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TRIPs Agreement & patentability of pharmaceutical products

On July 18, 2013 the Court of Justice of the European Union ruled on case C-414/11 concerning articles 27 and 70 of TRIPs Agreement as an answer for the preliminary ruling request made by the Athens Court of First Instance.

This preliminary ruling request was made within the litigation framework between Daiichi Sankyo Co. Ltd and DEMO Anonimos Viomikhaniki kai Emporiki Etairia Farmakon (DEMO).

Daiichi Sankyo was the holder of a Greek patent granted on October 21,1986 for a process of manufacture the chemical compound ‘levofloxacin hemihydrate’ which is used as an active ingredient in antibiotic treatments. Additionally, such patent claimed protection for the chemical compound as such. The protection of the patent was extended by means of a Supplementary Protection Certificate (SPC) under Regulation (EEC) No 1768/92 until 2011.

The scope of protection of that patent was limited to the manufacturing process, since Greece ratified the European Patent Convention subject to a reservation within the meaning of Article 167(2)(a) so as to deny protection for pharmaceutical product patents. This reservation expired on October 7, 1992.

Greece ratified TRIPs Agreement with effect from February 9, 1995.

On September 22, 2008 and July 22, 2009 Greek authorities allowed DEMO to place on the market generic medicinal products with the active ingredient ‘levofloxacin hemihydrate’.

On September 23, 2009 Daiichi Sankyo Co. Ltd filed a lawsuit against DEMO before the Athens Court of First Instance in order to request, inter alia, the cessation of all marketing of any medicinal product with the active ingredient ‘levofloxacin hemihydrate’

Thus, the object of the dispute is to determine whether the SPC held by Daiichi Sankyo from 2006 until 2011 (within the period during which DEMO was preparing to market medicinal products) covered the invention of the ‘levofloxacin hemihydrate’ as such or only the invention of its manufacturing process.

First of all, the CJEU considered that the rules on patentable subject-matter in Article 27 of the TRIPs Agreement fall within the field of the common commercial policy and therefore, TRIPs remains within the sole competence of the European Union.

Secondly, since pharmacology is regarded as a field of technology within the meaning of Article 27 of the TRIPs Agreement, it was stated that such Article 27 must be interpreted as meaning that the invention of a pharmaceutical product such as the active chemical compound of a medicinal product is capable of being the subject-matter of a patent, under the conditions set out in Article 27 of the TRIPs Agreement.

Finally, the CJEU stated that a patent obtained following a patent 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, does not, by reason of the rules set out in Articles 27 and 70 of the TRIPs Agreement, have to be regarded from the entry into force of that Agreement as covering the invention of that pharmaceutical product as such.