selon les molecules», et meme « des

selon les molecules», et meme « des disparites constatees d'une region a l'autre», et ajoute que le « NS » est plus difficilement explicable « lorsqu'il s'agit de molecules tres frequemment prescrites ou indiquees pour des pathologies peu sensibles ».

351. Deuxiemement, un nombre d'ordonnances « NS » superieur pour le clopidogrel peut aussi s'expliquer par le fait qu'il s'agit d'un traitement principalement initilpar des cardiologues et
renouvehpar des generalistes, qui repugnent a modifier la prescription initiale sans
information de la part du cardiologue qui l'a initiee. Ces generalistes ant done une propension plus grande a inscrire « NS » sur leurs ordonnances de clopidogrel. La CNAMTS a d'ailleurs evoque ce phenomene lors de son audition par les services d'instruction190

2.2 L'existence d'une indication encore protegee (SCA), representant 25 % des patients, explique qu'il existe davantage de NS pour le clopidogrel

352. Comme indique ci-dessus (voir pts. 17, 197 et 234), la principale consequence de l'information communiquee par Sanofi-Aventis France, selon la Decision, serait d'avoir amene les medecins a augmenter le nombre de mentions « NS » sur leurs ordonnances de Plavix, limitant ainsi le taux de generification de Plavix191

353. La Decision evoque egalement la part de marche « atypique »192 de Clopidogrel Winthrop, qui serait le signe que les pharmaciens ant favorise le generique de Sanofi-Aventis France au detriment de ses concurrents. Toutefois ce sont les mentions « NS » des medecins et le taux de generification de Plavix pretendument insuffisant qui fondent l'essentiel de la Decision, ainsi que les 38 millions d'euros d'economies soi-disant non realisees par la CNAMTS.
354. Pour aboutir a cette conclusion, la Decision se contente d'affirmer que le taux de « NS » de Plavix est superieur au taux moyen pour toutes les molecules confondues (12,6% pour Plavix contre
5% toutes molecules confondues, selon l'etude precitee de la CNAMTS193 .

355. Ce faisant, la Decision fait totalement l'impasse sur les effets lies a l'absence, dans I'AMM des generiques de clopidogrel 194 , de l'indication SCA. La Decision se contente d'affirmer que les
questions brevetaires seraient sans pertinence :

« Or; l'objectif de la reglementation europeenne et franr;aise en matiere de generique est( ... ) (de mettre] en place un mecanisme de substitution leur permettant de ne pas se preoccuper des questions de propriete intellectuelle ou de difference d'AMM, des fors que les generiques sont
autorises et inscrits au repertoire des generiques. »195

356. Or quand bien meme un droit de propriete intellectuelle detenu par Sanofi-Aventis France en serait a l'origine, il n'en resulte pas mains que l'indication SCA ne figure pas dans les AMM des
generiques de clopidogrel.

357. Le contenu des AMM est un determinant essentiel des prescriptions des medecins. L'article L. 5121-12-1 du Code de la sante publique, introduit par la loi du 29 decembre 2011, interdit toute prescription de specialite pharmaceutique en dehors des indications figurant dans son AMM, lorsqu'il existe sur le marche une alternative medicamenteuse appropriee disposant de l'indication


169 Point presse de la CNAMTS du 6 juin 2012 relatif a son etude, figurant au dossier d'instruction, cotes 1299 a 1305.
190 Dossier d'instruction, cote 2620.
191 Decision, pt. 512.
192 Decision, pt. 251.
193 Decision, pt. 522.
194 Hormis le Clopidogrel Winthrop (aujourd'hui Zentiva) et le generique de Ratiopharm.
195 Decision, pt. 472.

Résultats (Anglais) 1:

as molecules, "and even" the disparities observed from one region to another, "and adds that" ns "is more difficult to explain" when it comes to molecules very frequently prescribed or indicated for conditions not sensitive. "

351. secondly,a number of orders "ns" superior to clopidogrel may also be explained by the fact that it is primarily a treatment initilpar
renouvehpar cardiologists and generalists, who are reluctant to change the initial prescription information without
from the cardiologist who initiated it.these generalists ant therefore greater propensity to write "ns" on their orders clopidogrel. CNAMTS has also evokes this phenomenon during his hearing services instruction190
2.2 the existence of a still protected indication (sca), representing 25% of patients said that there are more ns clopidogrel
352. as indicated above (see pt.17, 197 and 234), the main consequence of the information communicated by sanofi-aventis France, according to the decision, would have brings physicians to increase the number of mentions "ns" on their orders plavix, thus limiting the rate of generics plavix191
353. the decision also evokes the market share "atypical" 192 clopidogrel winthrop,which would indicate that the ant pharmacists promotes generic sanofi-aventis France at the expense of its competitors. However, these are the words "ns" of doctors and the allegedly insufficient rate of generics of Plavix that underpin much of the decision, as well as 38 million of savings supposedly unrealized by CNAMTS.
354 .to reach this conclusion, the decision merely states that the rate of "ns" of plavix is ​​greater than the average for all molecules combined (12.6% against plavix
5% all molecules combined, according to the the study cited above cnamts193.
355. doing so, the decision is totally silent on the effects related to the absencein i'amm of generic clopidogrel 194, the indication sca. the decision merely states that
brevetaires issues are irrelevant

"Gold and the objective of the European regulation and franr; ease in matters of generic is (...) (To] establish an alternative mechanism for them not to be concerned of intellectual property or amm of difference, of the generic fora
are authorized and recorded the generic. "195
356 . well or even when an intellectual property detained by sanofi-aventis in France would be at the origin,there results no indication sca hands not in the amm of generic clopidogrel
.
357. amm content is a key determinant of the requirements of doctors. Article l. 5121-12-1 code of public health, introduced by the Act of December 29, 2011, prohibits any prescription pharmaceutical specialty outside of the indications in the amm,when there is a drug on the market with the appropriate alternative indication


169 points Press CNAMTS June 6, 2012 relating to the study, in the investigation file, dimensions 1299 190 1305.
dossier instruction, rating 2620.
191 decision, pt. 512.
192 decision, pt. 251.
193 decision, pt. 522.
194 except clopidogrel winthrop (now Zentiva) and generic ratiopharm.
195 decision, pt. 472.

Résultats (Anglais) 2:

According to the molecules', and even "disparities found in a region to another", and adds that 'NS' is more difficult to explain "when molecules very frequently prescribed or indicated for insensitive pathologies".

351. Second, a number of orders 'NS' superior to clopidogrel can also be explained by the fact that it is a treatment mainly initilpar of cardiologists and
renouvehpar of general practitioners, which repugnent amend the initial prescription without
information on the part of the cardiologist who has initiated. These GPS ant done a greater propensity has inscribed 'NS' on their clopidogrel prescriptions. The CNAMTS has also discussed this phenomenon during his hearing by the services of instruction190

2.2 the existence of an indication yet protected (SCA), representing 25% of the patients, explains that there are more NS for clopidogrel

352. As indicated above (see points. 17, 197 and 234), the main consequence of the information communicated by Sanofi-Aventis France, according to the Decision, would be to have brought the doctors increased the number of mentions "NS" on their prescriptions of Plavix, thus limiting the rate of generics of Plavix191

353. The evoque also Decision the market share of 'atypical' 192, Clopidogrel Winthrop, that would be the sign that the pharmacists ant favors the generic of Sanofi-Aventis France at the expense of its competitors. However mentions 'NS' of doctors and the rate of introduction of generics of Plavix insufficient allegedly underlying the so-called essence of Decision, and 38 millions of euros in savings not carried out by the CNAMTS.
354. To reach this conclusion, Decision merely to say that the rate of 'NS' of Plavix is higher than the average rate for all combined molecules (12.6% for Plavix
5% all molecules combined, according to the study referred to above of the CNAMTS193.

355) In doing so, made totally Decision deadlock on the related effects has the absence, in I'AMM of generic clopidogrel 194, the SCA indication. The Decision merely to assert that the
issues patent would be irrelevant:

'gold; aims of the European and franr; easy generic regulatory (... ) (put] a mechanism of allowing substitution of not is mindful of the issues of intellectual property or difference of AMM, fors that generics are
authorized and recorded of generics.) » 195

356. Or when well even an intellectual property right held by Sanofi-Aventis France would be at the origin, It is in follows step hands as the SCA does not appear in the marketing Authorisations of
generic clopidogrel.

357. The content of the AMM is an essential determinant of the requirements of physicians. Article l. 5121-12-1 of the Code de la sante public, introduced by the Act of 29 December 2011, prohibits any pharmaceutical specialty prescription outside the indications in the AMM, When there is on the market an alternative drug proper with the indication


169 press of the CNAMTS of 6 June 2012 on Point was his study, contained in the trial record, sides 1299 a 1305.
190 trial record, Coast 2620.
191 Decision, pt. 512
192 Decision, pt. 251
193 Decision, pt. 522
194. Except the Clopidogrel Winthrop (today Zentiva) and the generic by Ratiopharm.
195 Decision, pt. 472.

Résultats (Anglais) 3:

According to the molecules", and even "the disparities of a region has the other", and added that the "NS" is more difficult to explain" when it comes to molecules very frequently prescribed or indicated for pathologies little sensitive" .

351. Secondly,A number of orders "NS" above for the clopidogrel may also be explained by the fact that it is a treatment mainly initilpar cardiologists and
renouvehpar generalists, who are reluctant to change the initial prescription without
information on the part of the cardiologist who has initiated.These generalists ant done a greater tendency to put "NS" on their orders of clopidogrel. The CNAMTS has also mentioned this phenomenon during his hearing with the services of instruction190

2.2 The existence of an indication still protected (SCA), representing 25 per cent of patients, explains that there is more to NS for the clopidogrel

352. As indicated above (see pts.17, 197 and 234), the main consequence of the information communicated by Sanofi-Aventis France, according to the Decision, would be to have led the doctors to increase the number of particulars "NS" on their orders of Plavix, thus limiting the rate of generification of Plavix191

353. The Decision also refers to the market share of "atypical" 192 of Clopidogrel Winthrop,That would be a sign that the pharmacists ant favors the generic Sanofi-Aventis of France to the detriment of its competitors. However these are the markings "NS" of doctors and the rate of generification of Plavix allegedly insufficient which based the bulk of Decision, as well as the 38 million euros of savings so-called non-realized by the CNAMTS.
354.For reaching this conclusion, the Decision is simply the assertion that the rate of "NS" of Plavix is higher than the average rate for all molecules confused ( 12.6 % for Plavix against
5% all molecules confused, according to the above study of the CNAMTS193 .

355. In doing so, the Decision is totally the impasse on the effects linked to the absence,In I'AMM of generics of clopidogrel 194 , of the indication SCA. The Decision is simply the assertion that the
questions brevetaires would be without relevance:

" gold; the objective of the European regulations, and franr;easy in terms of generic is( ...) (To put in place a mechanism of substitution allowing them not to worry about intellectual property issues or difference of AMM, fors that generics are
authorized and included in generic directory. " 195

356. Gold when well even a right of intellectual property owned by Sanofi-Aventis France would be at the origin,It did not result hands that the indication SCA does not appear in the AMM of
generic clopidogrel.

357. The content of the AMM is a key determinant of physician orders. Article L. 5121-12-1 Of the Public Health Code, introduced by the law of the December 29, 2011, prohibits any prescription of pharmaceutical specialty outside the indications contained in his AMM,When there is on the market a drug alternative appropriate with the indication

169 press Point of the CNAMTS of June 6, 2012 relating to its study, contained in the trial record, sides 1299 has 1305.
190 Folder of instruction, side 2620.
191 Decision, pt. 512.
192 Decision, pt. 251.
193 Decision, pt. 522.
194 Apart from the Clopidogrel Winthrop (today Zentiva) and the generic Ratiopharm.
195 Decision, pt. 472.