Kim Parviainen of Castrén & Snellman Attorneys Ltd., Helsinki, Finland kim.parviainen@castren.fi Anna-Lena Orrenius of Oslo Patentkontor AS, Oslo, Norway aco@oslopatent.no Julie Shin of Lee&Ko, Seoul, South Korea Julie.shin@leeko.com Emre Kerim Yardimci of Deris Attorneys at Law Partnership, Istanbul, Turkey kerim.yardimci@deris.com Anna Mejlerö of Lundbeck A/S, Valby, Denmark annq@lundbeck.com Sami Nusair of Saba & Co. IP, Muscat, Oman snusair@sabaip.com Cheng Nien-Haw of Naexas Compass Group, Tokyo, Japan t.cheng@naexascompass.asia Edward Chatterton of DLA Piper Hong Kong, Central, Hong Kong, PR China Edward.chatterton@dlapiper.com Brian Gissane of Brandstock Services AG, Munich, Germany bgissane@brandstock.com Christoffer Vedal of Protector IP Consultants AS, Oslo, Norway cv@protector.eu Stefan Bojovic of MSA IP – Milojevic Sekulic & Associates, Belgrade, Serbia Stefan.bojovic@msa-iplaw.com Adrian Dykes of Simmons & Simmons LLP, London, UK Adrian.dykes@simmons-simmons.com Amund Brede Svendsen of Advokatfirmaet Grette DA, Oslo, Norway amsv@grette.no Wojciech Kreft of Novartis AG, Basel, Switzerland wojciech.kreft@novartis.com Moves and Mergers Darren Saunders has left Manatt Phelps & Phillips to join Wilson Keadjian Browndorf LLP in New York, USA. Darren can now be contacted at dsaunders@wkbllp.com Sema Salman Sinmez has left NSN Law Firm to join the telecommunications company, Turkcell Iletisim Hizmetleri AS, in Istanbul, Turkey. Sema can be contacted at sema.sinmez@turkcell.com.tr Please remember to let us know of any changes to your contact details. You can notify me either via the PTMG website www.ptmg.org or directly to Lesley@ptmg.org or by writing to me at Tillingbourne House, 115 Gregories Road, Beaconsfield, Bucks, HP9 1HZ Lesley Edwards PTMG Secretary Germany: Summary of product characteristics under direct attack Dr. Ralf Möller, Esche Schümann Commichau, Hamburg, Germany Back in 2013, the German Federal High Court of Justice fundamentally summarized the conditions established by the German jurisprudence for the lawfulness of pharmaceutical advertising and ruled on the significance of the marketing authorization and the product characteristics. In its landmark decision “Basisinsulin mit Gewichtsvorteil”, the court deemed certain claims which were made without referencing any study to be covered by the marketing authorization and/or the summary of product characteristics and therefore decided that these statements were not misleading. Thanks to the clear words of the German Federal High Court of Justice regarding the evidentiary value of the marketing authorization and/or the summary of product characteristics, it became advisable to even more thoroughly review to what extent healthcare-related advertising information can, as a matter of law, be evidenced in specific contexts with the marketing authorization and/or the product characteristics alone. By doing so, both the imponderables in connection with legal interpretations of scientific studies (a common issue in legal proceedings) and a possible prohibition of the advertising on account of its being misleading, could be avoided. In a recent decision dated 7 May 2015 "Äquipotenzangabe in Fachinformation", the German Federal High Court of Justice updated this jurisprudence and specified it in greater detail. In the case to be decided, the plaintiff took direct action against the – in its view – misleading content of the summary of product characteristics itself and not merely against the statements made in the advertising referencing said summary. The subject of scrutiny was a statement that a certain dose of a certain pharmaceutical would have the same effect as another medicine. The plaintiff asserted that this equipotency statement was not supported by sufficient scientific evidence. The court of appeal dismissed the complaint. According to the court, the content of the summary of product characteristics was beyond legal review due to the legitimizing effect of the marketing authorisation granted by the German Federal Institute for Drugs and Medical Devices (BfArM). The German Federal High Court of Justice dismissed this view by referring to the principles summarized in the “Basisinsulin mit Gewichtsvorteil” decision. According to the court, even statements in the summary of product characteristics are capable of being misleading if they are supported by studies that do not justify such claims. The statements contained in the summary of product characteristics are seen as commercial actions of the pharmaceutical company within the meaning of § 2 para. 1 no. 1 of the German Act Against Unfair Competition (UWG) aimed to promote the sales of its pharmaceutical products. According to the court, the summary of product characteristics is an additional source of information extending beyond the content of the package leaflet which is made available to doctors for their consideration in choosing therapies. Thus, public health will be jeopardized in both cases just the same so that it makes no difference whether a misleading healthcare-related advertisement is directly targeted to consumers or professional groups or whether a doctor’s therapy decision is influenced on account of some misleading statements in the summary of product characteristics lacking scientific evidence. The court went on to say that it is a legal option for the plaintiff to shake the confidence in marketing authorization’s indicative assumption that there is sufficient scientific evidence of the statements contained in the summary of product characteristics in accordance with the principles established in the “Basisinsulin mit Gewichtsvorteil”decision. In this specific case, however, the plaintiff was unable to furnish evidence to this effect so that his action was dismissed. Comment Thanks to this most recent decision, for the first time, the summary of product characteristics of a pharmaceutical comes into the unfair competition law focus and is forfeiting its privileged position. So far, pharmaceutical companies have had no opportunity to participate in the marketing authorization procedure of a competitor or to contest an erroneous assessment of the authorization authority regarding the safety, effectiveness or quality of a pharmaceutical product. The “Äquipotenzangabe in Fachinformation” decision now opens the door for competitors to directly attack certain statements of the summary of product characteristics providing them with new and far-reaching legal remedy options. It now becomes possible not only to prohibit certain advertisements but also the distribution of the summary of product characteristics itself. For this reason, it is advisable for pharmaceutical companies to regularly review and update the summary of product characteristics as to whether or not the content and information of said product characteristics are still in line with the current state of scientific knowledge. Otherwise, there is the risk that competitors will attack the summary of product characteristics as misleading by invoking new scientific evidence which became known after the marketing authorization date or which were not accessible to the authorization authority when it made its decision. 3