Abbott Respiratory, dosage regime (EPO, G 2/08, 2010)

Date	19 February 2010
Jurisdiction	European Patent Office
Court	European Patent Office, Enlarged Board of Appeal
Case number	G 2/08
ECLI	ECLI:EP:BA:2010:G000208.20100219
Parties	Abbott Respiratory LLC (demanderesse, requérante), procédure ex parte
Language of the decision	EN

Text of the decision · Texte officiel anglais, epo.org (fiche de la décision et PDF intégral g080002ex1.pdf)

Dhenne Avocats · 11 October 2026

Our analysis

Summary

The Enlarged Board of Appeal held that Article 54(5) EPC does not exclude the patenting of a known medicament for a different treatment of the same illness, including where a dosage regime is the only feature not comprised in the state of the art. It brought Swiss-type claims to an end where novelty derives solely from a new therapeutic use, with a three-month time limit from publication in the Official Journal. The decision opens protection to dosage regimes while subjecting them to the full body of case law on novelty and inventive step.

Facts and procedure

European patent application No. 94 306 847.8, filed on 19 September 1994 by Kos Life Sciences and now held by Abbott Respiratory LLC, was refused on 25 September 2003 for lack of novelty and under Article 52(4) EPC 1973. Claim 1, in Swiss-type form, concerned the use of nicotinic acid for the manufacture of a sustained release medicament for the treatment of hyperlipidaemia by oral administration once per day prior to sleep. In T 1319/04 of 22 April 2008, Technical Board of Appeal 3.3.02 held EPC 2000 applicable and referred three questions.

The applicable law

Article 53(c) EPC excludes methods of treatment by therapy but not products for use in such methods. Article 54(4) EPC protects the first medical use of a known substance; Article 54(5) EPC, introduced by the 2000 revision, allows protection of a substance already known as a medicament for “any specific use” not comprised in the state of the art.

Question

Can a medicament known to treat an illness be patented for a different treatment of the same illness, in particular where the only novel feature is the dosage regime, and in what claim format?

Decision

Article 53(c) EPC is clear: method claims directed to therapy are absolutely forbidden in order to leave the physician free, whereas product claims are allowable if new and inventive, both provisions carrying the same weight (point 5.7). Article 54(5) EPC refers to “any” specific use without requiring any degree of distinctiveness, and the Board declined to introduce a distinction the law does not make (points 5.9.1 and 5.9.1.1). Specificity is to be understood by contrast with the generic protection of the first indication, so that the new use need not be the treatment of another disease (point 5.10.3), as confirmed by the travaux préparatoires (point 5.10.4) and by earlier case law (point 5.10.7).

There is no reason to treat a new dosage regime differently (point 6.1). However, the claimed definition must reflect a different technical teaching rather than a merely verbal difference; a selection within a broader prior disclosure is novel only if the criteria for selection inventions are met, and a new technical effect is to be considered for inventive step (point 6.3). The Board noted the diverging English, Zurich and German national decisions (point 6.4). Protection under Article 54(5) EPC is likely broader than under a Swiss-type claim; the freedom of medical practitioners may be protected by other means at national level (point 6.5). Since the reason for the Swiss-type format has ceased with Article 54(5) EPC, that format is no longer available where novelty lies only in the new therapeutic use (points 7.1.2 and 7.1.3), without retroactive effect; the relevant date for future applications is the filing or priority date (point 7.1.4).

Key points for practice

A further medical indication may be a different treatment of the same illness, not only a new disease (point 5.10.3).
A dosage regime may be the only novel feature, provided it reflects a different technical teaching (points 6.1 and 6.3).
Swiss-type claims are no longer available for applications whose filing or priority date falls after expiry of the three-month time limit (point 7.1.4).
Practical point: support in the application the technical effect specific to the dosage regime, which bears on the novelty of selections and on inventive step (point 6.3).

Provisions applied

European Patent Convention: Art. 53(c), 54(4) and (5), 56; EPC 1973, Arts 52(4) and 54(5)
Other instruments: Vienna Convention on the Law of Treaties, Arts 31 and 32; TRIPS Agreement, Arts 27 and 30
Case law cited: G 5/83; G 1/04; G 1/07; T 116/85; T 19/86; T 290/86; T 182/90; T 893/90; T 820/92; T 51/93; T 82/93; T 254/93; T 138/95; T 233/96; T 836/01; T 1020/03; T 406/06; T 1074/06; T 1319/04; BGH, X ZR 236/01, 19 December 2006 (Carvedilol II); Commercial Court of the Canton of Zurich, AA 090075 and AA 090077, 14 April 2009; Actavis UK Ltd v Merck & Co Inc [2008] EWCA Civ 444

Related decisions

Eisai, G 5/83, EPO Enlarged Board of Appeal, 5 December 1984, origin of the Swiss-type claim, abandoned by the present decision.

Prepared by Dhenne Avocats from the text of the decision (epo.org, official English text), consulted on 11 October 2026. Only the official text is authoritative.