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Generics Cases: A Study of Preliminary Injunctions in France

Article published in Propriété Industrielle June 2014

Time to market for generic drugs is highly sensitive: too early, the innovator may obtain an injunction; too late, the generic manufacturer will lose the "bonus" of the first-mover. This study provides a practical approach of the pivotal dates in this process, more specifically the positions taken by the French courts at each stage of the launch of generic drugs onto the market.

1. The first difficulty is to define the "red line" in the process of placing on the market, beyond which the generic manufacturer is in danger (I). For its part, the patentee must assess the best procedural option in relation to its losses and to the generic manufacturer's conduct (II).

2. The assessment of the position of each party in the dispute is determined by the defence arguments: one key element is the effectiveness of the objection to the validity of patent in the context of a preliminary injunction (III).

Finally, in their risk analysis, the patentee and the generic manufacturer must consider the financial consequences of a preliminary injunction when there is a risk that the patent is subsequently cancelled. (IV).

I) "Imminent infringement": where is the red line for the generic manufacturer?

3. The generic manufacturer will attempt to carry out the majority of the administrative and commercial steps prior to launching in order to be ready as soon as the patent expires. It may also plan marketing even before the patent expires, because it considers that the innovator's monopoly is wrongfully assumed. In these two cases, the issue is to know at which point of process the patentee may start enforcing its rights.

4. To answer this question, case law uses both the concept of "likelihood of infringement" put forward by the French Intellectual Property Code and the indications of the French Public Health Code. This suggests that the fulfilment of the preliminary administrative formalities by the generic manufacturer is not sufficient  as  such  to  qualify  as  an  imminent  infringement (A), contrary to positive actions showing the desire to market before the rights expire (B).

A) Actions not yet constituting an imminent infringement

5. Article L. 615-3 of the Intellectual Property Code requires that it is verified that "the evidence, reasonably accessible to the Plaintiff, makes it likely that its rights have been infringed or that such an infringement is imminent". Article L. 613-5 of the same code clarifies this by excluding experimental use from the scope of counterfeiting, in other words "studies and trials required with a view to obtaining a marketing authorisation for a medicine, as well as [the] actions necessary for their performance and to obtain the authorisation" [1].

6. Article L. 5121-10 of the Public Health Code indicates that "the marketing authorisation may be issued before expiry of the rights (...) which are attached to the reference speciality". This article also provides that the generic manufacturer may be registered on the register of generic groups at the end of a sixty days period after the Agence nationale de la sécurité du médicament (National Agency for the Safety of Medicines and Health Products (ANSM) has informed the rights owner of the issue of the Marketing Authorisation (MA).

7. With this in mind, case law acknowledges the possibility for the generic manufacturer to obtain:

    - Registrations on the register of generic groups and on the list of reimbursable medicines [2];
    - Price of the medicines and the rate of reimbursement of the generic speciality from the Comité économique des produits de santé (Economic Committee for Health Products), even if, as noted by the Paris High Court in a ruling of 5 April 2011, "the publication of the price and the reimbursement rate in the Official Journal implies marketing within six months" [3].

8. These formalities are not hidden from the patentee. In fact, in addition to the publication of the price and the reimbursement rate for the generic medicine in the Official Journal, the patentee is able to monitor this process through various means of information:

    - The submission of the application for MA is notified by the generic medicines company and its issue is notified by ANSM [4];
    - Registrations on the register of generic groups and on the list of reimbursable pharmaceutical specialities are published by order;
    - The generic medicines company is required to inform the Managing Director of the ANSM of the indications, pharmaceutical forms and dosage of the reference speciality for which the rights have not yet expired, before any marketing [5].

9. In addition to these preparatory actions, case law examined the impact of positions (or the absence of positions) taken by the generic medicines company on its intention to market. The Paris Court of Appeal therefore considered that the response to a cease and desists letter in which the generic medicines company contested the validity of the patents did not constitute an imminent infringement [6].

10. The High Court in Paris had the same interpretation with regard to the absence of response to several warning letters, the due date for response to which was before the expiry of the patentee's rights [7]. The court declared that the patentee could not "force it to make declarations of intention and the silence kept by the Defendant on its will to bid for the tender in question (...) even after the court summons was served, is not sufficient to qualify as imminent infringement", also adding that the generic manufacturer could "legitimately oppose a court request intending to require it to unveil its marketing strategy" (8).

Thus, case law endeavours to punish an obvious wish to market before the expiry of the rights, rather than simple indications or "negative evidence" drawn from the generic manufacturer's silence.

B) Evidence of the willingness to market

11. In a judgement of 15 March 2011, the Paris Court of Appeal summarised this willingness to market before expiry of the patent as any information relating "to the setting up of manufacturing, solicitation or advertising", which it has expressed in practice by "preparations for manufacturing or marketing, (...) the distribution of brochures or advertising announcing the release of products or by visiting doctors with a with a view to prescribing the generic medicines" [9].

Likewise, displaying the product in the generic manufacturer's catalogue implying a marketing date prior to expiry of the patent enables imminent infringement to be qualified [10].

Regarding the appearance in a catalogue showing the generic manufacturer's product range, it will only be treated as "an offer for sale" if this presentation includes a price and if the medicine is available on French territory [11].

12. Case law has also inferred an imminent infringement to the patentee's rights from the official positions held by the generic manufacturer.

The Paris Court of Appeal considered that the "red line" had been crossed as the generic manufacturer had confirmed to the Economic Committee for Health Products that it could market the generic medicines without contravening the patentee's rights within six months of registration in the Official Journal, whereas in this same period, the patentee's rights had not yet expired [12].

13. Communication about the marketing date is therefore crucial for the generic manufacturer which must be especially vigilant in this regard. This is the choice made by a generic manufacturer which explicitly requested the Economic Committee for Health Products to defer publication of its medicine in the Official Journal so that it only takes place after expiry of the patent [13].

II) Ex parte injunctions rarely ordered

14. In accordance with Article L. 615-3 of the Intellectual Property Code, obtaining an ex parte injunction requires the demonstration of specific conditions such as an irreparable harm for the Plaintiff.

A quick summary of case law shows that ex parte injunctions are almost inaccessible for patentees in the pharmaceutical sector. Given the seriousness of the financial issues, judges are in fact especially attentive to the case presented by patentees to justify their request and do not allow any approximation. Rulings obtained ex parte are extremely rare and have a strong chance of being withdrawn.

A) The requirement of fairness by the plaintiff

15. This is the case between Novartis and Sanofi and Zentiva relating to the marketing of the generic medicine Valsartan. In this case, the court granted ex-parte measures of prohibition, the recall of products, and publication of a press release. The ruling was confirmed in the subsequent inter partes proceedings, except for the communication of information on the origin and the distribution channels [14].

However, the Paris Court of Appeal finally withdrew the order [15]. The Court carefully examined each element of the plaintiff's case which was intended to convince the imminence of the infringement. Having taken over Novartis' request by the opposing party, the Court noted that the document called "Evidence of the infringement" did not comply with "the principle of fairness and transparency in submitting evidence".

16. The Court then looked at the two seizures of counterfeit goods carried out in a pharmacy and in the generic manufacturer's production unit, which were supposed to provide evidence of the marketing of the medicines.

However, the Court noted that the first seizure had revealed "an absence of marketed products and that it was not possible to sell the product, the speciality shown on the pharmacy software including neither the sale price nor the purchase price". At the second seizure, the bailiff had not noted any recipient for the pallets of products he found. The Court concluded that there could be "a doubt over the imminent marketing of these products" [16].

Finally, the Court examined the evidence containing a treatment form on which the disputed generic drug was prescribed. It noted that there was no certificate produced by the pharmacist, doctor or patient and that therefore "the conditions under which it had been obtained were unknown".

17. The sincerity of the patentee is not only required for the evidence of the infringement. Special attention is also paid to omissions relating to the fragility of the title or even titles of the same family.

Recalling that ex-parte proceedings require "complete fairness vis-à-vis the judge on all circumstances surrounding the case", the High Court sanctioned a company which had concealed opposition to the European patent protecting the same inventionas the French patent having justified the request [17]. In its ruling, the Judge withdrew the request for injunction the reason that "if it is legally correct that a French patent is independent from the European patent which has been obtained to protect the same invention, this legal fiction cannot be opposed in ex parte proceedings. In fact, even a partial achievement of opposition to the  European  patent is likely to result in a discussion  regarding the validity of the French title, a discussion which can only take place in inter partes proceedings".

B) The severity of judges on the conditions of access to ex parte proceedings

18. The condition of urgency is strictly assessed by the French judges. In the Valsartan case, Novartis alleged that its request could only be presented seventeen days before the expiry of its Supplementary Protection Certificate (SPC) and that, taking weekends, public holidays and schools holidays into account, this time limit did not enable a ruling in the presence of all parties to be obtained. Censuring these reasons, the Court of Appeal recalled that there "is a procedure for emergency proceedings enabling the presence of both parties to be complied with within a shortened timescale" and that "the courts are likely to give dates for urgent hearings in particular at weekends or on public holidays and that school holidays have no effect on this option" [18].

In the same way, the High Court in Paris considered that the urgency to obtain recovery of a debt on French territory no longer justified an ex-parte proceedings as the infringing Chinese company was no longer on French territory at the time the request was submitted [19].

19. Regarding the irreparable harm which the plaintiff may allege to benefit from ex parte measures, its demonstration is equally delicate.

20. In the Valsartan case, the court admitted that "the premature introduction of the generic product on the same market during a relatively brief period [was] likely to create for them a serious financial loss by the loss of clients as well as by the reduction in prices" [20].

But there again, the Court of Appeal reversed this position, suggesting that the rights holder had sufficiently profited from its legal monopoly: "the investments made to develop the original product have been compensated by the protection granted by the patent and the SPC for several years; that the existence of generic products is promoted by the public authorities with public health in mind and that the harm resulting from such products being placed on the market, which necessarily results in a loss of markets for the NOVARTIS companies results from this authorisation and this placing on the market even independent from a premature offering for sale to that supposed to be proven for seventeen days".

It must be inferred from this that the proximity to the expiry of its title therefore greatly reduces the probability for the patentee to demonstrate an irreparable loss.

21. Finally, in the above-mentioned interim ruling of 17 March 2010, the patentee referred to a collection of circumstances which seemed fairly sound. However, demonstrating a certain benevolence with regard to the company accused of the infringement, the Presiding Judge of the High Court in Paris responded that in itself, each of these circumstances could not justify an ex-parte injunction:

    - Even if the patentee alleged that it was impossible for it to recover damages on the merit, the defendant's Chinese nationality was irrelevant, "except to establish discrimination between the different economic players";
    - The solicitation of clients had not been demonstrated and participation in a trade show was "normal practice in international trade",
    - Even more surprising, the refusal to cooperate at the time of the seizure had been "expressed by the fact that an individual had fled with the samples" was not a good enough reason [21].

III) Discussing the validity patent in preliminary injunctions: an effective defence?

22. Faced with a preliminary injunction request, the generic manufacturer's natural defence will be to contest the validity of the patent. This argument defence is controversial.

23. For supporters of a "strict" interpretation of Article L. 615-3 of the Intellectual Property Code, it is not the responsibility of the interim judge to examine the validity of a patent [22].

This interpretation is specifically based on the amendment to this article by the law of 29 October 2007 [23], which replaced the requirement therein of the "serious nature of the action on the merit" by that of the "probable" nature of the infringements of the patent.

24. On the other hand, the "flexible" interpretation of this article tends to assert that the probability of infringement of the patent must include the probability of the validity of the title [24].

Since patent cases have been regrouped in Paris in 2009 the controversy has kept ongoing. But it is perhaps not as deep as it appears and  may  in  reality  come  down to assessment case by case  assessment  made  by  the  judges  of the  abusive  position of one or other of the parties.

A) The wavering between "probable infringement" and obviousness of the invalidity

25. The requests for a preliminary injunction sought by the Sanofi Laboratory against Sandoz and Teva Santé with regard to the marketing of the generic drugs for the CoAprovel speciality [25], give a perfect example of this controversy.

26. On 10 August 2012, the High Court in Paris demonstrated the desire to follow an economic approach to the objection raised by Sandoz, indicating that: "the interim judge must rule on the objections which are raised before him to oppose the measures requested and these objections may relate to the validity of the title itself: it is then his responsibility to assess the seriousness of the objection in such a way to prevent the use of interim proceedings to obtain prohibitions having serious consequences which would distort competition" [26]. This approach resulted in the refusal of a preliminary injunction, the interim judge having been convinced of the "doubtful validity" of the title referred to for the reason that "the validity of the Supplementary Protection Certificate which relates to two specific active ingredients, whereas one of them only appears in the basic patent's claims under the vague term of diuretic and whereas the descriptive section of the patent gives no clarification on the nature of this diuretic, is likely to be seriously contested on the merit".

The requirement of the "seriousness" of the objection, close to the former wording of Article L. 615-3, had already been taken into account on several occasions by the Parisian judges [27].

27. A few months later, before the Court of Appeal, Sandoz continued to plead that the infringement of Sanofi's rights was unlikely, in particular with regard to the annulment ruling which had occurred in the meantime. In a ruling of 23 May 2013, the Court recalled that it could not take this ruling into account as, being under appeal, it had not yet acquired the absolute authority of res judicata [28]. On the other hand, the Court noted in turn that the validity of the SPC was "seriously debatable" considering, in the light of European Court of Justice case law, that a certificate relating to active ingredients not mentioned in the wording of the basic patent's claims should not have been granted [29]. It therefore confirmed the refusal to issue a preliminary injunction.

28. Yet the same causes do not necessarily result in the same effects: in a similar request for preliminary injunction sought against Teva Santé and based on the same title, on 3 October 2012 another judge of the High Court in Paris announced a more restrictive approach, indicating that "the assessment by the interim judge on the basis of Article L 615-3 of the Intellectual Property Code is limited to the obvious invalidity of the title, alone likely to make the infringement of its holder's rights improbable" [30]. However, if the judge concluded in this case on the absence of obvious invalidity of the SPC, it was after having examined around twenty pages of different reasons invoked and after having taken a position on the state of European case law applicable to the interpretation of several articles of (EC) Regulation No. 469/2009 of 6 May 2009 relating to SPCs [31].

29. The assertion according to which the role of the interim judge must be confined to the evidence perhaps finds its limits in this type of exercise. Above all, this ruling was finally overruled by the Court of Appeal on 23 May 2013 which, to be convinced of the invalidity of the patent, retained the lack of description on the way of obtaining the combination claimed [32].Alignment by the Supreme Court ban would therefore be sizeable.

B) The balance of interests associated with the parties' conduct

30. Even if, in relation to the rulings, the wording used by the judges as to whether or not to take the objection to the title into account varies by a degree between a serious or obvious nature, their assessment is clearly made in concreto with regard to the legitimacy of the requests by the patentee or the position of the generic manufacturer. A patentee who has worded his title badly, who is negligent in his defence or whose title has already been called into question several times may therefore be penalised; likewise for the generic manufacturer which attempts to enter the market, refraining from contesting the title protecting the reference speciality.

31. The High Court in Paris clarified the content of its balance of interests, explaining that it was responsible for "assessing the proportion  between the objection issued by the defendant company and the alleged infringement and to take, in view of the risks incurred on both sides, the decision as to whether or not to ban the marketing" [33].

Before rejecting the request for a preliminary injunction in this case, the judge was compelled to carry out an in-depth study of the patent. He criticised it for vague wording by noting that there was nothing in the description which enabled him to understand the technical issue resolved and that no analysis had been carried out from the results quoted. The judge also criticized the patentee which had not bothered to define the relevant person skilled in the art in its defence.

32. Following the same reasoning with regard to the patentee, in a judgement of 20 November 2012, the Court of Appeal confirmed the refusal to issue a preliminary injunction, after having verified that the process patent being opposed did not demonstrate "an appearance of validity". The Court specifically took into account the fact that the patent relating to the product obtained by this process had been revoked by the European Patents office, "an annulment indicative of the fragile nature of the patent" referred to) [34].

33. Furthermore, the above-mentioned ruling by the High Court in Paris of 3 October 2012 was also interesting in its assessment of the generic manufacturer's conduct prior to placing on the market [35]. Thus, with regard to the objection on the validity of the patent referred to, the judge criticised Teva of having "refrained from challenging its validity while it was in force". It then considered that TEVA could not "claim to establish the obvious absence of inventive activity of this claim twenty-two years after the patent's priority date".

34. In the same way, in a ruling of 21 March 2012, the Paris Court of Appeal firstly noted that fifteen patent offices worldwide had issued the disputed patent, before criticising the generic manufacturers which should have "engaged in a claim for invalidity of said patent within the time limits enabling them to obtain a judgement on the merit, before proceeding with the marketing of the disputed drug, to avoid any infringement of the rights of the owners of this patent" [36].

The generic manufacturer which wishes to enter the market before the rights expire has every interest in initiating an action for invalidity mainly to avoid this type of criticism [37].

35. It is nevertheless certain that the interim judge (or the   regular  judge  when  the  action  on  the  merit  is  already pending [38]) will be more inclined to analyse the validity of the title when the arguments used do not request a technical and in-depth examination of the prior art of the inventive activity, such as lack of description, the objection to a priority or even the absence of patentability.

This type of fragility must be anticipated both by the patentee and by the generic manufacturer: the first having to assess its flaws before attempting to obtain a ban to protect it for several years, the second having to assess the strength of its response if it decides to risk placing it on the market before the rights expire. The strategy of each must also take into consideration the statistical chances of success of the preliminary injunction which, in pharmaceutical cases, do not exceed more than a third of the requests.

IV) Compensation to the generic manufacturer having been the subject of an unlawful preliminary injunction

36. Any compensation of the generic manufacturer in the event of the patent being subsequently invalidated would only take place several years after the preliminary injunction.

The rare decisions having dealt with this compensation show that the amount granted will be influenced both by the generic manufacturer's ability to produce a case demonstrating heavy losses and by the more unpredictable assessment of the judges.

A) The hypothetical payment of compensation at the time of the preliminary injunction

37. Article L. 615-3 paragraph 4 of the Intellectual Property Code perfected the conditions of access by the patentee to interim measures by the option for the defendant to request a guarantee to be established "to ensure [its] potential compensation (...) if the action for infringement is subsequently judged to be groundless or the measures annulled".

The award of this guarantee by the interim judge is rare and the reasons for its refusal or its award appear to be unpredictable:

    - On 20 October 2009, the Lyon Court of Appeal ordered the patentee to pay €2m (out of the €5m demanded by the generic manufacturer), without specifying therein the reason and although the Court noted "the probable infringement of the indisputable rights" of the patentee [39].
    - In the case Negma vs. Biogaran detailed below, in 2009 the Strasbourg interim judge refused Biogaran the payment of €2m [40], while Biogaran was finally compensated by almost double in a ruling by the Paris Court of Appeal of 31 January 2014 [41].
    - The High Court in Paris refused payment by the patentee in the above-mentioned ruling of 31 October 2011 because it could not be "seriously claimed that the NOVARTIS companies did not have the financial means to compensate the loss suffered by the ruling if this turned out to be groundless" [42].

In case of failure of the request for payment, which will be most of the time, patent owners must bear in mind that execution of the preliminary injunction will always take place at its own risk.

B) Implementing the request for compensation

38. The principal case having to date dealt with compensation of the generic manufacturer victorious on the merit was Negma vs. Biogaran. At the time of a true judicial saga which began in 2008, Negma obtained a preliminary injunction on the generic drugs sold by Biogaran in 2009, the patent not being considered as "obviously invalid". For its part, Biogaran obtained the invalidation of the patent in 2010, confirmed on appeal. Accordingly, the preliminary injunction were also cancelled the same year and Biogaran was able to lodge an action on the merit to obtain compensation for its loss.

39. Negma then attempted to introduce a priority preliminary ruling on constitutionality, the rejection of which was ordered on 27 January 2012 by the High Court in Paris and confirmed on 6 July 2012 by the Paris Court of Appeal under these terms [43]: "The petitioner for the action must have the assurance that the patent which it is enforcing against third parties presumed to be counterfeiters is legally and technically valid and sound or that the acts of infringement of which it is accusing the presumed third parties are based on a high probability. The petitioner must bear this risk, the victim of the interim measures unjustly ordered being unable to remain subject to this risk without obtaining compensation". In addition to the rejection of the priority preliminary ruling on constitutionality, the judgement of 27 January 2012 retained Negma's liability and considered that Biogaran was founded in seeking compensation [44].

40. Biogaran's claims on the basis of fault-based liability were, however, rejected, the Court considering that no fault had been described, as Negma could not be accused of having used all the procedural means at its disposal to defend its monopoly which drew its legitimacy from the existence of a patent not cancelled at the time. In the absence of fault by Negma, the Court rejected compensation for the damage to Biogaran's image. As far as the financial loss directly linked to execution of the interim ruling is concerned, it was com-
-pensated taking into account the probability that other competitors were able to market their products during the period of the preliminary injunction. On this basis, the Court awarded compensation of almost €3m out of the total of the €8m demanded.

41. This award was recently increased by a ruling by the Paris Court of Appeal of 31 January 2014 which increased the compensation for the financial loss to €3.5m, and added €150,000 for reputational damage and €230,000 for legal costs [45]. Contrary to the High Court judges, the Court of Appeal on the other hand acknowledged that Negma had committed its fault-based liability on the basis of abuse of the right to take action. The Court in fact penalised the patentee's delaying tactics, the multiple and disproportionate procedural approaches and the denigration of Biogaran with other players in the market.

42. The compensation of the generic manufacturer is a safeguard against preliminary injunctions based on weak patents. Yet, by its size and complexity, the Negma case is not necessarily reassuring for manufacturers of generic products.

In addition, its implication must be clarified by the contribution of a judgement by the Supreme Court in Plenary Session issued on 17 February 2012 [46].

The Supreme Court in fact considered that the invalidation of a patent did not authorise the defendant previously convicted of infringement to claim compensation for the damages that it paid in accordance with an irrevocable ruling prior to the invalidation.

43. Each stage of the entry on the market of generic drugs involves finding a fair middle ground between the general interest of seeing  generics  appearing  quickly  on  the  market, on the one
hand, and on the other hand, the necessity of protecting the patentee until the end of the term of its monopoly, in order to continue to stimulate research and innovation.

To achieve this, the French judges have the responsibility of placing different cursors which are:

    - The legitimacy of the actions preparing for the launch of the generic drugs,
    - The urgent, serious or irreparable nature of the patentee's position faced with this entry onto the market,
    - The soundness of the patent referred to which will or will not justify continuation by the generic manufacturer,
    - The compensation of the loss which the generic manufacturer is able to demonstrate at the end of an unjustified preliminary injunction.

44. Thus, in spite of a certain lack of visibility on these cursors, it is obvious from recent interim cases that French judges have a more and more realistic and economic view of these and that they do not hesitate to take into account the procedural conduct of each party, their merit and their willingness to act fairly.

 

Benjamin May            Marie Liens
Partner                Senior Associate
Aramis                Aramis


Key words: Generic - patent - pharma - preliminary injunction


[1] This exemption is a result of the transposition in France of the said "Bolar Exemption" on the pre-marketing tests provided for in Article 10 (6) of Directive No. 2004/27/EC of 31 March 2004 amending Directive 2001/83/EC establishing a community code relating to medicines for human use.

[2] Paris Court of Appeal, 21 March 2012, No.11/12942, Novartis AG, SAS Novartis Pharma v. Sté Mylan, SAS Qualimed. - Paris Court of Appeal, 15 March 2011, No.10/03075, SAS Mylan, SAS Qualimed v. E.I du Pont de Nemours and Company, SNC Laboratoires Merck Sharp & Dohme-Chibret. - Paris High Court, Interim Ruling, 19 August 2010, No.10/56889, SA Aventis Pharma, SA Sanofi-Aventis France v. SAS Teva Santé.

[3] Paris High Court, Interim Ruling, 5 April 2011, No. 11/52706, Novartis AG, SAS Novartis Pharma v. SAS EG Labo-Laboratoires Eurogenerics. - See also Paris High Court, Interim Ruling, 19 August 2010, No.10/56889, mentioned above, note 2.

[4] Public Health Code, Article L. 5121-10, paragraphs 1 and 2.

[5]Public Health Code, Article L. 5121-10, paragraph 4.

[6] Paris Court of Appeal, 15 March 2011, No.10/03075, mentioned above, note 2.

[7] Paris High Court, Interim Ruling, 19 August 2010, No. 10/56889, mentioned above, note 2.

[8] See also on the absence of response to a warning, Paris Court of Appeal, 21 March 2012, No.11/12942, mentioned above, note 2.

[9] Paris Court of Appeal, 15 March 2011, No.10/03075, mentioned above, note 2.

[10] Lyon Court of Appeal, 20 October 2009, No. 08/06216, Mylan, Grünenthal GmbH, Laboratoires Grünenthal, Mundipharma Laboratoires GmbH v. Medochemie Ltd, Farmaceutisch Analytisch Laboratorium Duiven B.V.: JurisData No. 2009-018915.

[11] Lyon High Court, Interim Ruling, 21 July 2008, No. 08/01373, Mundipharma Laboratories GmbH, Grünenthal GmbH, SAS Laboratoires Grünenthal / Medochemie Ltd, Farmaceutisch Analytisch Laboratorium Duiven B.V, SAS Mylan.

[12] Paris Court of Appeal, 21 March 2012, No. 11/12942, mentioned above, note 2. - in the same way, Lyon High Court, Interim Ruling, 21 July 2008 No. 08/01373, mentioned above, note 11. - Paris High Court, Interim Ruling, 10 August 2012, No. 12/55806, Sanofi, SNC Sanofi Pharma Bristol-Myers Squibb, SA Sanofi Aventis France v. Sandoz.

[13]Paris High Court, Interim Ruling, 5 April 2011, No. 11/52706, mentioned above, note 3.

[14] Paris High Court, Interim Ruling, 31 October 2011, No. 11/15302, Sanofi-Aventis France, Sanofi Winthrop Industries, Zentiva KS v. Novartis AG, SAS Novartis Pharma.

[15] Paris High Court, 11 December 2012, No. 11/20113, SA Sanofi-Aventis France, Sanofi Winthrop Industries, Zentiva KS v. Novartis AG, SAS Novartis Pharma.

[16] Mentioned above

[17] Paris High Court, Interim Ruling, 8 July 2009, No. 09/08704, Zhejiang Huakang Pharmaceutical, Zhejiang Huakang Entreprises v. Roquettes Frères. See also in the same way and on the same patent: Paris High Court, Interim Ruling, 17 March 2010, No. 10/0887, Yucheng Lujian Biological Technology CO. Ltd v. Roquette Freres.

[18] Paris Court of Appeal, 11 December 2012, No. 11/20113, mentioned above, note 15.

[19] Paris High Court, Interim Ruling, 17 March 2010, No. 10/0887, mentioned above, note 17.

[20] Paris High Court, Interim Ruling, 31 October 2011, No. 11/15302, mentioned above, note 14.

[21] A few months earlier, in very similar circumstances, the same court had nevertheless admitted "that it is significant that a few countries, including China, are at the heart of almost all the counterfeits imported into France" and had accused the Chinese companies "of not having demonstrated that they had not solicited any French clients" before accepting the withdrawal due to the concealment by the patentee of information creating a doubt over the infringement of its rights: Paris High Court, Interim Ruling, 8 July 2009, No. 09/08704, mentioned above, note 17).

[22] See, for example, "The control of the judge referred to with a ban is limited to recording the reality of the rights of which the Plaintiff can take advantage and he does not have to carry out a critical in-depth analysis of the validity of the alleged patent, which comes under the assessment by the court referred to on the merit": Lyon High Court, Interim Ruling, 17 June 2008, No. 08/00818, SAS Seler / SAS Cellocoup International. - In the same way, Paris Court of Appeal, 21 March 2012, No. 11/12942, mentioned above, note 2.

[23] Law No. 2007-1544 of 29 October 2007 on the fight against counterfeiting having transposed the provisions of Directive No. 2004/48/EC of 29 April 2004 relating to compliance with intellectual property rights.

[24] In this way, Professor Jean-Christophe Galloux relies on the judgement by the European Court of Justice of 12 July 2012 (case C-616/10) concerning the interpretation of (EC) Regulation No. 44/2001 of 22 December 2000, known as "Brussels I", which admits that the judge referred to with a request for interim measures relating to counterfeiting, but who is not the judge with jurisdiction for the merit, may refuse these measures if he considers that there is a reasonable and not negligible chance that the patent referred to will be invalidated by the competent judge: J.-Ch. Galloux, "A few explanations relating to interim measures relating to counterfeiting": Industrial Property 2013, study 3.

[25] Compound of the main active ingredient irbesartan, with a diuretic, specifically the hydrochlorothiazide, HCTZ.

[26] Paris High Court, Interim Ruling, 10 August 2012, No. 12/55805, SA Sanofi Aventis France, SA Sanofi, SNC Sanofi Pharma Bristol Myers Squibb v. SAS Sandoz

[27] See in particular: Paris High Court, Interim Ruling, 20 January 2009, No. 08/58979, Mundipharma Laboratories GmbH / SAS Sandoz, Famar L'Aigle. - and Paris High Court, Interim Ruling, 5 July 2011, No. 11/55014, Astra Zeneca v. Ethypharm.

[28] Paris High Court, Interim Ruling, 23 May 2013, No. 12/16012, SA Sanofi Aventis France, SA Sanofi, SNC Sanofi Pharma Bristol Myers Squibb v. SAS Sandoz.

[29]The ECJ has since responded in a judgement of 12 December 2013, case C 443/12, Actavis Group PTC EHF, Actavis UK Ltd v. Sanofi, Sanofi Pharma Bristol Myers Squibb SNC, to a preliminary question asked with regard to this SPC confirming its invalidity for the reason that "Article 3 c) of (EC) Regulation No. 469/2009 of 6 May 2009, objects to the owner of this same patent obtaining a second Supplementary Protection Certificate relating to this compound of active ingredients, on the basis of the same patent, but from a subsequent marketing authorisation for a different medicine containing the said active ingredient in compound with another active ingredient, which is not, as such, protected by such patent".

[30] Paris High Court, Interim Ruling, 3 October 2012, No. 12/57056, SA Sanofi Aventis France, SA Sanofi, SNC Sanofi Pharma Bristol Myers Squibb v. Teva Santé.

[31] PE and Cons. EU Reg. No. 469/2009, 6 May 2009 relating to the Supplementary Protection Certificate for medicines: Official Journal of the European Union No. L 152, 16 June 2009.

[32] Paris Court of Appeal, 23 May 2013, No.12/16012, mentioned above, note 28.

[33] Paris High Court, Interim Ruling, 5 July 2011, No. 11/55014, mentioned above, note 27.

[34] Paris Court of Appeal, 20 November 2012, No. 11/16328, Astra Zeneca AB v. SAS Mylan, SA Ethypharm

[35] Paris High Court, Interim Ruling, 3 October 2012, No. 12/57056, mentioned above, note 30.

[36] Paris Court of Appeal, 21 March 2012, No. 11/12942, mentioned above, note 2.

[37] See for example the judgement by the High Court in Paris, 20 December 2013, No. 12/14402 by which Mylan and Ethypharm mainly obtained the annulment of the patent for the original product owned by Astra Zeneca.

[38] Paris Court of Appeal, 10 January 2014, No. 12/14361, SAS Laboratoire Pierre Fabre Medicament, SAS Pierre Fabre Medicament Production v. MC Neil AB, Pfizer Health Aktiebolag, Pharmacia Aktiebolag.

[39] Lyon Court of Appeal, 20 October 2009, No. 08/06216: JurisData No. 2009-018915, mentioned above, note 10.

[40] Strasbourg High Court, Interim Ruling, 10 March 2009, No. 09/00118, Negma v. Biogaran.

[41] Paris Court of Appeal, 31 January 2014, No. 12/05485, SAS Laboratoires Negma / SAS Biogaran, Laboratoire Medidom.

[42] Paris High Court, Interim Ruling, 31 October 2011, No. 11/15302, mentioned above, note 14.

[43] Paris High Court, 27 January 2012, No. 09/17355. - and Paris Court of Appeal, 6 July 2012, No. 12/05718, SAS Laboratoires Negma v. SAS Biogaran.

[44] In implementation of Law No. 91-650, 9 July 1991, relating to the reform of civil enforcement procedures, Article 31.
 
[45] Paris Court of Appeal, 31 January 2014, No. 12/05485, mentioned above, note 41.

[46] Supreme Court of Appeal in Plenary Session, 17 February 2012, No. 10-24.282: JurisData No. 2012-001980.