Friday, 28 June 2013

T 433/11 – Cistus Et Al

Both the patent proprietor and the opponents filed an appeal after the Opposition Division had maintained the patent in amended form.

The decision contains some interesting bits and bites.

Among other things, the novelty of claim 1 of the main request was discussed. This claim read:
Use of Cistus for producing a composition having an antiviral activity directed against rhinoviruses for inhibiting the infectiousness of rhinoviruses  for the prophylaxis and/or treatment of common cold diseases, wherein the common cold disease comprises a primary infection, caused by rhinoviruses. (additions with respect to claim 1 as granted are underlined)
*** Translation of the German original ***

[19] The Board is of the opinion that in view of the wording of present claim 1 the feature distinguishing the present claim from claim 1 as granted – “having an antiviral activity directed against rhinoviruses for inhibiting the infectiousness of rhinoviruses” – is an inherent property of compositions made from Cistus plants. The partial feature “for inhibiting the infectiousness of rhinoviruses”, when associated with the feature “for the prophylaxis and/or treatment of common cold diseases”, further indicates how the antiviral activity is obtained in the prophylaxis and treatment. However, in view of the way in which it is used in the claim, the feature “having an antiviral activity directed against rhinoviruses for inhibiting the infectiousness of rhinoviruses” does not have any effect on the definition of the common cold diseases that are to be treated. The explicit indication of this inherent property of the substance does not change the definition of the substance, and the indication of the mode of action (Wirkmechanismus) does not provide a more precise definition of the moment of administration during the prophylaxis or treatment. Thus the Board comes to the conclusion that the scope of protection of present claim 1 is the identical to the scope of protection of claim 1 as granted. […]

[28] Claim 1 concerns a so-called second medical indication, in which the use of a known product for the therapeutic treatment of a particular disease is claimed. Based on the Board’s interpretation of the claims (see point [19] above) it follows that claim 1 claims as an embodiment the “use of Cistus for producing a composition for the treatment of common cold diseases, wherein the common cold disease comprises a primary infection, caused by rhinoviruses”.

[29] Document D1 states […] under the heading “Viruses challenge the immune system”: “Sometimes the agents succeed in penetrating the natural “protective barrier”. A cold (Schnupfen) is above all caused by rhinoviruses that penetrate into the nasal mucosa. They then integrate the body’s own cells and have them produce and emit viruses. Thereby the surrounding tissue is damaged and the nasal mucosa becomes inflamed. The body reacts by increasing the production of mucus. Once the nose is congested, nose drops based on Cystus® can provide help because the polyphenols contained therein reduce the swelling and inhibit the inflammation. You can produce them by simply mixing 100 ml of Cystus® brew with 1 g of sea salt and fill the mixture into a dropper bottle from your pharmacy. […] Thus you can reach all nasal passages and you will soon be able to breathe deeply again. The inflammation of the nasal mucosa is often felt “further downwards” via a sore throat. Gurgling with Cystus® brew provides relief (also in case of purulent tonsillitis) […]. (emphasis by the Board).

[30] This extracts shows that document D1 discloses the use of nose drops made from Cytsus® (sic) brew for treating (symptoms such as a cold or sore throat) of  common cold diseases, wherein the common cold diseases include diseases due to a primary infection caused by rhinoviruses.

[31] Document D1 describes the treatment of common cold diseases by means of a medicament made from a substance called Cystus®. The document does not explicitly indicate how this substance was produced or which ingredients it contains. During the oral proceedings (OPs) the [patent proprietor] has not contested that the Cystus® products disclosed in document D1 are compositions containing constituents of plants of the genus Cistus. Thus the Board considers it to be established that document D1 discloses to the skilled person medicaments containing constituents of plants of the genus Cistus, and that any other interpretation of the expression Cystus® would go against the common understanding of the skilled person.

[32] Thus the Board is of the opinion that the skilled person knew, from document D1, both the composition defined in claim 1 as well as the therapeutic treatment of the disease mentioned therein by means of this composition. Thus document D1 discloses an embodiment within the scope of claim 1.

[33] The Board is of the opinion that the technical circumstances of the present case are clearly different from those underlying decision T 509/04. The case dealt with in decision T 509/04 concerned the “attainment of a therapeutic effect, promoting normal muscle growth in patients suffering from cerebral palsy”, which had not been disclosed in the published state of the art. In the present case, however, the treatment of patients suffering from common cold diseases caused by rhinoviruses is known from document D1. Therefore, the Board is of the opinion that the principles regarding novelty established in decision T 509/04 do not apply in the present case.

[34] The Board is also of the opinion that decision T 836/01 cannot be used for establishing novelty either. In this case the novelty of the claimed medical use was justified by the fact that the group of patients that received the treatment was different (distinct subgroup) from the one known from the state of the art, and thus novel. However, in the present case the group of patients or patient population that is to be treated is explicitly disclosed in document D1. Thus T 836/01 is irrelevant for the present case, too.

[35] The Board is of the opinion that the present case rather compares to the situation dealt with in decision T 254/93, which was later followed by the Boards in decisions T 669/01 and T 486/01. In decision T 254/93 it was decided that the mere explanation of an effect obtained when using a compound in a known composition, even if the effect was not known to be due to this compound in the known composition, cannot confer novelty to a known process if the skilled person was already aware of the occurrence of the desired effect (see headnote 2 and point [4.8] of the reasons).

[36] Thus the subject-matter of claim 1 does not comply with the requirements of A 54; the main request is to be dismissed.

The Board then dealt with the request for oral submissions by the chief executive (Geschäftsführer) of opponent 1:

[37] During the OPs, when the novelty of the main request was discussed […], [opponent 1] asked for its chief executive Dr. S. to be allowed to make submissions concerning document D1.

[38] The representative of [opponent 1] has made a corresponding statement during the OPs and has also confirmed in its letter […] in which he requested the minutes of the OPs to be corrected accordingly […] that Dr. S. wanted to make submissions in his quality as chief executive of [opponent 1]. However, as this request was only filed in the context of the discussion of novelty, the Board could only interpret this request to mean that Dr. S. wanted to make submissions from his point of view as a skilled person.

[39] The Board has dismissed this request after having heard all parties. The representative of [opponent 1] then objected that this dismissal violated its right to be heard.

[40] Irrespective of whether an employee of a party is entitled to complement the explanations of the professional representative authorized by this party in the course of OPs or whether the presence of this employee and the subject of the submissions he wants to make orally have to be announced, it appears to be appropriate indeed to give a chief executive of a party (in the present case, a Geschäftsführer of a German company, but also a person in a corresponding position in a non-German company) the opportunity to make submissions for this party because this person is de facto or at least apparently (depending on the rules laid down in the founding statutes (Gründungsstatut)) entitled to speak in the name of the company.

[41] However, the Board is of the opinion that in view of the request to be dealt with in the present case the central question is not the question of whether there is an authorisation to represent but the question of whether the request is admissible.

[42] It is irrelevant in this context whether Dr. S. wanted to make his submissions as a skilled person or as chief executive, or both. What matters is that his explanations would necessarily have contained facts (i.e. evidence or arguments) that had not been submitted before by [opponent 1] or its authorised representative. Otherwise there would not have been any reason to request that Dr. S. be authorised to make submissions. As a matter of fact, the Board is of the opinion that this request, is to be understood as a request for the admission of new facts and/or arguments that has been filed at a very late stage of the proceedings, i.e. during the OPs.

[43] However, it is within the discretion of the Board to admit new facts and arguments that have been submitted after the filing of the complete case of a party, and in particular after summons to OPs (see A 114(2) together with Article 13(1) and (3) RPBA […]).

[44] In a case that is as disputed as the present case – with pending proceedings before national courts of justice – in which the parties already had had the opportunity to make written submissions, the admission of new facts and arguments in favour of a party would very likely have caused the adverse party to request the admission of new counter-facts and counter-arguments, thereby delaying the proceedings or even requiring the OPs to be postponed. In this context it also has to be mentioned that [opponent 1] had in its letter dated September 19, 2011, filed a request for acceleration of the proceedings before the Board because of pending infringement proceedings and none of the other parties had objected to this request, which the Board has granted by summoning OPs at short notice (the original date for the OPs was February 29, 2012).

[45] Under these circumstances the Board has exercised its discretion and decided not to allow Dr. S. to make [oral] submissions.

[46] The Board does not agree with [opponent 1] that the refusal of submissions by Dr. S. has violated its right to be heard. Both [opponent 1] and all other parties to the proceedings were offered the possibility to comment on all issues that were discussed during the OPs, including the issue which Dr. S. wanted to comment, i.e. the novelty of the main request in view of document D1.

[47] Within the framework of the EPC the right to be heard enshrined in A 113(1) does not mean that the parties to the proceedings may without limitation express their opinion on all possible issues at any stage of the proceedings, because the right to be heard is, as far as the moment during the proceedings is concerned, limited by the possibility not to consider late filed submissions, which is enshrined in A 114(2) (see also Articles 13(1) and (3), which result from it).

[48] Finally, the Board notes that [opponent 1] was not adversely affected, even in case its right to be heard had been violated in any way, because its submission – even without the explanations by Dr. S. – have been successful in the end: the Board has indeed decided that document D1 destroys the novelty of the main request […].

The Board finally maintained the patent on the basis of the first auxiliary request. There is a noteworthy paragraph on the adaptation of the description that remained to be done:

[78] [Opponents 1 and 2] requested the description to be adapted during the OPs before the Board because the pending national infringement proceedings required the presentation of the final version of the impugned patent. However, the Board was of the opinion that precisely because the impugned patent is the object of national lawsuits it is necessary to be particularly careful when adapting the description. However, the Board considers this could not have been done at the end of the OPs towards 19:30 in view of the great length of the proceedings. Thus the Board has dismissed the request of [opponents 1 and 2] and has remitted the case for adaptation of the description, which, incidentally, is not unusual.

Refusing the chief executive of the opponent to make a statement under the pretense that he would intervene in the quality of a skilled person does not sound right to me. As the Board admits, when the manager speaks, the party speaks, and the party should never be refused the right to comment, even in the case where it has chosen to be represented by a patent attorney. I think the Board should not speculate on what the party would say and which consequences this could have; if the submissions are inappropriate, the Board can stop the party, just as it would stop the representative.

Should you wish to download the whole decision (in German), just click here.

The file wrapper can be found here.


Anonymous said...

So, why did the board take nearly 12 months to write their decision if they knew that the patent was involved in litigation proceedings? Something very wrong with the system here.

I suspect that the requests of the opponents to have the opposition proceedings completed at the second instance relates to the ability to file a revocation action at the BPatG but recent cases there indicate that a referral back to the OD for amendment of the text is not a bar to the filing and admissibility of such an action.

Anonymous said...

I do agree with Oliver about the refusal to let the chief executive speak.

I understand that such person IS the party, so that it is mandatory to hear him. If he brings new facts or evidence, they may be refused as being late filed by the board. But a new line of arguments cuold be accepted. But the decision to accept or refuse can only be done after haung heard the party.

This could (should?) lead to a petition for review, but Rule 106 has to be mentionned during OPs...

Roufousse T. Fairfly said...

I had a ridiculous idea.

Whenever CEO X wishes to speak:

As Geschäftsführer and authorised spokesperson of AAA GmbH (a resident of an EP state in the sense of Art. 133(2)), I hereby withdraw EPA Y from representation. Here is a EPO Form 1003 to that effect.

If the Board refuses to hear this declaration, then EPA Y stands up, walks to the front, and hands over Form 1003. X happens to be in the room, and the proceedings are continued. (EPA Y coaches X by whispering in his ear).

Whenever X wishes instead EPA Y to conduct proceedings he would instead formally reinstate the authorisation, or ask a person accompanying him to make presentations under his authority, thus turning the Attorney-Client relationship on its head. Or EPA Y states: "As an EPA I hereby declare to take over representation, as provided by the President in OJ 2007 p. xxx under the power conferred by rule 152(1)"

A pile of pre-filled forms 1003 would be ready before the OP. A date, hour (!) and signature would be added séance tenante.

The OP could possibly degenerate in a circus. I wonder if a Board would be capable of thinking on its feet and untangle this mess.

george said...

Yeah, you could also use a megaphone. But will it help your case?