Lundbeck's Belgian appeal success over escitalopram: now in English

From Annette Hirschfeld (Hoyng Monegier, Amsterdam) comes news of a case that has attracted considerable interest and attention in the world of SPCs, Lundbeck v Tiefenbacher, Ratiopharm, Teva and Eurogenerics (escitalopram).  In this Belgian litigation, the Brussels Court of Appeal reversed the decision of the Brussels Commercial Court (noted by Steven Cattoor for the EPLAW Patent Blog here) to revoke Lundbeck’s Belgian escitalopram SPC and confirmed the validity of both the SPC and its underlying basic patent: it found that both the patent's product claims and the process claim were novel and non-obvious, and that the SPC fulfilled the requirements of Articles 3(c) and 3(d) of the  SPC Regulation. Declaring that any generic product containing escitalopram as active ingredient would infringe, the Court of Appeal granted injunctive relief.

Of particular note in the Court of Appeal's judgment, which makes substantial reference to European Patent Law (EPO)  case law and Guidelines, are the following:

• As to the novelty of the product claims, in the light of the EPO decisions in T297/87 (Hoechst) and T1048/92 (Pfizer), the generic manufacturers had failed to show that the prior art (including the earlier patent on the racemate) unambiguously disclosed the specific configuration of the claimed S-enantiomer in the form of a technical teaching. Since no document cited would let the skilled person obtain the enantiomers of citalopram in an individualised form, the product claims on the S-enantiomer (i.e. the product escitalopram) were novel.

• As for inventive step, after restating the general principles of the EPO's problem-solution approach, the Court referred, inter alia, to the teaching in  T595/90 (Kawasaki Steel) that an otherwise obvious entity may become non-obvious (and thus claimable as such) if there is no known way in the art to make this entity and the patent is the first to achieve this in an inventive manner. The Court then examined whether the process set out in the patent was indeed the first and an inventive method to prepare escitalopram.

The full text of the judgment, all 128 pages of it, has now been rendered into English and can be read here.

This blogpost is based on a note by Steven Cattoor that was first posted on the EPLAW Patent Blog here.