Ipsen Pharma S.A.S. v Allergan, Inc - [2013] APO 50

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Ipsen Pharma S.A.S. v Allergan, Inc 2013 APO 50

Patent Application: 2005200251

Title:Method for treating pain associated with a muscle disorder

Patent Applicant:  Allergan, Inc
Opponent:  Ipsen Pharma S.A.S.
Delegate:  Sophina Calanni
Decision Date:  29 August 2013
Hearing Date:  5 June 2013, in Canberra
Catchwords:  PATENTS – final determination of an opposition under section 59 – whether amendments overcome the deficiencies in the opposed claims – claims lack novelty – claims lack an inventive step – application refused
Representation:  Patent Applicant: Dr Gavin Recchia and Ms Joanna Jones of Davies Collison Cave (Sydney)
Opponent: Mr Ian Horak of Counsel, instructed by Ms Amanda Jones of Watermark (Melbourne)

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2005200251

Title:Method for treating pain associated with a muscle disorder

Patent Applicant: Allergan, Inc.
Date of Decision: 29 August 2013
DECISION
Claims 1-7 lack novelty.

Claims 1-7 lack an inventive step.
I award costs against the Applicant, Allergan, Inc.
REASONS FOR DECISION
BACKGROUND

Grant of a patent for application 2005200251 in the name of Allergan, Inc. was opposed by Ipsen Pharma S.A.S.. Following a hearing on 21 September 2011, a Delegate of the Commissioner issued a decision upholding the opposition on the grounds that the claims lack novelty and an inventive step (see Ipsen Pharma S.A.S. v Allergan, Inc [2012] APO 21.)
The Delegate allowed the Applicant 2 months from the date of the decision to make suitable amendments to overcome the deficiencies. Amendments were proposed by the Applicant on 10 April 2012, and allowance was advertised in the Official Journal on 6 December 2012. The opponent requested to be heard on the final determination of the opposition.
DECISION
The amendments
Compared with the opposed claims, claims 1 and 6 were amended to incorporate the feature that the therapeutically effective amount of botulinum toxin used is 50 to 300 units.
With the additional text underlined, claim 1 as amended reads:

“1. A method for treating post stroke spasticity pain, the method comprising the step of intramuscular injection to a cholinergic influenced muscle of a patient a therapeutically effective amount of botulinum toxin type A, thereby reducing a post stroke spasticity pain, wherein the therapeutically effective amount of botulinum toxin is from 50 to 300 units.”
A similar amendment was made to claim 6. With the additional text underlined, claim 6 as amended reads:
“6. Use of botulinum toxin type A for the manufacture of a medicament for the treatment of post stroke spasticity pain, wherein the medicament is administered to a cholinergic influenced muscle of a patient by intra-muscular injection, wherein the administration is of a therapeutically effective amount of the botulinum toxin type A, and wherein the therapeutically effective amount of the toxin is from 50 to 300 units.”
Omnibus claim 7 was not amended.
The earlier decision is final and determined all the relevant issues that were capable of determination at the time (R v Smith; Ex parte Mole Engineering Pty Ltd [1981] HCA 25; (1981) 147 CLR 340 at 348-349). In the earlier decision, the Delegate of the Commissioner found that the matter claimed in the opposed application was not novel and lacked an inventive step.
Consequently, the issue to be decided in this final determination is whether Allergan’s amendments overcome the deficiencies. It is beyond my power to alter any decisions that were made in that earlier decision.
Novelty
The opposition was successful on the ground of novelty. Specifically, claims 1-7 were found to lack novelty in view of Konstanzer and Memin (see [2012] APO 21 at [69] and [75]).
Omnibus claim 7 has not been amended. As claim 7 is in the same form as the Delegate found to lack novelty, the deficiency with the claim remains.
As noted earlier, amended claims 1 and 6 introduce the feature that the therapeutically effective amount of botulinum toxin is from 50 to 300 units. That is, the scope of these independent claims has only changed insofar as a dosage range for botulinum toxin has been introduced.
In the earlier decision, when assessing the omnibus claim (claim 7) for novelty, the Delegate was compelled to consider Example 10 of the application and the features specified in that example. At [17] of that decision, the Delegate stated “I note that the claims include an omnibus claim that is referenced to Example 10. I will use this interpretation in my determination of novelty and inventive step.”
Example 10 reads:
“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 the hand and curling of wrist and forearm or the muscles involved in the closing of the legs…”
It follows then, that in deciding that claim 7 lacks novelty in view of Konstanzer and Memin, the Delegate has decided that these documents disclose the use of botulinum toxin within the relevant dosage range, namely 50 to 300 units. Therefore, by necessity it follows that the introduction of this feature into the other claims cannot confer novelty on the claimed subject matter.
At the hearing in relation to the final determination, the parties each provided submissions with respect to the dosage ranges disclosed in Konstanzer and Memin. Given the consideration above at [14] it is not essential for me to decide these matters. Nonetheless it is worth noting two points that support the decision made by the Delegate.
First, as stated by the Delegate in his decision at [89], “…the skilled person would read the claim to give it meaning and in doing so would understand that the spastic muscle is the cholinergic influenced muscle to be treated.” Accordingly, when a group of muscles is treated, the total dosage of botulinum toxin is apportioned amongst each of the muscles in the group. Thus, in determining the dosage delivered to an individual muscle, as specified in the present claims, I consider it reasonable to accept that the total dosage is divided by the number of muscles treated.
Turning to the total dose of toxin used in the Memin citation, the document states that: “The mean total dose per patient and per group was 9.1ng (maximum=16ng; minimum=4ng).” The Applicant submitted that, in effect, the average total dose was 18.2 ng (728 units), because the patients received two series of injections. I do not consider this to be a proper reading of the citation. If that were in fact the case, the authors would have surely referred to the higher total dose rather than misleading the reader of the document.
In summary, claims 1 to 7 lack novelty.
Inventive Step
In the earlier decision, at [82] the Delegate stated:

“…The Opponent pressed inventive step under both Section 7(2), obviousness in view of the common general knowledge, and Section 7(3): obviousness in view of a prior art document. This is largely a moot point in view of my finding in relation to the novelty of the claims, so I do not intend to further detail the submissions here. In short I consider that pursuant to the lack of novelty, the claims also lack an inventive step in view of Konstanzer and Memin. These documents describe the treatment of post stroke spasticity by intramuscular injection of botulinum toxin, and the treatment provides relief of post stroke spasticity pain. It follows from my determination that the claims also lack inventive step since the skilled person would need only to follow the instructions in those documents in order to arrive at the invention as claimed.”
The Applicant submitted (see [28]-[29] of their written submissions), that the reference by the Delegate to a discussion of inventive step being a moot point indicates that the Delegate did not consider and form a view with respect to whether the Konstanzer and Memin documents satisfy the requirements of s7(3). In support of this position, the Applicant also pointed to [84] of the decision where the Delegate states that “there is nothing in evidence to establish that the person skilled in the art would ascertain, understand and regard the document as relevant”.
I do not agree with the Applicant’s submissions. [82] and [84] of the Delegate’s decision relate to two distinct matters. [82] provides the Delegate’s decision with regard to inventive step, while [84] is a consideration of whether the objection could be overcome by a certain type of amendment.
In coming to the decision that “the claims also lack an inventive step in view of Konstanzer and Memin”, the Delegate has decided that the documents satisfy the requirements of s7(3) and that it would have been a matter of routine to proceed from the prior art to the claimed invention.
Thus, for similar reasons to those given above with regard to novelty, the introduction of a feature specifying a dosage range of 50-300 units cannot confer inventiveness on the present claims. The Delegate has already considered this question in his consideration of the omnibus claim (claim 7) in the earlier decision.
Further opportunity to amend
The next question that arises is whether the application contains patentable subject matter. In the earlier decision the Delegate pointed to the specification at page 8, where it states that:
“The dosages used in human therapeutic applications are roughly proportional to the mass of the muscle being injected. Typically, the dose administered to the patient may be up from about 0.01 to about 1,000 units; for example, up to about 500 units, and preferably in the range from about 80 to about 460 units per patient per treatment, although smaller of [sic] larger doses may be administered in appropriate circumstances such as up to about 50 units for the relief of pain and in controlling cholinergic secretions”.
While above passage suggests that there may be a different dosage amount for the relief of pain only, the Applicant has chosen not to incorporate any such limitation, nor provide any submissions to establish that such matter could validly be incorporated into the claims. Consequently, it is not clear that the Applicant could propose allowable amendments that address the deficiencies identified.
The Applicant has already had one opportunity to amend the specification to overcome the Delegate's findings. It is not evident that the Applicant has made a genuine attempt to address the Delegate’s findings, particularly considering that claim 7 is in the same form as was before the Delegate in the earlier decision, and the amendments made to the remaining claims have only introduced subject matter that was also considered in the earlier decision. In addition, it is not clear that the Applicant could propose allowable amendments that would overcome the identified deficiencies. I therefore make a final determination that patent application number 2005200251 together with each and every one of claims 1 to 7 is refused.
Costs
At the hearing, the parties submitted that costs should follow the event. I see no reason to depart from this premise. Therefore, I award costs against the Applicant, Allergan, Inc. These costs are the costs set out in schedule 8 of the Patents Regulations in relation to the hearing on the final determination.
Sophina Calanni
Delegate of the Commissioner of Patents