EPLAW Patent Blog

FR - Actavis v. Merck

Tribunal de grande instance de Paris, third chamber, 28 September 2010, N° RG : 07/16296, Actavis Group and Alfred E. Tiefenbacher GmbH v. Merck Sharp & Dohme Corp

The judgment handed down on 28 September 2010 by the Tribunal de grande instance, Paris in Actavis v. Merck decides that a dosage regime is not patentable because it is “plainly not” a second therapeutic application: “A specific dosage for the treatment of an illness constitutes neither a first nor a second therapeutic application but simply an indication of the range within which this substance is efficacious so as to treat such or such an illness in light of the tests and research completed and explained in the patent.”

 

EPO - Enlarged Board of Appeal decides on dosage regime - Swiss-type claims no longer available

EPO, Enlarged Board of Appeal, 19 February 2010, Decision No. G 02/08 - Dosage regime/ABBOT RESPIRATORY

The Enlarged Board of Appeal (EBA) answered the questions referred to it in T 1319/04 (OJ EPO 2009, 36) as follows:

Question 1:

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.

Question 2:

Such patenting is also not excluded where a dosage regime is the only feature claimed which is not comprised in the state of the art.

Question 3:

Where the subject matter of a claim is rendered novel only by a new therapeutic use of a medicament, such claim may no longer have the format of a so called Swiss-type claim as instituted by decision G 5/83. A time-limit of three months after publication of the present decision in the Official Journal of the European Patent Office is set in order that future applicants comply with this new situation.

UK - Actavis v. Merck / Dosage Regimes

Actavis UK Limited v. Merck & Co Inc, Court of Appeal (Civil Division) London, UK, 21 May 2008, Case No. [2008] EWCA Civ 444, with thanks to Marc Döring and Rowan Freeland, Simmons & Simmons

"The Court of Appeal's decision in Actavis v Merck (England & Wales Court of Appeal, 21 May 2008) is a landmark in pharmaceutical patent law and its finding on the patentability of (non-obvious and new) dosage regimes will be welcomed by pharmaceutical companies. However, it is also of relevance to patent litigators in all industries since it emphasises the importance of settled case law of the European Patent Office Boards of Appeal and creates a new exception, where such settled EPO jurisprudence exists, to the rule that the Court of Appeal is bound by its previous decisions."

Read the first instance decision (in English) here.

Read the Court of Appeal decision (in English) here.

Read the extended summary (provided by Rowan Freeland) here.