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In the case of Merz Pharma GmbH and Co KGaA v Allergan Inc [2006], a dispute arose as to the validity of a patent for the use of Botulinium toxins in a type of medical treatment.

Both the claimant and defendant companies were involved in the manufacture, marketing and development of pharmaceuticals. The defendant was the holder of a patent which concerned the use of the neurotoxin component of Botulinium toxins in the treatment of pain caused by muscular activity and contracture. The Botulunium toxins were a compound of the neurotoxin component and neurotoxin associated proteins .

The defendant filed their patent on 14 July 2003. It was a second generation divisional patent, the

original having been filed on 16 December 1994. By the priority date there were two formulations of Botulinium toxins available commercially. On of those was BOTOX. The defendant marketed BOTOX, but both were used to treat muscle conditions.

Issues arose concerning the validity of the patent in respect of two of the claims which provided:

* Claim 1: Use of the neurotoxin component of Botulinium toxin for the manufacture of a medicament for the treatment of pain associated with muscle activity or contracture .

* Claim 5: ‘Use according to any one of the preceding claims, wherein the neurotoxin component of Botulinium type A, B, C, D, E, F or G’.

The claimant sought the

revocation of the patent on the grounds that it was invalid. They argued that the patent disclosed additional matters that were not in the original application, namely that the original application concerned the use of Botulinium toxins to treat various disorders. By contrast, the patent specifications referred to the use of the neurotoxin component stripped of the neurotoxin associated proteins.

The defendant submitted that the neurotoxin component had been referred to in the original application in the technical background to the invention. They therefore argued that the matter had been sufficiently disclosed both implicitly and explicitly by the original application.

The revocation was be allowed on the basis that:-

*

It was settled law that a patent would be revoked in the event that any additional matters relevant to the invention were added to it.

* This would require consideration by a skilled addressee of the original application with regards to what was implicitly and explicitly disclosed by it.

* In this case, a skilled addressee would have understood claim 1 to cover the use of the neurotoxin component whether or not it formed part of the toxin complex.

* Therefore the original application disclosed only the use of the Botulinium toxin and not the neurotoxin component stripped of the neurotoxin associated proteins.

* There was no implicit or explicit disclosure of the use of the neurotoxin component on its own.

* The patent, having referred to the neurotoxin component explicitly, was invalid on the ground that it had disclosed additional matters.

The patent was revoked.

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RT COOPERS, 2006. This Briefing Note does not provide a comprehensive or complete statement of the law relating to the issues discussed nor does it constitute legal advice. It is intended only to highlight general issues. Specialist legal advice should always be sought in relation to particular circumstances.

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