T R I D E I N S D E

B U N A L GRANDE T A N C E P A R I S

 ORDER IN PRELIMINARY PROCEEDINGS handed down on 3 October 2012

Docket No.: 12/57056 No.: 1/FF Summons of: 8 August and 19 September 2012

by Marie SALORD, Vice-Presiding Judge of the tribunal de grande instance de Paris, acting through delegation of authority from the Presiding Judge of the tribunal CLAIMANTS SANOFI 54 rue la Boétie 75008 PARIS represented by Mr Pierre-Louis VERON, attorney-at-law, member of the PARIS Bar - # P024 VOLUNTARY INTERVENERS SANOFI PHARMA BRISTOL MYERS SQUIBB 54 rue la Boétie 75008 PARIS represented by Mr Pierre-Louis VERON, attorney-at-law, member of the PARIS Bar - # P024

SANOFI AVENTIS FRANCE 1/13 boulevard Romain Rolland 75014 PARIS represented by Mr Pierre-Louis VERON, attorney-at-law, member of the PARIS Bar, - # P024

CLAIMANTS TEVA SANTE 110 Esplanade du Général de Gaulle 92931 PARIS LA DEFENSE CEDEX represented by Mr François POCHART, attorney-at-law, member of the PARIS Bar - #P0438

DISCUSSION At the hearing of 26 September 2012, held publicly, presided by Marie SALORD, Vice-Presiding Judge, assisted by Estelle LAFAYE, Court Clerk

THE DISPUTE

The supplementary protection certificate at issue On 20 March 1991, Sanofi (the first company to bear this name), filed patent application No. 91400745TN, claiming priority from French patent applications of 20 March and 8 August 1990, granted as European patent No. 0 454 511, on 17 June 1998. This patent, entitled “N-substituted heterocycle derivatives, their preparation, compositions containing them” relates to the compounds which antagonise the action of the angiotensin II hormone, which is a powerful vasoconstrictor, on the receptors. These derivatives, which belong to the sartans family, prevent in particular the blood level from rising as a result of the hormone-receptor interaction. The description mentions that these processes are useful for treating cardiovascular diseases such as hypertension. Claim 1 of the patent teaches the general formula of a compound and its salts. Claim 7 relates to “a compound according to claim 1, characterised in that it is the 2-n-butyl-4-spirocyclopentane-1-(((2’-(tetrazol-5-yl) biphenyl-4-yl) methyl)-2-imidazolin-5-one or one of its salts with acids or bases” and discloses the chemical name of irbesartan. Claim 20 of the French designation of the patent reads as follows: “a pharmaceutical composition containing a compound according to any one of claims 1 to 7 in association with a diuretic”. On 1 January 1997, Sanofi (the first company to bear this name) granted Sanofi Pharma Bristol Myers Squibb SNC an exclusive licence to exploit patent EP 511 and the various titles which may derive therefrom.

TN

Error in the French text, the correct number is 91400745.5.

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On 9 July 2012: - the absorption of Sanofi, the first company to bear this name (trade and companies register entry No. 732 059 332), by Sanofi Synthélabo (trade and company register entry No. 395 030 844) by merger agreement of 9 April 1999 adopted on 18 May 1999, - the adoption by the latter of the name Sanofi-Aventis and, finally, of the name Sanofi, were entered in the national patent register. European patent No. 0 454 511 expired in March 2011. It was used as a basis for two supplementary protection certificates which were the subjects of the same transfer registered in the French Patent Register on 9 July 2012. - SPC No. 98 C 0024 On 15 August 1997, a first marketing authorisation was granted for Switzerland, authorising the manufacturing and marketing of irbesartan, the subject-matter of claim 7 of patent EP 511. On 27 August 1997, Sanofi Pharma Bristol Myers Squibb SNC obtained marketing authorisation No. EU/1/97/046/001 for the same product in France, marketed under the name Aprovel as a drug for the treatment of hypertension. On 4 May 2000, an SPC for this product, based on the said patent, was granted to Sanofi Synthelabo, which had replaced Sanofi, the first company to bear this name, under No. 98 C 0024. This supplementary protection certificate expired on 15 August 2012. - SPC No. 99 C0001 On 15 October 1998, Sanofi Pharma Bristol Myers Squibb obtained marketing authorisation No. EU/1/98/086/001 for the manufacturing and marketing of the combination of the active ingredients irbesartan and hydrochlorothiazide (HTCZ) (150mg/12.5mg, tablets, blister packs of 28 tablets), under the name CoAprovel, for treating essential hypertension, insufficiently controlled by one of the active ingredients alone. The following MAs were also granted: - No. EU/1/98/086/002 for the combination of the active ingredients irbesartan and hydrochlorothiazide (150mg/12.5mg, tablets, blister packs containing 56 tablets), - No. EU/1/98/086/003 for the combination of the active ingredients irbesartan and hydrochlorothiazide (150mg/12.5mg, tablets, blister packs containing 98 tablets), - No. EU/1/98/086/004 for the combination of the active ingredients irbesartan and hydrochlorothiazide (300mg/12.5mg, tablets, blister packs containing 28 tablets), * No. EU/1/98/086/005 for the combination of the active ingredients irbesartan and hydrochlorothiazide (300mg/12.5 mg, tablets, blister packs containing 56 tablets), * No. EU/1/98/086/006 for the combination of the active ingredients irbesartan and hydrochlorothiazide (300mg/12.5 mg, tablets, blister packs containing 98 tablets).

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According to the European Public Assessment Report (EPAR) drawn up by the European Medicines Agency (EMA) concerning the drug named CoAprovel, HCTZ is a diuretic, which is another type of hypertensive drug. It works by increasing urine output, reducing the amount of fluid in the blood and lowering the blood pressure. The combination of the two active ingredients has an additive effect, reducing the blood pressure more than either medicine alone. The drug CoAprovel is only recommended for the treatment of essential arterial hypertension, whereas the drug Aprovel is also recommended for the treatment of renal impairment in hypertensive patients with type 2 diabetes. On 14 January 1999, Sanofi (trade and companies register entry No. 732 059 332), then the holder of European patent No. 0 454 511, applied for an SPC on the basis of the said European patent for the combination of the active ingredients irbesartan and hydrochlorothiazide which had been the subject of MA No. EU/1/98/086/001. In a decision of 4 May 2000, SPC No. 99 C 0001 was granted to Sanofi Synthélabo, which had replaced Sanofi. This SPC, kept in force through the payment of the yearly fees, will expire on 15 October 2013. According to the leaflet included in the boxes sold in pharmacies, the branded drug CoAprovel is manufactured in France by Sanofi Winthrop Industrie. It is marketed by Sanofi Aventis France, with the cooperation of Bristol-Myers Squibb France. - The legal background Upon the expiry of SPC No. 98 C 0024 relating to Aprovel, pharmaceutical companies decided to market the generic of the drug, but also that of the drug protected by SPC No. 99 C 0001 relating to CoAprovel. On 25 and 26 July 2012, Sanofi served a summons for a preliminary injunction upon Sandoz, Mylan and Arrow Génériques in view of the imminent infringement through the marketing in the near future of the generic of the drug CoAprovel. By way of orders dated 10 August 2012, the Judge ruling in preliminary proceedings dismissed the request for a preliminary injunction against Sandoz, Mylan and Arrow Génériques on the grounds that the validity of the SPC may be seriously disputed on the merits insofar as one of its two active ingredients only appears in the claims of the basic patent under the imprecise word “diuretic”, while the descriptive part of the said patent does not specify the nature of this diuretic. SANOFI lodged an appeal against these orders on 29 August 2012.

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In addition, in Belgium, an ex-parte order was handed down on 26 July 2012 at Sanofi’s request against the Belgian company Sandoz N.V., authorising the physical seizure and the placing under seals of the stocks of generics of the drug CoAprovel. In Germany, at Sanofi’s request, a preliminary injunction measure was pronounced against Actavis in a decision handed down on 15 August 2012 by the Landgericht Düsseldorf which ACTAVIS has not appealed. On 7 September 2012, Teva Pharma B.V. initiated an action for invalidity of the Dutch SPC corresponding to supplementary protection certificate No. 99 C 0001 in force in France. In a judgment dated 14 September 2012, the Hague Court provisionally enjoined Teva Pharma B.V. from marketing the generic drugs. Finally, in the action for invalidity initiated by Actavis against the UK SPC, the UK Court, in a decision dated 20 September 2012, referred two questions to the Court of Justice of the European Union concerning the interpretation of Articles 3 a) and 3 c) of Regulation No. 469/2009. - The present dispute On 3 November 2009, Teva Pharma B.V obtained three marketing authorisations for generics of the drug CoAprovel, relating to irbesartan/hydrochlorothiazide Teva 150mg/12.5mg, coated tablets, irbesartan/hydrochlorothiazide Teva 300mg/12.5mg, coated tablets and irbesartan/hydrochlorothiazide Teva 300 mg/25mg, coated tablets. Having being advised by the Comité Économique des Produits de Santé (CEPS), on 27 June 2012, that Teva had applied for the registration of these generic drugs on the list of refundable drugs, Sanofi, in a letter of 19 July 2012, through its attorney-at-law, informed Teva Santé of its intention to initiate all useful proceedings based on SPC No. 99 0001. The setting of a price for this generic drug, its registration on the list of refundable drugs and on the list of authorised drugs for the use of public organisations and various public services were published in the Official Journal of 2 August 2012. Teva Santé is mentioned on the website of the EMA as the local representative of the marketing authorisation holder and of the manufacturing authorisation responsible for the batch release and as the manufacturer of the three drugs. On 7 August 2012, Sanofi was authorised to serve a summons upon Teva to appear in preliminary proceedings at the hearing of 11 October 2012 and served a summons for this purpose on 8 August 2012.

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Having called upon a bailiff to note the marketing of the generic drugs, which, according to Teva’s declarations at the hearing, were put on the market as of 2 September, Sanofi, Sanofi Pharma Bristol Myers Squibb and Sanofi Aventis France, by way of an order of 18 September 2012, were authorised to serve a summons with an emergency motion to be heard on very short notice upon Teva Santé. At the hearing of 24 September 2012, the case was referred back to the Court in accordance with the principle of due process, as new exhibits and a new pleading had been submitted to the discussion by the claimants. In their pleading referred to and developed at the hearing of 25 September 2012, Sanofi, claimant, and Sanofi Pharma Bristol-Myers Squibb and Sanofi Aventis France, as voluntary interveners, request that the Judge, pursuant to Article L. 615-3 of the French Intellectual Property Code: - Provisionally enjoin Teva from importing, holding, offering to sell and selling the generic drugs irbesartan/hydrochlorothiazide Teva, coated tablets, regardless of their dosage, or any other pharmaceutical product implementing Community supplementary protection certificate No. 99 C 0001, under a set penalty of €1,000 per recorded infraction, as of the service of the order to be handed down, it being specified that importing, holding, offering to sell and selling one single box (packaging delivered to the patient) of these generic drugs would constitute a distinct infraction; - Order that the tablets of the generic drugs irbesartan/hydrochlorothiazide Teva, coated tablets, regardless of their dosage, or any other pharmaceutical product implementing Community supplementary protection certificate No. 99 C 0001, found in Teva’s possession be placed under seals and held in their storage place or any other place under its control until 15 October 2013 at midnight, and that those which are not in its possession be removed from commercial distribution, so as to be set aside from these commercial channels during the proceedings on the merits of the case, under a penalty of €100,000 per late day as of the service of the order to be handed down, under the supervision of any bailiff of Sanofi’s choice and at the expense of Teva; - Order Teva, as required, to send to each of the clients to whom it offered to sell, sold or delivered infringing generic drugs the following circular letter under a penalty of €10,000 per late day per client as of the service of the decision to be handed down:

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- IMPORTANT! Dear, [...], we are obliged to inform you that the Judge ruling in preliminary proceedings of the tribunal de grande instance de Paris, in a decision dated [ _ ] 2012, decided, provisionally, that the acts relating to the combination irbesartan/HCTZ Teva, which we offered to you, constitute the infringement of Community supplementary protection certificate No. 99C 0001 and that, consequently, this product may no longer be sold, delivered or used in France, or offered for sale or held in stock. We hereby ask you to return all the above-mentioned products which are in your possession as quickly as possible. We will immediately refund the purchase price as well as all related costs incurred by the return of these Teva products; - Order Teva to send to Sanofi’s attorneys-at-law copies of the letters sent to its clients, under a penalty of €10,000 per late day as of the service of the order to be handed down; - Reserve its decision on the assessment of the penalty ordered pursuant to the provisions of Article L. 131-3 French Code on the enforcement of civil procedures; - Order the provisional enforcement of the order to be handed down in all its provisions; - Hold Sanofi Pharma Bristol-Myers Squibb and Sanofi Aventis France admissible in voluntarily intervening in the proceedings and in joining the proceedings in support of Sanofi’s request for an injunction; - Order Teva to pay the sum of €150,000 to Sanofi pursuant to Article 700 of the French Code of Civil Procedure, subject to adjustment; - Order Teva to pay the entire costs and hold they will be recovered pursuant to Article 699 of the French Code of Civil Procedure. In its pleading referred to and developed at the hearing, Teva requests that the Judge ruling in preliminary proceedings: - Hold that the claimants’ action based on Article 615-3 of the French Intellectual Property Code is inadmissible, - Note that CCP 99C0001 is obviously invalid, - Hold that the claimants are not founded and dismiss their claims and arguments,

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- Hold that the requirements laid down in Article L.615-3 of the French Intellectual Property Code are not validly met and that preliminary proceedings are not necessary, - Order the claimants to pay the sum of €150,000 to the defendant pursuant to Article 700 of the French Code of Civil Procedure, - Order the claimants to pay the entire costs. In addition, Teva indicated orally that, firstly, it was withdrawing its request relating to the invalidity of the summons, and, secondly, that it was offering a bank guarantee of the sum of 3 million euros. On Teva’s request, the exhibits submitted by the claimants 3 hours and thirty minutes before the hearing, namely exhibit 46, pages 3 to 14 of exhibit 47 and exhibit 51, were set aside from the discussion. GROUNDS It should first be recalled that the Judge ruling in preliminary proceedings is not the Judge ruling on the appeal of the orders handed down in preliminary proceedings on 12 August 2012 and that she is responsible for issuing a ruling having regard to the arguments developed in these proceedings and the exhibits submitted to the discussion by the parties. Article L. 615-3 of the French Intellectual Property Code provides that: “Any person with authority to bring an action for infringement may, in preliminary proceedings, request the competent civil court to order, under a penalty of a daily fine if necessary, against the alleged infringer or intermediaries whose services it uses, any measure aimed at preventing an infringement about to be committed against rights conferred by the title or aimed at stopping any further allegedly infringing act. The competent civil court may also order ex parte urgent measures when the circumstances require that such measures should not be taken in the presence of both parties, in particular when any delay would be likely to cause an irreparable damage to the claimant. The court, in preliminary or ex parte proceedings, may order the requested measures only if evidence, reasonably accessible to the claimant, make it likely that its rights are infringed or that such infringement is about to be committed”. On the claimants’ authority to bring an action By an agreement dated 1 January 1997, SANOFI, the first company to bear this name, granted Sanofi Pharma Bristol Myers Squibb SNC an exclusive licence to exploit patent EP 511 and the various titles which may derive therefrom.

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In addition, a sub-licence agreement was entered into between Sanofi Pharma Bristol-Myers Squibb and Sanofi-Aventis France in the presence of Sanofi on 25 July 2012 according to which the former, as the licensee of SPC 99 C 0001, grants a sub-licence to the second, which is already marketing the drug CoAprovel. Teva considers that Sanofi does not justify its authority to bring an action on the grounds that the term in the licence agreement of 1 January 1997 relating to the notion of “Affiliate” excludes the transfer of the intellectual property rights to Sanofi Synthelabo which absorbed Sanofi, the first company to bear this name, insofar as it had no link to it, contrary to the contractual provisions. It concludes therefrom that Sanofi, the second company to bear this name, is not the co-contracting party to the licence, so that neither the alleged licensee nor Sanofi Aventis is a licensee. It adds that the agreement submitted to the discussion is not that which governs the relationships between the parties and that there is a secret act which has not been submitted. The claimants put forward the provisions of Article L. 236-3.1 of the French Code of Commerce pursuant to which the merger/takeover of a company leads de facto to the universal transfer of their assets to the acquiring company. It suffices to note that SPC No. 99 C 0001 was granted on 4 May 2000 to Sanofi Synthelabo and that it results from the registration in the French Patent Register of 9 July 2012 that Sanofi now its holder, following the merger/takeover of Sanofi, the first company to bear this name, by Sanofi Synthelabo and the name changes. The objections of Teva, a third party to this agreement, to the transfer of the licence agreement are irrelevant and Sanofi, the main claimant in the main proceedings, which is the holder of the right on which its requests are based, is admissible in bringing an action in these proceedings. Teva then points out the lack of authority to bring an action of Sanofi Pharma Bristol-Myers Squibb and Sanofi Aventis France, the licensee and sub-licensee, which join the holder of the title to proceedings in which they lodge no claim. It alleges that the patentee and its exclusive licensee may alternatively take part in an action for infringement and that the voluntary intervention, ancillary to the proceedings, is excluded from the exception provided for in Article L. 615-2 paragraph 5 of the French Intellectual Property Code insofar as the voluntary interveners lodge no compensation claim. Finally, Teva alleges that the licence agreement of 1 January 1997 was not registered in the French Patent Register and, for this reason, cannot be invoked. Sanofi Pharma Bristol-Myers Squibb and Sanofi Aventis France’s authority to bring an action should be examined having regard to their capacity as voluntary interveners.

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Their intervention is ancillary insofar as they make no assertions of their own but support the assertions of the holder of the SPC, pursuant to Article 330 of the French Code of Civil Procedure. Yet, in their capacity as licensee and sub-licensee, as it results from the agreement dated 25 July 2012, these companies necessarily have an interest in bringing an action for maintaining their rights as the marketing of a product reproducing the SPC causes them damage and as they have an interest in seeing the injunction ordered. Moreover, the last paragraph of Article L-615-2 of the French Intellectual Property Code that authorises a licensee to bring an action in proceedings for infringement to obtain compensation for the damage it suffered gives him a specific right to bring an action in proceedings for infringement and cannot be interpreted as prohibiting him from benefitting from/taking advantage of an ancillary intervention on the basis of procedural rules of ordinary law. Finally, as a licensee whose agreement has not been registered in the French patent register may intervene in the infringement proceedings, he may also, pursuant to Article L 615-3 of the French Intellectual Property Code, intervene in the proceedings for a preliminary injunction. Consequently, the ancillary interventions of Sanofi Pharma Bristol-Myers Squibb and Sanofi Aventis France are admissible. Therefore, the plea of inadmissibility should be dismissed. On the likelihood of the infringement of Sanofi’s rights It has been established that since 2 September 2012, Teva has been marketing in France the generic drug reproducing the SPC of which Sanofi is the holder. Teva disputes the injunction on the grounds that the SPC is obviously invalid. In this respect, it should be recalled that the assessment of the Judge ruling in preliminary proceedings, ruling on the basis of Article L. 615-5 of the French Intellectual Property Code, is limited to the obvious invalidity of the title, and that only this can make the infringement of the rights of its holder unlikely.

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- On the arguments against the validity of patent EP 511 Teva asserts that the patent is obviously invalid, which leads to the invalidity of the SPC pursuant to Article 15 of Regulation 469/2009 providing that the certificate is invalid if, after the basic patent has expired, grounds for revocation exist which would have justified such revocation. This argument in dispute must be examined taking into account the fact that the defendant refrained from challenging the validity of the French designation of the patent while it was being kept in force and that it only marketed the generic drug of Aprovel once the protection certificate relating to the drug had expired. More generally, the national designations of the patent at issue were never disputed, whereas Aprovel, deriving from claim 7, had been a commercial success and the generic drugs manufacturers waited until the expiry of the SPC relating to this drug to market their products. - On the insufficiency of description Teva describes the skilled person as an organic chemist having specific knowledge in the field of the new compounds blocking angiotensin II and the claimants describe him as a team, which includes a pharmacologist, in charge of developing a new drug against arterial hypertension. As the patent aims to develop new molecules to combat hypertension, the skilled person should be considered as including an organist chemist and a pharmacologist, the former having knowledge of the blocking of angiotensin II and the latter having knowledge on products for treating arterial hypertension and their effects. Teva asserts that claim 20 of the patent, protecting the combination which is the subject of the SPC, which it describes as a speculative idea, is not sufficiently described for the skilled person, as it does not contain examples establishing the efficacy of the combinations of active ingredients, results or tests, or the mention of the technical advantages. It alleges that it was impossible for the skilled person to determine the diuretic to chose and which dose should be administered. Article 138-1 -b) EPC provides that the European patent shall be held invalid by the courts of a Contracting State “if patent does not disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art”. Therefore, the insufficiency of description presupposes the presence of serious reservations substantiated by verifiable facts.

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Yet the information in the Vidal book, the indications by the WHO, the article by the American Heart Association and the report of 1988 by the Joint National Committee on the Detection, Evaluation and Treatment of High Blood Pressure - all dating from before the priority date – all establish sufficiently strongly at the stage of the preliminary proceedings that HCTZ, which has existed since 1959 and represented almost one third of the prescriptions for hypertensive drugs in the United States in 1985, were sufficiently identified by the skilled person as having an effect, when combined with another active ingredient, on hypertension. Therefore, no obvious insufficiency of description is established. - On the lack of inventive step Article 56 EPC provides that “an invention shall be considered as involving an inventive step if, having regard to the state of the art, it is not obvious to a person skilled in the art”. In order to appraise the inventive nature of an invention, it has to be determined whether, having regard to the state of the art, the skilled person, considering the problem which the invention purports to solve, would have obtained the technical solution claimed by the patent on the basis of his professional knowledge and by performing simple operations. The inventive step is defined having regard to the specific problem with which the skilled is faced. According to Teva, the teaching of Dupont de Nemours, a pioneer in the field of antihypertensive drugs, has made it possible to reach the Irbesartan/HCTZ combination in an obvious way which shows no technical advantage in comparison with those of the prior art. However, in order to question the lack of inventive step of claim 20, which is a dependent claim, the main claim must be disputed. Therefore, the arguments on the lack of inventive step of claim 20 in and of itself, are irrelevant. Teva also criticises the patent in general, due to its lack of further technical effect in comparison with Dupont de Nemours’ patent applications, which have led to the drug Losartan. It points out that the priority date of the patent in dispute is only two months later than that of the application for patent EP 310, which it describes as a pioneer patent.

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However, the obvious lack of validity of a patent cannot result solely upon this indication and requiring that the patent holder demonstrate the “technical progress”, which is not a legal criterion, of his invention in comparison with another one would amount to reversing the burden of proof. Claim 1 of this patent is drafted as follows:

“1. A compound of the formula in which : R1 and R2 are similar or different and are each independently hydrogen or a group selected from a C1 -C6 alkyl, a C1 -C4 alkoxy, an amino, an aminomethyl, a carboxyl, an alkoxycarbonyl in which the alkoxy is C1 -C4, a cyano, a tetrazolyl, a methyltetrazolyl, a methylsulfonylamino, a trifluoromethylsulfonylanino, a trifluoromethylsulfonylaminomethyl, an N- cyanocarbamoyl, an N- hydroxycarbamoyl, an N-(4- carboxy -1,3thiazol -2- yl)car-55 bamoyl, a ureido, a 2- cyanoguanidinocarbonyl, a 2cyanoguanidinomethyl, an imidazol -l- ylcarbonyl, a 3 -cyano-2methylisothioureidomethyl, with the proviso that at least one of the substituents R1 or R2 is other thanhydrogen; R3 is a hydrogen, a C1 -C6 alkyl which is unsubstituted or substituted by one or more halogen atoms, a C2 -C6 alkenyl, a C3 -C7 cycloalkyl, a phenyl, a phenylalkyl in which the alkyl is C1-C3, a phenylalkenyl in which the alkenyl is C2 -C3, said phenyl groups being unsubstituted or monosubstituted or polysubstituted by a halogen atom, a C1-C4 alkyl, a C1 -C4 halogenoalkyl, a C1 -C4 polyhalogenoalkyl, a hydroxyl or a C1 -C4 alkoxy;

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R4 and R5 are each independently a C1 -C6 alkyl, a phenyl, a phenylalkyl in which the alkyl is C1 -C3, said alkyl, 5 phenyl and phenylalkyl groups being unsubstituted or substituted by one or more halogen atoms or by a group selected from a C1 -C4 perfluoroalkyl, a hydroxyl, a C-C4 alkoxy; or R4 and R5 together form a group of the formula = CR7R8, in which R7 is hydrogen, a C1 -C4 alkyl or a phenyl and R8 is a C1 -C4 alkyl or a phenyl; or else R4 and R5 bonded together are either a group of the formula (C1-12) or a group of the formula (CH2)pY- (CH2)q, in which Y is either an oxygen atom, or a sulfur atom, or a carbon atom substituted by a C1 -C4 alkyl group, a phenyl or a phenylalkyl in which the alkyl is C1 -C3, or a group N -R6, in which R6 is a hydrogen, a C1-C4 alkyl, a phenylalkyl in which the alkyl is C1-C3, a C1 -C4 alkylcarbonyl, a C1 -C4 halogenoalkylcarbonyl, a C1 -C4 polyhalogenoalkylcarbonyl, a benzoyl, an alpha aminoacyl or an N- protecting group, or R4 and R5, bonded together with the carbon atom to which they are bonded, form an indane or an adamantane; p +q =m; n is an integer between 2 and 11; m is an integer between 2 and 5; X is an oxygen atom or sulfur atom; z and t are zero or one is zero and the other is one; and its salts”. Teva cannot allege that it establishes the obvious lack of inventive step of this claim, 22 years after the priority date of the patent, while the replacement of the hydroxymethyl group by a ketone function, firstly, and, secondly, the substitution of the chlorine atom for a spirocyclopentan function, cannot be appraised in an a posteriori reasoning and, more importantly, while these two changes clearly show that the skilled person was not necessarily led to this solution. It results therefrom that this argument is irrelevant. - On the arguments against the validity of the supplementary protection certificate Regulation 469/2009, codifying Regulation 1768/92 concerning the creation of a supplementary protection certificate for medicinal products, provides in its Article 3 four conditions for the grant of the SPC: “a) the product is protected by a basic patent in force; b) a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate; c) the product has not already been the subject of a certificate; d) the authorisation referred to in point (b) is the first authorisation to place the product on the market as a medicinal product”.

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The defendant disputes the validity of the SPC having regard to a), c) and d).” - On the protection of CoAprovel by patent EP 511 Claims 20 of the patent relates to a “pharmaceutical composition containing a compound according to any one of claims 1 to 7 in association with a diuretic”. The SPC relates to the combination of irbesartan and HCTZ and it is established that irbesartan is the subject-matter of claim 7. Teva contends that as patent EP 511 does not mention HCTZ, it is not an acceptable basic patent having regard to the case law of the Court of Justice Medeva since the SPC cannot relate to an active ingredient which is not mentioned in the wording of the claims. It considers that the term diuretic does not identify HCTZ, as there is no specific active ingredient, and that considering the fact that the word diuretic covers an extremely large category, nothing makes it possible to affirm that HCTZ was the “natural” candidate for an association whereas the various diuretics have different structures and chemical properties. According to Teva, holding that the SPC is valid would maintain a legal uncertainty that would be inacceptable for the third parties and would systematically lead to its holder being entitled to a maximum protection period of 25 years for a product. Sanofi considers that the Medeva case law does not require that the basic patent claim individually and by its name the product the subject of the SPC, i.e. either the active ingredient referred to or each of the active ingredients of the combination referred to. It alleges that it must claim all the active ingredients to which the supplementary protection certificate relates, whether by their individual or group chemical name, or by their assigned function in the composition and that in this case, claim 20 refers to the combination of two active ingredients, the first one being identified by its chemical name and the second one by its therapeutic function. Whereupon The Court of Justice, in the Medeva decision (C-322/10), replying to a question on the validity of an SPC relating to active ingredients which did not appear in the basic patent, held that an SPC cannot be granted if it relates to “active ingredients not mentioned in the wording of the claims of the basic patent”. This case law does not apply here as claim 20 of the basic patent relates to the association between irbesartan and a diuretic and as it is established that HCTZ is a diuretic.

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The question which must be considered in this case is whether the fact that the patent does not identify HCTZ in the diuretics family makes the protection of a combination containing it by an SPC impossible. Yet, as HCTZ, of which it is not disputed that it belongs in the pharmaceutical field to a therapeutic category of active ingredients, namely the diuretics family, could easily be identified at the time of the priority date of the patent, as was seen concerning the dispute relating to the lack of description, it is not obvious that the SPC is not valid. It cannot be inferred from the Medeva case law, as the defendant does, that for a combination of active ingredients to be protected by an SPC, the basic claim must refer to all the active ingredients of the product. It should be pointed out on the contrary that the Luxembourg Court (Georgetown decision (C-422/10)) accepts that an SPC does not reproduce the wording of the claims of the basic patent when the drug, the subject of the MA, includes this active ingredient and another one. Although that case is not similar to the present case, it establishes nonetheless that considering the fact that the SPC aims to stimulate pharmaceutical research, it can adapt to the constraints thereof, as the patent relates to the invention and the SPC to its application in the pharmaceutical field. The fact that the UK Court, ruling on an invalidity claim concerning the SPC in dispute, has referred a question to the Court on the interpretation of Article 3a) relating to the criteria for deciding whether the product is protected by the basic patent insofar as it considers that the answers brought by the Court on this matter in questions that had been previously referred to it are not clear, does not constitute a dispute preventing the Judge ruling in preliminary proceedings from acceding to the preliminary injunction measures. - On the compliance of the certificate with Article 3 c of the Regulation Teva asserts that only one SPC may be granted on the basis of a patent and that in this case, as an SPC has already been granted for Aprovel, the second one relating to CoAprovel cannot be valid. The defendants reply that there is no provision in the regulation preventing the grant of more that one SPC for more than one product protected by the basic patent, which is correct. It is established that a Dutch court (decision dated 11 July 2012) and a UK court (decision dated 20 September 2012) referred a question to the Court of Justice on the possibility of granting an SPC for each of the products claimed in the basic patent. However, the Judge ruling in preliminary proceedings must issue a ruling taking into account the state of case law and it cannot be inferred from the Biogen decision of the Court (C-181/95) that its case law prevents the grant of more than one SPC per basic patent since that case related to one product protected by several basic patents.

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In addition, the Court’s sentence in the Medeva decision “where a patent protects a product, (…) only one certificate may be granted for that basic patent” (§ 41), when referring to the Biogen decision, is not relevant either. Finally, it is not disputed that it is an established practice of the patent offices to grant several SPCs for one and the same basic patent, even though according to the UK Court, the Dutch patent office has recently stopped granting more than one certificate per basic patent. Therefore, an injunction measure requested by the holder of an intellectual property right cannot be rejected by taking into account only the possible evolution of the interpretation of Regulation 409/2009. - On the compliance of the SPC with Article 3d Teva considers that the basic MA is not the first one pursuant to the regulation as the MA previously granted for Aprovel in 1997 already contained indications allowing SANOFI to exploit the combination of claim 20, the summary of the features of the product mentioning the association of Aprovel with HCTZ. It adds that the MA for CoAprovel was granted on the basis of the same clinical tests as those which made it possible to include in the SmPC of Aprovel the recommendation for the combination and that it does not matter much that a complete authorisation application should have been formally filed with the Medicines Agency for the authorisation to market CoAprovel. Sanofi replies that the combination of two compounds constitutes, according to Regulation No. 469/2009, a product distinct from any one of the compounds taken individually as the added compound confers a specific therapeutic effect for the therapeutic use of the medicinal product and HCTZ has a diuretic therapeutic action which combines with the therapeutic activity of irbesartan. It adds that the product the subject of SPC No. 99 C 0001, namely the combination of the active ingredients, is different from the product the subject of SPC No. 98 C 0024, namely irbesartan. WHEREUPON The regulation defines the product as “the active ingredient or combination of active ingredients of a medicinal product”. It is established that the basic patent protects two active ingredients, in its claim 7 irberstan alone and in its claim 20 the combination irbesartan/diuretic, HZCT here. Besides, it is not disputed by Teva that this combination results in an active ingredient which is different from irbesartan, and the MA granted for Aprovel does not apply to this combination, regardless of the fact that tests have already been performed.

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On the contrary, the two MAs refer to different products and the mere mention in the SmPC of Aprovel of the possibility of prescribing it with HCTZ does not constitute a marketing which only relates to a product and not a possibility which, even though it was authorised by the health authorities, is not implemented by the drug. Deciding the contrary would amount to granting a marketing authorisation for all the combinations with other ingredients mentioned in the SmPC. Moreover, the case law of the Court of Justice Neurim (C-130/11) relating to a veterinary product which was the subject-matter of a new SPC based on a new MA for an administration of a drug to human being, cannot apply here, as in that decision, the products were similar. It results therefrom that TEVA fails to prove that SPC No. 99 C 0001 is obviously not valid. On the requested provisional measures Teva asserts that in the absence of an injunction measure, the possible harmful consequences could be compensated for, taking into account its financial strength. It argues that the preliminary injunction would be against the general principle of proportionality of the ordered measures. It adds that while its competitors may remain on the market pursuant to the orders of August 2012, it would be scandalous that the marketing of its products be prevented; this would infringe competition law and lead to diametrically opposed solutions handed down by the same court and relating to the same subject and the same claims, after an interval of two months. Whereupon It should be taken into account that the marketing of the drug CoAprovel generates a turnover in France of more than 117 million euros and that it holds 23.6% of the market shares of the sartans combos. Moreover, the evaluation of the decrease in the turnover generated by the marketing of the generic drugs before the expiry of the SPC to the sum of 75 to 90 million is not disputed. It is established that this sudden decrease in the turnover of the branded drug, taking into account the diminution in market shares and having regard to the lifetime of the SPC, jeopardizes the claimants’ interests. In this context, the bank guarantee provided by the defendants in the amount of 3 million euros is not sufficient to compensate for the damage suffered by Sanofi. The issue as to contrary orders being handed down in preliminary proceedings will be settled in appeal and notwithstanding a preliminary injunction, each generic manufacturer should evaluate the action to be taken.

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Therefore, the injunction measures as set out in the operative part of the order should be acceded to, without it being necessary, having regard to the principle of proportionality, to order that the products be recalled from the commercial circuits. However, the information measure concerning professionals is proportionate, in order to inform them of the injunction measure, but it is not necessary to order a penalty, or to dictate to Teva what the content of this information should be. On the other claims Teva Santé, as the unsuccessful party, will be ordered to pay the costs. The request for collecting the costs will not be acceded to, as Article 699 of the French Code of Civil Procedure does not apply to preliminary proceedings since the representation by an attorney-at-law is not compulsory. Teva will be ordered to pay compensation to Sanofi, which is the only one to lodge such a request, for the irrecoverable costs incurred to assert its rights in these proceedings, in the amount of €50,000. It is not necessary to order the provisional enforcement of this decision, which applies ex officio pursuant to Article 489 of the French Code of Civil Procedure. ON THESE GROUNDS We, Judge ruling in preliminary proceedings, ruling publicly in the presence of all the parties and in first instance, by way of an order made available at the Court Clerk’s office, HOLD that SANOFI’s claims and Sanofi Pharma Bristol-Myers Squibb and Sanofi Aventis France’s voluntary intervention, ancillary to the proceedings, are admissible, ENJOIN TEVA SANTE, provisionally, as of the day following the pronouncement of the order, from offering to sell and selling in France the generic drugs Irbesartan / Hydrochlorothiazide Teva, coated tablets, under a set penalty of €1,000 per recorded infraction, the offer to sell and sale of one single box (packaging delivered to the patient) of these generic drugs constituting a distinct infraction, HOLD that this penalty will begin to run after one week as of the day the order is pronounced and will last until the expiry of the SPC, i.e. 15 October 2013, RESERVE our decision on the assessment of the penalty, ORDER that the tablets of the generic drugs in the possession of TEVA SANTE “Irbesartan / hydrochlorothiazide Teva” coated tablets, be placed under seals and held in their storage place or any other place under its control until 15 October 2013 at midnight, failing an agreement between the parties or a decision of the Judge ruling on the merits, under the supervision of any bailiff of SANOFI’s choice and at the expense of Teva, ORDER TEVA SANTE to send to each of the clients to whom it offered to sell, sold or delivered the generic drugs a letter informing them of this decision, within fifteen days as of the day the order is pronounced,

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ORDER TEVA SANTE to communicate to SANOFI’s attorneys-at-law copies of these letters, DISMISS SANOFI’s other claims, ORDER TEVA SANTE to pay the sum of €50,000 to SANOFI pursuant to Article 700 of the French Code of Civil Procedure, ORDER TEVA SANTE to pay the entire costs. RECALL that this order is provisionally enforceable. Drafted in Paris on 03 October 2012 The Clerk,

The President,

Estelle LAFAYE

Marie SALORD

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