C-316/95

* Original language: English. 1 — Council Directive 65/65/EEC of 26 January 1965 on the 3. The Court is also asked whether it is approximation of provisions laid down by law, regulation or justifiable to grant a patentee, by way of a administrative action relating to proprietary medicinal prod- ucts: OJ, English Special Edition 1965, p. 20. Article 3 of that remedy for infringement of that law, an Directive was amended by Article 1 of Council Directive 93/39/EEC of 14 June 1993, amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC in respect of medicinal products, OJ 1993 L 214, p. 22, to take account of the fact that the system of national authorization to which Directive 65/65 referred has been replaced, in respect of cer- 2 — See Article 47 of the Rijksoctrooiwet (Netherlands law on tain products, by the system of Community-wide authoriza- patents) 1910 ('the ROW 1910'), now Article 49(2) of the tions set up under Council Regulation (EEC) No 2309/93 of Rijksoctrooiwet 1995 ('the ROW 1995'), and Article 63 of 22 July 1993, laying down Community procedures for the the European Patent Convention. (The Munich Convention authorization and supervision of medicinal products for of 5 October 1973 on the grant of European Patents, which human and veterinary use and establishing a European entered into force on 7 October 1977.) Agency for the Evaluation of Medicinal Products, OJ 1993 3 — See Article 2 of the ROW 1910, Article 4 of the ROW 1995, L 214, p. 1. and Article 54 of the European Patent Convention.

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GENERICS v SMITH, KLINE & FRENCH

4. The problem encountered by patentees as a result of the delays involved in obtaining 6. The second patent was granted on 19 June marketing authorizations has now been 1991 (patent No 187.240), pursuant to an addressed directly by Council Regulation application dated 4 September 1973 and fol­ (EEC) No 1768/92 of 18 June 1992 concern­ lowing publication of the application on ing the creation of a supplementary protec­ 18 February 1991 ('the second patent'). It tion certificate for medicinal products ('the expired on 4 September 1993. The patented Supplementary Protection Regulation', or process concerned the preparation of a 4 simply 'the Regulation'). That Regulation, medicinal product having an antagonistic which I consider more fully below, makes it effect on the histamine receptor. The phar­ possible for patentees to apply for an exten­ maceutical preparation produced by that sion to the usual period of national patent process has the generic name cimetidine and protection in respect of an authorized prod­ is marketed by SKF in the Netherlands uct. The extension is calculated by reference under the brand name Tagamet. It appears to the period which elapsed between the date that that product was in fact protected by upon which the application for a basic patent both the first and second patents. was lodged and the date upon which the first authorization to place the product on the 5 market in the Community was granted. Application for such protection, however, is not possible if, as in the present case, the first authorization to place the product on the 7. The date upon which SKF obtained mar­ market was obtained before 1 January 1985. 6 keting authorizations for the patented prod­ ucts is not stated. However, the referring court does state that the authorizations were obtained prior to 1 January 1985. The rel­ 4 — OJ 1992 L 182, p. 1. evance of that date is, as explained above, 5 — Article 13. that a supplementary protection period for 6 — Article 19(1). (Different dates arc provided in that Article in respect of Denmark, Germany, Belgium, and Italy.) patents cannot be applied for under the

11. According to the order for reference, in a judgment dated 18 December 1992 ('the 10 1992 judgment') the Hoge Raad held that, where samples of a medicinal product manu­ factured in accordance with a patented pro­ cess were, during the currency of the patent, 9. SKF contends that the submission of provided to the CBG by a person other than samples to the CBG constituted an infringe­ the patentee so as to be able to place the ment of its patents, which were still in force product on the market immediately after the at the date the samples were submitted. It expiry of the patent, Article 30(3) was not applicable; accordingly, the patent was infringed. 7 — Cited in note 4. 8 — At the oral hearing SKF maintained that two of the three applications were in fact made by Generics, transferred to Genfarma and, following authorization, transferred back to Generics. Nothing, however, turns on that aspect of the 9 — Now Article 53(3) of the ROW 1995. facts. 10 — Medicopharma v ICI NJ 1993, 735.

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GENERICS v SMITH, KLINE & FRENCH

12. Although, as Generics points out, that against Generics on 6 August 1993. It case concerned more than the mere submis­ claimed that Generics should be ordered: sion of samples to the CBG, the judgment has been taken to mean that the submission of samples alone constituted an infringement of the patent and the first question referred is worded on the assumption that that is the — not to offer or supply cimetidine for con­ position under Netherlands law. sumption in any form whatever on the Netherlands market until 14 months after 4 September 1993 (that is to say, not before 5 November 1994), on pain of a 13. The referring court explains that the penalty payment of HFL 50 per gramme 1992 judgment implies the following: of cimetidine product;

I - 3935

OPINION OF MR JACOBS — CASE C-316/95

terms to that requested by SKF. It prohibited to reach a decision upon a registration within Generics from making use of registrations 120 days of the application and provides that obtained pursuant to applications filed prior the only possibility of extension is an addi­ 1 to 4 September 1993 and from offering or tional 90 days in exceptional cases. 1That supplying cimetidine for consumption in any provision had been implemented in Nether­ form whatever on the Netherlands market lands law at the relevant time by Article 8(1) before 5 November 1994, on pain, respec­ of the Besluit Registratie Geneesmiddelen tively, of penalty payments of HFL 25 000 (Decree on the registration of medicinal per offer made and HFL 50 per gramme of products). 12 Generics argues, that the cimetidine product supplied. It further pro­ national authorities cannot derogate from the hibited Generics from transferring the afore­ time-limit laid down in Article 8 of that mentioned registrations to a third person or Decree and that, in so far as they do not allowing such third person to make use comply with that time-limit, the additional thereof before 5 November 1994, on pain of delay cannot form the basis of a sanction a penalty payment of HFL 10 000 per day. against third parties. At the oral hearing, Generics appealed against that order to the Generics also suggested that compensation, Gerechtshof te 's-Gravenhage (Regional or cancellation of the marketing authoriza­ Court of Appeal, The Hague) but the order tions, should have been considered as an was upheld. Generics then appealed (in cas­ alternative to an injunction. sation) to the Hoge Raad.

18. Generics further objects that, even if the order made by the Rechtbank were to be 11 — Article 7 of Directive 65/65, cited in note 1, provided origi- upheld in principle, an injunction for a nally that Member States should take all appropriate mea- sures to ensure that the procedure for granting an authori- period of 14 months is excessive. Whilst rec­ zation to place a proprietary medicinal product on the market was completed within 120 days of the date of sub- ognizing that 14 months is the usual time mitting the application, but that, in exceptional cases, that taken in practice to register an application time-limit could be extended for a further 90 days. Article 7 was amended by Article 1(6) of Directive 93/39, cited in for a marketing authorization, Generics note 1, so as to extend the time-limit to 210 days in all cases. Member States were obliged to implement that points to the fact that Article 7 of Article before 1 January 1995. Directive 65/65 requires national authorities 12 — Staatsblad 1977 537.

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GENERICS v SMITH, KLINE & FRENCH

(3) Where, during the currency of a patent, an infringement of that patent is com­ mitted under national law and there is a danger that the person committing that 20. Article 30 of the Treaty prohibits, in infringement or a third person may still trade between Member States, quantitative profit from the infringement following restrictions on imports and all measures hav­ the expiry of the patent, or that the pro­ ing equivalent effect. By virtue of the first prietor of the patent may still suffer sentence of Article 36, Article 30 does not some disadvantage as a result of the preclude prohibitions or restrictions which infringement following the expiry of the are justified on grounds of the protection of patent, does a judicial prohibition industrial and commercial property. By vir­ imposed in order to prevent that poten­ tue of the second sentence, such prohibitions tial harm which restrains, for a specified period after the expiry of the patent, the placing on the market of products 13 — Second Council Directive 75/319/EEC of 20 May 1975, on which were protected by the patent dur­ the approximation of provisions laid down by law, regu- ing its currency, constitute a measure lation or administrative action relating to proprietary medicinal products, OJ 1975 L 147, p. 13. That Directive, which is prohibited by Article 30 of the together with Council Directive 75/318 of 20 May 1975 on the approximation of the laws of the Member States relating EC Treaty and which is not covered by to analytical, pharmacotoxicological and clinical standards the exception contained in Article 36 of and protocols in respect of the testing of medicinal prod- ucts, OJ 1975 L 147, p. 1, extended the harmonization pro- the EC Treaty? cess initiated by Directive 65/65.

21. SKF maintains that intra-Community trade is not affected because the samples sub­ mitted to the CBG came from Canada. Indeed it emerged at the oral hearing that Generics does not dispute SKF's contention 23. The United Kingdom argues that that the samples were imported into the Article 30 has no application to the present Netherlands from Canada. However, the case, regardless of the origin of the samples. order for reference is silent as to the origin It states that the Court has only applied of the samples and it is upon the information Articles 30 and 36 to prevent the exercise of contained in that document that the Court intellectual property rights in two types of should base its judgment. case: where the product which is the subject of the action has been put on the market by the proprietor of the right or with his con­ sent (the 'exhaustion of rights' doctrine); and where the measures permitted by national laws constitute a means of arbitrary discrimi­ nation or a disguised restriction on trade. It observes that, since the samples were placed 22. In any event, even if the samples in ques­ on the market neither by the patentee nor tion were imported from Canada, an issue with his consent, the prohibition on the use under Article 30 still arises because it does of samples cannot be objected to on the not necessarily follow that all the products grounds that the patentee has exhausted his to be marketed by Generics would come rights. It then reasons that, since the law in from the same source as the samples. Indeed, question also does not discriminate on Generics explained at the hearing that it law­ grounds of nationality or residence or fully produces and markets cimetidine in Ire­ between imported and domestically pro­ land, where SKF's patent has expired and duced goods, prima facie Article 30 has no where Generics obtained a marketing autho­ application. It considers that national laws rization in 1992. Since the effect of the law defining the extent of infringing use, particu­ relating to the submission of samples is to larly where harmonized as they are in

24. Even assuming that the Court has held that Articles 30 and 36 restrict the exercise of intellectual property rights only in the cases suggested by the United Kingdom, I do not 25. The answer to the first question is thus agree that other cases fall outside the scope that a rule of national law which confers on of Article 30. Where the Court has held that the proprietor of a patent in respect of cer­ Articles 30 and 36 do not restrict the exercise tain medicinal products the right to oppose, of those rights, it has done so on the ground during the currency of that patent, the sub­ that the restrictions, although falling within mission by another person of samples of the Article 30, are justified under Article 36. patented medicinal products (or of medicinal That is true even in the cases which have products produced in accordance with the come before the Court in relation to the pre­ patented process) to the authority respon­ conditions to the grant of an intellectual sible for the registration of medicinal prod­ property title, a matter which the Court has ucts, falls within the scope of Article 30 of regarded as essentially a matter for national the Treaty. law — cases such as Keurkoop v Nancy Kean Gifts, 17 Thetford v Fiamma, 18 CICRA v 19 20 Renault and Deutsche Renault v Audi. In those cases the products in question had not been marketed previously by the intel­ lectual property owner or with his consent and the Court considered there to be no arbitrary discrimination or disguised restric­ Article 36 (Question 2) tion on trade. However, the Court held that the national laws in question were justified under Article 36, rather than holding that they fell outside Article 30. It is clear, there­ fore, that the Netherlands law in question

27. However, according to the Court's case- patent was necessary to protect the exclusive law, the exercise of patent rights, where it right to first marketing or the reward. affects trade between Member States, must be 'justified for the purpose of safeguarding rights which constitute the specific subject- matter' of a patent. The 'specific subject- matter' of a patent includes the 'guarantee that the patentee, to reward the creative effort of the inventor, has the exclusive right to use an invention with a view to manufac­ turing industrial products and putting them into circulation for the first time, either 29. That argument does not seem conclusive. directly or by the grant of licences to third Indeed the 'specific subject-matter' test parties, as well as the right to oppose could lead to the opposite result. The Neth­ infringements' (the 'specific subject-matter' erlands law effectively extended, by a short 21 test). period, the duration of the patentee's exclu­ sive right to first marketing and so provided some compensation for the period lost while his product was undergoing the authoriza­ tion procedure and before he could take advantage of his invention. Since the reason­ ableness of the length of patent protection is not contested, it could be argued that the Netherlands law is justified for the purpose of safeguarding the exclusive right to first marketing which falls within the 'specific subject-matter' of the patent. 28. Generics argues that the Netherlands law is not a justified restriction on that test. It contends that the specific subject-matter of a patent is the exclusive right to first market­ ing, and the right to oppose infringements so as to obtain a fair reward, only during the validity of the patent. It accordingly reasons that, since in the present case no products were, or were to be, marketed until after expiry of the patent, it cannot be said that a 30. It cannot be expected, in my view, that prohibition on submission of samples to the the 'specific subject-matter' test should pro­ registration authority during the validity of a vide a clear-cut answer. In fact that test, which was first formulated in Centrafarm v 22 Sterling Drug in 1974 to provide a rational basis for the notion of Community exhaus­ 21 — Case 15/74 Centrafarm v Sterling Drug [1974] ECR 1147, paragraph 9 of the judgment. Sec also Case 187/80 Merck v tion, is not apt, and was not I think intended, Stephar and Exler [1981] ECR 2063, Case 19/84 Pharmon v Hoechst [1985] ECR 2281, Casc 434/85 Allen and Han- to be used to solve detailed aspects of the burys v Generics [1988] ECR 1245, Thetford v Fiamma, scope of patent protection such as those cited in note 18, Case C-235/89 Commission v Italy [1992] 1-777, Case C-30/90 Commission v United Kingdom [1992] ECR 1-829, Case C-191/90 Generics and Harris Pharma- ceuticals [1992] ECR I-5335 and Joined Cases C-267/95 and C-268/95 Merck and Others v Primecrown and Others, judgment of 5 December 1996. 22 — Cited in note 21.

31. In the present cases, whether or not one takes the 'specific subject-matter' test as the starting-point, the decisive considerations seem to me to be the following, which focus 34. Thirdly, the present case bears no resem­ on the justification for the restriction in con­ blance to those in which the Court has held crete terms. that the rights of the patentee may be limited to the extent necessary to avoid those rights being used in such a way as to divide up the market. In particular there is no question in this case of the patentee having exhausted his rights or having consented in any way, directly or indirectly, to the conduct in ques­ 32. First, in so far as the submission of tion. samples is treated as infringing the patent independently of its effect on the period of protection, the approach of the national pro­ visions in issue seems both reasonable in itself and in line with other legal systems both within and outside the Community. That point is fully developed below.

36. In saying that there is no discrimination, into conformity, as far as practicable, with I do not suggest that only discriminatory corresponding provisions of the European measures are unlawful. But the absence of Patent Convention, the Agreement relat­ discrimination, the absence of any abnormal ing to Community Patents and the Patent 27 protection of patent rights, and the absence Cooperation Treaty'. of any dividing up of the market by the pat­ entee or with his consent, appear cumula­ tively to remove any reason for Community law to intervene, and to suggest that the measures in issue are justified under the first sentence of Article 36. If however there were discrimination, the measures would of course in any event be unlawful under the second sentence of Article 36, as they would be if 38. The original Community Patent Con­ 28 there were a disguised restriction on trade vention was signed at Luxembourg in 1975 between Member States. by the then nine Member States but never came into force. The amended Community 29 Patent Convention , which is substantially the same, was signed at Luxembourg in 1989 but is similarly not yet in force because it has not been ratified by a sufficient number of Member States. Nevertheless the Court has been willing to take account of the Conven­ 30 Other legal systems tion.

the subject-matter of the patent, or import­ 41. Furthermore, there has been some guid­ ing or stocking the product for these pur­ ance from national courts as to the scope of poses'. The exceptions to that right are very the patentee's protection in circumstances limited. The only ones which might be similar to those of the present case. For regarded as relevant for present purposes are example, the following acts have been held 'acts done privately and for non-commercial by national courts to constitute infringement purposes' and 'acts done for experimental of the patent when carried out during its purposes relating to the subject-matter of the validity: in Italy, in a case with little reason­ 3 patented invention'. 1That second exception ing on the point, even the simple submission is in similar terms to the exception contained of a request for authorization of a pharma­ 32 in Article 30(3) of the ROW (referred to at ceutical product; in Germany (albeit paragraph 10 above). Neither exception is before the introduction of an exception relat­ sufficient, in my view, to cover the submis­ ing to experiments), trials of a pesticide in sion of samples for commercial purposes. preparation for its marketing after expiry of 33 the patent; in Austria (although not in the 34 context of pharmaceutical products), the production of a sample in relation to future marketing; and in the United Kingdom, trials of a herbicide undertaken to demonstrate to a third party (whether a client or an authori­ zation authority) the efficacy of the product, or in order to amass information to satisfy 35 such third party.

constitute an infringement of the patent. authorization was not a new, nor a local, That case in fact involved the same product problem, and that, even if it had not been as the present case, cimetidine, and SKF was raised in the cases mentioned, it had lain the plaintiff. Cooke P. considered that the behind them. He concluded, however, that, defendant had 'acted for the commercial whilst the courts had recognized the prob­ advantage or springboard of being more lem, they had insisted that any solution ready to launch into the market when the required legislative and not judicial interven­ patent expired'. Hardie Boys J concluded tion. Cooke P. observed that the New that the submission of samples was clearly a Zealand courts were operating in an interna­ use of the patent and that 'it would be a dis­ tional environment where consistency of tortion of the meaning of what is an ordi­ approach was important. nary English word to hold otherwise'. With regard to experimentation, he considered that 'doubtless experimentation will usually have an ultimate commercial objective; where it ends and infringement begins must often be a matter of degree. If the person concerned keeps his activities to himself, and does no more than further his own knowl­ edge or skill, even though commercial advan­ 44. It is true that in a German case it was tage may be his final goal, he does not held that the request for authorization of a infringe. But if he goes beyond that, and uses certain type of broadcasting receiver did not the invention or makes it available to others, constitute an infringement of the patent and in a way that serves to advance him in the that the national court did not appear to actual market place, then he infringes, for the have been influenced by the fact that the market place is the sole preserve of the pat­ request had been accompanied by a specimen entee'. 37 of the receiver in question.

46. However, the Court of Appeal of New 40 Zealand, in the case cited earlier, expressly distinguished the decision of the English High Court in the Upjohn case, stating that 48. The position in Italy might be compared 'the furnishing of data is one thing, the sup­ with that in the United States of America, ply of a sample another: it is a direct physical where it had been held by the Court of use of the subject matter of the patent itself'. Appeals for the Federal Circuit that the import of a patented compound in order to make dosage form capsules, upon which tests would be conducted in order to obtain data required for the approval of a regulatory body, constituted an infringement of the 42 patent. That decision was only reversed by 47. Again, in an Italian case, in an order legislation when the possibility of a supple­ dated 12 June 1995, the Tribunale di Milano mentary period of protection was made held that experiments carried out during the available. According to the Supreme Court, validity of a patent by a competitor, in order the provision in The Drug Price Compe­ to prepare the documents necessary for the tition and Patent Term Restoration Act of application for a marketing authorization, 1984 (commonly known as the 'Hatch- and the submission of the application did not Waxman Act'), which provided, in effect, 41 constitute a breach of the patent. How­ that the submission of samples during the ever, that decision, in contrast to the earlier validity of a patent was no longer to be Italian judgment to the opposite effect, cited regarded as an infringement of that patent, above, was given in relation to a patent was complementary to the provision in that which could benefit from the entry into same Act providing for the possibility of force of the Supplementary Protection Regu­ additional protection to compensate for the lation: i. e. from the possibility of obtaining a time lost in obtaining marketing authoriza­ 43 certificate granting a supplementary period tions. I should perhaps add at this point of protection in order to compensate for the that I do not consider it necessary for the time lost in obtaining a marketing authoriza­ Court to consider the justifiability of the

Justification of supplementary protection 'Whereas medicinal products, especially those that are the result of long, costly research will not continue to be developed in the Community and in Europe unless they are covered by favourable rules that provide for sufficient protection to encourage such research; 50. The Supplementary Protection Regu­ 44 lation, already referred to, is also relevant to the justification of the measure in issue. Its adoption demonstrates the importance attached by the Community legislature to the erosion of the initial period of patent protection by the delays involved in obtain­ Whereas at the moment the period that ing a marketing authorization. Even if, as elapses between the filing of an application Generics submits, the judgment of the Hoge for a patent for a new medicinal product and Raad of 18 December 1992 interpreting an authorization to place the medicinal prod­ Article 30(3) of the ROW did not aim to give uct on the market makes the period of effec­ supplementary protection, I consider it rea­ tive protection under the patent insufficient sonable for this Court to have regard to the to cover the investment put into the research; practical effect of that law since the justifica­ tion of a measure must be assessed in terms of its effects.

44 — Sec paragraph 4 above.

I - 3946

GENERICS v SMITH, KLINE & FRENCH

53. According to the Commission's 46 Explanatory Memorandum, the date of 54. However, that does not mean that the first authorization which was originally pro­ Commission considered prior national pro­ posed (after 1 January 1984), which is not far tection to be unacceptable. On the contrary, off the date eventually adopted, was selected the Regulation was adopted for the very rea­ in order to permit European industry to son that the justifiability of various national catch up with its American competitors who measures Was recognized. In paragraph 7 of had benefited from the possibility of a its Explanatory Memorandum, the Commis­ supplementary period of protection since sion argued that the fact that there were sev­ 1984. The Commission also stated in that eral parliamentary initiatives at national level, Memorandum that limiting the grant of of which one was at a very advanced proce­ supplementary certificates to patents which dural stage, to provide for supplementary were still in force as at 1 July 1992 in addi­ protection for patented medicinal products, made it necessary to harmonize the matter at Community level. As the sixth recital to the Regulation indicates, the aim was to avoid 45 — The first patent expired on 9 March 1992, before the Regu- lation came into force (six months after its publication on 2 July 1992 in the Official Journal), and the second patent, albeit in force at the date the Regulation entered into force, was the subject of a marketing authorization prior to 1 January 1985. 47 — Paragraph 61(b). 46 — COM (90) 101 final — SYN 255. 48 — Paragraph 25.

57. With regard to the injunction, it is established that such a prohibition on the sale of the goods by a national court falls 50 within the scope of Article 30. I accord­ ingly turn to the question of justification of that injunction under Article 36. 55. It is also noteworthy that an amendment to Article 63 of the European Patent Con­ 49 vention was agreed by a conference of all the Contracting States in December 1991 in order to provide for the extension of the term of a European patent beyond 20 years, in relation to certain products (including pharmaceutical products) where official approval is required before a patented prod­ uct can be marketed. However, the amend­ 58. The law breached by Generics in the ment has not yet come into force. present case is national law, not Community law, and I have concluded that the national law which the injunction is protecting is jus­ tified under Community law. Nevertheless, the remedy granted under national law might not be justified under Article 36 if it went further than was necessary to protect the right in question, since the Court has held that 'national rules or practices do not fall within the exception specified in Article 36' 56. For all the above reasons, I consider that if the interest in question can be 'as effec­ Article 30(3) of the ROW, as interpreted by tively protected by measures which do not the Hoge Raad in its judgment of 18 Decem­

50 — See Case 58/80 Dansk Supermarked v ¡merco [1981] ECR 49 — Cited in note 2. 181 and Allen and Hanburys, cited in note 21.

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GENERICS v SMITH, KLINE & FRENCH

59. As to the choice of an injunction by way of remedy, the Court has already dealt with that issue to a certain extent in Thetford v 52 Fiamma. In that case, which concerned the import of articles infringing a national 61. Generics further argues that the choice patent, Fiamma maintained that, in accord­ of an injunction by way of a remedy is dis­ ance with the principle of proportionality, proportionate because SKF could have the most that should be ordered was pay­ applied for an injunction earlier, and because, ment of a reasonable royalty since the spe­ as it argued at the oral hearing, the court cific subject-matter of the patent would be could have considered awarding compensa­ adequately protected by conferring on the tion, or cancelling the marketing authoriza­ proprietor the right to obtain reward for the 53 tions, as an alternative to an injunction. marketing of the patented article, without going so far as to give him the right to obtain an injunction. However, the Court dismissed that argument by holding simply that the right of the proprietor of a patent to prevent the import of products manufactured with­ out a licence is 'part of the substance of patent law' and that accordingly 'where national law normally provides for the issue of an injunction to prevent any infringement, 62. The choice of the appropriate remedy is that measure is justified under Article 36.' in my view essentially a matter for the national courts, and this Court should not intervene unless the national courts were to grant a remedy which was manifestly dispro­ portionate. Merely to illustrate that point, I make the following observations. First, on the suggestion that damages might have been awarded rather than an injunction, I would 60. Generics argues, however, that the observe that it might be very difficult to present case is different because it concerns

65. The United Kingdom points out that Directive 65/65 allows periods of suspension 54 in certain cases and that it is not clear whether the average of 14 months includes such periods, so that it is not entirely clear 63. The above observations are made simply that 14 months is a breach of the Directive. to indicate that the balancing act required in However, the Hoge Raad phrases its ques­ order to assess the most appropriate remedy tion in terms of a period which 'exceeds the in a particular case concerning an infringe­ maximum period prescribed by Directives ment of national law should, as a matter of 65/65 and 75/319,' so the question is put on general principle, be for the national court. the basis that that period is in breach of the This Court cannot become involved in such Directives. evaluations, save in cases in which it is clear from the order for reference that the remedy granted was manifestly disproportionate. 54 — See Article 7, as amended bv Article 1(6) of Directive 93/39 That is not the case here. and supplemented by Article 4(c) of Directive 75/319.

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GENERICS v SMITH, KLINE & FRENCH

66. In my view, however, even assuming that 68. It is true that Community law requires the delay of 14 months is not compatible that a remedy be available to applicants for with Community law, Directive 65/65 is of marketing authorizations where the authori­ no assistance to Generics' case. ties are in breach of Community law by exceeding the time-limits specified in Directive 65/65. However, Community law does not require that the remedy available in such circumstances should take a form which would have the effect of limiting the rights of the patentee. Generics may have a remedy, in other proceedings, against the authorities responsible for any delay in granting autho­ rization, but cannot invoke any such delay in those proceedings as a basis for challenging the duration of the injunction.

70. Finally, Generics seeks to base an argu­ been able to lodge its applications for mar­ ment on the fact that the product in question keting authorizations prior to expiry of that here, cimetidine, was protected by two pat­ patent (on 9 March 1992). By that time, the ents owned by SKF. All three applications second patent had been granted (19 June for marketing authorizations in respect of 1991) and thus the authorizations could not the competing products to be marketed by lawfully have been applied for because it is Generics were made before the second accepted that the applications would have patent had been granted or even published constituted a breach of the second patent if it and two of the three marketing authoriza­ had been in force at the time they were tions (those in respect of 200 mg and 400 mg made. Thus, in calculating the injunction tablets) were even awarded before such grant from the expiry of the second patent, all that 55 the national court was doing was putting or publication. According to Generics, Generics back in roughly the position in therefore, the lodging of the samples with which it would have been if it had not the CBG only constituted a breach of the breached the national law prohibiting the first patent, not the second. Generics thus submission of samples during the validity of argues that it is unjust to grant an injunction 56 the first patent. As I concluded earlier, that prohibiting it from selling all its products for is a justifiable aim. a period running from the expiry of that sec­ ond patent.

(2) The judicial prohibition imposed in the present case restraining, for a specified period following expiry of the patent, the marketing of products whose mar­ keting authorization was obtained in breach of the patent falls within the scope of Article 30 of the Treaty but is justified under Article 36 of the Treaty on the ground of the protection of industrial and commercial property. That is so notwithstanding that that period exceeds the period specified in Directives 65/65 and 75/319 for the authorization of medicinal products.

I - 3953