Friday, 29 May 2015

T 0908/10: Sufficiency of disclosure second medical use claim


This appeal case discusses inventive step and sufficiency of disclosure as grounds for dismissing the appeal. The Board refused most requests because they lack an inventive step. Auxiliary request 8 has been refused because it lacks sufficiency of disclosure for a second medical use claim in this request. This case shows which disclosure the Board expects in the context of a second medical use claim. In the present case the Board concludes that the skilled person has to set up a complete research program to carry out the invention.
The appeal lies against the interlocutory decision of the opposition division and was filed by the proprietor of the patent (the appellant).


Background / Summary of Facts and Submissions
(...)
IV. With its letter dated 6 July 2010 the appellant filed a statement of grounds of appeal, a main request and auxiliary requests 1 to 9. The claim requests were identical to the corresponding requests underlying the decision under appeal. Claims 1, 9, 10, 11 and 12 of the main request read as follows:

"1. Use of a variant of human prolactin having a substitution of the glycin at position 129 for the preparation of a medicament for inhibiting the proliferation of a breast or prostate cancer cell which expresses a prolactin receptor.

 9. A fusion protein comprising a variant of human prolactin which is linked to another protein, wherein the variant has a substitution of the glycine at position 129.

10. A fusion protein according to claim 9, wherein the prolactin variant is linked to interleukin 2.

11. A fusion protein according to claims 9 or 10, wherein the variant has a substitution of the glycine at position 129 with arginine.

12. Use of a fusion protein according to any one of claims 9 to 11 for the preparation of a medicament for treating breast or prostate cancer, wherein said breast or prostate cancer expresses a prolactin receptor."

(...)
IX. The appellant's arguments submitted in writing and orally may be summarized as follows:
Main request
(...)
Sufficiency of disclosure: claim 12
Claim 12 was drawn up as a second medical use claim and was thus limited to fusion proteins that treated breast or prostate cancer. The opposed patent gave one example of a suitable fusion partner, IL-2, and described in detail how to screen fusion proteins for their ability to inhibit proliferation of breast and prostate cancer cells. Although it was not predictable whether or not a fusion protein possessed the therapeutic effect, the skilled person could design and produce suitable fusion proteins and test them using the assays disclosed in the patent in suit.
Auxiliary requests 1 to 8
No further arguments were submitted relating to these requests.

(...)
Reasons for the Decision
Main request

Introduction

1. The patent in suit relates to the inhibition of the cell proliferation-promoting effects of prolactin (PRL) on its receptor. The prolactin receptor (PRLR) is a member of the cytokine receptor superfamily and binds a group of hormones, including not only PRL but also growth hormone (GH) (see e.g. document D2, abstract). PRL and GH possess two binding sites for the receptor, termed binding site 1 and binding site 2. Binding of PRL or GH to PRLR is sequential. First the hormone, e.g. PRL, interacts with the receptor through its binding site 1, forming an inactive complex. The hormone then binds to a second receptor through its site 2, which leads to receptor homodimerisation and formation of an active complex (see e.g. document D1, page 10, left hand column, first full paragraph; Figure 3A).

2. By replacing small side chain residues with amino acids carrying large side chains, PRL and GH analogs whose binding sites 2 are sterically hindered and unable to interact with their receptor are generated. With these hormone analogs receptor dimerisation cannot occur and the hormone analog is inactive. Moreover, since such mutants maintain the ability to bind through their binding site 1, they block the receptor in the inactive 1:1 stoichiometry and thus act as hormone antagonists (see document D1, page 10, right hand column, first full paragraph; Figures 3B and 3C).

Inventive step (Article 56 EPC): claim 1

(...)
17. In view of the above considerations, the subject-matter of claim 1 of the main request lacks an inventive step and the request is therefore for this reasons alone not allowable.Sufficiency of disclosure (Article 83 EPC): claim 12

18. In view of the fact that the main request is in any event not allowable for lack of inventive step, it is strictly not necessary for the board to say anything about the Article 83 EPC objection against claim 12 of the main request. However, the board's view on this issue has consequences for the auxiliary requests and so it is convenient to deal with the issue here.

19. Claim 12 of the main request concerns the use of a fusion protein comprising a variant of human prolactin which is linked to another protein, wherein the variant has a substitution of the glycine at position 129 for the preparation of a medicament for treating breast or prostate cancer, wherein said breast or prostate cancer expresses a prolactin receptor.

20. Claim 12 is drafted as a second medical use claim and thus attaining the claimed therapeutic effect, namely treating breast or prostate cancer, is a functional technical feature of the claim. The relevant question to be addressed in the context of Article 83 EPC is whether or not the patent in suit provides enough guidance for the skilled person to manufacture fusion proteins which also show the claimed therapeutic effect without undue burden or rather whether the skilled person is faced with a research program for which no guidance is forthcoming.

21. The sole disclosure in the patent as regards fusion proteins is to be found in paragraphs [0017] and [0027]. Paragraph [0017] discloses a fusion protein comprising a PRL variant having a substitution of the glycine at position 129 linked to another protein while [0027] reads as follows:
"In yet other embodiments, a prolactin variant having a substitution of the glycine at position 129 is linked to another protein as part of a fusion protein. As one specific embodiment, the prolactin variant may be linked to interleukin 2. One nonlimiting example of such an embodiment is a G129R variant of human prolactin linked to interleukin 2."

22. These paragraphs thus disclose the linkage of hPRL variants, e.g. of the G129R-hPRL variant, to other proteins, e.g. to interleukin 2, but are silent as regards the type of linker used, the location of the linkage on the prolactin variant, or any other suitable fusion partner of the prolactin variants wherein the resulting fusion protein will have the effect of treating breast or prostate cancer.

23. According to the patent, the treatment of breast or prostate cancer relies on the inhibition of the cell proliferation-promoting effects of PRL on its receptor (see paragraphs [0001], [0018]). The patent is silent as regards the mechanism underlying this inhibition. From the prior art it is however clear that the prolactin variants act as antagonists by binding to the hPRL receptor through their binding site 1 while at the same time not dimerizing it, due to changes in their binding site 2 (see point 2 above). In order to function as an inhibitor of cell proliferation the fusion protein must thus retain the ability of the prolactin variant to bind to the hPRL receptor through binding site 1. The board considers it likely that the size of the fusion partner and the location of the linkage on the prolactin variant have an influence on the binding of the prolactin variant to the hPRL receptor by virtue of, e.g., changes in the three dimensional conformation of the protein and/or steric hindrance.

24. Without any information in the patent as regards the effect of the linker, the fusion partner or the location of linkage on the binding site 1 of the prolactin variant, the skilled person has to produce and test each and every fusion protein by a trial and error in order to determine whether or not the particular choice of linker, fusion partner and location of linkage provides a fusion protein having the claimed therapeutic effect.

25. This was not contested by the appellant, who conceded that without testing a particular fusion protein it was not predictable whether it would possess the claimed therapeutic effect.

26. The board considers that in the present case, in view of the lack of technical guidance and details in the patent, the production and the testing of fusion proteins showing the claimed therapeutic effect amounts to a research program which represents an undue burden for the skilled person.

27. The board concludes from the above that the subject-matter of claim 12 of the main request fails to meet the requirement of Article 83 EPC.

(...)
Auxiliary request 8: sufficiency of disclosure (Article 83 EPC)
29. In the board's judgment the board's conclusions under Article 83 EPC for the subject-matter of claim 12 of the main request (see points 18 to 27, above) apply, mutatis mutandis, to the corresponding claim of auxiliary request 8 (and indeed of auxiliary requests 1, 2, 3, 5 and 7), so that auxiliary request 8 is for this reason alone not allowable.

(...)
Order
For these reasons it is decided that:
The appeal is dismissed.


This decision has European Case Law Identifier: ECLI:EP:BA:2015:T090810.20150115. The whole decision can be found here. The file wrapper can be found here. Photo "Alien Research lab" by Paul Albertella obtained via Flickr under CC BY 2.0 license (no changes made).

Tuesday, 26 May 2015

T 557/13 - Poisonous or nothing wrong?

At the closure of the debate in oral proceedings in T 557/13, the Chairman announced that the Board will refer one or more questions to the Enlarged Board of Appeal in relation to what is often referred to as partial priority, poisonous divisionals and poisonous priorities. The questions are not yet formulated - the decision will be given in writing.  The topic is however of such an interest that we want to post it already now on our blog -- we will come back to the topics once the referral is done. 

Background / Summary of Facts and Submissions

Friday, 22 May 2015

T 359/11 - Notoriously known - not searched, not allowing request


This appeal lies from a decision of the examining divisions to refuse the application.
The searcher in the international phase apparently considered the claimed invention to make no technical contribution. In line with the EPO policy of OJ 2007, 592, a search report was issued, but no prior art was cited - "the technical aspects identified in the present application (Art. 15 PCT) are considered part of common general knowledge. Due to their notoriety no documentary evidence is found to be required" (instead of the former approach of giving a "no search" declaration).

In the regional phase, the applicant disagreed with the lack of inventive step reasoning of the examiner. In an effort to overcome the objection, new claims were filed. The EPO rejected those as having added subject-matter (Art.123(2)).
The applicant reformulated the claims in a main and auxiliary request close to the original wording. The examining division used its discretion under R.137(3) to not admit these requests as "not addressing prima facie any objections under Art.56 EPC".
The refusal was thus based on "there being no text on file which has been agreed by the applicant"

The Board concludes that the Examining Division wrongly applied its discretion: "By refusing its consent to the main request, the Examining Division effectively took the position that any admissible request had to incorporate amendments aimed at overcoming its objections under Article 56 EPC. This unreasonably deprived the applicant of the opportunity of simply disagreeing with the Examining Division and obtaining a decision based on a set of claims, duly admitted into the procedure, reflecting what had been its fundamental position throughout."
The Board then had a look at whether or not the invention should have been searched. the Board reviews the case law and produced the following 

Catchword:

"Where the relevant search authority has stated, either in a search report or in a declaration that no search report will be established, that it is not necessary to cite any documentary evidence of the prior art on the grounds that all of the technical features of the claimed invention are notorious, it is always incumbent upon the examining division to consider whether an additional search is necessary. The criterion to be applied is that if the invention as claimed contains at least one technical feature which is not notorious, the application should normally not be refused for lack of inventive step without performing an additional search (see Reasons, point 3.9, and T 690/06, Reasons, point 8)".



Tuesday, 19 May 2015

T 1164/11 - Use the force




This Examination appeal concerns a medical apparatus for cutaneous administration of medicaments, i.e., through the skin. The main claim in the appeal reads:
 
"A medical apparatus for cutaneous administration of medicaments comprising:
- a supporting frame (100);
- an energy emitter (9) in engagement with the frame (100) and active on the molecules of at least one medicament to cause penetration of same into a skin region to be treated (10); (...) said energy emitter (9) being an electromagnetic wave generator (11) emitting a laser light of a wavelength comprised in the range of 600 to 650 nm."

The board has its doubts whether such a electromagnetic wave generator can really  be  active on the molecules of a medicament to cause penetration into a skin region. The board  evaluates if there is a plausible explanation of the claimed effect and, in the absence thereof, the available evidence.

Saturday, 16 May 2015

R 8/13 - Call for a Diplomatic Conference

1973 diplomatic conference

Prior to the oral proceedings in petition for review proceedings before the Enlarged Board in its five-member composition, the petitioners, by letter dated 2 June 2014, filed further submissions in support of their petition and, on pages 12 and 13 of those submissions, stated with reference to R 19/12 that: "In any event as an auxiliary measure and in order to safeguard the rights of the petitioners-patentees and not to be precluded in other proceedings, we herewith object to the chairman of the current composition of the Enlarged Board of Appeal in this case for suspicion of partiality in line with the reasoning of R 19/12".

The reader may find the below worthwhile in view of the EPO's Online consultation: Boards of Appeal (click here), where the The European Patent Office invites of users of the European patent system concerning to suggest and comment on possible improvements of the functioning of the Boards of Appeal with respect to both their autonomy and the perception of their independence and their efficiency. The user consultation will run until 30 June 2015.
The consultation is done in the context of a structural reform of its Boards of Appeal that has been launched by the European Patent Organisation. The main features of the proposed reform are described in the document (CA/16/15 (pdf)), which has been presented by the European Patent Office to the Administrative Council in March and has met with broad support. The aim of the reform is to ensure and increase the organisational and managerial autonomy of the Boards of Appeal, the perception of their independence as enshrined in Article 23 EPC, as well as their efficiency within the legal framework of the current European Patent Convention. 
See also the EPO News message of 30 April 2015.

Friday, 15 May 2015

T 1756/11 - Third party excluded from the party?


This is an appeal against a decision of the Opposition Division to maintain European Patent No. 1 219 158 in amended form in accordance with the proprietor's first auxiliary request.

The opponent filed its notice of appeal on 9. August 2011 while paying the appeal fee. The grounds were filed on 23. September 2011.

Observations by third parties were filed on 17. January 2013 and, in accordance with Art. 114 (2) EPC, communicated by the Board towards the parties.

The preliminary opinion of the Board was issued on 30. September 2014. Oral proceedings took place on 14. January 2015.

Neither the Appellant or respondent commented on the Observations by third parties.

The Board in this decision decides to disregard the late-filed third party observations and to refrain from mentioning them in its decision. Cited below is the board's motivation for this.

Headnote

"See Reasons 2"

Briefly paraphrased and translated as:

Reason 2.3: Art. 114(2) gives the Opposition Division the right to disregard late-filed facts or evidence. However, this applies to filings by parties to the proceedings, which according to Art. 115 a third party is not. Nevertheless, Art. 114(2) is considered to still apply to third party observations which were filed after the opposition time limit by way of a legal fiction according to T 951/91, reason 5.9.

The reasoning behind this is to prevent Art. 115 being (ab)used to expand the rights of third parties or even parties to the proceedings.

Reason 2.5: Although a third party thus has no right to have its observations considered by the Opposition Division, it is common practice for the Opposition Division to at least comment on the relevance of such late-filed third party observations in their decision.

Reason 2.6: Due to the third party not being a party to the proceedings, there is thus no need to, in case of late-filed third party observations (i.e., filed after the time limit for filing the notice of opposition), to comment on their inadmissibility in case the Opposition Division considered the observations not relevant and further disregarded them.

Reason 2.7: On the other hand, the Opposition Division may nevertheless consider and examine such late-filed observations out of its own motion under Art. 114(1) if it considers them prima facie relevant.

Reason 2.8: However, in appeal proceedings, the own-motion principle applies to a lesser degree ("verliert (...) das Gewicht"), especially in inter-partes proceedings, G 9/91, G10/91, reason 18. Here, the impartiality of the Board of Appeal is of up-most importance.

Reason 2.9: The Board of Appeal thus generally needs to disregard late-filed third party observations, except when they relate to amendments during the opposition or appeal-proceedings, G 9/91, G10/91, reason 19, in which case the Board may or may not admit them into the proceedings.

Reason 2.10: A party to the proceedings may however at all times submit comments on new facts or evidence from such third party observations, when these in their view can affect the decision. This right comes forth from Art. 113(1), i.e., the right to be heard. In this case, the Board has to decide on the (in)admissibility of such late-filed comments from the party to the proceedings.

Reason 2.11: In the present case, despite there being claim amendments during the opposition proceedings, the Board is of the opinion that the (anonymous) late-filed third party observations are to be disregarded and not mentioned in the decision. No party commented on the observations either in accordance with reason 2.10.

Wednesday, 13 May 2015

T 995/10 - Purity isn't everything


A clear cut case, wherein the Board of Appeal overrules an earlier decision by the Opposition Division. The decision deals with an aspect in claim 1 that relates to the purity of a virus preparation that is used in cancer therapy. It was indicated in the application as filed and also not disputed by the parties, that a virus preparation should be 'clonal' or as clean as possible, which means that it should have low numbers of defective particles to reduce negative side effects (such as immune responses by the patient). The invention as claimed was directed to the word 'clonal' in the main claim, but unfortunately did not show (in the application as filed) that there was a difference in activity between a clonal preparation and a non-clonal preparation. Post-filed data did not help the proprietor to re-formulate the problem to be solved in the inventive step assessment. Yet another example that it is still wise to have the real data in there, when filing the application, and not simply rely on what might appear logical as the solution to the posed problem, or new formulated problem to be solved.

Summary of Facts and Submissions
I. The appeal of the opponent (hereafter "appellant") lies against the decision of the opposition division rejecting the opposition filed against
European patent No. 1 032 269.
II. The patent at issue has the title "Treatment of neoplasms with interferon-sensitive, clonal viruses".
Claim 1 as granted reads as follows:
"1. Use of an interferon-sensitive, replication-competent clonal RNA virus for the manufacture of a medicament for treating a neoplasm in a mammal." [...]
IV. The opposition division decided that the subject-matter of the claims as granted was novel and involved an inventive step.
V. The following documents are referred to in this decision:
D1 WO 94/25627
[...]
D14 Technical information, submitted by the respondent with letter dated 14 July 2005
[...]
VIII. The parties were summoned to oral proceedings to be held on 11 December 2014. The board expressed its preliminary view in a communication pursuant to Article 15(1) RPBA.
IX. By letter dated 22 October 2014 the respondent announced that it would not attend the oral proceedings.
[...]
XI. The appellant's arguments as submitted in writing and orally may be summarised as follows:
Main (sole) request
Inventive step (Article 56 EPC)
Document D1 represented the closest prior art. The subject-matter of claim 1 differed from the disclosure of document D1 only in the clonal character of the virus population. The technical effect of this difference was, according to paragraph [0079] of the opposed patent: "to ensure or increase the genetic homogeneity of a particular virus strain and to remove defective interfering particles". The objective technical problem was thus the provision of an improved virus-based therapy for the treatment of neoplasms in a mammal, where the improvement consisted in increased purity.
Defective virus particles could cause an unwanted stimulation of the patient's immune system. This was in particular disadvantegous in the treatment of cancer patients due to their usually weak constitution. A high genetic homogeneity of the administered virus particles was moreover desirable for safety reasons, as viruses with deviating sequences could show increased virulence and cause non-reproducible therapeutic effects. These aspects played a crucial role in market authorisation for viral preparations for therapeutic purposes. Hence, it was the constant aim of the person skilled in the field to improve virus-based therapies by reducing the number of defective particles in the virus preparation and by ensuring that the functional virus particles were genetically homogenous. The skilled person would thus be motivated to improve the purity and genetic homogeneity of the virus population disclosed in document D1 and to provide a clonal virus population. Therefore, the skilled person would combine the teaching of document D1 with the virus purification methods disclosed in either document D4 or D11 and arrive at the claimed subject-matter in an obvious manner.
A comparison between a parent virus and a clonal population derived therefrom had not been carried out in the patent in suit. The technical effect - high therapeutic index of the clonal population - allegedly shown in document D14 could not be relied on for the formulation of the technical problem because this effect was neither disclosed in nor derivable from the patent in suit.
Document D12 would not have deterred the skilled person from using a clonal virus population in the treatment of neoplasms in mammals.
XII. The respondent's arguments as submitted in writing may be summarised as follows:
Main (sole) request
Inventive step (Article 56 EPC)
Document D1 represented the closest prior art. In the light of document D1, the objective technical problem was to provide an improved virus-based therapy for treating neoplasms. This problem was solved by the use of an interferon-sensitive clonal virus as defined in the claims of the main request.
Since the examples of the patent demonstrated a credible anti-cancer activity for clonal viruses, the supplementary post-filed evidence provided by document D14 could be taken into consideration. This document, which compared clonal virus strain PV701 and the non-clonal parent strain MK701, showed that clonal viruses resulted in lower mortality of non-cancer cell types and a higher therapeutic index. The principal concept underlying the claimed invention was that clonal viruses demonstrated lower cytotoxicity to normal cells than non-clonal viruses.
Starting from document D1, the skilled person would have found no suggestion to use a clonal virus for the treatment of neoplasms. Even if in view of document D1 a skilled person could have produced a clonal virus, the question was whether he would have done so in the expectation of some improvement. Also, there was a general acceptance in the art that viral therapies should use non-clonal viruses, see for example document D12, page 1, last paragraph, which confirmed that NDV vaccines should use uncloned NDV. Hence, the skilled person seeking to prepare an improved anti-cancer therapy would have been led towards the use of a non-clonal virus.
XIII. The appellant requested that the decision under appeal be set aside and the patent be revoked.
The respondent had requested in writing by letter dated 10 December 2010 that the appeal be rejected in its entirety, i.e. that the patent be maintained as granted.
Reasons for the Decision
[...]
Main (sole) request
Introduction
3. The patent in suit concerns the treatment of mammalian neoplasms with viruses that are able to cause the death of neoplastic cells which have a deficiency in the interferon-mediated anti-viral response while normal cells which possess an intact interferon-mediated anti-viral response limit the replication of the virus and are not killed. The viruses are RNA viruses, in particular paramyxoviruses such as Newcastle Disease Virus (NDV).
Inventive step (Article 56 EPC)
[...] 5. It is common ground between the parties that document D1 represents the closest prior art with respect to the claimed subject-matter. Document D1 (see paragraph bridging pages 3 and 4; page 10, lines 11 to 15; examples) discloses a method of treating cancer in mammals by administering to the mammal an effective amount of a paramyxovirus. In a preferred embodiment the virus is NDV. The document discloses that NDV has direct cytolytic activity on the cancer cells and is capable of specifically differentiating cancer cells from normal, healthy cells. It is reported that one dose of NDV, given intralesionally to athymic mice, causes complete and permanent eradication of a wide variety of human tumours. Document D1 thus relates to the same purpose as the patent in suit - the treatment of cancer using interferon-sensitive, replication-competent RNA viruses capable of selectively killing neoplastic cells - and discloses one of the preferred viruses of the patent in suit, namely NDV.
The technical problem to be solved
6. There was no dispute among the parties that the subject-matter of claim 1 differed from the disclosure of document D1 only in the feature relating to the clonal character of the virus population. [...]
9. The board notes that the patent in suit does not compare the efficacy of the parent non-clonal virus and a clonal population derived therefrom. Pursuant to paragraph [0074] of the patent in suit the viruses of the invention possess the following three characteristics: "(i) they infect neoplastic cells resulting in their death; (ii) they are replication-competent in the neoplastic cells; and (iii) they are limited in killing of normal cells by the antiviral effects of interferon". This passage refers to the specific cytotoxicity of the viruses of the invention towards neoplastic cells, but not to a possible advantage of cloned versus uncloned virus populations. Indeed, the mention of "limited killing of normal cells" in this paragraph applies to any interferon-sensitive virus regardless of its clonality because, unlike neoplastic cells which are deficient in an interferon-mediated anti-viral response, normal healthy cells possess an intact interferon-mediated anti-viral response which protects them from virus-induced cytolysis, see paragraph [0050] of the patent in suit.
10. Accordingly, document D14 can not be relied on for the formulation of the technical problem because the technical effect shown in document D14 is neither disclosed in nor derivable from the patent in suit (see Case Law of the Boards of Appeal of the EPO, 7th edition 2013, section I.D.4.4.1).
11. It follows from points 7 to 10 above that starting from document D1 the problem to be solved is the provision of an improved virus-based therapy for the treatment of neoplasms in a mammal. The board is satisfied that the solution provided by the subject-matter of claim 1 solves this problem.
Obviousness
12. It remains to be answered whether or not the skilled person, when faced with the technical problem defined in point 11 above, would have modified the teaching in the closest prior art document D1 so as to arrive at the claimed invention in an obvious manner.
13. The prior art describes the provision of clonal sub-populations of NDV strains by plaque purification, see document D4, page 435, third full paragraph, and document D11, page 116, lines 1 to 3.
14. Moreover, as submitted by the appellant, the skilled person would have known that the regulatory approval of any virus-based therapeutic composition would require detailed information indicating that the composition was safe and that the therapeutic effect was reproducible. For this it was necessary to provide a virus population which was devoid of defective particles which could cause an unwanted stimulation of the patient's immune system. A high genetic homogeneity of the administered virus particles was also desirable for safety reasons, as viruses with deviating sequences could show increased virulence and cause non-reproducible therapeutic effects. The respondent has not disputed this line of argument. [...]
16. The board is not convinced that document D12 would have deterred the skilled person from using a clonal virus population in the treatment of neoplasms in mammals. The paragraph relied on by the respondent states that "[w]e must be aware that the populations of Newcastle disease virus that spread in the field, or the populations that make up a vaccine stock [note by the board: the NDV vaccine for use in chickens] are not clonal". In the board's view this corresponds to what was known in the art at the priority date, namely that "both wild-type isolates and laboratory cultured strains of Newcastle disease virus contain several subpopulations", see document D11, page 113, first paragraph. A requirement that NDV should be uncloned when used in mammals, not in chickens, and for the treatment of neoplasms, and not as a vaccine, is not apparent from document D12.
17. Starting from the teaching of document D1 and faced with the problem of providing an improved virus-based therapy for the treatment of neoplasms in a mammal, the skilled person aware of the non-clonal character of NDV strains and of the regulatory requirements for obtaining marketing authorisation for viral preparations for therapeutic purposes would have readily considered providing a clonal virus population by plaque-purifying the NDV strain of document D1 pursuant to the teaching of document D4 or D11. He would thus have arrived at the subject-matter of claim 1 in an obvious manner. [...]
Order
For these reasons it is decided that:
1. The decision under appeal is set aside.
2. The patent is revoked.
This decision has European Case Law Identifier: ECLI:EP:BA:2014:T099510.20141211. The whole decision can be found here. The file wrapper can be found here. Picture by GH.

Friday, 8 May 2015

T 0081/14: use claim of a product defined as a product-by-process


This appeal extends from a decision of the Opposition Division. The patent owner (Appellant) filed the appeal. Claim 8 of auxiliary request 3 has an interesting claim construction. It is a "use-claim", and as such a claim which relates to a "process". In the claim, the product-to-be-used has been defined as a product-by-process. This claim relates to a post-grant amendment and, as such, the Board has to discuss the Art. 84 EPC objection of the respondents (Opponents). When considering the Art. 84 PC objection, the Board has to consider whether the well-established case law regarding product-by-process claims also applies to this "use-claim". In this context, the Board also discusses argument of the Appellant which relate to "the interpretation of such a claim by a national court in infringement proceedings" and "similarities with Swiss-type claims".

Summary of Facts and Submissions

(...)
 
Claim 1 of auxiliary request 2 reads as follows:"1. A method of producing a sintered cemented carbide body having increased resistance to plastic deformation, comprising tungsten carbide, a binder phase comprising at least one metal of the iron group or an alloy thereof, and a solid solution phase comprising at least one of the carbides and carbonitrides of a combination of zirconium, niobium, and tungsten, wherein said body has a mass ratio Nb/(Zr+Nb) of at least 0.5, and wherein said solid solution phase is the sole solid solution phase of said body and (i) consists of a carbide or carbonitride of a combination of zirconium, niobium and tungsten or (ii) comprises a carbide or carbonitride of a combination of zirconium, niobium and tungsten, and at least one carbide, nitride or carbonitride of one or more of titanium, hafnium, vanadium, tantalum, chromium, and molybdenum;
said method comprising the steps of
a) providing a powder mixture comprising tungsten carbide, a binder metal powder comprising at least one metal of the iron group or an alloy thereof, and at least one of the carbides and carbonitrides of both, zirconium and niobium;
b) forming a green compact of said powder mixture;
c) vacuum sintering or sinter-HIP said green compact at a temperature of from 1400 to 1560 °C;
characterized in that in step a) a powdered solid solution of the carbides or carbonitrides of zirconium and niobium having a mass ratio Nb/(Zr + Nb) of at least 0.5 is used to form said powder mixture."
Claim 1 of auxiliary request 3 differs from claim 1 of auxiliary request 2 in that the claimed method is limited to the production of a body with
"a mass ratio Nb/(Zr+Nb) of 0.6 or more".
Moreover, auxiliary request 3 comprises use claims 8-12, the independent claim 8 of which reads as follows (emphasis added):
"8. Use of the sintered cemented carbide body obtained according to the method of any one of claims 1 to 7 for the production of a cutting tool."

(...)

Reasons for the Decision

(...)
 
3. Auxiliary request 3 - Article 84 EPC

3.1 The feature that the use of claim 8 concerns a product "obtained according to the method of any one of claims 1 to 7" was not present in the claims as granted but is the result of a post-grant amendment. Hence, the objection under Article 84 EPC raised against this feature has to be considered.

3.2 Article 84 EPC provides that the claims shall define the matter for which protection is sought and that they shall be clear and concise and be supported by the description. The requirement laid down in this article that the claims have to be clear reflects the demand for legal certainty, which is of paramount importance in any system where the rights of the public are affected by the grant of a monopoly.

3.3 Present claim 8 is directed to the use of the sintered cemented carbide body obtained according to the method of any one of claims 1 to 7 for the production of a cutting tool. Hence, the claim [claim 1] comprises process and product features and is notionally equivalent to a claim directed to a process for the production of a cutting tool using the sintered cemented carbide body (see G2/88, point 5.1 of the Reasons, OJ 1990, 93). Accordingly, as acknowledged by the appellant itself, the steps of the method for the production of the sintered cemented carbide body do not form part of the claimed activity [claim 8]. Indeed, had the appellant intended to include these steps in the claimed method it could have drafted the claim in different terms, for instance by directing it to a process for the production of a cutting tool using a sintered cemented carbide body and comprising the production of said sintered cemented carbide body according to the method of any one of claims 1 to 7.
Therefore, the reference in claim 8 to the steps of the method for the production of the sintered cemented carbide body does not define process features but solely the features of the product (the sintered body) used in the claimed method. As a consequence, the issue at stake when considering this reference in the context of Article 84 EPC is the assessment of the clarity of product features.

3.4 To ensure legal certainty the definition of a product is normally done by means of the structural features of the product, i.e. by features which can be verified on the product. A definition in terms of the process of manufacture, in the following a "product-by-process definition", in lieu of a definition in terms of structural features is reserved for cases wherein the latter definition is not possible. This principle is well established in the case law for a claim which is directed to a product, in the following a "product-by-process claim" (see for instance T150/82, point 10 of the Reasons, OJ 1984, 309).
It is true that present claim 8 is not directed to a product but to a process. However, there is no reason to make the principles underlying the assessment of the clarity of product features dependent on the fact that said product features appear in a claim directed to a product or in a claim directed to a method.

3.5 The appellant disagreed with this position and submitted that in case of infringement the features pertaining to the method of production of the sintered carbide would be fully taken into account by the court, so that the use of a sintered body which is merely obtainable by the method of any one of claims 1 to 7 but not actually obtained by this method would not infringe claim 8.
However, the Boards of Appeal are concerned only with validity and not with infringement, which is a matter reserved for the courts of the different contracting states, which may interpret the same claim in different ways. Accordingly, the Board is not in the position of considering the (possibly different) interpretations given to a "product-by process definition" in national infringement proceedings. This applies all the more in a case like the present one, wherein no specific decision of a national court has been submitted for consideration to the Board.
Moreover, although it is in general desirable that the interpretation of the meaning of the claims given by a court in infringement proceedings and that given by a board of appeal or a court when considering the validity of a claim are consistent with each other, situations exist wherein this is not achieved. Indeed an example of such a situation concerns "product-by-process claims". In the decision of the UK High Court of Justice, Chancery Division, Patents Court of 21 November 2014, in Hospira v. Genentech ([2014] EWHC 3857, points 143 to 147) Mr Justice Birss considered that, as far as infringement is concerned, a product "obtained by" a process means a product which has actually been obtained by that process. However, he did not adopt the same interpretation for the issue of validity but took instead the view that a new process which produces a product identical to an old product cannot confer novelty on that product, an interpretation corresponding to the established case law of the Boards of Appeal for a "product-by-process claim" (Case Law of the Boards of Appeal of the European Patent Office, 7h edition 2013, II.A.7.). Hence, the issue raised by the appellant is not specific to the use of "product-by-process definitions" in use claims but concerns also "product-by-process claims". Therefore, it cannot support the appellant's view that the requirements to allow a "product-by-process definition" are to be considered only for claims directed to a product and not for claims directed to a use.
Finally, the issue to be considered in the present case is not the interpretation of the claim for assessing novelty and inventive step, but rather whether the definition of the product chosen by the appellant is clear or not.
In view of these considerations, the allegedly different way in which claim 8 would be interpreted in infringement proceedings fails to dissuade the Board from applying the principles developed for "product-by-process" claims when considering the definition of the sintered body used in claim 8.

3.6 The same applies in respect to the reference to Swiss type claims made by the appellant. The so-called Swiss-type claims are claims directed to the use of a substance or composition for the manufacture of a medicament for a specified therapeutic application. According to decision G5/83 (OJ 1985, 64) they were to be allowed even in a case in which the process of manufacture as such does not differ from known processes using the same active ingredient, provided that the therapeutic application is new and inventive. The application of this special approach, which derived the novelty from the intended therapeutic use of the medicament, was restricted to claims to the use of substances or compositions intended for use in a method referred to in Article 52(4) EPC 1973 (corresponding to present Article 53(c) EPC), a so-called "medical use" (G5/83, last paragraph of point 21 of the Reasons). Accordingly, this approach finds no place in the consideration of a "product-by-process definition", i.e. a definition which does not involve the intended use of a product, let alone an intended "medical use", but rather concerns its process of production.

3.7 Therefore, the Board is satisfied that when considering the definition of a product in terms of its production process the principles developed in the jurisprudence for the "product-by-process claims" are in general to be applied, also in the case of a claim directed to the use of that product.

3.8 Applying said principles to present claim 8 the Board sees to reason why it would not have been possible to define the sintered body in terms of structural features, namely composition, microstructure and mechanical properties, i.e. the features which characterise the product in the examples of the patent in suit.
The appellant failed to convince the Board to the contrary, because it did not indicate concretely in which respect it would not be possible to define in terms of structural features a carbide body obtained by the method of claims 1 to 7.

3.9 Accordingly, the use of a product-by-process definition in claim 8 of auxiliary request 3 results in a lack clarity.

(...)


Order

For these reasons it is decided that:
1. The decision under appeal is set aside.
2. The case is remitted to the Opposition Division for further prosecution on the basis of Auxiliary Request 4 filed with the statement of grounds of appeal on 24 February 2014.


This decision has European Case Law Identifier: ECLI:EP:BA:2015:T008114.20150312. The whole decision can be found here. The file wrapper can be found here. Advertisement  "Old Processee Starchee no goodee" "It smellee rots & makee shirts yellee", "I will never use any other but the New Process Starch" published by Boston Public Library obtained via Flickr under CC BY 2.0 license.

Tuesday, 5 May 2015

Online consultation on reforms to the EPO boards of appeal



The European Patent Organisation has launched a structural reform of its Boards of Appeal. 
The main features of the proposed reform are described in the document (CA/16/15), which has been presented by the President of the European Patent Office to the Administrative Council in March and has met with broad support. The Council gave its general support to the policy lines as presented. First concrete proposals will be elaborated for decision at the next Council meeting, in June 2015. These proposals will have to take due account of contributions received as a result of a broad consultation of stakeholders. The user consultation was launched on 30 April and will run until 30 June 2015.

The aim of the reform is to ensure and increase the organisational and managerial autonomy of the Boards of Appeal, the perception of their independence as enshrined in Article 23 EPC, as well as their efficiency within the legal framework of the current European Patent Convention.

The aim is also to take account of national, European and international developments aiming at enhancing the autonomy of the Judiciary and/or the efficiency.

The European Patent Office, which will prepare the relevant concrete proposals to be submitted to the Administrative Council, would welcome contributions from the users of the European patent system concerning possible improvements of the functioning of the Boards of Appeal with respect to both their autonomy and the perception of their independence and their efficiency. Contributions from the users will be duly considered in the preparation of the future concrete proposals and presented to the Administrative Council. Contributions will be processed and presented to the Administrative Council in an anonymised manner and an excerpt of the contributions will be made available to the general public.

The EPO in particular welcomes contributions concerning the following questions:
  • Question A: Position of the Boards of Appeal – Independence
  • Question B. Work of the Boards of Appeal - Efficiency
  • Question C. Work of the Boards of Appeal – Procedure 
  • Question D. Boards of Appeals Committee (BOAC)
  • Question E. Proceedings of petitions for review
  • Question F. General

The user consultation will run until 30 June 2015, and is available to June 30, 2015 on the EPO website under https://forms.epo.org/law-practice/consultation/ongoing/boards-of-appeal-form.html.



T 2541/11 - "Right to be heard not absolute, but must be balanced"

The appellant-opponent lodged an appeal against the interlocutory decision of the opposition division  on the amended form in which European patent no. 1394387 could be maintained. The appellant-proprietor also lodged an appeal against the above interlocutory decision. The appellant-opponent filed a new document, E12, with their grounds of appeal. The Board did not admit this new document.

Background / Summary of Facts and Submissions
I. The appellant-opponent lodged an appeal, received 12 December 2011, against the interlocutory decision of the opposition division posted on 13 October 2011 on the amended form in which European patent no. 1394387 could be maintained and paid the appeal fee simultaneously. The statement setting out the grounds of appeal was filed on 23 February 2012.
The appellant-proprietor also lodged an appeal, received 14 December 2011 against the above interlocutory decision and paid the appeal fee simultaneously. The statement setting out the grounds of appeal was filed on 20 February 2012.
II. The opposition was filed against the patent as a whole and based inter alia on Article 100(a) together with Articles 52(1) and 54(3) EPC for lack of novelty and Article 56 EPC for lack of inventive step.
The division held, inter alia, that the grounds for opposition (novelty and inventive step) mentioned in Article 100(a) EPC did not prejudice maintenance of the patent as amended according to an auxiliary request, having regard to the following documents, amongst others: E1, E4, E6, E9.
III. The appellant-opponent filed the following document with their grounds of appeal: E12.
IV. Oral proceedings before the Board were duly held on 17 December 2014. During the oral proceedings, the appellant-opponent filed an objection under Rule 106 EPC in writing. It reads as follows:
Objection acc. to Rule 106 EPC; in the name of the opponent.
The decision to not admit reference E12 into the proceedings constitutes a violation against the right to be heard for the following reasons:

Friday, 1 May 2015

R 8/13 Partiality settled for the time being




Background
In an interlocutory decision of 25 April 2014 in the Petition for Review case R19/12, the Chairman of the Enlarged Board of Appeal was replaced having been accused of potential partiality in view of his role as Vice President of the EPO and as such subject to the supervisory authority of the President of the EPO under Article 10(2)(f) EPC (R19/12 r.14.1 in conjunction with r.16).

As a consequence, the EPO took internal measures to reduce the consequences of the double function, but did not officially publish the measures.

In R 2/14 suspected partiality of the chairman was raised again. The Enlarged Board had to decide whether the measures taken removed the grounds. It decided that that was the case. It reasoned:

r.39.6 Consequently, the Board considers that it is appropriate to apply the legal concept of "normative concordance" so that a balance between the conflicting legal / institutional provisions of Article 10(3) EPC (in respect of management functions) and Article 23(3) EPC (in respect of judicial functions) can be achieved with regard to the Chairman's dual duties as VP3 and Chairman of the Enlarged Board of Appeal.
r.39.7 In applying the concept of "normative concordance" to the present case, the Board concludes that the President's power to give instructions to the Chairman in his function as VP3 pursuant to Article 10(2)(f) and (3) EPC is limited by virtue of Article 23(3) EPC.

The Chairman is accordingly relieved of any obligation

(a) to obey any presidential instructions or
(b) to observe other administrative/executive directions or
(c) to assist the President pursuant to Article 10(3) EPC

if and to the extent that any such instruction, direction or assistance might affect him and/or any other member of the boards of appeal, including the Enlarged Board of Appeal, directly or indirectly, in performing their judicial duties (see also Braendli, Münchner Gemeinschaftskommentar EPÜ, supra, Art. 10, para. 53, and Art. 11, para. 37).

In R. 8/13 this issue is raised for the third time. The focus now shifts to whether the current way of working complies with international law.
The Enlarged Board decides that that is the case. This decision seems for the time being to end the discussion on partiality of the Chairman of the Enlarged Board in view of the double function of also being a Vice President (of DG3). 
The Enlarged Board reiterates that it would be best to remove the organisational conflicts but that that is in issue for the legislator. 

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