TRIPS, EU competence and a dose of levofloxacin

One of the more unusual references to be made to the Court of Justice of the European Union (CJEU) in recent times is Case C‑414/11, Daiichi Sankyo Co. Ltd, Sanofi-Aventis Deutschland GmbH v DEMO Anonimos Viomikhaniki kai Emporiki Etairia Farmakon, a request for a preliminary ruling from the Polimeles Protodikio Athinon (Greece), exactly two years ago to the day.  According to the Curia press release, which is a good deal more concise and readable than the full judgment:

"The Agreement on Trade-Related Aspects of Intellectual Property (TRIPS) falls within the exclusive competence of the European Union

A patent granted before the entry into force of the TRIPs Agreement for the process of manufacture of a pharmaceutical product does not, after its entry into force, cover the actual invention of the product

Daiichi Sankyo Co. Ltd obtained a national patent in Greece in 1986 for levofloxacin hemihydrate, a chemical compound used as an active ingredient in antibiotic treatments, in particular in an original medicinal product called Tavanic. It granted a licence to Sanofi-Aventis Deutschland GmbH to distribute it in Greece, under an authorisation to place it on the market granted by the competent Greek authorities in 1999. The application for the patent sought protection for the product (the active ingredient) and its process of manufacture. The protection conferred by the patent, which was due to expire on 20 June 2006, was extended by a supplementary protection certificate (SPC) [under Council Regulation 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products] for five years, to 2011.

In 2008 and 2009 DEMO AE obtained authorisations in Greece to place on the market a generic medicinal product called Talerin, which also had the active ingredient levofloxacin hemihydrate. In those circumstances Daiichi Sankyo and Sanofi-Aventis asked the Polimeles Protodikio Athinon (Court of First Instance, Athens) to order DEMO to cease all marketing of Talerin or any other medicinal product with the active ingredient levofloxacin hemihydrate.

The Greek court explains that the main proceedings have to determine whether the SPC held by Daiichi Sankyo from 2006 to 2011 – in other words, in the period during which DEMO was preparing to market the medicinal product containing the pharmaceutical product – covered the invention of the pharmaceutical product or only the invention of its process of manufacture. If the protection under the SPC covers the product, the fact that Tavanic and Talerin have the same active ingredient would mean that DEMO infringed Daiichi Sankyo’s patent. If, on the other hand, the protection covers only the process of manufacture, the fact that Tavanic and Talerin have the same active ingredient would only raise the presumption that the generic medicinal product was manufactured on the basis of the process protected by the SPC. In that case, it would be sufficient for DEMO to rebut that presumption by showing that that medicinal product was manufactured by a different process.

Greece ratified the Convention on the Grant of European Patents (EPC) in 1986, but it was only from 1992, on the expiry of a reservation previously expressed, that Greece also recognised the patentability of pharmaceutical products. In that context, the national court essentially asks the Court of Justice whether 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, because of that reservation, granted only for the process of manufacture, must none the less, by reason of the TRIPS Agreement and from the date of its entry into force, be regarded as also covering the invention of the pharmaceutical product.

It also asks to what extent the TRIPS Agreement, which was concluded by the Community and the Member States by virtue of shared competence, still falls within the competence of the Member States.

... the Court of Justice starts by observing that since the Treaty of Lisbon the common commercial policy – which is within the context of the European Union’s external action and relates to trade with non-member countries – also concerns the commercial aspects of intellectual property. If a European Union act is intended to promote, facilitate or govern international trade, it falls within the common commercial policy.

The rules in the TRIPS Agreement have a specific link with international trade. The agreement itself forms part of the liberalisation of international trade, and its objective is to strengthen and harmonise the protection of intellectual property on a worldwide scale and to reduce distortions of international trade in the territory of the Member States of the WTO. The agreement therefore now falls within the field of the common commercial policy and the exclusive competence of the European Union. 

... according to the actual wording of the TRIPS Agreement – any invention, whether a product or a process, which is new, involves an inventive step and is capable of industrial application is patentable, provided only that it belongs to a field of technology. Pharmacology belongs to such a field and the invention of a pharmaceutical product is therefore capable of being patented.

Moreover, in accordance with the European Union regulation, the protection conferred by the SPC was subject to the same limitations as those affecting the protection conferred by the basic patent.

The reservation, permitted by the EPC, under which medicinal products were not patentable in Greece from 1986 to 1992, applied by analogy to national patents, such as that of Daiichi Sankyo.

Similarly, the rule that the effect of the reservation continues throughout the term of the patent was also applicable by analogy to national patents. Consequently, Daiichi Sankyo’s national patent and its SPC were of no effect as regards the invention of the pharmaceutical product, notwithstanding the patentability of pharmaceutical products in Greece from 1992. 

Consequently, while the TRIPS Agreement obliges the Member States of the WTO to make it possible to obtain patents for pharmaceutical products, it does not oblige them to regard patents which were granted solely for processes of manufacture of those products as covering, after the entry into force of that agreement, the inventions of those products as such".

In other words, says the IPKat, TRIPS does not apply retrospectively so as to confer protection for pharma products that were not so protected at the time a Greek patent was sought and granted. The IPKat's friend Rob Harrison (24ip) gets a katpat for explaining why this case is not as important as one might think:

"On the face of it, the case may be more of historical interest, rather than current commercial interest. It concerns the situation in Greece in which on joining the European Patent Convention the country entered a reservation concerning patent protection for pharmaceutical products under the former Art 167(2)(a) (now deleted in the revised EPC 2000). In common with many countries, Greece used to only grant protection on methods of production of pharmaceuticals, but not on the end product itself. The question posed by the Greek court to the CJEU was whether the entry into force of TRIPS meant that the product protection was granted from the date of entry into force, despite the earlier reservations entered by the Greek government. The court decided that this was not the case.

More intriguingly is the court's discussion as to whether TRIPS falls solely under Union law or whether there is divided jurisdiction between the Member States and the Union. The court concluded that the Union had sole competence (see paragraph 61) - because the primary purpose of TRIPS was the liberalisation of trade, rather than harmonisation of (intellectual property) laws.

This decision clearly opens up an interesting line of appeal in those areas of patent law in which the provisions of national law and the European Patent Convention differ from the provisions in TRIPS. Most prominent among these is the exclusion of computer programs as such from patentability. There is no such exclusion in TRIPS [This Kat is delighted to read this, since he used to tell his students this in his IP lectures year after year]. The EPO's Enlarged Board of Appeal has decided that the provisions of TRIPS do not apply to the EPO as it is not a party to the Agreement (see G 2/02 and G 3/02, regarding the claiming of priority). Arguments based on TRIPS have also failed when made in Appeal cases concerning the rejection of software-implemented inventions, as noted in T1173/97 (Computer Program Product). There is current no avenue of appeal from the EPO to the CJEU directly (although this will change on entry of the Unitary Patent). However, the proprietor of a granted European patent facing the loss of a patent in a national revocation action on the grounds that the patent (possibly after amendment) related to a computer program as such might be able to request a referral to the CJEU. It would seem that the CJEU would be competent to decide the matter -- and who knows what their decision would be".

Merpel sort of speculates that there is no precise analogy with the concept of Federal Pre-Emption in the United States and that EU Member States can carry on directly applying TRIPS to their hearts' content in areas where there is no EU legislation ...