T 0691/04 (Assembly comprising a device and a pharmaceutical composition in semisolid form/TARO PHARMACEUTICAL) 31-01-2007

I. European patent application No EP-A-0 614 659 based on European application No. 94 301 695.6 was filed with 18 claims.

Claim 1 read as follows:

"1. A pharmaceutical composition comprising a semisolid in the form of a gel or suspension containing an effective amount of an orally active pharmaceutical agent useful for systemic treatment in combination with a pharmaceutical agent useful for systemic treatment in combination with a pharmaceutically acceptable vehicle consisting essentially of liquid base selected from a member of the group consisting of water, propylene glycol, glycerin and a combination thereof; thickening agent selected from a member of the group consisting of starch, sodium carboxymethyl cellulose, hydroxypropyl methyl cellulose, microcrystalline cellulose, tragacanth, acacia, pectin, gelatin, polyethylene glycol and carbomer in an amount effective to provide Brookfield a viscosity [sic] of about 2500 to 70,000 cps and a consistency which allows the composition to be squeezed easily through an orifice of about 0.1 mm to 5 mm in diameter; sweetener, preservative and optionally, flavouring matter, colouring matter, buffer, sodium chloride and solubilising agent for the orally active pharmaceutical agent."

Independent claim 6 read as follows:

"6. A device for containing and measuring a unit dose of a pharmaceutical composition in semisolid form comprising a squeezable container for holding the pharmaceutical composition having an outlet defining a flow channel for delivering said composition from the container, and closure means adapted to be connected to the outlet, the closure means comprising a spoon-shaped element having a shaft with channel means connected thereto so that the bowl of the spoon-shaped element projects from the closure means and the channel means are in fluid communication with the flow channel of the squeezable container and sealing means in said closure means positioned to seal the container when the closure means is fully closed and to provide space for the contents of the container to flow through the channel means into the spoon-shaped element in response to pressure on the container when the closure means is partially opened, whereby contents of the squeezable container can be squeezed into the bowl of the spoon-shaped element and administered therefrom."

Independent claim 7 read as follows:

"7. A device for containing and measuring a unit dose of a pharmaceutical composition in semisolid form comprising a squeezable container for holding the pharmaceutical composition having an open neck with threads for attaching a cap thereto and a cap with threads suitable to engage the threads of the neck of the squeezable container, a spoon having a shaft with channel means fixed in the cap so that the bowl-shaped end of the spoon projects outside the cap and the shaft projects into the cap and the channel means are in alignment with the open neck of the squeezable container and sealing means in said cap positioned to seal the container when the cap is fully closed and to provide space for the contents of the container to flow through the channel means into the spoon in response to pressure on the container when the cap is partially opened, whereby contents of the squeezable container can be squeezed into the bowl-shaped end of the spoon and administered therefrom."

Independent claim 16 read as follows:

"16. A child proof device for containing a pharmaceutical composition useful for administration to children comprising a container with an open neck for holding said pharmaceutical composition, a cap fitted permanently on the neck of said container, a rotatable spring biased step cylinder positioned in said cap having channel means which allows for passage of said pharmaceutical composition through the cap when said rotatable spring biased step cylinder is pressed downward against the spring and seals the container when not pressed, a button on the exterior and near the top of said rotatable spring biased step cylinder and a cavity in the exterior of the cap adjacent to said rotatable spring biased step cylinder which matches the size and shape of said button, said button being positioned on said rotatable spring biased step cylinder so as to prevent the downward movement of said spring biased cylinder unless said button is aligned with said cavity."

Independent claim 17 read as follows:

"17. An assembly comprising a pharmaceutical composition in semisolid form which comprises an effective amount of an orally active pharmaceutical agent useful for systemic treatment in combination with a pharmaceutically acceptable vehicle comprising a thickening agent in an amount effective to provide a Brookfield viscosity of about 2500 to 70,000 cps at 25ºC at a spindle speed of 10 rpm contained in the device defined in any of Claims 6 to 16."

II. The following documents have been cited inter alia during the examination proceedings:

(1) EP-A-0 479 005

(2) EP-A-0 379 147

III. The present appeal lies from the second decision of the examining division refusing the application under Article 97(1) EPC, pursuant to the requirements of Article 56 EPC, which was sent to the applicant on 29 March 2004.

IV. Briefly, the examining division considered document (2) to represent the closest prior art. The examining division defined the problem to be solved as "to provide an assembly allowing easily [sic] administration of orally active pharmaceutical agents for systemic treatment, avoiding spillage, particularly when used by children or adults with motoric problems." (page 5 of the examining division's decision).

The examining division considered that the proposed solution was obvious in the light of the prior art documents (2) and (1). Moreover, in the examining division's view, to increase viscosity for avoiding spillage was a trivial measure, merely reflecting the skilled person's common general knowledge.

V. The appellant (applicant) lodged an appeal (second appeal) against the (second) decision of the examining division, paid a (second) appeal fee and filed grounds of appeal. The appellant filed with the (second) grounds of appeal a main request, and a first and a second auxiliary request (they had been previously filed as second, third and fourth auxiliary requests. The appellant abandoned its previous main request and first auxiliary request).

Claim 1 of the main request read as follows:

"1. An assembly comprising:

a semisolid pharmaceutical composition in the form of a gel or a suspension, which comprises an effective amount of an orally active pharmaceutical agent useful for systemic treatment in combination with a pharmaceutically acceptable vehicle consisting essentially of liquid base selected from a member of the group consisting of water, propylene glycol, glycerin and a combination therefore [sic]; thickening agent selected from a member of the group consisting of starch, sodium carboxymethyl cellulose, hydroxypropyl methyl cellulose, microcrystalline cellulose, tragacanth, acacia, pectin, polyethylene glycol and carbomer in an amount effective to provide a Brookfield viscosity of 250 to 7,000 Pa.s (2,500 to 70,000 cps) at 25ºC at a spindle of 10 rpm, and a consistency which allows the composition to be squeezed easily through an orifice of about 0.1 mm to 5 mm in diameter, sweetener as necessary to make the semisolid palatable; and optionally, flavoring, coloring matter, filler, preservative, buffer, sodium chloride and carriers usual in pharmaceutical compositions,

contained in a device for containing and measuring a unit dose of said pharmaceutical composition, said device comprising a sealed squeezable container, said container having an outlet, the container comprising an outer flexible squeezable wall which can be squeezed laterally with respect to an axis of said outlet whereby a predetermined unit dose of the pharmaceutical composition can be easily squeezed from the container, measured, and administered orally."

Claim 1 of the first auxiliary request merely differs from claim 1 of the main request in that the viscosity values have been specified as a "Brookfield viscosity of 750 to 4,000 Pa.s (7,500 to 40,000 cps)".

Claim 1 of the second auxiliary request differs from claim 1 of the main request in that the thickening agent has been defined as follows: "carbomer as thickening agent and in an amount effective to provide a Brookfield viscosity of 750 to 4,000 Pa.s (7,500 to 40,000 cps) at 25ºC at a spindle speed of 10 rpm, and a consistency which allows the composition to be squeezed easily through an orifice of about 0.1 mm to 5 mm in diameter".

VI. The board expressed in its communication of 11 July 2006 that there had been a wrong interpretation of Article 109(1)EPC by the department of the first instance, which constituted a substantive procedural violation. The board also mentioned that it was inclined to decide the reimbursement of at least one appeal fee.

In the said communication the board raised objections re Article 123(2) EPC in respect of all sets of claims.

VII. As a response to the board's communication mentioned above, the appellant filed a letter dated 6 September 2006. It also filed two further auxiliary requests. The appellant also requested oral proceedings pursuant to Article 116 EPC.

Claim 1 of the third auxiliary request differs from claim 1 of the main request in that the device was defined as follows:

"in a device for containing said semisolid pharmaceutical composition, said device comprising a squeezable container with means for measuring and administering therefrom a single dose of said semisolid pharmaceutical composition and resealing the container thereafter."

Claim 1 of the fourth auxiliary request differs from claim 1 of the main request in that the device was defined as follows:

"in a device for containing said semisolid pharmaceutical composition, said device comprising a squeezable tube with means for measuring and administering therefrom a single dose of said semisolid pharmaceutical composition, said tube being sealed by a cap".

VIII. The board sent a communication as an annex to the summons to oral proceedings in which it raised objections re Articles 123(2) and 84 EPC to all requests.

IX. The appellant announced in a letter dated 19 December 2006 that it would not attend oral proceedings. It did not comment on the objections raised by the board in the communication sent as an annex to the invitation to oral proceedings.

X. Oral proceedings took place on 31 January 2007 in the absence of the appellant.

XI. The appellant's arguments filed in writing with its letter of 6 September 2006 may be summarised as follows:

Claim 1 of the main request related to an assembly comprising a semisolid pharmaceutical composition contained in a device for containing a unit dose of said pharmaceutical composition. Claim 1 of the main request recited that the container comprises an outer flexible squeezable wall and an outlet, and that said flexible squeezable wall can be squeezed laterally with respect to an axis of said outlet.

In the appellant's view these features appearing in claim 1 were directly and unambiguously derivable from page 14 of the application as originally filed. In particular, a tube 1 was disclosed with reference to figures 1-4, from which a semisolid composition can be squeezed.

Furthermore, the appellant submitted that a device of the invention was shown on figure 1 which represented a container sealed with a cap 3. Said cap 3 could be replaced by a cap 5 arranged with a spoon-shaped element 7 as depicted in figure 2. Figure 4 showed a cross sectional view of said container in which said cap 5 was provided. Such a device was used to measure and administer therefrom a unit dose (or single dose) of the semisolid pharmaceutical composition of the invention, as disclosed on page 14 as originally filed.

In the appellant's opinion, figure 1 clearly showed that the tube 1 comprised an outer side wall and it was common knowledge for any person that, in order to squeeze the content out of the tube, the side wall must be squeezed to collapse. Moreover, it was common general knowledge that the outer side of a tube must be squeezed laterally with respect to an axis to the opening of the tube in order to squeeze the content out of the tube. Additionally, it was shown in figure 4 that the tube 1 of the application as filed had an outlet within its neck 2.

The appellant further submitted that the reasoning for the main request also applied mutatis mutandis to the auxiliary requests 1 to 4.

Additionally, the appellant also submitted that the additional restrictions further undertaken in the auxiliary requests were also derivable from the description as originally filed.

The appellant's letter of 19 December 2006 did not contain any comment in respect of Articles 123(2) and 84 EPC.

As regards the appellant's request for reimbursement of at least one appeal fee, the arguments on file may be summarised as follows:

The second decision of refusal (date of decision 29 March 2004) of the application in suit was caused by a practice of the examining division which was in total contradiction to Article 109 EPC.

The application was already refused (date of first decision: 20 March 2003) and a notice of appeal was filed on 20 May 2003. The statement of grounds were then filed on 18 July 2003. More than three months later, the examining division sent a summons to attend oral proceedings, still considering that the invention lacked inventive step over the same documents.

The appellant also stressed that it had unsuccessfully requested that the case be remitted to the board of appeal in accordance with Article 109(2) EPC. In the appellant's view there was no basis for such invitation to oral proceedings before the examining division. The appellant also stressed that it had been asked by the examining division to withdraw its request for oral proceedings, although that request was in the notice of appeal for the attention of the board of appeal and not for the attention of the examining division.

Moreover, the appellant submitted that upon its withdrawal of the request for oral proceedings, another decision of refusal (dated 29 March 2004) was issued.

The appellant also submitted that its (first) statement of grounds of appeal was filed on 18 July 2003, i.e. more than three months before the examining division acted on the file. The fact that additional technical data concerning formulations according to documents (1) and (2) were filed with the first grounds of appeal for comparison purposes with the technical data filed on 28 January 2003 (the latter being filed before the first decision of refusal) was insubstantial for the examining division's course of action since the examining division was still unconvinced by the applicant's arguments and still considered the claims to lack an inventive step over the same documents.

Furthermore, the appellant stressed that the requests presented in its first appeal had already been examined by the examining division. In the decision of refusal of 20 March 2003 the examining division had already decided to refuse all requests for lack of inventive step based on the same objections and over the same documents.

XII. The appellant had requested in writing that a patent be granted on the basis of the main request or first or second auxiliary request filed with the grounds of appeal of 30.04.04, or on the basis of one of the third or fourth auxiliary requests filed with letter dated 06.09.06, and the reimbursement of at least one of the appeal fees.