By Dr Michael Paroussis of Dr Helen Papaconstantinou, John Filias and Associates
The 2009 decision by the Athens Multimember Court of First Instance (Commercial Law Division) over the drug Lipitor was a decisive step towards the prevalence of the TRIPs Agreement over statutory IP Law in Greece. But it refuses to settle things.
The story goes back to a Law Decree from 1926, as a result of which only processes for the preparation of pharmaceutical products, but not the final medicines, were patentable in Greece. At the time of ratifying the EPC, Greece then made use of its right to file reservations (after article 167.2) by not allowing the patent protection of final pharmaceutical products. Although the reservation ended on October 7 1992, all patents for which an application was filed before that day continued to be regulated by the old regime.
On February 9 1995 the TRIPs Agreement took effect in Greece, a fact that had important consequences for pending applications, especially on pharmaceuticals since article 27 provided that "patents shall be available for any inventions, whether products or processes, in all fields of technology".
The Lipitor decision was followed by other first instance courts (6289/2010, 1392/2010, 7469/2009 and 7062/2009), which restated the conclusion that patents filed before October 7 1992 that were not protected on the basis of the Greek reservation to the EPC, received the full range of protection after the adoption of TRIPs in Greece. But it seemed not all judges and IP scholars were convinced, since decision 1178/2009 seemed to follow the older position of the Court expressed in 397/2007, with legal protection only for the preparation process.
The same Court has now taken another option to assess the right solution (3838/2011). In adjudicating the legal action of the producer and the licensee of the pharmaceutical Tavanic and the compound Levofloxatin Hemihydrate against the generic producer of Talerin, the Court requested a preliminary ruling of the Court of Justice of the EU.
Based on the fact that there is, on the one hand, dissent on the ambiguous prescriptions of TRIPs in Greek case law, and no existing clarification by the Court of Justice, nor conceptual obviousness on the other, the Athens Multimember Court of First Instance has addressed to the Court of Justice three questions concerning the interpretation of Articles 27 and 70 of the TRIPs Agreement under Article 234 of the EC Treaty:
1) Whether Article 27 TRIPs, which embraces the scope of patent protection, constitutes or not a sector in which the Member States remain primarily responsible, and if so, whether the Member States themselves can attribute or not a direct effect on that provision and furthermore whether the national Courts may or may not apply directly the above provision under the requirements of national law
2) For the purposes of the provision of Article 27 TRIPs, whether chemicals and pharmaceuticals can or cannot make the object of patents supposed that they meet the conditions for their protection, and if so what is the range of protection, and
3) How should art. 27 and 70 TRIPs be interpreted in view of the Greek legislation, and especially whether patents attributed to preparation processes automatically extend themselves after 9.2.1995 to the pharmaceutical products, or if even after this date the claims still refer only to the method of manufacture, or if the content of the patent application should be finally considered, as referring only to the preparation process or only to the product or both.
Should question three be primarily of national interest, questions one and two will no doubt contribute to the development of case law in matters of relations between EU law and the TRIPs Agreeement.