March 2018 The European consensus on the patentability of dosage regimes is not shared throughout the national laws of all of the individual member states. Thus, in some member states, it is unclear whether granted claims to dosage regimes can be enforced against infringers. This article sheds some light on the position in the UK and now also in France.
Europe
The Enlarged Board of Appeal in G 02/08 clarified that second medical use claims to new and inventive dosage regimes are patentable, even where the substance or composition, and the disease to be treated, are the same as in the prior art.
Nevertheless, the European consensus on the patentability of dosage regimes is not shared throughout the national laws of all of the individual member states. Thus, in some member states, it is unclear whether granted claims to dosage regimes can be enforced against infringers.
The UK
In BMS vs. Baker Norton Pharmaceuticals [2001] RPC 1, the Court of Appeal unsurprisingly found that second medical use claims must define a new and inventive purpose, i.e. treatment of a disease previously unknown to be treatable with the claimed substance or composition. It was held that claims which define the new use in other terms, e.g. a new dosage regime, were disguised method of treatment claims, and also lacked novelty over the use of the substance or composition to treat the same disease at a different dosage.
Nevertheless, the Court of Appeal in Actavis v Merck [2008] RPC 26 disagreed with the above-mentioned part of the BMS vs. Baker Norton Pharmaceuticals decision. The Court noted that a second medical use claim which defines the use in terms of a new and inventive dosage regime is valid, even if the substance or composition in question has been used in the prior art to treat the same condition at a different dosage.
In the UK, therefore, second medical use claims which differ from the prior art exclusively by the dosage regime used are considered patentable. Nevertheless, it is important to note that, in most cases, a new dosage regime will lack inventive step, as investigating appropriate dosage regimes is considered standard practice to the skilled person.
France
Until now it has been unclear as to whether French patent law recognises dosage regime claims as patentable subject-matter. On 6 December 2017, however, the French Supreme Court issued a decision in MSD vs. Teva and Actavis (Decision Nos 1514 FS-P+B+R+I and 1515 FS-D) which may shed some light on this area.
Although the Supreme Court was principally concerned with the requirements for sufficiency of disclosure applicable to second medical use claims, it considered the patentability of dosage regime claims implicitly.
In coming to a decision on whether the claims in question were sufficiently disclosed, the Court had to repeatedly refer to the dosage regime claims present in the patent. It would seem highly unlikely that the French Supreme Court would consider these claims in so much detail for the assessment of sufficiency of disclosure if, in fact, the claims were inherently unallowable based on non-patentable subject-matter. Thus, it can be concluded that dosage regime claims are patentable in at least France, as well as in the UK.
Other Member States
It is understood that G 02/08 is followed in both Germany and the Netherlands, meaning that dosage regime claims are also patentable in these member states. Nevertheless, the situation is less clear in other member states, e.g. Italy, in which no official position has yet been reached.
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