Merz Pharma GmbH & Co. KGaA v Allergan Inc.

In construing a Swiss-form medical-use claim, the court must read the language in the context of the specification as a whole. A claim to using a neurotoxic component was not limited to the isolated component where the specification described botulinum toxin complexes and gave examples using those complexes.

For novelty, prior disclosure or use must communicate information which necessarily enables the skilled person to work the invention. A secret, uninformed or uninformative use does not anticipate. Obviousness may involve overcoming a technical prejudice, but the prejudice must be generally held in the art. The patent was nevertheless invalid because its claims added matter, lacked novelty and were obvious.

Merz sought revocation of Allergan’s patent concerning the use of botulinum toxin neurotoxic components in medicaments for treating pain associated with muscle activity or contracture. The challenges alleged added matter, lack of novelty, obviousness and insufficiency.

The principal construction issues were whether the claims were limited to isolated neurotoxic components, whether they excluded other botulinum toxin components, and whether claim 5 was restricted to one serotype. The court also considered prior applications, commercial products, publications, and an earlier clinical use.

1. Construction. Claim 1 was a Swiss-form process claim. Read in the context of the specification, it covered use of the neurotoxic component whether or not it remained associated with neurotoxin-associated proteins. The specification’s field, detailed description, dosing information and examples were largely expressed in terms of botulinum toxin complexes. The claim did not exclude a medicament containing another active component, including another botulinum toxin. Claim 5 likewise permitted use of more than one neurotoxic component, provided that at least one was from the listed serotypes.
2. Added matter. Under Patents Act 1977, s.72(1)(b) and s.72(1)(d), the disclosure in the patent had to be compared strictly with the disclosure in the earlier application through the eyes of the skilled addressee. Applying Bonzel v Intervention [1991] RPC 553, the earlier application disclosed botulinum toxin complexes, not the isolated neurotoxic component. The patent also added matter by presenting a formulation of the isolated component that was not disclosed in the earlier application.
3. Novelty. Under s.2 of the Act, the relevant question was whether the prior art conveyed sufficient information to work the invention. Applying Merrell Dow v Norton [1996] RPC 76 and Synthon v SmithKline Beecham [2005] UKHL 59, disclosure and enablement were distinct requirements. The earlier application 923 anticipated the claims on the broad construction. BOTOX and DYSPORT also made the claimed inventions available because their known use for torticollis necessarily involved treatment of associated pain. The SCRIP article was ambiguous and did not clearly disclose the isolated component. The clinical use by Professor Rohkamm was uninformative to the public and did not anticipate.
4. Availability of products. Following G 01/92 Availability to the public [1993] EPOR 241 and Milliken v Walk Off Mats [1996] FSR 292, a product may be prior art where its composition could have been discovered without undue burden, even if nobody had a reason to investigate it. The evidence indicated that the composition of the supplied material could have been determined without undue effort, although that finding was unnecessary to the result.
5. Obviousness and insufficiency. By the priority date there was no generally held technical prejudice that the isolated component could not be formulated or would necessarily cause unacceptable side effects. It was therefore obvious to use it to make a medicament for treating pain associated with muscle activity or contracture. The insufficiency allegation failed because the conventional formulation described in the patent was capable of working.
6. Disposition. Claims 1 and 5 were invalid for added matter, lack of novelty and obviousness. The patent was revoked.

First-instance decision of the High Court (Patents Court). No appellate history was stated in the judgment.