However, the decision has also closed a loophole in EU patent law that had allowed so-called 'Swiss-type' claims, which have been used to couch some drug applications in more patentable terms.
In September 2003, Kos Life Sciences (now Abbot Respiratory LLC) was refused a European patent on its nicotinic acid treatment for hyperlipidemia – a condition in which the blood has abnormal levels of fatty molecules. In its first claim, Kos asserted that the drug took effect through once-daily oral administration before sleep. Examiners rejected the application on the grounds that: i) the use of nicotinic acid in such a treatment was anticipated by prior art, and ii) the dosage regime was considered an unpatentable activity under Article 52 of the European Patent Convention (EPC).
Kos duly appealed. Standing by its original claim, the company argued that by itself, the once-daily, pre-sleep dosage was a non-obvious, inventive step. Meanwhile, legislative changes played a role: Kos's original application was pending on 13 December 2007, the date on which a set of amendments to the EPC – called EPC 2000 – took effect. As such, the EPO viewed Kos's appeal in that context. Finding that the question over the dosage regime's patentability was an important point of law, it referred three questions to the Enlarged Board of Appeal (EBoA). The questions – and the EBoA's responses of late February – were:
Q1. Can a known drug be patented under the provisions of EPC 2000 for use in a different, new and inventive treatment by therapy of the same illness?
EBoA: YES. If a drug has a track record in treating a specific illness, EPC 2000 does not exclude this drug from patentability for use in a different treatment by therapy of the same illness.
Q2. If the answer to Q1 is yes, is patentability still possible if the treatment's only novel feature is an inventive dosage regime?
EBoA: YES. If that dosage regime is the only feature not comprised in prior art, it is not excluded from patentability.
Q3. Are any special considerations applicable when interpreting and applying the relevant articles of EPC 2000?
EBoA: YES. If the subject matter of a claim is rendered novel only by the new therapeutic use of a drug, such a claim may no longer have the format of a so-called 'Swiss-type' claim.
Q3's answer refers to a form of claim construction devised by the Swiss Federal Institute of IP in the early 1980s. As the EPC precluded treatment methods themselves from patentability, the Swiss Institute suggested phrasing each relevant claim as 'use of compound X in the manufacture of a therapy for the treatment of disease Y' – the language denoting a chemical process rather than a treatment. In Kos's claim, this appeared as: 'The use of nicotinic acid … for the manufacture of a sustained-release [drug]' for use in the once-daily, pre-sleep treatment of hyperlipidaemia.
The EBoA said that it was aware 'that patents have been granted and many applications are still pending seeking patent protection for claims of this type'. In order to ensure legal certainty and to protect applicants' legitimate interests, the new law contained in the decision would 'have no retroactive effect'. The EBoA added that 'an appropriate time limit of three months after publication of the present decision … is set in order for future applications to comply'.
