ES –Shionogi & Astrazeneca v. Ratiopharm / Rosuvastatin / Interim Injunction Opposition
Shionogi Sieyaku Kabushiki Kaisha, AstraZeneca UK Limited, AstraZeneca Farmacéutica Spain, S.A. v. Ratiopharm España, S.A., Barcelona Commercial Court No. 5, 12 July 2017, Docket No. 148/2017
In a decision rendered on 12 July 2017, Commercial Court No. 5 of Barcelona overruled its previous order of 21 February 2017, pursuant to which it granted ex parte precautionary measures against Ratiopharm, ordering it to temporarily refrain from launching its generic drug rosuvastatin. The order was revoked because the Court concluded, in line with previous Spanish Court decisions on this matter, that the use claims of the Spanish validation of patent EP 0521471 were affected by the Spanish reservation to the EPC and should therefore be deemed ineffective.
On 20 February 2017,Shionogi and AstraZeneca filed a request for urgent, ex parte interim relief against Ratiopharm in order to stop the launching of the generic drug ROSUVASTATINA RATIO. The plaintiffs invoked their rights derived from SPC No. 200900012 granted for the Spanish validation ES2153824 of European patent EP0521471. Said patent covers a drug for the treatment of hypercholesterolemia called rosuvastatin in its calcium salt form, which is exploited byAstraZeneca’s drugs CRESTOR® and PROVISACOR®.
The patent comprises 16 claims classified in different categories: product claims (claims 1 to 6 and 9), process claims (claims 7, 8, 10, 12, 13 and 14) and use claims (claims 15 and 16). It was filed on 30 June 1992 and granted on 25 October 2000. It expired on 30 June 2012, butan SPC was granted on 1 July 2012 by the Spanish PTO extending the duration of protection until 30 December 2017.
In view of prima facie evidence of an imminent infringement of said patent, Commercial Court No. 5 of Barcelona ordered Ratiopharm to cease the launching of its generic drug, which was expected to take place beginning in March 2017. In this sense, the Court decided that Ratiopharm’s drug ROSUVASTATINA RATIO, in its zinc form of rosuvastatin, fell within the scope of the plaintiffs’ patent.Ratiopharm thenfiled an opposition against this ruling. Following the most recent case law doctrine issuedby the Spanish courts, the defendant claimed the ineffectiveness in Spain of the patent claims at stake due to the Spanish reservation to the EPC.
By way of background, Spain made a reservation back when it joined the EPC, according to which the inventions of chemical and pharmaceutical products were not patentable in Spain until 7 October 1992.Thus, any patent registered in Spain prior to that date containing claims for chemical and pharmaceutical products was ineffective. But with the entry into force of the TRIPS Agreement in Spain on 25 January 1995, patent holders turned to said Agreement to defend the enforceability of pharmaceutical product claims in Spain of European patents filed before 7 October 1992. As a consequence, some patent holders who had submitted a separate set of claims for Spain before the Spanish PTO (without including product claims) applied for a modification of their patent in order to include the protection of their pharmaceutical product claims. Others who, conversely, had validated the same set of claims (including product claims)in Spain tried to invoke the rights conferred by the TRIPS Agreement in order to enforce their pharmaceutical product claims.
This approach was corroborated by the Spanish Courts (it became well-established case law of the Supreme Court:see, for example,judgments of 10 May 2011 and 5 December 2012, the olanzapine and losartan cases, respectively) which recognized the direct effect of the TRIPS Agreement and its primacy over the Spanish reservation to the EPC.In so doing, the Courts proclaimed the enforceability of pharmaceutical product claims filed before 7 October 1992 in Spain and admitted that, if patent owners had submitted a separate set of claims for Spain without including product claims, it was possible to file a modification of the translation of the European patent specification in order to add said pharmaceutical product claims (since they had not been included in the Spanish validation of the patent because of the EPC reservation). Therefore, this position adopted by Spanish Courts allowed pharmaceutical product claims initially affected by the reservation to the EPC tobe deemed enforceable due to the application of the TRIPS Agreement.
However, new doctrine later emerged from an ECJ judgment dated 18 July 2013 in case C-414/11 “Daiichi”. Contrary toconsistentSpanish Supreme Court case law, it was decided that a patentobtained by filingan application that claimedthe invention of both the manufacturing process of a pharmaceutical product and of the pharmaceutical product as such, but granted solely in relation to the manufacturing process, does not, by reason of the rules set out in the TRIPS Agreement, have to be regarded, beginningwiththe entry into force of that agreement, as covering the invention of that pharmaceutical product.The Barcelona Court of Appeals followed the same reasoning in the Escitalopram and Sildenafil cases of 22 October 2014 and 20 July 2016, respectively. The Spanish Supreme Court also took note of thisand overturned its jurisprudence in a decision rendered on 21 December 2015 in the Quietapine case. In conclusion,the Spanish Courts revisedprevious case law doctrine and adopted the ECJ’s interpretation.
The present decision relies on this new case law doctrine and further clarifies the issue with regard to use claims. In particular, the Court had to answer the question of whether use claims should be deemed affected by the Spanish reservation to the EPC.
The controversy was limited to claim 16 of the patent, which is a use claim in Swiss-type format. The plaintiffs claimed that, contrary to product claims, use claims would not fall within the scope of the EPC reservation, as they do not protect a pharmaceutical product. In other words, Shionogi and AstraZeneca arguedthat claim 16 should be considered effective in Spain.
However, the Court did not accept this argument. In the first place, it found that Swiss-type claims are process-type claims. In this regard, the Court mentioned that,as explained in precedent national and foreign case law,Swiss-type claims are process claimssince their scope of protection is the same as that of process claims,given that their protection is restricted to use of same for the preparation of a pharmaceutical compound for a specific treatment.
Secondly, it was decided that use claim 16 of the patent, as a process claim, was affected by the Spanish reservation to the EPC. The Court stated that admitting that claim 16should not be affected by the EPC reservation would deprive the reservation of any effectiveness. It was further held that, according the “Daiichi” ECJ Judgment, an invention has to be considered in its entirety, taking into account “what is protected” and not only “what is claimed” through product, process or use claims. The Court also warned the plaintiffs that arguing that claim 16 as a process claim would not be affected by the EPC reservation, implies avoiding the application of the reservation for the invention as a whole. This act would constitute an abuse of law, resulting in the application of the rule which the plaintiffs purported to avoid.
Thus, the Court declared the patent’s product claims, together with use claims 15 and 16,to be ineffective in Spain.
As a result, the Court annulled the decision issued on 20 February 2017, awarding urgent, exparte precautionary measures against Ratiopharm.
Additionally, it is also worth noting thatin its opposition,Ratiopharm also claimed as a non-infringement argument that its zinc salt of rosuvastatin would not fall within the scope of protection of claim 1 of the patent at stake. Even though this argument was no longer relevantin view of the ineffectiveness of the patent, the Court decided to issue an obiter dicta pronouncement. In this regard, the Court ratified its previous rulinggranting the exparte preliminary measures in which it was decided that the zinc salt would fall within the patent’s scope of protection, mainly because it understood that claim 1 could not be interpreted in a literal way and needed to be understoodtogether with the description.
Lastly, the Court noted that the defendant could have filed a protective letter to avoid the granting of ex parte precautionary measures. Protective letters have been regulated in Spain sincethe entry into force of the new Patent Act in April 2017, so the Court’s observation could be considered a call to take advantage ofthis procedural mechanism.
As to the case law doctrine concerning EPC reservation, the ECJ’s interpretation seems to be definitively incorporated into theSpanish Courts’decisions. The present case further concluded that according to this new doctrine,use claims (being process claims) would also fall within the scope of the Spanish reservation to the EPC together with product claims.
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