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.

A nullity action against the French part of this patent has been introduced by Actavis (a generic company) before the Court of Paris, arguing that a posology shall be considered as being a method of treatment explicitly excluded from patentability pursuant to Article 53(c) of the EPC. In response, MSD sustained that the patentability of such inventions cannot be contested in view of EBA decision G02/08. The court’s decision is therefore mainly focused on the patentability of the dosage regimen under the French patent law (or, more precisely, on the industrial applicability of such inventions).

The decision of the French court

In its grounds for decision, the court noted that French jurisdictions were not bound by the decisions issued by the EPO, which is an administrative organisation but not a jurisdiction (unlike, for example, the European Court of Justice). These decisions, therefore, even when issued by the EBA, should be seen as mere indications of the principles applied by the EPO when examining patent applications.

According to the court, the same applies to the decisions rendered by the other EU jurisdictions, which do not bind the French courts and should only be seen as a simple indication of the reasoning followed by them.

The court has also stated that, despite the fact that new provisions of the French Intellectual Property Code (CPI) and of Article 54(4) of the EPC (2000) allow the same substance to be patented for different medical uses without using a ‘Swiss claim’, these articles remain totally silent on the possibility of patenting a dosage regimen posology.

Accordingly, the court considered that EBA decision G02/08, under which the patentability of posology has been recognised, cannot be inferred from the EPC, but relies on an interpretation of what can be considered a ‘second medical use’.

Following this reasoning, the court considered that posology cannot be seen as a ‘second medical use’. It found that a ‘second medical use’ should be construed as designating the use of a known medicament for treating a new disease and shall not be extended to the choice of a specific dosage within an efficient interval of dosages.

The court has thus sustained that determining posology is down to the medical practitioner, in view of various parameters such as the age, weight and sex of the patient, its antecedents, the other treatments already administered, etc.

This position has been strengthened by the fact that the notice accompanying any medicine distributed in France stipulates that posology/ doses are for indications only and that it is necessary to consult a practitioner.

The court has thus concluded that “it is possible to patent a medicament for treating a first disease, then a second disease, but not a posology adapted for the treatment of such diseases since by doing so, one is attempting to patent a therapeutic treatment which is excluded (from patentability) as belonging to the care domain and as depending on the sole freedom and responsibility of each practitioner, and that the patent was null and void as covering an unpatentable subject matter pursuant to Article 53(c) EPC 2000”.

Despite the fact that this decision remains a first instance decision and is currently under appeal, it is very important in that it is:

This decision appears well substantiated, the legal reasoning has been well detailed and it does not seem to contain any legal mistakes or misinterpretations. Nevertheless, as rightly emphasised by the judges in the first instance decision when discussing EBA decision G02/08, assessment of the patentability of dosage regimen/posology remains a question of interpretation and it is difficult to predict whether the Court of Appeal will reverse or confirm this first instance decision.

In any case, the question of the patentability of dosage regimen under the French patent law should be clarified much quicker by the courts than has been the question of the patentability of second or nth medical use.

Position of other foreign jurisdictions and consequences

In the UK, the Supreme Court has finally overruled a decision of the High Court of Justice that had nullified the English part of the European patent as lacking novelty and as protecting unpatentable subject matter. The Supreme Court has thus acknowledged the patentability of dosage regimens. It was the first such decision in the UK.

In Germany, the Bundespatentgericht held that the German part of the European patent was invalid for lack of novelty considering that if a dosage recommendation is not eligible for patent protection, and is one of several characteristics of a patent claim, the assessment of novelty and inventive step cannot be based on it. This decision is currently under appeal.

The existing discrepancy in the ‘enforcement’ of decision G02/08 by various national jurisdictions in Europe, and more generally in the position of such jurisdictions on so important and strategic question, reinforces the need for a unitary and autonomous Community Patent together with a centralised Community Intellectual Property Court in charge of examining infringement and validity, to guarantee unity of law and interpretation.

Stéphane Agasse is a French and European patent attorney at Germain & Maureau. He can be contacted at: stephane.agasse@germainmaureau.com