T 1396/07 03-04-2008

Summary of Facts and Submissions

I. By its interlocutory decision posted on 27 June 2007, the opposition division decided to maintain the European patent No. 0 948 371 in amended form according to the second auxiliary request then on file. The claims as granted had been refused for lack of novelty of the claimed subject matter, whereas the first auxiliary request was not admitted to the proceedings as it was held late filed.

II. The patentee (appellant I) lodged an appeal against this decision by notice received on 27 August 2007 and paid the appeal fee on the same day. A statement setting out the grounds of appeal was filed on 29 October 2007.

III. Notice of appeal against this decision was also lodged by the opponent (appellant II) on 22 August 2007, and the appeal fee was paid on the same day. A statement setting out the grounds of appeal was submitted on 22 October 2007.

IV. On appeal, essentially the following documents have been relied upon by the parties:

D5: SE-B-437 700 & EP-A-0 126 718

D6: US-A-3 822 700

D7: US-A-4 857 068

V. As to acceding to the patent proprietor's request for accelerated prosecution of the case set out in its letter dated 29 October 2007, oral proceedings as requested by both parties were held before the Board on 3 April 2008.

The following requests were made:

The patentee requested that the decision under appeal be set aside and the patent be maintained as granted (main request), or on the basis of one of the auxiliary requests 1 to 4 filed on 3 March 2008 or of auxiliary request 5 filed during the oral proceedings.

The patentee's former request to disregard document D6 was withdrawn at the oral proceedings.

The opponent requested that the decision under appeal be set aside and the that the European patent No. 0 948 371 be revoked.

VI. The single claim as granted (main request) reads:

"Device for administrating a toxic fluid, comprising an infusion device (10) for connection to an infusion bag, which infusion device is provided with an insertion portion (11) for connecting the bag, and an infusion chamber (12) for dosing a fluid flow via a flow duct (13) in the insertion portion from the bag to an outlet arranged on the chamber, which insertion portion also comprises a ventilating duct (14) which extends between the bag and the outside of the infusion device and ends in a connection (16) arranged on the side of the infusion device for supplying fluid to be administrated, characterized in, that the connection is provided with at least one membrane (17), which is air tight and penetrable by an injection needle."

Compared thereto, the claims set out in the first to fourth auxiliary requests read (amendments in bold letters):

First auxiliary request:

"... that the connection is provided with at least one uninterrupted membrane (17), which..."

Second auxiliary request:

...needle, the said connection (16) constituting the sole connection for supplying fluid to the ventilating duct (14) from outside of the infusion device (10) via the infusion device."

The claim of the third auxiliary request includes the amendments of those of the first and second auxiliary requests.

Fourth auxiliary request:

"...air tight, thereby preventing any air flow both in a direction from the outside of the device to the inside of the device and from the inside of the device to the outside of the device when the device is connected to the bag, and penetrable by an injection needle."

Fifth auxiliary request:

"Method for administrating a drug to an infusion bag containing infusion fluid prior to infusion, comprising the steps of

o connecting an infusion device (10) for administrating a toxic fluid to an infusion bag, whereby the infusion device is provided with an insertion portion (11) for connecting the bag and an infusion chamber (12) for dosing a fluid flow via a flow duct (13) in the insertion portion from the bag to an outlet arranged on the chamber, which insertion portion also comprises a ventilating duct (14) which extends between the bag and the outside of the infusion device and ends in a connection (16) arranged on the side of the infusion device for supplying fluid to be administrated, whereby the connection (16) is provided with at least one membrane (17), which is air tight and penetrable by an injection needle,

o filling the infusion chamber (12) with infusion fluid,

o mounting an injector that is loaded with a drug to be administered and with an injection needle connected thereto on said connection (16), and

o supplying said drug to be administrated to the infusion bag by penetrating said at least one membrane (17) by the injection needle."

VII. The arguments of the appellant I are summarised as follows:

The patent addressed the problem of eliminating the risk of contaminating the ambient breathable air by a toxic drug, such as cytotoxic drugs or antiviral antibiotics, when the drug was supplied to a flexible infusion bag of standard type prior to its use. This was achieved by the single connection (16) which was closed at its end with an airtight membrane and attached to the insertion portion (11) of the device depicted in Figure 1 of the patent. Any kind of fluid supplied to the infusion liquid was injected through this single access point i.e. membrane (17), via a needle mounted on a syringe piercing the membrane. When the needle was withdrawn, the membrane re-sealed and closed the connection. Contrary to the solution dispenser shown in D6, the claimed device did not include an additional air-inlet nipple that was closed with a ball check valve for admitting air to the infusion bottle as shown in Figure 2 of D6. If, however, a flexible collapsible infusion bag of standard type was used, pressure could be exerted on the bag by pressure cuffs forcing the toxic liquid to seep through the ball check valve and to come into contact with breathable air. The risk of seepage or leakage through the ball check valve was specifically referred to in document D7, column 7, lines 49 to 52. To overcome this problem, D7 advocated the use of a replaceable sealing tab member (18) to be used in combination with a check valve to prevent leakage or seepage of fluid from collapsible containers. Hence any dispenser comprising two ports, as did the infusion dispenser of D6, was not suitable for supplying a toxic fluid of the type identified in the patent, since it did not reliably solve the problem. Consequently the claimed subject matter was novel over D6.

The amendments to the claim of the fourth auxiliary request were unambiguously derivable from the application documents as a whole and by the function of the airtight membrane. Therefore the claim of the fourth auxiliary request satisfied the requirements of Article 123(2), (3) EPC.

As to the fifth auxiliary request, the following was noted: At the time of D6 only infusion bottles were known, before the advent of the collapsible and flexible fluid containers used today. An essential difference between the method for using the claimed device and the usage of the device described in D6 resided in that the claimed apparatus for administering a toxic drug was connected to a collapsible (standard) infusion bag. Such a flexible bag always comprised two pierceable stoppers, one for being connected to the infusion device and another e.g. for supplying additive drugs or even air. The claimed method eliminated the need for administering toxic additives through one stopper of the bag and the problems of leakage associated therewith. Another difference to D6 was brought about by administering the toxic drug to the infusion bag prior to infusion rather than when the device was already in use, as set out in D6, column 2, lines 21 to 23.

As regards in particular the passages [0010] and [0011] of the patent specification describing the use of the claimed device including two membranes, the patent proprietor, by referring to document D5, explained that piercing the membrane by the injection needle was carried out in that embodiment in combination with the specific sealing device depicted in Figures 1 and 2 of D5 and also comprising a membrane. In so doing the safety level when administering toxic fluid was further enhanced.

VIII. The arguments of the appellant II are summarised as follows:

Document D6 related to an intravenous solution dispenser which solved the same technical problem as it was addressed in the patent specification, i.e. supplying drugs to a standard infusion bag or bottle through a pierceable re-sealable diaphragm. The known device was provided with an insertion portion (18) for connecting the device to the stopper of a bag or bottle. Spike (16, 18) comprised a liquid conduit (2) allowing flow of the infusion liquid from the bottle to the drip chamber and a passage for air (26) (ventilating duct) ending (a) in connection (34) (air inlet nipple 28) and (b) passageway (36) closed at its end by a pierceable re-sealable and air-tight diaphragm through which additives could be made via a syringe having a needle thereon. In its use, the known device was not restricted to any type of drug, toxic or non-toxic. Depending on the patient's needs, the physician could supply whatever additive to an infusion liquid stored in any kind of infusion container. Hence, the subject matter of the claims according to the main and first to fourth auxiliary requests lacked novelty over the disclosure of document D6.

By the amendments to the claim of the fifth auxiliary request, the focus of the opposed patent was shifted to "another invention" that was neither discussed in the opposition proceedings nor reflected in the impugned decision. However, the device known from D6 worked in the same way and could be used either prior or after the infusion at any stage. Moreover, collapsible standard infusion bags did not necessarily comprise two stoppers, as alleged by the patentee at the oral proceedings. Contrary thereto, collapsible bags with only one stopper existed.