Patentability of dosage regimens in Europe
Following decision G02/08 dated February 19, 2010, by which the Enlarged Board of Appeal (EBA) of the European Patent Office (EPO) recognised the patentability of a dosage regimen, its application in national jurisdictions was questionable, especially in France where the patentability of second or ‘nth’ medical use has always been contested and has never been strictly confirmed by a court. A first instance decision was rendered on this matter by the Paris Court on September 28, 2010.
Patentability of dosage regimes/posology: the EPO’s position
Evolution of the case law
Until the beginning of the 2000s, most patent applications aiming at protecting new dosage regimens for medicines already known to treat diseases were rejected by the EPO Board of Appeals, even though the applicants were using so-called ‘Swiss claims’ (i.e. claims under which a ‘second medical use’ was considered to be patentable by the EPO under the European Patent Convention (EPC) decision G05/83) for protecting them.
Mainly, the board pointed out that determining the best individual treatment schedule, in particular prescribing and modifying drug regimens used for administering a particular medicine, to comply with the specific needs of a patient, appeared to be part of the typical activities and duties of the doctor exercising his professional skills of curing, preventing or alleviating the symptoms of suffering and illness.
These were typical non-commercial and non-industrial medical activities that Article 52(4) of the EPC intended to free from restraint.
In decision T1020/03, the board adopted a different position and came to the conclusion that, if the subject matter of the claim avoided the method of treatment by therapy prohibited in Article 52(4), as would be the case for a claim in the approved ‘Swiss’ form, compliance with this provision did not need to be considered further, and certainly not for imposing restrictions on the breadth of the claim.
It added that there was no interference with the freedom of the physician because the patent proprietor would have a remedy only against the maker of or dealer in the composition. Consequently, the board construed decision G05/83 as allowing Swiss form claims directed to the use of a composition for manufacturing a medicine for a specified new and inventive therapeutic application, where the novelty of the application might lie only in the dose to be used or the manner of application.
This decision, contradicting the dominant case law until then, has been followed in other similar decisions.
In view of the legal uncertainty generated by these contradictory decisions, the question of the patentability of dosage regimen was referred to the EBA (referral G02/08).
Decision of the Enlarged Board of Appeal
In its decision G02/08 issued on February 19, 2010, the EBA considered that where it is already known to use a medicament to treat an illness, Article 54(5) EPC does not exclude that this medicament be patented for use in a different treatment by therapy of the same illness.
The EBA further considered that patenting is not excluded where a dosage regime is the only feature claimed that is not included in the state of the art, provided that a new technical effect caused by said feature will be considered when examining inventive step under Article 56 EPC.
The patent under discussion
The patent in question is the French part of a European patent in the name of Merck Sharp and Dome (MSD). The main granted claim of this patent covers the use of finasteride for the preparation of a medicament for oral administration useful for the treatment of androgenic alopecia in a person and wherein the dosage amount is about 0.05 to 1.0 mg.
Finasteride is a medicine commercialised by MSD under the name Propecia®. The use of finasteride for treating androgenetic alopecia by oral administration (systemic) in a posology ranging from 5 to 2000 mg was known at the priority date of the patent.
Accordingly, the patent aims at protecting a specific dosage regimen/posology.
