In its two recent decisions, the Düsseldorf Higher Regional Court redefined the requirements for the infringement of second-medical-use patents. Besides the cases of "purposeful preparation" of a medicament for the protected use, now, a direct infringement also "in some other way" may be considered if the medicament is objectively suitable for the patented use and the supplier takes advantage of external circumstances, which ensure that the offered medicament is used for the patented purpose. Thus, the recent case law increases liability risks for the infringement of secondmedical-use patents.
BACKGROUND INFORMATION: SECOND-MEDICAL-USE PATENTS
Second-medical-use patents claim the use of an already known substance or combination of substances for a new therapeutic use. According to the previous case law of the European Patent Office (EPO), second-medical-use patents were granted as manufacturing use claims ("Swiss-type claims"), which are directed towards the "use of a substance X for the preparation of a medicament for the treatment of the disease Y". Since the coming into effect of Art. 54 para. 5 of the EPC in the version of 13 December 2007, which corresponds with Sec. 3 para. 4 of the German Patent Act (GPA), second-medical-use claims, henceforth, as use claims can also be directed towards a "substance X for the treatment of disease Y" if the therapeutic use is new and inventive (cf. German Federal Court of Justice (FCJ), GRUR 2014, 461 – Kollagenese I).
As clarified by the FCJ in various decisions (cf. recently GRUR 2016, 921 – Pemetrexed), (pharmaceutical) use patents and manufacturing use patents grant a "purpose-limited substance protection". In both cases, the claim relates to the suitability of an already know substance for a specific therapeutic use and, therefore, ultimately to a property which is inherent to the substance itself. Accordingly, in infringement cases, Swisstype claims are treated like "ordinary" purposelimited substance claims (cf. Düsseldorf Higher Regional Court, GRUR 2017, 1107 – Östrogenblocker).
PREVIOUS CASE LAW: DIRECT INFRINGEMENT REQUIRES PURPOSEFUL PREPARATION
According to previous case law, the protection of a second-medical-use patent does not only cover the immediate therapeutic use of a medicament (e. g. prescription or application by a physician) for the patented therapeutic purpose, but already in the commercial run-up when manufacturing, offering and supplying the substance for this purpose (cf. FCJ, GRUR 2001, 730 – Trigonellin). In that respect, it is required that the substance is not only objectively suitable but also "purposefully prepared" for the protected therapeutic use. This is the case if there is a direct and targeted link between the act of purposeful preparation on the one hand and the manufacture and supply of the substance (or the medicament) on the other hand, which clearly directs the user towards the patented use. Such purposeful preparation may, for example, be realized by a formulation, dosage, packaging, labelling, package leaflet and/or SmPC of the medicament which specifically direct towards the patented use (cf. FCJ, GRUR 1987, 794 – Antivirusmittel; FCJ, GRUR 2001, 730 – Trigonellin).
However, in the legal practice, the requirements for purposeful preparation in the context of second-medical-use patents have been comparatively high so far. Generally, purposeful preparation was only assumed by the courts if the SmPC and/or the package leaflet explicitly referred to the patented use. This did not change even when in reality the use of the attacked medicament also for the protected therapeutic purpose could not be ruled out entirely (cf. Düsseldorf Regional Court, GRUR-RR 2004, 193 – Ribavirin). Furthermore, purposeful preparation was even ruled out when elsewhere separate from the specific medicament the use for the protected indication was explicitly pointed out in general advertising materials or by sales representatives of the concerned supplier, since it was not certain whether the recipient of the medicament takes note of the separate advertisement at all and whether that actually results in the protected use of the medicament (cf. Düsseldorf Higher Regional Court, decision of 31.1.2013 - I-2 U 54/11, BeckRS 2013, 11782 – Cistus Incanus). Due to this narrow scope of application of the principles of purposeful preparation, a patent infringement could regularly be easily bypassed through a regulatory carve-out in the SmPC according to Sec. 11a para. (1e) of the German Drug Act or Art. 11 para. 2 of the Directive 2001/83/EC ("skinny label").
Lower liability requirements were assumed by the Hamburg Regional Court in case of cross-label use (GRUR-RR 2015, 330 – Rabattvertrag). In the pregabalin decision, the court concluded that due to the regulatory substitution mechanism according to Sec. 129 para. 1 sent. 1 no. 1, sent. 2 and 3, para. 2 of the German Social Code Book V (SCB V) it is evident that discounted generic medicaments will be dispensed to a significant extent also for the patent protected indication, if generics companies enter into unlimited discount agreements with statutory health insurers according to Sec. 130a para. 8 of the SCB V, which also cover the patent protected indication of the substance. The Hamburg Regional Court assumed that in this case the attacked generic medicaments are already purposefully prepared for the patented purpose, since they can be readily used for the treatment in the patented indication. In contrast to the case law of the Düsseldorf courts, according to the Hamburg Regional Court, a purposeful preparation does not necessarily require any further physical steps or the addition of any physical means, but rather only the designation of a specific purpose or use. Such designation was primarily made by the pharmacist who substitutes according to Sec. 129 para. 1 sent. 1 no. 1, sent. 2 and 3, para. 2 of the SCB V, the acts of whom are attributed to the generic company, since the substitution is not only certainly foreseeable for the generic company due to the existing social law mechanisms but is also intended by the laws.
DÜSSELDORF HIGHER REGIONAL COURT: DIRECT INFRINGEMENT ALSO WITHOUT PURPOSEFUL PREPARATION
In its recent decisions, also the Düsseldorf Higher Regional Court considers that patent infringement, particularly in the context of cross-label use, may now also be possible under less strict requirements (GRUR 2017, 1107 – Östrogenblocker and decision of 1.3.2018 – 2 U 30/17, BeckRS 2018, 2410). Based on the ruling of the FCJ, according to which the focus of protection granted by a manufacturing use patent is on the objective suitability of the respective medicament for the patented use, the Düsseldorf Higher Regional Court concludes that direct infringement of a second-medical-use patent may even be considered if a medicament is not purposefully prepared for the specific use by the supplier himself "in an active way" according to "traditional" standards, however, the protected use is ensured "in some other way".
The Düsseldorf Higher Regional Court has defined the requirements for the direct infringement of a second-medical-use claim as follows:
a) suitability of the medicament for the patented purpose; and
b) taking advantages of circumstances by the supplier of the medicament, which – similar to an "active" purposeful preparation by the infringer himself – ensure that the medicament offered and distributed is used for the patented therapeutic purpose.
The latter requires, according to the court, sufficient and not only occasional use of the medicament according to the patent as well as respective knowledge or at least bad faith of the supplier. According to the Düsseldorf Higher Regional Court, the aforesaid requirements may primarily be fulfilled in case of cross-label use. Therefore, in such cases it was justified and appropriate to hold the supplier of the medicament liable under patent laws if the supplier knows or should have known the prescription and substitution practice, which is favorable for him, and if he takes advantage of this practice nevertheless by supplying wholesalers.
The recent case law of the Düsseldorf Higher Regional Court increases the risks of liability for the infringement of second-medical-use patents since a direct infringement now also has to be taken into account if due to external circumstances it is evident that the medicament will be used for the patented purpose.
The main field of application of this case law are cross-label-use cases as pointed out by the Düsseldorf Higher Regional Court, where only a carve-out will not be sufficient to prevent liability anymore. Besides that, also such cases may become more relevant where guidelines of medical associations or directives (e. g. of the German Joint National Committee or the Medical Chamber) may recommend certain diagnostic or therapeutic procedures, which may not be explicitly mentioned in the SmPC or package leaflet and the execution of which may realize the protected teachings of the patent. Also here it is to be expected that irrespective of the existing patent protection physicians will generally comply with such scientifically justified and practiceoriented recommendations at least insofar as they reflect medical standards.
As regards cross-label use, now potential liability is not only to be considered – like in the pregabalin decision of the Regional Court Hamburg – in the context of unlimited discount agreements, but due to the "standard substitution regulations" according to Sec. 129 para. 1 sent. 1 no. 1, sent. 2, para. 2 of the SCB V even for cross-label use without any discount agreements and despite of a carve-out. According to these standard substitution rules, a generic medicament could be dispensed for the protected use even without the existence of a discount agreement, particularly if this medicament (under further requirements) is one of the three cheapest medicaments having the identical active substance like the originator drug. However, here, the taking advantage of external circumstances by the supplier for the commitment of a patent infringement may be less evident than in the case of unlimited discount agreements since also prices of competitor drugs need to be taken into account as well as the fact that there is no delivery obligation towards statutory health insurers for the protected therapeutic use. It then may be necessary to prove the scope of actual use of the medicament in the patented field, which may be – as recent case law of the Düsseldorf Higher Regional Court shows (decision of 1.3.2018 – 2 U 30/17, BeckRS 2018, 2410) – difficult in the individual case, for example in case the SmPC is silent on a specific handling of a medicament by physicians.
The Düsseldorf Higher Regional Court leaves open which measures may be expected from suppliers to prevent liability. In particular, a "substitution and patent notice" in drug databases and software for physicians and pharmacists may be considered. However, it is questionable to which extent the expected effects may be achieved only by such notice. Particularly, due to the existing regress and prescription bill auditing system, according to which physicians and pharmacists may be sanctioned for uneconomical prescriptions and substitutions, they will rather adhere to the patent infringing substitution mechanism. Therefore, further notices of the supplier towards statutory health insurers as well as associations of physicians and pharmacists for the avoidance of sanctions of physicians and pharmacists, who respect the concerned patent, may be necessary.
On the contrary, a "patent warning notice" on the packaging, the SmPC and/or the package leaflet of concerned medicaments, as frequently discussed, seems to be rather difficult. According to European marketing approval regulations, which are largely identical with national regulations, information on the labelling, SmPC or package leaflet beyond the mandatory information pursuant to Art. 11, 54 and 59 of the Directive 2001/83/EC are only possible to a limited extent. This mandatory information is primarily related to clinical and pharmacological properties of medicaments as well as their safe and effective handling, however, not to legal information. Furthermore, according to Art. 62 of the Directive 2001/83/EC, "other information" on the outer packaging or the package leaflet going beyond the scope of mandatory information must be useful for health education and compatible with the SmPC. A "patent warning notice" may, however, not fulfill these requirements since they are not useful for the health education of patients in any case. In that regard, it may not be decisive how such warning notice is attached to the packaging (cf. as regards the illicit advertisement on drug packaging FCJ, GRUR 2013, 857 – Voltaren).