In a recent decision, the Court of Justice of the European Union (CJEU) has ruled on the applicability of the Trade-Related Aspects of Intellectual Property Rights (TRIPs) agreement. While the decision merely confirms the already accepted position for patenting pharmaceutical products, it could have potential significance in opening up a new route of appeal for challenging objections of unpatentable subject-matter in other areas of technology, particularly software.
The original, 1973 version of the European Patent Convention (EPC) contained a temporary exclusion to the normal patentability criteria: member states were permitted to exclude chemical, pharmaceutical and food products from protection for a certain time period after becoming EPC member states. However, this exclusion did not apply to processes for producing such products. Greece became an EPC member state in 1986, subject to this exclusion, which it also applied to its national patent law. The exclusion expired in 1992.
The TRIPs agreement forms part of the general agreement which established the World Trade Organisation (WTO) in the mid-1990s.
Article 27 of the TRIPs agreement is aimed at harmonising standards for the availability and scope of intellectual property rights. It requires that patents be available for inventions in all fields of technology, provided they meet the usual criteria of novelty, inventive step and industrial applicability.
However, Article 70 indicates that TRIPs does not place obligations on member states which apply before it came into force in that state. Greece signed the TRIPs agreement in 1995.
The patent which was the subject of the CJEU ruling was a national Greek patent owned by Daiichi Sankyo, relating to the hemihydrate form of the antibiotic levofloxacin. The patent application, filed in 1986, originally claimed both levofloxacin hemihydrate and a process for its production. However, according to the exclusion under Greek national patent law on patenting pharmaceutical products, only the process claims were granted by the Greek Patent Office. The normal 20-year term of the basic patent expired in 2006, and was extended by a Supplementary Protection Certificate (SPC) until 2011.
Under the EU SPC regulation, the protection conferred by an SPC cannot exceed the limits of the basic patent.
While the SPC was in force, the generic pharmaceutical company DEMO was granted a marketing authorisation for generic levofloxacin hemihydrate. Daiichi Sankyo sued DEMO in the Greek courts to prevent them putting their generic product on the market. DEMO argued that the basic patent, and therefore the SPC, only covered a process for manufacturing levofloxacin hemihydrate, and not the product itself: if they could show their generic product was produced by a different process, they would not infringe the patent and SPC.
The Greek court provisionally ruled in DEMO’s favour, but was uncertain whether the provisions of TRIPs could retroactively apply, and therefore allow the patent to extend to cover the compound itself. The court was also uncertain whether the application of TRIPs was a matter for the EU or its member states, and therefore referred the matter to the CJEU.
The CJEU decision
The EPC is an inter-governmental treaty signed by its member states, and is wholly independent of the EU. As such, the CJEU does not generally have jurisdiction on matters of substantive patentability: only on matters which are the subject of specific EU legislation, such as biotech inventions and SPCs. However, as the TRIPs agreement was negotiated jointly by the EU and its member states, the CJEU had jurisdiction to hear the case.
Article 207 of the Treaty of the Functioning of the European Union (TFEU), in force since 2009, sets out the EU’s common commercial policy. The CJEU considered that EU rules on intellectual property rights have a specifi c link to international trade and therefore fell within the scope of this policy. As the TRIPs agreement has the same overall purpose, the CJEU also ruled that Article 27 of the agreement also fell within the scope of this policy.
Article 27(3) of TRIPs allows member states to exclude from patentability methods of medical treatment, as well as plants and animals and essentially biological processes for their production. The CJEU ruled this exclusion did not apply to pharmaceutical products. However, the court decided that, for patents granted before TRIPs entered into force, and which only claimed processes for manufacturing pharmaceutical products, Article 70 does not oblige member countries to extend such patents to the products themselves.
The CJEU’s decision regarding pharmaceutical process patents is not a surprise. On this particular matter, it is also mainly historical, as the temporary exclusions in the original EPC regarding patenting pharmaceutical products have all long expired.
For patents currently in force, the CJEU’s stance that it may in effect be competent to judge patent matters on the basis of TRIPs is of interest for those litigating patents in national courts. It may be of particular interest in technical fields wherein the exclusions from patentability under national law differ from those provided in TRIPs.
In particular the current prohibition in the UK on patenting computer programs ‘as such’, whilst often possible to overcome, would appear more restrictive than that envisaged by TRIPs. There is no such exclusion in Article 27(3) of TRIPs on patenting programs for computers, suggesting that these qualify as a field of technology.
There is no route of appeal from the EPO or its Boards of Appeal to the CJEU (although this may change when the unitary patent comes into force). However, this decision may open up the possibility of appealing decisions of national courts on issues of unpatentable subject-matter to the CJEU on the basis of TRIPs, at least in the field of software. However, it is possible that the CJEU may still choose to resort to the argument that computer programs as such are already protected by copyright as literary works, leaving us in the UK back were we started, arguing about the meaning of the term ‘as such’.
In conclusion, whilst the possibility of appeal to the CJEU is an interesting prospect, it may result in little effective change – but on the other hand the CJEU could use this decision as basis for involving itself in matters of software patentability, and open up a Pandora’s box. We will await further developments with interest.