NATIONAL JUDGES' PRESENTATIONS
Recent developments in European and national patent law and case law
EPO European Patent Office
Lawyer, Legal Research Service of the Boards of Appeal, European Patent Office
Recent developments in the case law of the boards of appeal of the EPO
Ladies and Gentlemen
The task of summarising the case law of the boards of appeal over the last two years is an impossible one. For an overview, I would like to refer you to two publications – one is the book about the case law of the boards of appeal and the other is its update: the supplementary publication of the Official Journal that was sent to you a few weeks ago. As these publications are the work of my department I am always happy to receive comments, suggestions and, of course, criticism.
For this brief talk I have chosen the following three areas which, I hope, will be of interest to you: firstly, clarity of claims in opposition proceedings; secondly, two cases on patentability issues in the biotech area, and lastly, a recent case concerning possible double-patenting and Swiss-type claims.
I. Clarity of claims in opposition proceedings – referral to the Enlarged Board of Appeal
Let us start with clarity of claims in opposition proceedings. Decision T 373/12 from April 2014 referred questions of law to the Enlarged Board of Appeal. The referral is pending as G 3/14. The answers of the Enlarged Board, whatever they are, will have a considerable effect on opposition and opposition appeal proceedings.
The issue is this: Under Article 84 EPC the claims must be "clear and concise and be supported by the description". Clarity is thus examined by the examining divisions pre-grant. Post-grant, the ability to raise issues of clarity in opposition proceedings was usually considered to be limited. The principal reason for this is that clarity is not a ground for opposition. As you know, it is also not a ground for national revocation under Article 138 EPC. The only circumstance in which clarity could traditionally be raised in opposition proceedings was where amendments were made in the course of such proceedings which gave rise to a new problem of clarity, i.e. one which did not previously exist. In such cases clarity was examined in compliance with the EPC (Art. 101(3)(b)) to ensure that a patent as maintained met all the requirements of the EPC. The Enlarged Board said in one of its earlier decisions, G 9/91, that "...in cases of amendments of the claims or other parts of a patent in the course of opposition or appeal proceedings, such amendments are to be fully examined as to their compatibility with the requirements of the EPC."
Much of the case law of the boards of appeal on the role of Article 84 EPC in opposition proceedings is concerned with identifying what types of changes to the claim wording open the door for an opponent to raise issues of clarity. In the past it has usually been held that an examination of clarity is only possible in the case of an amendment which is substantial in the sense that it introduces a technically meaningful amendment to a claim's content over the granted claims. A mere combination of the wording of granted independent and dependent claims was not understood to be a substantial amendment which permitted the examination of clarity. This conclusion was based on the reasoning that such an amended claim was in substance a granted claim, in respect of which clarity was not a ground of opposition.
A decision reached in December 2012 came to a different conclusion. In T 459/09 the board held that clarity of an amended claim could, in principle, be examined, even if the amendment only consisted in a literal combination of claims of the patent as granted. The board regarded the distinction between "substantial" and "non-substantial" amendments as problematic and argued that all amendments made in opposition proceedings were necessarily substantial (otherwise they would not and could not have been made) and thus permitted unrestricted examination of clarity. The decision was followed in T 409/10.
In T 1459/05 the board held it could examine the clarity of a feature introduced into an independent claim as granted taken word for word from a dependent claim as granted. In the board's view there could no longer be an unqualified assumption that all the features of the dependent claims of a granted patent had been systematically examined for compliance with Article 84 EPC during the grant procedure.
Because of this divergent case law the board of appeal in T 373/12 referred the following questions to the Enlarged Board of Appeal:
1. Is the term "amendments" as used in decision G 9/91 to be understood as encompassing a literal insertion of (a) elements of dependent claims as granted and/or (b) complete dependent claims as granted into an independent claim, so that opposition divisions and boards of appeal are required always to examine the clarity of independent claims thus amended during the proceedings?
2. If yes, is then an examination of the clarity limited to the inserted features or may it extend to features already contained in the unamended independent claim?
3. If the Enlarged Board answers Question 1 in the negative, is then an examination of the clarity of independent claims thus amended always excluded?
4. If the Enlarged Board comes to the conclusion that an examination of the clarity of independent claims thus amended is neither always required nor always excluded, what then are the conditions to be applied in deciding whether an examination of clarity comes into question in a given case?
Given that the answers to these questions will have a considerable impact on opposition and opposition appeal proceedings, this case has been given priority. It will be put online as soon as it comes out. If you want to be kept up-to-date on new cases you can subscribe to an RSS feed.
II. Exceptions to patentability and biotechnology: cases concerning human embryonic stem cells
Let us move to exceptions to patentability and biotechnology. The first case I would like to highlight is T 2221/10. It was decided in February this year and follows the decision of the CJEU in the Brüstle case. As you know, patents may not be granted if the invention concerns "the uses of human embryos for industrial and commercial purposes" – this is Rule 28(c) EPC in conjunction with Article 53(a) EPC.
In the case mentioned here, claims 1 and 2 of the appellant' sole request referred to methods of maintaining human embryonic stem cells – in short HES cells – in culture in an undifferentiated state. Claim 5 referred to a cell culture comprising HES cells. The explicit wording of the claims deliberately avoided a step of obtaining HES cells by the use, involving their destruction, of human embryos. According to an embodiment commercially available HES cell lines could be used for putting the invention into practice. The appellant argued that methods using commercially or otherwise publicly available HES cell lines were not excluded from patentability, because to perform them no de novo destruction of human embryos was necessary.
The board disagreed. The invention was excluded from patentability (under Article 53(a) EPC in conjunction with Rule 28(c) EPC), because the commercially available HES cell line on which the invention relied had been originally produced by a method involving the destruction of human embryos. The board referred to G 2/06 as authority for the proposition that, for the purposes of Rule 28(c) EPC, all steps preceding the claimed use of HES cells which are a necessary precondition for carrying out the claimed invention have to be considered. It is immaterial for this consideration whether the steps have been carried out by the inventor or another person. It is also immaterial whether the steps took place in direct preparation of the experiment leading to an invention or whether they took place at a time further remote from these experiments.
So in a nutshell the case can be summarised as follows: Inventions which make use of publicly available human embryonic stem cell lines which were initially derived by a process resulting in the destruction of the human embryos are excluded from patentability.
The second case which involves embryonic stem cells and which may be of interest is T 1836/10. Claim 1 was directed to a method for isolating pluripotent embryonic stem cells without destroying the embryo. The base material used in the method was blastocysts. In order to avoid the exclusion from patentability, the applicant included in claim 1 a disclaimer. This disclaimer excluded the stem cells' industrial or commercial use if the blastocyst used was human. The board had to decide whether this disclaimer indeed restricted the claimed subject-matter in such a way that it no longer fell under the exclusion of Article 53(a) in conjunction with Rule 28(c) EPC.
The board held that the disclaimer did not limit the subject-matter of the claim in any way, as the disclosed possible future use of the stem cells was not even covered by the scope of the claim. The disclaimer was, therefore, not allowable with regard to the requirements of Article 123(2) EPC. Consequently, the subject-matter of the claim, which also after the introduction of the disclaimer referred to the use of human embryos as base material in an industrially applied method for isolating embryonic stem cells, was to be regarded as "use for industrial or commercial purposes" which was excluded from patentability.
III. No double patenting: Swiss-type claims and Article 54(5) EPC claims
I would now like to move to my last topic. Article 54(5) EPC, which was introduced with the EPC 2000, replaced the Swiss-type claim format for second medical use claims. Given that a claim formulated under Article 54(5) EPC is a product claim and a Swiss-type claim is a process claim, it was not entirely clear to what extent the legislator's intention that Article 54(5) EPC matches as closely as possible the scope of protection conferred by a Swiss-type claim could be achieved.
In T 1780/12 the board examined in the context of the issue of double-patenting whether the subject-matter and the scope of protection of a claim formulated under Article 54(5) EPC were the same as those of a Swiss-type claim.
The facts were as follows: the application was a divisional application where the claims were formulated under Article 54(5) EPC. They were directed towards the second or further therapeutic use of a substance or composition. The parent application, which had been granted, contained Swiss-type claims directed towards the same therapeutic use of the same substance or composition.
The examining division held that the claims of the parent and the divisional applications were directed towards the same subject-matter "in the sense that both these claims concern the same invention claimed in a different format." It refused the application on the basis that double-patenting was prohibited.
The board allowed the appeal against this decision and held that there was no double-patenting. The prohibition of double-patenting meant that no second patent may be granted for the same subject-matter for which a patent has already been granted (G 1/05, G 1/06). It followed from decision G 2/88 that the category of claim and its technical features constitute its subject-matter and determine the protection conferred.
The claims in question were of different categories: Swiss-type claims are purpose-limited process claims and claims formulated in accordance with Article 54(5) EPC are purpose-limited product claims. As regards the technical features, both sets of claims defined the same compound and the same therapeutic use, but the Swiss-type claim comprised in addition the manufacture of a medicament whereas the claim in accordance with Article 54(5) EPC did not. The claimed subject-matter was thus different. This outcome has been followed in a very recent decision (T 879/12).
As regards the scope of protection the board referred to the generally accepted principle underlying the EPC that a claim to a particular physical activity such as a method, process or use conferred less protection than a claim to a physical entity per se. It followed that a purpose-limited process claim, such as a Swiss-type claim, also conferred less protection than a purpose-limited product claim, such as a claim in accordance with Article 54(5) EPC.
The board was at pains to emphasise that its assessment had to be distinguished from an assessment under Articles 76(1), 123(2) and 87 EPC where the whole content of the application has to be considered.
That brings me to the end of my brief talk about the highlights of the case law of the boards of appeal in the last year or two.
Thank you very much for your attention.