Saturday 21 July 2012

T 2003/08 – A Call For Witnesses


I found this decision noteworthy because it is the first time I see an interlocutory decision on taking of evidence.

Both the patent proprietor and the opponent had filed an appeal against the maintenance of the opposed patent, which is directed at the treatment of dilated cardiomyopathy by removal of autoantibodies.

[1] Document E1 in the present proceedings is a so-called “Eidesstattliche Versicherung” by Dr W. dated 10 February 2005. Document E2 is an “Eidesstattliche Versicherung” by Dr K. dated 9 February 2005.

[2] Dr W. inter alia states in document E1 that he attended a public symposium on “The role of immune mechanisms in cardiovascular disease” from 14 to 16 December 1995 in Berlin and that he gave on 15 September 1995 on the occasion of the symposium a presentation with the title “The possible pathogenic role of autoantibodies in myocarditis and dilated cardiomyopathy”.

[3] As to the contents of his presentation Dr W. declares the following in paragraphs 3 to 5 of document E1.

*** my translation of the German original ***
“In my oral presentation on September 15, 1995, I presented, inter alia, slides showing the results obtained in my research group at the Max-Delbrück Centrum related to the identification and characterisation of autoantibodies against the β1 adrenergic receptor of patients suffering from dilated cardiomyopathy, which had been purified by means of affinity chromatography. For this purpose I used peptides corresponding to the structures of the receptor that connect with the antibodies.

Moreover, I have presented data regarding the extracorporeal removal of immunoglobulins or autoantibodies against the β1 adrenergic receptor, respectively, from the body or the blood plasma of patients suffering from dilated cardiomyopathy, by means of immune apheresis. In this [method] the blood plasma that is separated from cells is led to columns containing ligands that specifically connect to the immunoglobulins of human plasma and thereby retain it. The plasma purified by removal of the immunoglobulins is then intravenously re-administered to the patient.

The immune adsorption decreases the levels of β1 adrenergic antibodies in a statistically significant and partly long-lasting manner. Directly after the immune adsorption a immunoglobulins preparation is intravenously administered to the patient in order to compensate the deficiency caused by the adsorption. After the immune adsorption the heart function of patients suffering from dilated cardiomyopathy is improved. I have shown this by means of several slides one of which is reproduced as an example in figure 3 of my above mentioned publication.”
*** end of the translation ***

[4] Dr K. inter alia states in document E2 that Dr W. gave (“hielt”) a presentation with the title “The possible pathogenic role of autoantibodies in myocarditis and dilated cardiomyopathy”. He furthermore indicates some of the topics presented by Dr W. […] in paragraphs 3 to 5 of document E2:

*** my translation of the German original ***
“… and presented the results obtained in his research group at the Max-Delbück Centrum regarding the pathogenetic significance of autoantibodies in cases of myocarditis and dilated cardiomyopathy as well as [results] regarding the treatment of dilated cardiomyopathy by means of extracorporeal removal of immunoglobulins by means of immune adsorption from the blood plasma of patients. In this [method] blodd plasma is led to columns containing ligands for human immunoglobulin which are coupled to the column and which are specific for immunoglobulins. This method is commonly referred to as immune apheresis or therapeutic apheresis. The plasma that has been mostly and significantly purified from the immunoglobulin is then intravenously re-administered to the patient.

In this context Dr W. presented the therapeutic effectiveness of extracorporeal removal of anti β1 adrenergic receptor autoantibodies from the blood of patients suffering from dilated cardiomyopathy. He was able to show that after the blood plasma of patients had passed through a column specifically binding immunoglobulin, containing ligands that are appropriate for binding human immunoglobulin, the content of autoantibodies against the dilated β1 adrenergic receptor in the blood plasma was significantly reduced both immediately and also several weeks later. The immunoglobulin reduction in the blood plasma was greater than 80% after the immune adsorption. The pathogen β1 receptor autoantibody was eliminated, too. Immediately after the immune apheresis immunoglobulin preparations were intravenously administered to the patient in order to restore humoral immune competence. After the therapeutic apheresis the heart function of the patients improved.

The sustained decrease of the β1 adrenergic autoantibody and the improved heart function several weeks after the immune apheresis were shown in a slide that is reproduced in figure 3 of Dr W’s article in the above mentioned book.”
*** end of the translation ***

[5] Evidence shall be taken on whether or not the information recited in paragraphs [3] and [4] above was made publicly available during Dr W.’s presentation in order to establish whether or not it is prior art pursuant to A 54 by hearing of the witnesses Dr Gerd W. […] and Dr Rudolf K. […]

The witnesses are asked to also bring any documentary material that could be relevant with regard to the issue on which they will be heard.

[6] The taking of evidence will be made on the first day, i.e. on 20 September 2012, of the oral proceedings summoned to take place on 20 and 21 September 2012 […].

[7] Pursuant to R 122(2) witnesses who are summoned by and appear before the EPO shall be entitled to appropriate reimbursement of expenses for travel and subsistence.

[8] In accordance with R 122(1) the board makes the taking of evidence conditional upon appellant II making a deposit of an advance payment of Euro 4300,00 for each of the witnesses to be heard (i.e. in toto Euro 8600,00) to secure payment of the costs arising from any possible reimbursement.

[9] Instead of making a deposit of an advance payment it is also possible to file a waiver of costs signed by each witness.

[10] The deposit or the waiver should be made or filed, respectively, within one month from notification of this decision.

Should you wish to download the whole decision, just click here.

The file wrapper can be found here.

3 comments:

Roufousse T. Fairfly said...

I wonder on what basis the amount of 4300 Euros was calculated. I was under the impression that witnesses were reimbursed according to the same tables which are used for duty travel at the EPO. A mission of one day including say, air fare in business class within DE and an overnight stay, should still come to a smallish fraction of the amount demanded as a security deposit.

I note that the proceedings right on the eve of the Oktoberfest...

IIRC, opposition divisions are instructed to request the addition of a fourth, legally qualified, member, should potentially delicate situations such as the taking of evidence arise. In the present case the three technically qualified members of the board did not see fit to invite two jurists to join them as Art. 21 would allow them to.

pat-agoni-a said...

A board of appeal is composed either by two technically and one legally qualified members or by three technically and two legally qualified members.

"Wer lesen kann, ist klar im Vorteil..."

Roufousse T. Fairfly said...

I shouldn't have relied solely on my memory, but should have instead look up the EPC. I did get the article number right, that should be worth half a point, isn't it? ;-) Das Gedächtnis kann nich immer das Lesen ersetzen...

When I saw the composition of the board I saw a chairman and two technically qualified members. I automatically assumed that the chairman was technically qualified too, as if it were first instance division.