Daiichi: now at least we know what the dispute is all about

Yesterday the IPKat celebrated the fact that two extra days were given to anyone who wants to advise the UK government whether -- and how -- to intervene in  Case C-414/11 Daiichi Sankyo Company Limited, Sanofi-Aventis Deutschland GmbH v DEMO Anonimos Viomikhaniki kai Emporiki Etairia Farmakon , a Greek reference for a preliminary ruling by the Court of Justice of the European Union on some TRIPS-related issues (see his earlier post here).   Since then, he has received two good pieces of news. 

The CIPA's Life Sciences Committee:
bearing up under the strain of
Court of Justice references

The first, from the Chartered Institute of Patent Attorneys (CIPA) President Tim Roberts, is that CIPA's Life Sciences Committee is meeting tomorrow morning and expects to discuss this [This is one day after the original deadline for submissions; the fact that CIPA's experts can discuss the case together and make a recommendation if they so desire is a big relief]. Tim adds that CIPA members with views are invited to email them to mail@cipa.org.uk by 10.30am tomorrow morning. Thoughts from non-members are likewise welcome.

The second is that the Kat can now tell his readers what the case is about, thanks to Petroula Vantsiouri (a PhD Candidate in the Faculty of Law, University of Cambridge).  She writes:

"Unfortunately, Greek courts do not translate their decisions in other languages, but I would be happy to send the Greek decision to you or anyone else interested. The decision's number is 3838/2011 Polimeles Protodikio Athinwn (the multimember first instance court of Athens).

The claimant, Daiichi Sankyo Company Limited, a company active in the fields of research, development, production and trade of pharmaceuticals, holds Greek national patent number 801028/20-6-1986 for the chemical compound LEVOFLOXACIN HEMIHYDRATE, which is an active ingredient of the original new medicine TAVANIC®. This chemical compound constitutes a new invention and is protected by a supplementary protection certificate for pharmaceutical patents, which was issued by the Greek IPO on 12.05.2006.

The defendant, DEMO AVEEF, is a Greek pharmaceutical company which holds a marketing authorisation from the Greek National Organisation of Pharmaceuticals to place in the Greek market a medicine named TALERIN. TALERIN contains quantitavely and qualitatively the same active ingredients as TAVAIC, ie the patented LEVOFLOXACIN HEMIHYDRATE.

The defendant argues that placing TALERIN in the Greek market does not infringe the claimants' patent and supplementary protection certificate, because their patent was issued in 1986 and thus protects only the method of production of the pharmaceutical and not LEVOFLOXACIN HEMIHYDRATE as such.

In particular, when Greece acceded to the European Patent Convention of 1973, it made (along with Spain and Austria) the reservation provided for in Article 167, para 2(a) (OJ EPO 1986, 200), according to which

"European patents, in so far as they confer protection on chemical, pharmaceutical or food products, as such, shall, in accordance with the provisions applicable to national patents, be ineffective or revocable; this reservation shall not affect protection conferred by the patent in so far as it involves a process of manufacture or use of a chemical product or a process of manufacture of a pharmaceutical or food product;".

This reservation ceased to have effect after 7 October 1992 (OJ EPO 1992, 301).

As a result, the European patents that protected pharmaceuticals and were issued based on applications filed before 7.10.1992 were considered ineffective in Greece and until the same date patents were granted in Greece only for the process of manufacture of pharmaceuticals and not for pharmaceuticals as such.

However, according to Article 27 of the TRIPS Agreement

"patents shall be available for any inventions, whether products or processes, in all fields of technology".

The Greek court questions the scope of the protection offered to pharmaceutical patents granted in Greece before 7.10.1992, whose duration is stretching after the expiry of the reservation provided for in Article 167(2)(a) of the 1973 European Patent Convention. In other words, in cases where the patent was filed to protect the invention of a pharmaceutical, however because of the time of the filing of the application, it protected only the process of manufacture of the pharmaceutical, the question arises whether after the expiry of the reservation and the adoption of TRIPS, the patent also protects the pharmaceutical product as such or whether it still protects only the process of manufacture of the pharmaceutical. The case deserves greater attention, as the Greek court asks the CJEU to clarify its jurisprudence on the direct effect and interpretation of the TRIPS agreement following Merck Genericos".