowable for a second or further medical indication if they are directed to the use of a substance or composition for the manufacture of a medicament for a specific new and inventive therapeutic application. According to the unchallenged teaching of previous EPO case law, this application need not relate to a different illness; it is sufficient for it to relate for example to a novel group of subjects treated or a new mode of administration (see e.g. Benkard/Melullis, loc. cit., No. 231 et seq. re Article 54 EPC 1973; Heinrich, loc. cit., No. 55 re Article 2 SPL/Article 53 EPC 2000, No. 7 re Article 7d SPL/Article 54 EPC 2000; Reinhard Spangenberg, in: Margarete Singer/Dieter Stauder [ed.], Europäisches Patentübereinkommen, 5th ed. 2010, No. 94 et seq. re Article 54 EPC 2000; Rainer Moufang, in: Rainer Schulte [ed.], Patentgesetz mit EPÜ, 8th ed. 2008, No. 270 re Article 52 EPC 2000). Thus there is no evident reason why a purportedly new dosage regime or a specific dosage regime for a known medicament should be treated differently to these recognised features. Hence patentability is not necessarily excluded if the only feature claimed which is not in the state of the art is a dosage regime.
For purposes of patentability, however, the dosage regime has to be new and inventive (Article 52(1) EPC 2000). So merely defining it differently in the claim is not enough; it must contain a technical teaching divergent from the state of the art. It needs to be stressed that a dosage regime in the great majority of cases will be obvious, especially as it is obvious to try out different dosages when developing medicaments.
2.2.10 The Federal Court's conclusion on the significance of dosage regimes in patent law was also reached by the England and Wales Court of Appeal in a decision dated 21 May 2008 and thus preceding G 2/08 (in re Actavis vs. Merck [2008] EWCA Civ 444; see Thierry Calame, Court of Appeal stellt gefestigte EPA-Praxis über eigenes Präjudiz: Patentschutz für zweite medizinische Indikation aufgrund neuen Dosierungsregimes bejaht, in sic! 12/2008, p. 925 et seq.). The lower court took this ruling into account, but wrongly deemed it irrelevant on the grounds that it made no reference to ingestion frequency, which was a feature of major significance in the case in point. In doing so it failed to note that with its ruling - still under EPC 1973 - the Court of Appeal, after a thorough examination of European case law, radically changed its previous jurisprudence on dosage regimes and now allows patent protection for a second medical indication under a new dosage regime. In particular, it overturned the precedent of the decision in re Bristol-Myers Squibb vs. Baker Norton, by which both the High Court and the Court of Appeal had still held themselves to be bound in the decisions cited by the lower court in connection with the parent of the patent in suit. The significance of this change of practice is emphasised by the fact that the Court of Appeal in this decision established a new exception to the binding force of its own rulings. Consequently, the two English rulings taken into account by the lower court are immaterial to the present case, while the latest case law clearly follows that of the EPO's boards of appeal.
The divergent judgment 07/16296 of the Paris Tribunal de Grande Instance of 28 September 2010 on the other hand, while mentioning Enlarged Board decision G 2/08, does not take it into consideration, maintaining that the decisions of the EPO's boards of appeal do not have a binding effect. Hence this first-instance ruling is of limited significance for the present case, as is the German Federal Court's Carvedilol II decision of 19 December 2006 (X ZR 236/01), cited by the lower court, which in relation to the assessment of dosage regimes does not investigate European case law on the treatment of Swiss-type claims.
2.2.11 Contrary to the respondents' view, it is not materially significant that G 2/08 ultimately relates to the new Article 54(5) EPC 2000, which is not yet applicable to the patent in suit. In construing this provision the Enlarged Board chiefly relied on the old interpretation of Articles 52(4) and 54(5) EPC 1973 and went to great lengths to demonstrate that the patentability principles developed in the case law continued to apply with the introduction of Article 54(5) EPC 2000 because the lawmaker had intended no change in that respect (G 2/08 of 19 February 2010, loc. cit., p. 478 et seq., point 5.9 et seq.; see in particular: p. 480, point 5.9.1.2, and p. 486, point 5.10.8; see also André Escher, Der Entscheid "dosage regime", in sic! 7-8/2010, p. 549 et seq.). ... Consequently the latest EPO case law is also relevant to the legal situation under the EPC 1973.
2.2.12 Yet it should be noted that under the revised EPC 2000 differences will arise over the extent of protection. According to new Article 54(5) EPC 2000, use-related product claims directed to the substance itself may now be granted, whereas under the old EPC 1973 only Swiss-type claims were allowed, i.e. claims directed to the use of a substance for the manufacture of a medicament for a therapeutic application. The new claim category of purpose-bound substance protection under Article 54(5) EPC 2000 is likely to offer the patent proprietor broader rights than before, which in the Enlarged Board's view might in particular lead to restrictions on the freedom of physicians to prescribe or administer generic drugs (G 2/08 of 19 February 2010, loc. cit., p. 490, point 6.5).
Fears that physicians might face facing patent infringement actions, particularly in the absence of any specific provision to protect them, were ultimately the reason for the lower court's contested decision to deny patentability for claim 1 of the patent in suit. It should be recalled that the claim in question is drafted as a Swiss-type claim and thus is directed to the use of alendronate for the manufacture of a medicament, which means that patent infringement is not so much of an issue as under the broader scope of protection expected by the Enlarged Board for the use-related product claims that are now allowable under Article 54(5) EPC 2000. In particular, though, it should be borne in mind that in Article 52(4) EPC 1973 and Article 53(c) EPC 2000 the contracting states adopted unitary rules on patentability, whereas infringement of European patents is governed by national patent law (see Article 64(3) EPC 1973/EPC 2000). Thus the unitary patentability rules and the exceptions thereto are not to be interpreted in terms of national law or in the light of the lack of national provisions allowing actions that particularly deserve protection to be excluded from the effect of the patent. If this means that action to protect the freedom of medical treatment is required, lawmakers should provide for exemptions from the patent's effect accordingly (see Article 9 SPL). It therefore seems appropriate to alert the Swiss lawmaker to the issues involved. However, the lack of a special national provision to the effect that doctors treating their patients will not normally be regarded as infringing a patent cannot justify a divergent interpretation of the EPC and a widening of the patentability exclusions under its harmonised rules.
3.
The lower court wrongly deemed a new dosage regime to be normally non-patentable. It wrongly subsumed claim 1 of the patent in suit under the exception to patentability under Article 52(4) EPC 1973 and Article 53(c) EPC 2000.
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CH 1/11