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New EPO Jurisdiction re Second Medical Use Claims

The Enlarged Board of Appeal (EBA) of the European Patent Office EPO recently decided (G 2/08) on the conditions under which substances and compositions known as such are patentable if claimed for use in a novel and inventive medical treatment.

Background

Hitherto, an invention residing in a novel manner of making a known therapeutic substance or composition applicable to medical purposes (so-called "second medical use") had to be claimed, in European patent applications, in a specific matter focusing on the use of the substance or composition for the manufacture of a medicament for the treatment of the medical condition in question. This requirement had been laid down in Enlarged Board of Appeal decision G 5/83.

In the wake of amendments to the European Patent Convention EPC, coined "EPC 2000", an uncertainty arose whether the ruling of G 5/83 would still be applicable under EPC 2000.

What is G 2/08 about?

The legal basis is now formed by Arts. 53(c), 54(4) and 54(5) EPC 2000: Art. 53(c) EPC 2000 stipulates that European patents shall not be granted in respect of "methods for treatment of the human or animal body by surgery or therapy an diagnostic methods practised on the human or animal body"; but that this provision shall not apply to "products, in particular substances or compositions, for use in any of these methods."
Art. 54(4) EPC 2000 stipulates that "the patentability of any substance or composition, comprised in the state of the art, for use in a method referred to in Article 53(c), shall not be excluded provided that its use for any such method is not comprise in the state of the art; and Art. 54(5) EPC 2000, that "the patentability of any substance or composition referre to in paragraph 4 for any specific use in a method referred to in Article 53(c)" shall not be excluded, provided that such use is not comprised in the state of the art (emphases added).

The Essentials of G 2/08

The EBA now clarified in G 2/08 that this means that there are no further substantive constraints for the patentability of a substance or composition; in particular, that the novel an inventive use need not be related to the treatment of a new disease. Thus, while a claim directed to "a method for the treatment of disease X with the substance Y in a manner Z", being directed to a method of treatment, will still be unallowable under EPO regulations, a claim directed to "a substance Y for use in a treatment of disease X in a manner Z" may be allowable provided the manner Z is novel and inventive.

This type of claim is known as "use-related product claim" as distinct from the previously advocated "swiss-type" claim. Its crucial property is that it may derive notional novelty and inventiveness solely from the particulars of the specifically claimed use, which use is considered to present a technical feature of the substance per se. This enables applicants to claim known substances for the treatment of known diseases, subject to the condition that the particular manner of treatment envisaged is novel and inventive. Such a particular manner may, e.g., reside in a dosage regime.

National Implications

Another general issue associated with claims of European patent applications is their enforceability in the various contracting states. The EPC only governs the application and granting procedures, including possible oppositions; after grant, however, a European patent is validated in a number of contracting states, and then has an according number of national parts. Enforcement of some national part is governed by the pertaining law an jurisdiction of the respective state. While at least  the UK (Actavis v Merck) appear to have accepted the formerly prescribed "swiss-type" claims, this is not certain of the new, somewhat broader claim format. The German BGH has already decided (in X ZR 236/01 - Carvedilol II) that any relevant dosage specification must exclusively relate to a preparing step in the claimed manufacturing of a medicament; but not to its administration. Thus, wherever an invention resides in a new dosage regime, the only claim version enforceable in Germany may be even more limited than "swiss-type" claim.

How to Deal With G 2/08

This situation may entice applicants to draft main claims directed to a substance Y for use in the treatment of medical condition X in the manner Z; followed by a "swiss-type" claim directed to the use of the substance of the main claim in the manufacture of a medicament for the treatment of the medical condition X in the manner Z; and further followed by a dependent use claim, additionally defining the preparing of the medicament for administration according to the manner Z. If the main claim is granted, so should be the use claims. In any contracting state, at least one of such claims should be enforceable (assuming, of course, that the dosage regime Z is indeed novel and inventive).

Usually, applicants of pending European patent applications will have drafted their original second-medical-use-claims according to the formerly required "swiss-type" format. For European patent applications past the search stage, it may no longer be readily possible to re-draft their claims. These applicants may therefore be faced with the decision whether to file European divisional applications, in order to fully exploit the new EBA ruling. In this context, it may be noted that if the first office action issued in the respective patent family dates back to 2008 or earlier, the time limit for filing divisional applications may soon expire. In such cases, immediate action may be required.

Precautionary Note

The EBA have expressly noted in decision G 2/08 that it will have to be assessed in each individual case, whether a claimed dosage regime is indeed novel and inventive, in particular since usually some (other) dosage regime will be comprised in the state of the art. Insomuch the new interpretation seems to be more lenient in formal matters, this does not necessarily extend to the issue of novelty and inventive step: Some surprising improvement traceable to the claimed dosage regime will still have to be present in order for novelty and inventive step to be acknowledged.