JUDGE KEEPS A STRAIGHT FACE AS BOTOX PATENT WRINKLES AND DIES

Judge keeps a straight face as Botox patent wrinkles and dies

LexisNexis Butterworths' subscription service was first off the mark with Merz Pharma GmbH and Co KGaA v Allergan Inc, a Patents Court decision of Mr Justice Kitchin on Monday.

Merz and Allergan both developed, made and sold pharma products. Allergan owned a patent for the use of botulinium toxins, in particular the neurotoxic component, in medicines for use in relieving pain related to muscle activity or contracture. Those botulinium toxins were a compound comprising of the neurotoxic component and proteins called neurotoxin associated proteins (NAPs). This patent, applied for in 2003, was a second generation divisional patent, the original having been filed in 1994. By the patent's priority date, two formulations of botulinium toxins were commercially available. One of them was marketed by Allergan under the BOTOX trade mark and they were both used to treat various muscle conditions.

Issues arose concerning the validity of the patent in respect of two of its claims. Claim 1 was for

‘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’,

while Claim 5 covered

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

Merz applied to have the patent revoked on the ground (among others) that the patent disclosed additional matter to that contained within the original application since the original application referred only to the use of botulinium toxin to treat various disorders while the specification of the patent as granted referred to the use of the neurotoxin component stripped of the NAPs. Allergan disagreed, arguing that, since the original application referred to the neurotoxin component in the technical background to the invention, the matter had been sufficiently disclosed, both explicitly and implicitly, by the original application.

Kitchin J allowed Merz's claim and ruled that the BOTOX patent was invalid. In his view

* It was long settled that a patent could be revoked for added subject-matter where what was disclosed, both explicitly and implicitly, by the original application and the granted patent, it was apparent that some subject matter that was relevant to the invention had been added, whether by deletion or addition.

* In this case the skilled addressee would have viewed Claim 1 as covering use of the neurotoxic component regardless of whether it formed part of the toxin complex. Accordingly the original application disclosed only the use of the botulinium toxin - not the neurotoxic component stripped of the NAPs.

* Since the original application contained no explicit or implicit disclosure of the use of the neurotoxic component of the stripped botulinium toxin, the patent, having referred explicitly to the neurotoxin component, had disclosed additional matter. Accordingly, the patent was invalid and would be revoked.

The IPKat suspects that, given the value of the patent (which is the UK version of a European patent), Allergan may be thinking of an appeal. Merpel cautions: Kitchin J has a good track record so far, so don't bank on the appeal succeeding.

More bad news for BOTOX: you can remove the appearance of wrinkles with tiny plastic crystals suspended in bovine collagen.
All about botulism here
Botulinium toxin and biological warfare here