Pharmaceutical Analysis GA&P | February 2015 1 1. Supreme Court case law Of late and to the extent that protection did not extend to product claims where such a reservation was entered upon accession to the European Patent Convention (EPC), one o f the main problems related to chemical-pharmaceutical patents has concerned the effects of the entry into force of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). Clearly, the problem arises in Contracting States, such as Spain or Greece, which, under art. 167(2) EPC, reserved the right to provide that European patents, insofar as they confer protection on chemical or pharmaceutical products, as such, shall be ineffective or revocable. 1.1. Patents validated in Spain with the same set of claims In Spain, inventions of chemical and pharmaceutical products were not patentable before 7 October 1992 [First Transitory Provision of the Spanish Patents Act 1986, Instrument of Accession to the EPC of 10 July 1986, and Transitory Provision of Royal Decree 2424/1986 of 27 November 1986 implementing the EPC in Spain]. Having regard to the non-patentability of chemical-pharmaceutical products in Spain until 1992, the European Patent Office (EPO) recommended a separate set of claims when filing a European patent application designating Spain (Notice from the President of the European Patent Office dated 13 May 1992). Many European patent applicants followed this recommendation, validating patents in Spain with a separate set of claims containing no product claims. However, many other European patent applicants prior to 7 October 1992 did not follow the recommendations of the EPO and validated the same set of claims in all designated countries, including Spain. This despite the Transitory Provision of Royal Decree 2424/1986 stating that while the EPC reservation were in force, European patents designating Spain would not have any effect therein if they conferred protection to chemical and pharmaceutical products. As things stood, after the entry into force of the TRIPS Agreement, said Agreement was relied on to defend the validity and enforceability of European patents containing product claims and validated in Spain before 7 October 1992. It was contended that the TRIPS Agreement Chemical-pharmaceutical patent applications filed during the period in which an epc reservation was in force: has Supreme Court case law become obsolete? Ángel García Vidal Professor of Commercial and Company Law, Universidad de Santiago de Compostela Academic Counsel, Gómez-Acebo & Pombo Following the recent judgment no. 338/2014 of the Barcelona ‘Audiencia Provincial’ (Fifteenth Chamber) of 22 October, this paper examines the case law of the Supreme Court and of the Court of Justice of the European Union on European patent applications containing pharmaceutical product claims falling under an EPC reservation.Pharmaceutical Analysis GA&P | February 2015 2 contains rules that recognise the validity of chemical-pharmaceutical patent applications containing product claims that were filed prior to 7 October 1992, rules that are directly applicable by the Spanish courts. Said rules would be art. 27(1) and art. 70. This interpretation has been endorsed by Spanish courts, which have recognised that, following the entry into force of the TRIPS Agreement, European pharmaceutical patent applications containing product claims filed prior to 7 October 1992 and validated in Spain can no longer be deemed unenforceable. In fact, this view has become consistent case law of the Supreme Court (First Chamber) in its judgments of 10 May, 27 October and 11 November 2011, and is essentially based on the recognised direct effect of the TRIPS Agreement and the wording of Article 70(2) of the same, which provides that “(e)xcept as otherwise provided for in this Agreement, this Agreement gives rise to obligations in respect of all subject matter existing at the date of application of this Agreement for the Member in question, and which is protected in that Member on the said date, or which meets or comes subsequently to meet the criteria for protection under the terms of this Agreement.” 1.2. Patents validated without including product claims and subsequent modification of translations On the other hand, the TRIPS Agreement has also been relied on by those patent holders (patentees) who accepted the recommendation of the EPO and submitted a separate set of claims for Spain, without including product claims. In these cases it has been contended that the TRIPS Agreement allows them to add new product claims. In this context, the Notice from the European Patent Office dated 8 March 2007 established that applicants for patents pending could expand claims after the entry into force of the TRIPS Agreement. This Notice was interpreted by some as a recognition by the EPO that the TRIPS Agreement permitted the amendment of chemical-pharmaceutical patents granted before the entry into force of the TRIPS Agreement, in order to include the protection of chemical-pharmaceutical products as such. Therefore, and in order to clarify this point, on 18 June 2007 the EPO published a new Notice which clarified that the Notice dated 8 March 2007 referred solely to European patent applications still pending before the Office. Thus, some holders of European patents, applied for prior to the date on which the patentability of pharmaceutical products in Spain was possible, in order to add product claims resorted to the modification of the translation of the European patent specification, regulated by art. 70 EPC, which provides that any State that requires a translation of the claims of a European patent must allow the patent applicant or owner to submit a revised translation of the European patent application or European patent (similarly, art. 12 of Royal Decree 2424/1986 implementing the EPC). And this approach has been corroborated by the case law of the Supreme Court (Third Chamber), having given several judgments on the matter [4 November 2010 (RJ\2010\7928 and RJ\2010\7103), 3 March 2011, 16 September 2011, 21 November 2011 (JUR\2011\413826) or 16 May 2012 (JUR\2012\180836)], which concludes that the revision of the translation not only allows for the correction of errors or inaccuracies, but also enables the “inclusion of claims contained in the European patent but for some reason not included in the translation submitted in another State”, provided that such remains within the boundaries of the text of the European patent. Additionally, in such cases where the translation is modified, the Supreme Court (First Chamber) has also admitted the incorporation of new claims by modifying the translation as a determinant of the scope of patent protection [Judgments no. 631/2012 of 26 October (RJ 2012\9728) and no. 719/2012 o f 5 D e c em b e r (JUR 2012\406382)]. 2. CJEU case law The Court of Justice of the European Union (CJEU) has also made pronouncements on the effects of the TRIPS Agreement on pharmaceutical patents filed prior to expiry of Pharmaceutical Analysis GA&P | February 2015 3 an EPC reservation preventing protection of product claims, particularly in relation to Greek patents, country which - as already noted - upon ratification of the EPC in 1986 also entered a reservation pursuant to art. 167(2)(a) EPC with regards to pharmaceutical products, reservation that expired on 7 October 1992. In fact, neither was the protection of pharmaceutical products by way of national patents allowed in Greece. [Pursuant to the Greek Patents Act 1733/1987, as long as the reservation made by Greece under art. 167(2)(a) of the EPC remained in force, patents for pharmaceutical products should not be granted (only the grant of patents protecting the invention of a process of manufacture of a pharmaceutical product was authorised). And before the passing of this Act, no pharmaceutical product patents were granted, deeming that the scope of the earlier patents act was limited by the EPC reservation]. 2.1. Patents applied for and granted before the entry into force of the TRIPS Agreement The CJEU’s first and most relevant pronouncement was made in the judgment of the Grand Chamber of 18 July 2013 in Case C 414/11, Daiichi Sankyo Co. Ltd., Sanofi-Aventis Deutschland GmbH v. DEMO Anonymos Viomichaniki kai Emporiki Etairia Farmakon (ECLI:EU:C:2013:520), given in connection with a case in which a patent was applied for whilst the reservation was in force and granted before the entry into force of the TRIPS Agreement for Greece. The patent contained a claim for protection both for levofloxacin hemihydrate as such and for its process (method) of manufacture and was extended by a supplementary protection certificate until 2011. Indeed, pursuant to the Greek legislation to which reference has been made, the patent did not cover product claims, but the issue was whether the entry into force of the TRIPS Agreement implied a change, so that from that time on the patent extended to the product as such. The Court was of the opinion that the rules on patentable subject matter in art. 27 of the TRIPS Agreement fell within the field of the common commercial policy rather than the field of the internal market. That is, the context of these rules is the liberalisation of international trade, not the harmonisation of the laws of the Member States of the European Union. And according to art. 207(1) TFEU “[t]he common commercial policy shall be conducted in the context of the principles and objectives of the Union’s external action”. Therefore, as the Member States did not have primary competence, the Court stated that it no longer needed to examine whether Member States themselves could accord direct effect to that provision and whether a national court could apply it directly subject to the requirements laid down by national law. Moreover, the CJEU held that although “Article 27 of the TRIPs Agreement obliges members of the WTO to make it possible to obtain patents for inventions of pharmaceutical products”, such “obligation cannot, however, be understood as meaning that members of the WTO which, in a period anterior to the date of that agreement’s entry into force, excluded protection of inventions of pharmaceutical products claimed in patents granted for inventions of processes of manufacture of those products must, from that date, regard those patents as covering those inventions of pharmaceutical products.” 2.2. Patents pending upon entry into force of the TRIPS Agreement The aforementioned CJEU ruling concerned a situation in which the patent was granted before the entry into force of the Agreement. Subsequently, however, the CJEU was referred for preliminary ruling matters relating to cases where the patent had been applied for whilst an EPC reservation was in force and the application was still pending at the EPO on the date of entry into force of the TRIPS Agreement. This is what happened in Cases C-462/13 (WarnerLambert Company LLC and Pfizer v. Minerva Farmakeftiki AE, ECLI:EU:C:2014:62) and C-372/13, Warner-Lambert Company LLC and Pfizer AE v. SiegerPharma Anonymi Farmakeftiki Etaireia, ECLI:EU:C:2014:61). However, in orders of 30 January 2014, the CJEU held that the interpretation Pharmaceutical Analysis GA&P | February 2015 4 of the judgment of 18 July 2013 in the Daiichi Sankyo case was fully applicable to such cases. 3. Implications of CJEU case law for Spanish case law 3.1. The CJEU rulings generated some debate about its implications for Spanish case law given that, inasmuch as the Daiichi Sankyo judgment concerned a Greek national patent, it was debatable to what extent the rulings affected European patents (although the fact is that the reservation concerning European patents applied by analogy to Greek national patents, and the orders of the CJEU of 30 January 2014 no longer refer to a national patent, but to a European patent with product claims granted by the EPO). In any case, the question is examined, directly, by the recent judgment no. 338/2014 of the Barcelona Audiencia Provincial of 22 October (JUR\ 2014\284803). 3.2. The factual circumstances underpinning the judgment concerned a European patent filed for in 1989, with a separate set of claims for Spain (including o n l y process claims), granted on 15 March 1995 and with its original translation published (including only process claims) on 1 May of that year. On the basis of this translation, a supplementary protection certificate (SPC) was requested and obtained. Subsequently, the Supreme Court judgment of 16 September 2011 recognised the holder the right to incorporate, through the procedural route under art. 12 of Royal Decree 2424/1986, product claims of the European patent, since at that time it was deemed that TRIPS Agreement was only binding on the Spanish State from 1 January 1996. Such being the case, actions for infringement of the SPC, as well as for unfair competition, were brought against several companies that marketed the generic medicine in Spain. And one of the arguments of the defendants was that the revised translation of the patent, on which the SPC was based, had no effect in Spain, to the extent that it would confer greater protection than the text of the patent as was granted by the EPO for Spain. 3.3. The first instance judgment handed down by the Barcelona Companies Court no. 4 of 10 January 2013 held that as a separate set of claims had been validated in Spain, excluding product claims, the latter could no longer be included by way of a revision of the translation. According to the judgment: “It is true that the answer I am offering to the claimant is worse than the holders who, ignoring the Spanish reservation and notice from the EPO, included chemical or pharmaceutical product claims in patents designating Spain, but the truth is that in those cases there is no discrepancy between the original and the translated right, between the patent as was granted and its translation. The Notice from the President of the EPO was not mandatory, so submitting a separate set of claims was an option of the holders in their interpretation of the Spanish reservation, which eventually proved wrong and prejudicial to them.” This interpretation of the Barcelona Companies Court no. 4 follows that adopted in other pronouncements of this Court, as in Order no. 130/12, which was the subject of my May 2012 Gómez-Acebo & Pombo Document & Analysis, “The revision of translations of European patents in order to include chemical-pharmaceutical product claims: A change of course?”. This interpretation closed o f f the possibility of holders of European chemical- -pharmaceutical patents, who submitted for Spain a separate set of process claims, from relying on product claims they may have incorporated by revising the translation. 3.4. However, the Barcelona Audiencia Provincial has rejected this interpretation, stating that “we are of the opinion, contrary to the approach adopted by the first instance judgment, that according to well established case law - outlined in the above points of law – at the time the Supreme Court ordered the publishing of the revised translation of the Escitalopram patent, Articles 27 and 70 of the TRIPS Agreement allowed extended protection by incorporating product claims”. Despite acknowledging that the Supreme Court’s case law implied that patent protection was extended to the products, Pharmaceutical Analysis GA&P | February 2015 5 Para más información consulte nuestra web www.gomezacebo-pombo.com, o diríjase al siguiente e-mail de contacto: email@example.com. Barcelona | Bilbao | Madrid | Valencia | Vigo | Bruselas | Lisboa | Londres | Nueva York the Barcelona Audiencia Provincial has found that such case law cannot be applied insofar as superseded by CJEU legal doctrine: “We are of the opinion that the CJEU judgment contradicts established case law of the Supreme Court on the direct effect of the TRIPS Agreement, at least in relation to process patents granted whilst the EPC reservation was in force. According to the CJEU’s answer to the third question raised, a patent obtained following an application claiming the invention both of the process of manufacture of a pharmaceutical product and of the pharmaceutical product as such, but granted solely in relation to the process of manufacture, cannot, by reason of Article 70 of the TRIPS Agreement, be regarded from the entry into force of that agreement as covering the invention of that pharmaceutical product”. Thus, the Audiencia Provincial believes that the Supreme Court would not have followed the interpretation it followed if its rulings had been preceded by those of the CJEU: “We believe, however, that the Supreme Court would have reached a different determination in light of the CJEU ruling of 18 July 2013 and the orders of 30 January 2014, which set forth a different criterion. The European patent, applied for with product and process claims, but with a separate set of claims for Spain, was granted only with process claims. The extension of protection to product claims was done on the basis of Articles 27(1) and 70(1) and (2) of the TRIPS Agreement, circumstances identical to those subject matter of the CJEU judgment of 18 July 2013” And in this respect, the Barcelona Audiencia Provincial stresses that although the CJEU judgment of 18 July 2013 may seem to only refer to patents applied for and granted before the entry into force of the TRIPS Agreement, the CJEU Orders of 30 January 2014 extending the CJEU’s interpretation to cases where the patent is applied for, with the reservation in force, before the TRIPS Agreement comes into force and is awarded after. And that is precisely the case of the patent to which the case dealt with by the Barcelona Audiencia Provincial refers to, for when the patent in question is granted, 15 March 1995, the TRIPS Agreement was already in force for Spain (as the First Chamber of the Supreme Court, as of the judgments of 26 October 2012 and 5 December 2012, puts an end to the doctrinal and case law debate on the application of the TRIPS Agreement in Spain, ruling that it occurs from 25 January 1995, date following its publication in the Official Journal of Spain). 3.5. The judgment of the Barcelona Audiencia Provincial is especially relevant because this court was in favour of case law subsequently enshrined by the Supreme Court (vide, for instance, the judgment of the Barcelona Audiencia Provincial of 17 January 2008 or 2 October 2008). Therefore, one might say that the Audiencia Provincial shares the interpretation of the Supreme Court but, nevertheless, believes that the subsequent case law of the CJEU runs counter to the same and, consequently, must be abandoned. However, it remains to be seen whether the Supreme Court shares or not this interpretation of the Barcelona Audiencia Provincial.