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European IP Bulletin, Issue 36, November 2006 - Patents

5. Is Treating Pain a Novel Issue?

On 30 October 2006,  the English Patents Court handed down its decision in Merz Pharma GmbH & Co. KGaA v Allergan Inc., concerning a patent (the “Patent”) held by Allergan. 

The Patent, with a priority date of 28 December 1993, relates to the use of botulinum toxins and, in particular, the active component of such toxins in medicaments to relieve pain related to muscle activity or contracture. Botulinum toxins comprise an active component, called the neurotoxic component in a complex with other proteins which are known as neurotoxin associated proteins (NAPs). Allergan said that the patent concerned the component stripped of all NAPs whereas Merz contended that the patent covered the component either with or without the NAPs to make a medicament and alleged that the patent was invalid for the following reasons:

1. the Patent was a second generation divisional patent, filed some 9 years after the original application, the Patent disclosing additional matter over original application;
2. the patent lacked novelty over another international application, three articles, the known use of BOTOX and DYSPORT and the prior disclosure and use of the invention by two experts in the field;
3. the patent was obvious over the common general knowledge, the disclosures and uses mentioned above; and
4. if the Patent was not invalid for added matter, anticipated or obvious, it was insufficiently disclosed.

The court, after having heard the expert witnesses, reached the conclusion that in December 1993 the following was common general knowledge:

1. the existence, composition and operational mode of the seven various serotypes (from A to G) of the botulinum toxin complex;
2. that the neurotoxic component could be separated from the botulinum complex;
3. that BOTOX and DYSPORT were commercially available and were formulations of botulinum toxin A;
4. that DYSPORT was 3-5 times less potent than BOTOX and there were significant side effects in using these products with one widely accepted explanation being that the toxin was diffusing from the site of the injection;
5. by 1993 the concern as to the side effects stemming from a high dosage had been replaced by concern over secondary non responders, that is patients that had became resistant to the medicament after a first period of apparently good results.

The claims of the Patent at issue were numbers 1 and 5, where the former concerned the use of the neurotoxic component of botulinum toxin for the manufacture of a medicament for the treatment of pain associated with muscle activity or contracture, and the latter, the specification that the neurotoxic component is the neurotoxin component of botulinum type A to G.

According to the court, claim 1 covers the use of the neurotoxic component whether or not it forms part of the toxin complex and is not limited to the use of a neurotoxic component stripped of all the NAPs and claim 5 requires the use of a neurotoxic component of one of the seven serotypes known at the priority date.

As to the allegation of added matter, the court found that the disclosure of the original application was concerned with the use of the botulinum toxin and not the neurotoxic component stripped of the NAPs; therefore the disclosure of the Patent constituted added matter over the original application. As to the anticipation, the court held that claims 1 and 5 are anticipated by another of Allergan’s prior patent applications, by the manufacture, sale and use of BOTOX and DYSPORT and by the prior disclosure of a physician to a colleague. As to the inventiveness of the Patent, the court found that it was obvious, in 1993, to use the neurotoxic component to make a medicament for the treatment of pain. Finally, the insufficiency allegation failed.

The Court therefore held that claims 1 and 5 were invalid for added matter, lack of novelty and obviousness and revoked the Patent.

 

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