T 0393/15 - New objections in appeal

Key points

• In this appeal case, the patent proprietor had requested transfer of the patent during the appeal. [For some reason,] the Board examines the submitted evidence. The Board finds the assignment to be insufficient, because it was signed by the professional representative, who had not a clear authorization for assignments and transfers of of the patent. [edit: The Board assumes competence in addition to the legal division, see the "or" in paragraph 1.3. ].
• In this case, insufficient disclosure was allowable as new objection against the claims as held allowable by the OD, because in these claims a feature taken from the description had been added. 
• The patent proprietor had filed a letter withdrawing the "patent application". The Board finds that this is not unambiguously a request for revocation of the patent.
• The Board then finds that the claims are sufficiently disclosed and inventive, and reject the appeal. 

EPO T 0393/15 -  link

Entscheidungsgründe

1. Antrag der Beschwerdegegnerin auf Umschreibung

1.1 Die vorliegende Entscheidung betrifft die Li-Tec Battery GmbH als Patentinhaberin und Beschwerdegegnerin. Die Beschwerdegegnerin beantragt, das Streitpatent auf die Daimler AG umzuschreiben.

1.2 Artikel 72 EPÜ bestimmt, dass die rechtsgeschäftliche Übertragung einer europäischen Patentanmeldung schriftlich erfolgen muss und der Unterschrift der Vertragsparteien bedarf. Nach Regel 22(1) EPÜ wird ein Rechtsübergang der europäischen Patentanmeldung auf Antrag eines Beteiligten in das europäische Patentregister eingetragen, wenn er dem EPA durch Vorlage von Urkunden nachgewiesen wird. Nach Regel 22(2) EPÜ gilt der Antrag erst als gestellt, wenn eine Verwaltungsgebühr entrichtet worden ist. Diese wurde im vorliegenden Fall auch entrichtet. Regel 22 EPÜ ist gemäß Regel 85 EPÜ auch auf einen Rechtsübergang des europäischen Patents während der Dauer des Einspruchsverfahrens anzuwenden (T 1855/06, Punkt 2 der Entscheidungsgründe).

T 1138/12 - Independent claims as request

Key points

• What is the purpose of dependent claims after grant? In some countries, in revocation procedures, the Courts examine the patentability of each dependent claim separately. Hence, the patent is not entirely revoked if only one of the claims is not patentable. See Article 138 (2) EPC, stating that if the grounds for revocation affect the patent only in part, the patent shall be limited by a corresponding amendment of the claims and revoked in part.
• In contrast, in EPO opposition, a (claims) request is not allowed (in appeal) if only one of the claims is not allowable. 
• In this opposition appeal, the patent proprietor requested the Board to maintain the patent on the basis of any of the claims as granted which were considered allowable. The Board does  not admit the request into the proceedings, as being not clearly defined.
• The Board essentially reasons that Article 101(3) EPC prescribes that the the patent is examined for compliance (of all the claims) with the EPC " taking into considerations the amendments made by the proprietor ... during the opposition proceedings". In the proprietor's request for claim by claim examination, no amendments are made to the patent.
• The headnote also concerns the alleged procedural violation before the OD, because during the oral proceedings the OD had deliberated only for a very short time about one of the issues. The Board holds that this did not amount to a procedural violation.The Board explains that it in case the members of the OD had a preliminary opinion and had not changed their mind by the oral arguments, they can agree on their decision with eye contact or a nod.
• Finally, the decision contains also an issue about the opponent having been subjected to a de-merger (or splitting off). The Board holds that this issue does not affect the standing of the opponent, because "da keine Anhaltspunkte bestehen, dass mit der Abspaltung auch eine Übertragung des konkreten Einspruchs vereinbart wurde" (there are no reasons to assume that with the demerger also a transfer of the specific opposition was agreed). In my opinion, this goes against the reasoning in G 4/88, [6], that "the opposition constitutes an inseparable part of those assets" and that " the opposition [] must also be regarded as transferable or assignable in accordance with the principle that an accessory thing when annexed to a principal thing becomes part of the principal thing". Hence, the opposition considered an "accessory thing"  that is part of the principal things, and hence automatically follows with the transfer of the relevant business assets without a separate transfer of the opposition being necessary. 

EPO Headnote

1. Ein Antrag, das Patent im Umfang derjenigen Patentansprüche eines Anspruchssatzes aufrechtzuerhalten, die als gewährbar angesehen werden, ist inhaltlich nicht hinreichend bestimmt und daher nicht ins Verfahren zuzulassen (siehe Punkt 5).

2. Sowohl die Dauer als auch die Form der Beratung zwischen den Mitgliedern einer Einspruchsabteilung hängt vom Umfang und von der Komplexität der im konkreten Fall zu beratenden Themen ab. Hierbei spielt auch der Grad der Vereinbarkeit möglicherweise divergierender Auffassungen der Mitglieder der Abteilung eine wesentliche Rolle (siehe Punkte 13.2 bis 13.4).



EPO T 1138/12 - link

Entscheidungsgründe

Einsprechendenstellung

1. Mit Schreiben vom 9. März 2017 hat die Beschwerdegegnerin dem Europäischen Patentamt eine Änderung des Namens und der Gesellschaftsform der Einsprechenden, vormals "Alstom Technology Ltd" in "General Electric Technology GmbH" angezeigt und die Umschreibung im Register beantragt.

T 0488/16 - Plausibility at the EPO (Dasatinib I)

Key points

• In this opposition appeal case (about a blockbuster medicine), the core issue is that the application as filed does not contain experimental evidence showing that the claimed compound works as medicine, in particular as PTK inhibitor. The patentee submitted post-published evidence. The Board recalls that such evidence can only be considered  " if it is already plausible from the disclosure of the patent that the problem is indeed solved".
• " Indeed, there is no evidence at all in the application as filed that shows that any of the compounds falling within the scope of formula I, let alone [the now claimed compound] dasatinib, is active as an inhibitor for any of the specific protein tyrosine kinases, except a mere assertion [] that "Compounds described in the following Examples have been tested in one or more of these assays and have shown activity." No further information is provided. No individual values or range of values are given."
• The core issue is proprietor's argument that "the EPC does not require experimental proof. A summary statement as provided on page 50, lines 1 to 2 was sufficient to meet the low plausibility threshold, which was satisfied in the absence of any substantiated doubts. [] As the threshold test had been met, the post-published evidence which merely confirmed the PTK inhibitory activity of dasatinib should be taken into account." 
• The Board rejects this argument strongly. " In the board's judgement, it is not acceptable to draw up a generic formula, which covers millions of compounds, vaguely indicate an "activity" against PTKs and leave it to the imagination of the skilled reader or to future investigations to establish which compound inhibits which kinase and is therefore suitable to treat the respective diseases associated therewith." Therefore, " It is [] a conditio sine qua non that it is shown that the technical problem underlying the invention was at least plausibly solved at the filing date. If, as in the present case, the nature of the invention is such that it relies on a technical effect, which is neither self-evident nor predictable or based on a conclusive theoretical concept, at least some technical evidence is required to show that a technical problem has indeed been solved. " 
• The patent is revoked for inventive step (of the product claims), for lack of technical effect.

• The proprietor had also submitted expert declarations. " As a preliminary remark, the board would like to point out that the opinion of highly skilled experts on how a disclosure of a document is to be understood does not reflect the view of the notional skilled addressee, who is a person of ordinary skills aware of what is common general knowledge in the art at the relevant date. " 
• Note 07.08.2018: the petition for review of proprietor has been refused (R0009/17). 

EPO T 0488/16  - link

4. Post-published documents

4.1 Documents (9) and (10), in particular document (9), on which the appellant relied as evidence that the presently claimed compound dasatinib showed protein tyrosine kinase (PTK) inhibitory activity and was therefore suitable in the treatment of disorders associated therewith, particularly cancer, were filed more than three years after the filing date of the patent in suit (document (9) in December 2004 (on the Internet in July 2004); document (10) in November 2003). In the decision under appeal, the opposition division decided not to take these documents into account on the grounds that the alleged activity had not been made plausible at the effective date of the patent in suit and that the post-published documents were the first disclosure going beyond speculation. This decision was challenged by the appellant, who continued to rely on these documents as confirmation for a plausible disclosure of dasatinib as PTK inhibitor.

4.2 It is established jurisprudence of the boards of appeal that the assessment of inventive step is to be made at the effective date of the patent on the basis of the information in the patent together with the common general knowledge then available to the skilled person. Post-published evidence in support that the claimed subject-matter solves the technical problem the patent in suit purports to solve may be taken into consideration, if it is already plausible from the disclosure of the patent that the problem is indeed solved (see Case Law of the Boards of Appeal, 8th edition, I.D.4.6; T 1329/04, point 12 of the Reasons; T 1043/10, point 12 or the Reasons).

Thus, for post-published evidence to be taken into account, it is necessary to establish whether or not the asserted activity has been made sufficiently plausible for dasatinib at the effective date of the patent in suit. Basis for this assessment is the application as filed and the common general knowledge of the person skilled in the art at the filing date.

T 0758/12 - Genotype and business method

Key points

• In this examination appeal, claim 1 is directed to a method for selecting medication for a patient, comprising the steps of (essentially) providing the patient's genotype wherein the genetype has a specific allele (i.e. selecting patients having that allele) and the step of selecting the medication based on the genotype.
• " Without further limitation, the term "providing a patient's genotype" includes the provision, i.e. the making available, of patient data, for instance, in the form of a print-out on a piece of paper when such data have been obtained in a step preceding the steps of the claimed method. Under these circumstances, the claimed method is reduced to a scheme, rule or method for performing a mental act or doing business with those data which as such is excluded from patentability (Article 52(2)(c) EPC)."

EPO T 0758/12 - link

V. Claim 1 of the main request reads:

"1. A method for selecting a psychotropic medication for a patient, said method comprising
(a) providing said patient's genotype for a panel of genes, wherein said panel comprises a CYP2D6 gene, a CYP2C19 gene, a CYP1A2 gene, a serotonin transporter gene, and a serotonin receptor 2A gene; wherein said genotype for said CYP2D6 gene comprises the 2D6*41 allele; and
(b) selecting said psychotropic medication based on said genotype."

Reasons for the Decision

Extent of examination in appeal proceedings

1. In an appeal from a decision of an examining division, the board is not limited to examine issues on which the examining division decided adversely, in the present case issues under Articles 123(2) and 56 EPC. Rather, the board is empowered to examine whether or not the claims on file and the invention to which they relate fulfil all requirements of the EPC and, accordingly, raise new objections if it considers it necessary (see Order of decision G 10/93, OJ EPO 1995, 172). In the present case, the board considers that issues under Articles 52(2)(c) and 84 EPC must be addressed.

Article 113(1) EPC - right to be heard

2. As announced in writing, the appellant did not attend the oral proceedings. Nor did it file substantive arguments in reply to the board's communication pursuant to Article 15(1) RPBA (cf. point III, above). By neither replying to the board's communication in substance nor attending the oral proceedings, the appellant effectively chose not to avail itself of the opportunity to comment or present its observations on the board's provisional opinion (Article 113(1) EPC). As a consequence of appellant's course of action, there are no submissions on file as regards the patentability of the claimed subject-matter (Article 52(2)(c) EPC) or the compliance with the requirements of Article 84 EPC, issues mentioned in points 6 to 10 of the board's communication pursuant to Article 15(1) RPBA and relating to the main and the auxiliary request.

Article 52(2)(c) EPC

3. As presently worded, claim 1 of the main and the auxiliary request encompasses subject-matter excluded from patentability. Claim 1 of both requests defines a method for selecting a psychotropic medication for a patient comprising the steps of (a) providing a patient's genotype, and (b) selecting said medication. Without further limitation, the term "providing a patient's genotype" includes the provision, i.e. the making available, of patient data, for instance, in the form of a print-out on a piece of paper when such data have been obtained in a step preceding the steps of the claimed method. Under these circumstances, the claimed method is reduced to a scheme, rule or method for performing a mental act or doing business with those data which as such is excluded from patentability (Article 52(2)(c) EPC).

Article 84 EPC

4. Step (a) of claim 1 of both requests is ambiguous and therefore unclear within the meaning of Article 84 EPC.

The step comprises the provision of a patient's genotype for a panel of genes which comprises the CYP2D6 gene and "wherein said genotype for said CYP2D6 gene comprises the 2D6*41 allele". This wording allows three possible interpretations:

(i) the feature "wherein said genotype for said CYP2D6 gene comprises the 2D6*41 allele" is interpreted as merely stating that the 2D6 alleles which can possibly be identified in said patient include or comprise the 2D6*41 allele, or

(ii) the feature "wherein said genotype for said CYP2D6 gene comprises the 2D6*41 allele" specifies that the patient carries said 2D6*41 allele. The claimed method is thus limited to selecting a psychotropic medication (step (b) of claim 1) for a patient who is already known to be a carrier of at least one 2D6*41 allele, or

(iii) the feature "wherein said genotype for said CYP2D6 gene comprises the 2D6*41 allele" is interpreted as requiring that "providing said patient's genotype" comprises determining experimentally if said patient comprises the 2D6*41 allele.

5. In view of this ambiguity, neither claim 1 of the main request nor claim 1 of the auxiliary request provide a clear definition of the claimed subject-matter.

6. Furthermore, claim 1 of both requests lacks essential technical features.

According to the established case law of the Boards of Appeal, Article 84 EPC has to be interpreted as meaning not only that a claim must be comprehensible from a technical point of view, but also that it must define the object of the invention clearly, that is to say indicate all the essential features thereof. All features which are necessary for solving the technical problem with which the application is concerned have to be regarded as essential features (see "Case Law of the Boards of Appeal of the EPO", 8th edition 2016, II.A.3.2, page 272).

7. The goal of the method of claim 1 is the selection of a "psychotropic medication for a patient". The method comprises the determination of the patient's genotype for a panel of five genes (CYP2D6, CYP2C19, CYP1A2, a serotonin transporter gene (5-HTT), and a serotonin receptor 2A gene (HTR2A)) (step(a)), followed by the selection of said medication based on said genotype (step (b)). Step (b) does however not define any rules, criteria, parameters or properties for the selection of a psychotropic medication based on a patient's genotype of the five genes. The claim therefore lacks essential technical features.

8. Moreover, according to Article 84 EPC, the claims must not only be clear but also supported by the description. This requirement reflects the general legal principle that the extent of the patent monopoly, as defined by the claims, should correspond to the technical contribution to the art in order for it to be supported, or justified (see decision T 409/91, OJ EPO 1994, page 653, point 3.3 of the Reasons for the decision).

9. The patent application does not provide instructions how to select a psychotropic medication if a patient is a carrier of a 2D6*41 allele, either in combination with a second 2D6*41 allele or in combination with a different 2D6 allele, and particular alleles of the other genes mentioned in the claim.

Although the patent application discloses allelic variants of several cytochrome P450 genes (Table 1), there is no information on the activity level of any of the mentioned alleles except for some CYP2D6 alleles (Table 10). Nor is there any information on the activity levels related to or associated with the polymorphisms of the serotonin transporter and the serotonin receptor 2A listed in Table 2.

The application contains also no information on the (exclusive) substrate and conditions to be used for determining the activity level of the CYP2D6 alleles. There is no reference to a "standard assay" (well known and generally accepted in the art) for measuring such activity levels, let alone to "standard assays" for measuring the activity of each and every allele of the other genes listed in the claims. Nor is there any information on the criteria (threshold) used for classifying a CYP2D6 allele as a poor, intermediate, extensive or ultra-rapid metabolizer.

10. Thus, claim 1 of the main and the auxiliary request, directed to a method for selecting a psychotropic medication, relates to subject-matter which, after reading the description, is not at the disposal of the person skilled in the art.

11. The subject matter of claim 1 of the main and the auxiliary request is neither clearly defined nor supported by the description (Article 84 EPC).

Conclusion

12. In the absence of an allowable request, the appeal must be dismissed.

Order

For these reasons it is decided that:

The appeal is dismissed.

T 0875/14 - Attacking all claims

Key points

• In this opposition case, the Patent proprietor restricted in the fifth auxiliary request to some of the granted claims. These had not been attacked in the Notice of opposition. A later attack against these claims is not admitted.
• " Therefore, the subject-matter of the operative set of claims corresponds to that of granted claims, which could and should have been objected to from the beginning of the first instance proceedings and during the written phase of the appeal proceedings, which was not done," 
• In particular, each of the three independent product claims as granted should have been attacked. " The fact that in the present case the granted patent contained a rather large number of independent claims cannot justify to offend the stipulations of Article 12(2) RPBA according to which the statement of grounds of appeal should contain the appellant's complete case." 

EPO T 0875/14 -  link

5.2 D4 as closest prior art - Admittance

5.2.1 The second line of argumentation starting from D4 as closest prior art was put forward by the appellant for the first time during the oral proceedings before the Board. Therefore, it represents an amendment to a party's case pursuant to Article 13(1) RPBA and its admission to the proceedings is subject to the Board's discretion (Article 13(1) RPBA) and underlies the additional stipulations of Article 13(3) RPBA.

5.2.2 It was not disputed by the appellant that operative claims 1-3 are identical to claims 17, 19 and 26 of the main request i.e. of the granted patent and that operative claims 4 to 9 correspond to granted claims 29 to 34 (with the corresponding dependency). Therefore, the subject-matter of the operative set of claims corresponds to that of granted claims, which could and should have been objected to from the beginning of the first instance proceedings and during the written phase of the appeal proceedings, which was not done, as explicitly agreed upon by the appellant during the oral proceedings before the Board.

T 1592/12 - Plausibility and prophetic example

Key points

• In this case, the Board finds a Swiss-type for a dosage regime to be insufficiently disclosed. The claim specifies maintenance doses of an antibody every three weeks. Prior art is weekly doses, because the half-life of the antibody was considered to be around one week. The Board requires that the application makes the therapeutic effect credible for the less frequent doses. "From the general principle that the extent of the monopoly conferred by a patent should correspond to, and be justified by, the technical contribution made to the art, it follows that it is the suitability of this different administration frequency to treat breast cancer which needs to be disclosed in the patent for the requirements of sufficiency of disclosure to be met" 
• The experimental examples are based on weekly doses. The fact that the longer half-life can be inferred from the experimental data, is not relevant, because " no conclusions are drawn in the patent in suit from the data depicted in Figure 3, and no pharmacokinetic analysis of the data of Table 2 or Figure 3 is carried out. In these circumstances the board considers that the skilled person had no reason to analyse the data of example 2 with a view to reassessing the half-life of [the antibody] Herceptin**(®)." 
• The prophetic example 6 with administration every three weeks does not provide sufficiency of disclosure, because "the patent in suit neither explains why the treatment regimen will be effective nor contains data demonstrating the actual performance of the treatment regimen described." 
• " Post-published document D70 [a filing of patentee to the FDA] is considered to corroborate the board's finding in this respect. Document D70 discloses that preliminary data from 15 patients treated with Herceptin(®) administered every three weeks in combination with Taxol(®) "now indicate that the half-life Herceptin(®) is considerably longer than was originally determined" (see page 1). The document thus provides evidence that the appellant [patentee] itself, although in possession of the data of example 2 of the patent in suit and in particular of the data depicted in Figure 3 [from which the longer half-life could be inferred], had only reconsidered the half-life of Herceptin**(®) when analysing the data obtained from the clinical trial proposed in [prophetic] example 6 of the patent in suit. However, these data [of the trial] are neither contained in the patent in suit nor disclosed in the prior art. Accordingly, the [patentee's] submission that the notional skilled person reading the patent in suit would have realised from the data in its example 2 that the half-life of Herceptin**(®) was considerably longer is also contradicted by the evidence provided in document D70." 

EPO T 1592/12 -  link

Sufficiency of disclosure - claim 1

14. Independent claim 1 is formulated as a "Swiss-type" claim and relates to the use of the anti-ErbB2 antibody huMab 4D5-8, commonly known as trastuzumab (Herceptin**(®)), for treating a human patient diagnosed with breast cancer, whereby the antibody is administered at an initial dose of 8 mg/kg followed by maintenance doses of 6 mg/kg every three weeks (in brief 8/6/3).

T 0299/12 - Consisting essentially of

Key points

• In this case, the Board finds added matter in replacing "comprising"  with "consisting essentially of".
• " The board cannot agree with the [proprietor's] view in this respect and notes that the [proprietor's] arguments rely on a preliminary selection of the examples that contain only testosterone, oleic acid, ethanol, isopropanol, propylene glycol, carbomer, water and, optionally, cross-linking agents and preservatives, a selection that would result in a very limited number of embodiments, namely formulation [...] and the formulation of example 9. The selection, however, would leave out of the scope of claim 1 typical compositions lacking any of the ingredients now considered essential by claim 1 (e.g. formulations A and B of example 1 and the formulations of examples 3-4) []. But, more importantly, all of the selected examples on which claim 1 would be based appear to contain triethanolamine (i.e. a cross-linking agent), thereby suggesting that, for the particular combination of components (a) to (e) and water defined in present claim 1, triethanolamine would be an essential feature. Hence, even though the passage on page 7, lines 15-24, generally mentions cross-linking agents as being optional ingredients, the teaching of the application as filed for the particular combination of ingredients now in claim 1 (i.e. testosterone, oleic acid, ethanol, isopropanol, propylene glycol, carbomer and water) is that cross-linking agents, in particular triethanolamine, are essential. [] In conclusion, at least for the reason that claim 1 defines triethanolamine as being optional rather than essential, it encompasses subject-matter which extends beyond the content of both the application and the parent application as originally filed."

EPO T 0299/12 - link

Main request

3. Added subject-matter (Article 100(c) EPC in combination with Articles 76(1) and 123(2) EPC)

3.1 The description of the application as originally filed essentially corresponds to the text of the parent application as filed, wherein the claims of the parent application were designated in the present application as clauses. The discussion below relating to the application as originally filed (Article 123(2) EPC) therefore applies mutatis mutandis to the parent application as filed (Article 76(1) EPC).

3.2 In its arguments on added subject-matter, the respondent started from the composition defined by the combination of clauses 1 and 2 in the application as filed, which would establish the essential components of present claim 1, i.e. components (a) to (e). Starting from that composition, the board observes that claim 1 of the main request contains restrictions on three main aspects: firstly, claim 1 restricts the number of possible components present in the composition by the expression "consists essentially of", which limits said components to (a) to (e), water and, optionally, preservatives and cross-linking agents; secondly, the claim restricts the nature of the components (a), (c), (d) and (e) to be specifically testosterone, ethanol/isopropanol, propylene glycol and carbomer, respectively; and thirdly, the claim introduces a restriction on the concentration of the essential components (a) to (e).

The board is of the opinion that the introduction in claim 1 of said first restriction, i.e. the expression "consists essentially of", already results in the addition of subject-matter in the sense of Articles 76(1) and 123(2) EPC, for the reasons explained below.