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DOSAGE REGIMENS


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.


Te 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). Tese 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.


Te 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. Te 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.


“ FRENCH JURISDICTIONS [ARE] 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.”


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


• The first time that the patentability of second or nth medical use is clearly acknowledged in France, and


• The first decision rendered by a French Court since the patentability of dosage regimen was officially accepted by the EPO.


Tis 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


66 Life Sciences Intellectual Property Review 2011


Stéphane Agasse’s main fields of expertise include chemistry, cosmetics and pharmacy. He handles all patent-related matters in these fields, including defining protection strategy, draſting and prosecuting patent applications, patentability and freedom to operate opinions, opposition proceedings and litigations, but also draſting IP-related agreements such as MTAs, assignments, licence agreements and co-ownership agreements.


Tis 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.


Te 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”.


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. Te 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. Tis decision is currently under appeal.


Te 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


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