1. The urgency assumption of § 12 Abs. 2 UWG is not refuted, if the applicant is not taken against similar violations of third parties.
2. The statement, is a substance “the only DPP4 inhibitor without CYP-450 metabolism”, is misleading lack of scientific evidence, when metabolism of “zero” results neither from the technical information even from scientific studies. A scrutiny at the level of traffic understanding reinterpretation of the claim in the statement of the absence of a “significant” or “clinically relevant” Metabolism occurs in the face of the clear wording of the specification is not considered.
HansOLG Hamburg, 3. Civil Division, Judgment of 4. July 2013, The. 3 You 161/11,
§ 3 UWG, § 4 No. 11 UWG, § 5 UWG, § 8 UWG, § 12 Abs 2 UWG
The appeal by the defendant against the judgment of the Regional Court of Hamburg, Civil Chamber 15, from 8.9.2011, Business Number. 315 The 187/11, is rejected.
The defendant shall bear the costs of the appeal.
The applicant, distributes the diabetes drug, opposes an advertisement the defendant for two diabetes drugs.
The applicant sells the product X. with the active ingredient and the product V Sitagliptin. with the active substances, sitagliptin and metformin. The defendant sells the product J. the vildagliptin and the product I. with the active substances vildagliptin and metformin. Das production J. is with the time of the Fa. N. vermarkteten Product G. identical. The active substances, sitagliptin and vildagliptin are each called to. DPP4-Hemmer, which increase insulin release of the body and thus help to lower blood sugar levels. The metabolism (Metabolism) of medicinal drugs in the liver usually involving the CYP-450 enzyme system. When two substances by the same enzyme systems – etwa CYP-450 – are metabolized, this may have consequences for the passage of substances in the body, because – figuratively speaking – which dealt with the removal of a drug enzyme system can not pay in full at the same time the reduction of other drug.
The defendant for their products with the system as AST 1 present and display the statement "vildagliptin – the only DPP4 inhibitor without CYP-450 metabolism advertised ". The warning letter from the applicant 25.3.2011 has the defendant under the 31.3.2011 rejected (Anlage AST 16). The applicant then warned first under the 1.4.2011 the Fa. S.P. GmbH (Anlage AST 15a) and then under the 5.4.2011 the Fa. S.P. From Germany (Anlage AST 15). The Fa. S.P. Germany GmbH with effect from 30.7.2010 been merged with the respondent (Capabilities AST 19 and 19a).
The applicant submitted, the impugned statement containing consider the claim, that vildagliptin would not degraded by the liver and, consequently, the doctor had to worry about interactions, which are to be expected in connection with the dismantling of drugs by CYP-450. This assertion, Vildagliptin will not metabolized by the liver, there is insufficient scientific evidence. After the contents of the technical information this question is explicitly open. The further study submitted (Anlage AST 6) had shown, that vildagliptin would metabolised at least to a small extent, Namely, in an amount of 1,6 %. The challenged statement was also an impermissible unique statement, because they might suggest in an inappropriate manner, that the doctor can not be sure when competition preparations, whether it was likely to CYP 450 interactions induced.
The applicant has requested,
it legal to prohibit the defendant under penalty order means in the way of interlocutory, in business for purposes of competition for the drug J. and I.
1. To advertise with the statement, that vildagliptin is the only DPP4 inhibitor without CYP-450 metabolism, as happened in the printed output as a system map [it follows the footprint of the rack card];
2. to advertise in the enclosed tax map, provided in the printed text, the mandatory "S.P. Germany GmbH "is called.
The District Court of Hamburg, Civil Chamber 15, has on 20.4.2011 adopted in accordance with the application for an injunction.
In opposition proceedings the respondent has submitted: The matter was not urgent. The applicant was aware of the content of the challenged advertising card for over a year already aware. The employees of the respondent Mr. L. was the product manager for the applicant Ms N., whose knowledge must be imputed to the applicant, in March 2010 u.a. a so called. Transmitted guidelines card by email, the present case, the impugned statement was also included verbatim into an interferer. The challenged statement was not misleading, because their content was scientifically proven. Gem from the study submitted by the applicant. Anlage AST 7 apparent, that vildagliptin would not metabolized by CYP-450. In the statement referred to in the study, that the production of small metabolites'll probably reached about P450, Whether they are at best a vague assumption. Is crucial for the Verstoffwechselungspotential a DPP4 inhibitor, whether it constitutes a substrate for CYP-450 enzymes in the respective active or not. Unlike for Sidagliptin stand for vildagliptin fixed but, that it is not a substrate for the enzyme cytochrome P (CYP) 450 and is CYP 450 enzymes not yet hemme induziere. So the prescribing information give the knowledge back, that a clinically relevant metabolism of vildagliptin does not have to be determined. Stand firm and this is also clear, that vildagliptin is not a substrate for CYP-450 enzymes, so is logically excluded, that metabolism by CYP 450 exist. Contrary to what the applicant consider including the challenged statement is no unique claim. Because it was based solely on the metabolism and not just on the interaction potential of vildagliptin.
The defendant sought,
the injunction in section. I.1 cancel, reject the request directed to its adoption and extent of the applicant to pay the costs of the proceedings.
The applicant has requested,
to confirm the preliminary injunction.
The applicant has responded: Urgency Harmful prior knowledge of the applicant was not given. On the merits, the CYP 450 metabolic rate of vildagliptin was not significant although; but this does not justify the statement, that vildagliptin would ever not metabolized by CYP-450. The applicant has even in the way of the traffic survey 60 get certified doctors, that the advertising was misleading map above in mind. The 48% of respondents have indicated, that the impugned statement on the interaction / compatibility of vildagliptin refer (Anlage AST 21).
The District Court of Hamburg with the 8.9.2011 judgment delivered the injunction to point. Confirmed I.1. Regarding the justification is made to the content of the judgment.
Against this judgment, the defendant spent time with their loaded and reasoned appeal. She repeated and deepened their presentation first instance and adds it as follows: The district court had wrongly assumed a disposal ground. The knowledge of Ms N. urgency is harmful. Because it rich knowledge of each employee from, could be expected from the function to its, that he could see some competition Relevance of the behavior of competitors and pass on his knowledge to the people also responsible for initiating legal action. The District Court wrongly decides that the challenged information is misleading. In medical science, the presence or absence of certain circumstances will typically measured at certain limits. The admissibility of a "non-inferiority statement" was not recognized as being conditional on, that absolutely no measurable differences were detected. Rather stood differences found the "non-inferiority statement" does not preclude, as long as they were moving in a corridor accepted scientific. It is enough to been accepted in the science scale of a security 95%, recognized in the p-value <= 0,05 zum Ausdruck komme. Dieses Maß sei auch heilmittelwerberechtlich als hinreichender Nachweis eines signifikanten Unterschieds anerkannt. Ferner stehe die Substrateigenschaft von Vildagliptin fest; ebenso, dass Substrate nicht über die Leber verstoffwechselt würden. Wenn eine Untersuchung nach dem Goldstandard wie diejenige von He et al. ergebe, dass eine Metabolisierung nicht in irgendwie quantifizierbarer Weise stattfinde, so sei bis zum Beweis des Gegenteils davon auszugehen, dass eine solche Metabolisierung nicht stattfinde. Dass He et al. eine 1,6%ige Metabolisierung gefunden hätten, spreche nicht gegen dieses Ergebnis. Denn bei In-vivo-Untersuchungen könne grundsätzlich eine große Zahl an Störungen auftreten, da neben den CYP-Enzymen zahlreiche andere Metabolisierungswege zur Verfügung stünden. Ein belastbarer Nachweis, dass die gefundenen Metabolite durch CYP-Enzyme hergestellt worden seien, hätten auch He et al. nicht gefunden. Deshalb sei es konsequent, wenn die Studienverfasser die Involvierung von P450 ausdrücklich als nicht signifikant bezeichnet hätten. Die von der Antragstellerin vorgelegte „Online-Befragung“ sei im vorliegenden Zusammenhang nicht verwertbar, weil sie nicht die angegriffene Unterlage betreffe.
The defendant sought,
by using a modification of the judgment of the Regional Court of Hamburg 8.9.2011 the injunction of 20.4.2011 repeal and reject the directed their adoption application and the applicant to pay the costs;.
The applicant requested,
dismiss the appeal.
The applicant repeated and deepened their presentation first instance. It complements her presentation as follows: To The District Court had confirmed the injunction. The urgency presumption is not rebutted. The challenged statement was also misleading. Both according to common language and understanding of science will the statement "without CYP-450 metabolism" understood as, that absolutely no metabolism of vildagliptin on CYP 450 enzymes takes place. Moreover, contrary to the defendant is the CYP-450 metabolism of vildagliptin quite quantifiable. That vildagliptin would not "significantly" implemented, is not equivalent to the statement, that CYP-450 is a non-existing metabolic pathway for vildagliptin was. The technical information will bring true expression, that vildagliptin in a "non-quantifiable" and not result in significant extent will metabolised by CYP 450. Even when using a highly sensitive in vitro system for the detection of metabolism are likely metabolites found in vivo can not be ignored in the opinion of the EMA, even if they were detected in vitro or only to a small extent; So it was not as – as the defendant insinuiere – that such effects are not medically relevant and should be compared with scientific experts apostrophized as nonexistent.
For further details of the property- and the dispute, reference is made to the contested decision and the gereichten by the parties to file briefs with attachments.
The admissible appeal is unfounded.
1. With their appeal, the defendant defends against the motion to 1. ban handed down,
- J for drug. and I. To advertise with the statement,
- that vildagliptin is the only DPP4 inhibitor without CYP-450 metabolism,
- as happened in the printed output as a system map [it follows the footprint of the rack card].
This application relates to the designated system characterized by the specific form of infringement.
2. The application is admissible, in particular, there is a reason available. The urgency assumption of § 12 Abs. 2 UWG is not refuted.
Here can be left open, whether – how does the defendant contends – a possible knowledge of Mrs N. the applicant falls urgency harmful to the load. Similarly, there are, whether it is that of the defendant as an attachment AG 1 Promotional card is presented to the one card, the beginning of the year 2010 of Fa. S.P. GmbH has been published.
After the publication of the AG by the defendant as an attachment 1 submitted rack card at the beginning of the year 2010 does not constitute a starting point for the adoption of urgency harmful knowledge. Although the failure of a creditor's claim, the urgency of a nuclear repeated later the same act of infringement may, after taking cognizance of an earlier act of infringement affect (s. nur Senat GRUR-RR 2011, 376). However, the main DC in this sense is only an act of the same obligor. However, the urgency is not recognized as being affected by the inaction of the applicant, is not taken against similar violations of third parties. Because the decision, whether and to what he is going infringer, lies solely in the hands of the applicant (Köhler / Bornkamm, 31. Divide. 2013, § 12 Rn. 3.19). In the present case it was not at the taken by the defendant in relation to a previous action advertising are those of the defendant, but an act of Fa. S.P., with effect from the first 30.7.2010 has been merged with the respondent (Capabilities AST 19 and 19a).
3. The applicant is in accordance with the claimed injunction. §§ 3, 4 No.. 11, 5, 8 UWG i.V.m. § 3 HWG to, as the district court correctly decided and with true justification. Because it is more likely than, that the disputed advertising claim for lack of sufficient scientific evidence is misleading. On the issue of illegal unique claim it is no longer so.
a) The applicant has submitted the following understanding traffic: With the impugned statement will against the doctors mentioned a statement made to the effect, that – scientifically proven – Vildagliptin does not have the liver (this'm naming the receptor CYP 450) 'll metabolized.
This medical transport understanding, the determination of the case law of the Senate by the members of the court is in any case possible, when – as in the present – the state of knowledge of science was presented in terms of the relevant facts and also – as here – no indications are given, that a doctor could understand the German language other than someone, has also completed a scientific study (Senate, Judgment v. 21.12.2006, The. 3 You 77/06, PharmaR 2007, 204), is applicable. The expectations regarding the effect of the traffic comes to a reference specification in the rule being, indicating that the effect is scientifically proven (Riegger, Drug Advertising, Get. 3 Rn. 25, 33). For the present question raised by the digestion, So the way of the substance in the human body – a pharmacological effect of the preceding and presumed facts of this – may otherwise apply.
One – the result advocated by the defendant – Reinterpretation of the claim in the statement of the absence of a "significant" or "clinically relevant" metabolism comes in view of the clear wording of the indication shall not be considered. It is true, that in medical and scientific circles, the presence or absence of certain circumstances is typically measured at certain limits and the basis of studies carried out lege artis scientific proof is always loaded with the following from the basis of a recognized significance of residual scale uncertainty. However, these medical-scientific convention for the classification of study results is at the level of trade usage not the reverse, that, therefore, fully doctors coming true statement of the absence of an effect relativized almost automatically to the effect, the effect was present at most in a non-significant degree. The same applies to a related to the clinical relevance, limited understanding of the information. In the area of health promotion, in the material due to the high protection of health of individuals and populations in the accuracy, Precision and clarity are to make the statements particularly strict requirements ("Strengeprinzip", s. Senate, Judgment v. 21.12.2006, The. 3 You 77/06, PharmaR 2007, 204), is the assumption, the addressee of a message shall understand these close down in a different way by the text, even less space than in the general under competition law ban misleading, where such a "corrective understanding" hardly ever comes into consideration.
b) The advertising claim is misleading, because the absence of any metabolism by the liver (CYP-450) is no scientific evidence.
aa) The applicant refers in that regard to the content of the SmPC, after this question was explicitly open. In the prescribing information for J. It is in the section 5.2:
"Vildagliptin is not metabolised by CYP 450 enzymes to any quantifiable extent. Therefore, it is assumed, the metabolic clearance of vildagliptin is not affected by co-medications, CYP 450 inhibit or induce. Showed in vitro studies, that vildagliptin CYP-450 enzymes does not inhibit / induce. Therefore, vildagliptin is not likely to affect the metabolic clearance of co-medications, by CYP 1A2, CYP 2C8, CYP 2C9, CYP2C19, CYP 2D6, CYP2E1 and CYP 3A4 / 5 metabolized. "
The applicant further submits, that further study submitted He et al. (Anlage AST 6) had shown, that vildagliptin would metabolised at least to a small extent, Namely, in an amount of 1,6 %. The study (Anlage AST 6) it is:
“The formation of minor metabolites, M.20.9 and M21.6 is probably mediated by P450s. However, these pathways accounted for only approximately 1,6 % of the dose, indicating a lack of significant P450 involvement.”
and (S. 452, wrong side, second paragraph):
“The results indicated that [14C] vildagliptin was not metabolized in human liver microsomes nor by any P450 enzymes examined to any quantifiable extent.”
The applicant also refers to the European Assessment Report for the preparation G., to the J. identical, which states:
„CYP-450 isoenzymes are involved in vildagliptin metabolism only to a minor extent. Hence, the potential for interactions with vildagliptine metabolism is very small.”
bb) It is noted in all probability, that there is a lack of adequate scientific substantiation of the challenged statement.
The advertising of medicinal products subject to the strict requirements of health-related advertising, which – as above in a) performed – because of the high protection of the good health of individuals and populations in the accuracy, Precision and clarity are to make the statements particularly strict requirements (Senate, Judgment v. 21.12.2006, The. 3 You 77/06, PharmaR 2007, 204). Therefore advertiser promotions in this area are only allowed, if they comply with sound scientific knowledge (BGH GRUR 1971, 153 – Tampax). Compared to the unsubstantiated allegation of the applicant, one attacked by him as misleading health-related advertising lacks the scientific basis or. the testimony is scientifically controversial, it is for the defendant, to prove the scientific substantiation of the advertising message (Hard / Henning / Weidert, UWG, 2. Divide. 2009, § 5 C Rom. 175). Because the advertiser has advertised with a professionally controversial opinion and this portrayed in advertising as objectively correct, without referring to the concerns and to mention the opposite opinion, he thereby takes, that he decides on a particular view and a certain statement is true, responsibility for their accuracy, which he – Notwithstanding the general rules – must demonstrate by a supreme court ruling in the dispute and to prove (BGH GRUR 91, 848, 849 – Rheumalind II m.w.N.; Senate GRUR-RR 2002, 173). Information in the prescribing information typically give the relevant authorities at the time of admission decision state of the science again and can therefore attain indizielle significance for the evidence of adequate scientific substantiation (BGH, Urt. in. 6.2.2013, I ZR 62/11, Rn. 35 f., 43 – Basal insulin with weight advantage).
In the present case arises from the technical information that taken by the defendant to complete an metabolization scientific substantiation of "zero" is not. Instead, there is talk, that vildagliptin would not metabolized by CYP 450 enzymes to any quantifiable extent; that metabolism does not take place, this information is not apparent. The further from the applicant referenced scientific votes substantiate this result: Sowohl the Study He et al. (Anlage AST 6) and the Assessment Report for G. speak of, that is metabolized by CYP-450 in a minimum well, although this is also very limited clinical significance. The impugned statement puts so – in advertising pleasing, under the scope of Strengeprinzips not acceptable manner – the state of science.
5. The decision on costs is based on § 97 Abs. 1 Code of Civil Procedure.