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NEWS - JUNE 2008EPO: Enlarged Board of Appeal Referral concerning the patentability of dosage regimes under Articles 53(c) and 54(5) EPC 2000. The Enlarged Board of Appeal of the European Patent Office has been asked to provide clarification as to whether a claim to a known medicament for use in methods of treatment by therapy is patentable under Articles 53(c) and 54(5) EPC 2000 where the only novel feature is a dosage regime. The referral comes from the Technical Boards of Appeal case T1319/04, in which the Board had to consider the refusal by the Examining Decision of an application claiming a new dosage regime for a known pharmaceutical for the treatment of hyperlipidemia. The Examining Division had considered that claimed feature of a specific dosage regime reflected a medical activity excluded from patentability under Article 52(4) EPC 1973, and accordingly that the claim could not derive novelty from this feature. Since the application was pending on the date on which the EPC 2000 came into force, the application has now to be considered under the Articles 53(c) and 54(5) EPC 2000. The European Patent Convention (EPC) excludes methods of treatment by surgery or therapy and diagnostic methods from patentability. The reasoning behind this exclusion is the view that medical decisions or actions which are specific to the professional activity of a physician should not be restricted by patent rights. The EPC provides that this exclusion does not apply to products, such as compounds or compositions, for use in such methods. The case law of the Boards of Appeal of the EPO has established that this exclusion from patentability should be interpreted narrowly. In the landmark Enlarged Board of Appeal case G5/83 the Enlarged Board decided that not only was it allowable to obtain protection for a known compound or composition for a first use as a medicament (i.e. where use of the compound/composition in medicine was not previously known), but also that it was legitimate to allow claims directed to the use of a compound or composition for the manufacture of a medicament for a specified new and inventive therapeutic application. Thereby G5/83 established the basis for the protection of a second, or further, medical use of a compound that had already been used in therapy but for a different indication. However the cases considered by the Enlarged Board in G5/83, and parallel cases, concerned the use of a known medicament to treat a new illness. There had therefore been no need to distinguish between the use of a known medicament to treat a different illness, and the use of a known medicament to treat the same illness but with a different dosage regime. The Technical Board of Appeal in the present case considered that the case law since G5/83 provides conflicting guidance with respect to patentability in the case that the only novel feature in the claim relates to a dosage regime. In particular the Board referred to Technical Board of Appeal Decision T1020/03, in which it was held for the first time that a second medical use claim in which the only novel feature is found in the dosage regime was not excluded from patentability. The Board also recognised that there were a number of cases that had reasoned that pure dosage regimes were not patentable, in part because the disclosure of a medicament for treating a particular illness was deemed to make known all possible dosage regimes using that known substance for treating that disease. The justification for this view being that assessing the correct dosage was so much a question for between physician and patient that preservation of the physician’s freedom to assess the right dosage must take precedence over any right to obtain a patent. The Board noted that the patentability of novel dosage regimes is an important point of law, as the situation arises quite frequently, and recognised that applicants need to know for certain whether patentability is to be excluded where the only novel feature is a dosage regime.
Accordingly, the Board has referred questions to the Enlarged Board of Appeal as to: (1) Where it is known to use a particular medicament to treat a particular illness, whether this known medicament can be patented under Articles 54(3) and 54(5) EPC 2000 for the use in a different, new and inventive treatment by therapy of the same illness. (2) In the affirmative, whether such patenting is possible where the only novel feature of the treatment is a new and inventive dosage regime. (3) Whether any special considerations are applicable when interpreting and applying Articles 54(3) and 54(5) EPC 2000.
The case is pending under G 2/08 and the EPO has invited third parties to file any statements concerning the referred questions by the end of October 2008. For further information see: |