T 611/08 – Killing The Pain (And The Patent)

The opponent filed an appeal against the decision of the Opposition Division (OD)to maintain the patent in amended form.

Claim 1 of the patent as maintained (main request) read (the differences with respect to claim 1 as filed are underlined):

The use of from 50 to 300 units of a botulinium toxin for the manufacture of a medicament for treating pain associated with a muscle disorder, whereby the muscle disorder is a hand, wrist, forearm or leg spasticity condition secondary to a stroke or a cerebral vascular event.

[1] A 123(2) prohibits amendments generating “subject-matter which extends beyond the content of the application as filed”. In order to determine whether or not the subject-matter of an amended claim satisfies this requirement it has to be examined whether that amended claim comprises technical information which a skilled person would not have objectively and unambiguously derived from the application as filed. It was agreed that the published “A1” application represented the application as filed.

[2] Claim 1 of the main request differs from claim 1 as filed by the inclusion of a dosage interval (“from 50 to 300 units”) and by the definition of the muscle disorder as being “a hand, wrist, forearm or leg spasticity condition secondary to a stroke or a cerebral vascular event”.

[3] The OD concluded that these new features in claim 1 of this request had a basis in the example described on page 8, lines 10 to 20 of the published “A1” application, which reads as follows:

“Example 9

The use of Botulinum toxin Type A-G in the Treatment of Muscle Spasms and Control of Pain Associated with Muscle Spasms in Spasticity Conditions Secondary to Stroke, Traumatic Brain or Spinal Chord Injury

[0062] A male, age 70, post-stroke or cerebral vascular event, is injected with 50 to 300 units of Botulinum toxin in the major muscles involved in severe closing of hand and curling of wrist and forearm or the muscles involved in the closing of the legs such that the patient and attendant have difficulty with hygiene. Relief of these symptoms occurs in 7 to 21 days.”

[4] However, the [opponent] maintains that the differences (i) to (iv) between claim 1 and Example 9 (paragraph [62]) of the published “A1” application

(i) The age of seventy years is specified in the example, while omitted in claim 1;

(ii) In the example, the muscle spasms were characterized as being severe and causing closing of hand and curling of wrist and forearm or the muscles involved in the closing of legs, while in claim 1 no degree of severity and no specific spastic symptom was indicated;

(iii) The patient of the example suffered from more than one spastic muscle while according to claim 1, the muscles disorders of the hand, wrist, forearm or leg were linked by "or", indicating that only one muscle disorder at a time was considered;

(iv) The example was not limited to the treatment of pain since it stated that the patient experienced relief of symptoms of severe closing of hand and curling of wrist and forearm or the muscles involved in the closing of legs upon administration of 50 to 300 units of botulinum toxin.

have an influence on the dose of botulinum toxin to be administered. Hence, the interval “50 to 300 units” (Example 9) cannot be generalised, as done in present claim 1.

[5] The board observes that the Example described on page 8, lines 10 to 20 of the published “A1” application (see point [3] supra) relates to the treatment of both the pain associated with muscle spasms (originating from spasticity conditions secondary to stroke, traumatic brain or spinal chord injury) and the muscle spasms themselves (see the title of the example and lines 18-19 of page 8, where it is stated that the “relief of these symptoms occurs in 7 to 21 days”).

Therefore, the board agrees with the [opponent’s] view that this example is not limited to the treatment of pain only. Example 9, in the board’s view, is indeed akin to Example 7 of the published “A1” application, which also deals with the treatment of both pain and spasms (see the wording “relief of pain associated with muscle spasms, possible reduction of jaw clenching occurs in about 1-3 days”).

[6] Once it has been established that Example 9 on page 8, lines 10 to 20 of the published “A1” application is not limited to the treatment of pain, the question arises whether or not treating pain only (claim 1) requires the same dose of botulinum toxin as treating both pain and spasms (the example of the published “A1” application).

[7] In connection with this, the [patent proprietor] has always insisted on the differences existing between the treatment of pain and the treatment of spasms (submission dated 3 April 2006, page 4, lines 3-4: “Treatment of pain does not necessarily involve a treatment of the muscle disorder per se”; submission dated 23 December 2010, page 3, lines 2-4: “As the claim is about the treatment of pain, the severity of the closure of the hand is obviously not relevant”; submission of 16 April 2012, page 3, last paragraph: “The treatment of muscle spasms is a separate effect”; submissions during the oral proceedings before the board: “The severity of spasms does not correlate 1:1 to the severity of pain” and “Severity of pain and not of spasm is relevant for the dose to be administered”).

[8] The board notes that this [patent proprietor’s] view is in keeping with paragraph [0026] of the published “A1” application, according to which a smaller dose (up to 50 U) of botulinum toxin may be used for the relief of pain.

[9] In view of the foregoing, the board must conclude that the dosage of “50 to 300 units” (Example 9 of the published “A1” application) was meant for the treatment of both severe muscle spasticity conditions and pain, not for the treatment of pain alone (present claim 1). Hence, the technical feature in present claim 1 that “50 to 300 units” botulinum toxin should be used for the treatment of pain only cannot be derived directly and unambiguously from the application as filed and the subject-matter of claim 1 of the main request does not satisfy the requirements of A 123(2).

Finally the patent was revoked.

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