Report of the 5th meeting of EPO PAOC (Pure and Applied Organic Chemistry) directors with epi (EPPC) members, Munich, 16th May 2017
Ruurd Jorritsma, Chair of EPPC PAOC Subcommittee
The annual EPO-epi meetings serve to discuss new developments and problems in the communication between representatives and first instance divisions of EPO in the fields of pure and applied organic chemistry, which include pharma and medical uses. Most or all of the PAOC directors participate in the meeting. epi is represented by the 12-membered PAOC group, which is a subcommittee of EPPC.
A report of the 4th meeting was present in epi information 1/2017 and at the same time epi members were invited to come up with any issues that would deserve a discussion with the EPO directors at the fifth meeting, which was held in Munich on 16th May 2017. This invitation did not result in any questions. The PAOC group itself collected some 15 topics for discussion with the EPO directors. These are summarised below.
Topics discussed at the 5th annual PAOC meeting
A. Substantive matters
1. Mechanical sub-assembly for use in connection with surgery
The question concerns application of Art. 53(c) EPC dealing with exclusion from patentability of "methods for treatment of the human or animal body by surgery ...". Is a method of operation of a mechanical sub-assembly, which itself is not invasive, for cooperation with a skin incision, excluded from patentability under Art 53(c)? If yes, why?
(Directors): It will depend on the wording of the claim. If the skin incision is part of it, then subject-matter may be excluded. If the sub-assembly is in fact a computer program or imaging, the rules for C-I-I may (also) apply. It is difficult to do examination of specific case in this discussion. Specifically, if a method claim devoted to operation of a mechanical sub-assembly for cooperation with a skin incision device necessitates surgery intervention into the body, it goes under Art. 53(c) EPC, wherein extent of intervention (serious/delicate) and need or not for assistance of professional staff has no importance.
2. Surgical/non-surgical methods
It is important for applicants to know how borderline cases are examined where G1/07 does not give a clear answer whether a method is to be objected to under Art 53(c) as relating to surgery (i: substantial physical intervention on the body; ii. which requires professional medical expertise to be carried out; and iii. which entails a substantial health risk even when carried out with the required professional care and expertise). Guidelines (G-II 220.127.116.11) are not of much help, either. Such borderline cases seem to call for assessment by a medical expert, rather than EPO examiners.
(Directors): Internal discussion of G1/07 in 2010 resulted in an Internal Harmonisation Note including a list of examples which the directorate (PAOC/Biotech) would consider to be surgical, borderline or non-surgical. The list was drawn up with external experts and is updated. It is exclusively used by examiners. Only a small part of the guidance is reflected in the Guidelines for examination. The question was discussed why (parts of) the list is not in the publicly available Guidelines, because the guidance is very useful for applicants as well (time-saving, predictability, etc.). While the directors seemed to understand the need for applicants to have access to the internal criteria as used by examiners, EPO is reluctant to publish more, because of the sacrosanct nature of the Guidelines and sufficient room should be left for case-by-case judgement. It was discussed that "Examination Matters" or dedicated workshops may be the right forum to arrange more guidance for users on where the borderline for surgical methods is set by EPO.
3. Therapeutic/non-therapeutic methods
How are cosmetic and dermatologic uses to be distinguished, where e.g. active components (not only herbal extracts) of cosmetics have an impact on the condition of skin or hair in the way medicaments have? How about unity?
(Directors): The field is evolving and there are some 50 examiners dealing with cosmetics. It depends on the effect whether cosmetic or therapeutic or both uses can be claimed. And on the prior art whether there is unity. When the cosmetic use and the therapeutic use have a common working mechanism, both can be claimed in a single application, though with different claim format. The wording of the claims is very important to differentiate the uses. There is hardly any new case law, because of the cooperative setting between examiners and applicants. The borderline mirrors the borderline between medical and food applications. Some borderline examples, such as sunscreens, sweeteners were discussed without reaching clear conclusions. It was emphasized that every case is very much context-dependent. Three possible wordings of independent claims were hypothetically mentioned: 1) A new composition comprising X; 2) A (new) composition for therapeutic use comprising X; 3) Non-therapeutic use of a (new) composition comprising X.
4. Medical use claim format before EPO as ISA/IPEA
EPO examiners dealing with international phase applications often object to Swiss-type or method claims in medical use cases, as not meeting the "required" format (EPC 2000). However there is no such required format under the PCT and a change of format can be detrimental for the efficiency of procedures in other jurisdictions.
(Directors): A warning about the methods not being allowable in the EPO is correct, but the directors agree that the PCT Guidelines, despite A9.08 (Methods need not be searched, but substances for use therein do) do not provide a basis for requiring a change in claim format, since there is no mention of Swiss-type claims not being acceptable or searchable. They will check the current practice.
(epi): The current version of the "Euro-PCT Guide": PCT procedure at the EPO (10th edition, updated until 1 January 2017) appears to contain a mistake. In fact, on the topic of excluded subject-matter (point 219) the Guide refers to its own annex IV, which in turn refers to point A9.07, option  of the ISPE guidelines, but in the current version of the ISPE guidelines (December 15, 2016) point A9.07 addresses schemes, rules or methods of doing business (and, incidentally, does not present two options, so that an option  is missing) rather than methods of treatment or 2nd medical use claims (be they in the form of Swiss-type claims or EPC2000-compliant).
epi will endeavour to send the above information to the directors so that in the next edition of the Euro-PCT Guide the above mistake may be corrected.
As regards the warning about Swiss-type claims or method of treatment claims not being in the "required" (EPC2000-compliant) format, the directors are looking for examples of EPO-ISA Written Opinions in which that warning is worded in terms that are not limited to the EPO practice, so that EPO may take steps to amend the standard language of that warning.
5. Plausibility threshold for pharma cases
There is a concern about a gradually rising plausibility threshold of medical effects, and whether it will be possible to use internal, unpublished data contemporaneous with the filing date to establish plausibility (T488/16).
(Directors): Referring to the specific case, the directors wait for the reasons for the decision by the Board in question. The decision will not necessarily imply a change in practice. Generally speaking, if the evidence is needed for plausibility, it should be incorporated in the application. The general consensus among the directors was that, if the application itself does not already make the invention sufficiently plausible, then unpublished data cannot be used to remedy that defect even if the data are contemporaneous with the filing date of the application.
6. Art. 123(2) allowability of combination of dependent claims
Some examiners are very strict in not allowing any combination of dependent claims except where they have a dependency to all preceding claims. In some cases this may be reasonable, in particular when the dependent claims refer to different embodiments. But these objections are made also in cases wherein e.g. claim 1 refers to a composition comprising a wax, a fat and an oil, claim 2 defines the wax as bees wax, claim 3 (referring to claim 1) defines the oil as olive oil, and the main claim is limited to claims 2 and 3.
(Directors): This is indeed a frequent reflex of examiners. With some variation, most of the directors would consider the example as incorrect (it should be allowable). Preferred embodiments may be combined. The notion of (selection from) lists (whether long or "of a certain length") is not always helpful. Stopgap formulations by applicants, such as "wherever embodiments or preferences are mentioned in the description, it is contemplated by the inventors that these can be combined" would be ignored by examiners. What is essential is whether there is a new teaching. It was said that the EPO is now moving from a "literal" approach to a "conceptual" approach, e.g. when considering combinations of claims, which is not always noted by users yet. The question was appreciated by the directors, because they see things moving and will have their internal discussions.
7. Art. 123(2) allowability of combination of ranges
Where the description defines a parameter as (...) more preferably 14 % to 18 %, at least 15 % of the total (...), why would a limitation to 15-18% not meet Art 123(2)? OD in case argued that 15% "may be understood to represent a minimum requirement to be fulfilled in order to arrive at a composition as envisaged by the opposed patent, irrespective of any upper limit, thus corresponding to an alternative general range. But isn't it up to the skilled person (gold standard), perhaps even to a skilled person willing to understand?
(Directors): Much the same principles and considerations as in the preceding topic. It was stressed that when assessing admissibility of combining of ranges, it is important to correlate specific ranges with specific properties. If correlated specific properties are different, than associated specific ranges then ranges cannot be combined. These days, EPO considers itself rather liberal as to ranges. An amendment of the exemplified case would be allowed, with some reservation for specific circumstances.
8. Toxic priorities
G1/15 has terminated poisonous divisionals (Art. 54.3). Do OD's (and ED's) also apply G1/15 so as to a priori deny novelty attacks based on priority documents?
(Directors): Stayed cases are now unstayed. The practice will be that A54(3) novelty attacks based on divisionals or on priority applications will be denied a priori using the conceptual approach dictated by G1/15, implying that the part enjoying priority right and the part being novel, because not enjoying priority right, are always fully complementary (in line by the way, with the epi amicus brief). Whereas the "conceptual approach" now replaces the "literal approach", there is no change in current test for "Is it the same invention".
B. Opposition proceedings
1. Conduct at oral proceedings
For the purpose of enhancing quality and efficiency of oral proceedings and without imparting the right to be heard, it could help if chairs take some more grip on the parties by indicating what they do and do not need to hear, and by keeping parties from unnecessary repetitions and elaborations. Also summons could be clearer as to what will be important to be discussed during oral proceedings and what not.
(Directors): It is difficult for chairs to improve this. Many attorneys do not listen and just go on arguing their way. The problem is with the right to be heard. Usually, a chair cannot comment on an attorney's contribution until the attorney has spoken. EPO will continue to work on training the chairs to be more confident. Chairs should give more guidance by summarising the case at the start of the hearing and point at the issues where they still need some input. This may also result in a party being reassured that his point as presented before (in writing) has been taken and does not need to be repeated, and that he can focus on the points that have not been taken yet.
2. Setting different dates in preparation of oral proceedings
Summons to oral proceedings in inter partes cases set three different dates: 1) the date for oral proceedings, 2) the date for written submissions and 3) the date for informing about language. Why not combine 2) and 3)?
(Directors): The dates are set under different rules and procedures for formalities and therefore cannot be adjusted without changing the rules and procedures, which is quite far-reaching. EPO will nevertheless look at it and see whether any harmonisation can be achieved.
3. Late filed documents and requests: fairness to the other party
Late filing of documents is generally unfair on patentees more than on opponents. A patentee may have an answer to a new document but may not have time to formulate the answer at the oral proceedings. It is not always possible to deal with the new documents by filing Auxiliary Requests - drafting on the fly during oral proceedings is not easy. New documents can also be a problem for opponents: if the patentee files a new document alleging that it shows data proving inventive step, it may be difficult for the opponent to show that the data are flawed or not persuasive. It seems therefore to be a good idea to discuss again the criteria for allowing new documents and requests into the proceedings at a late stage.
(Directors): Test results, auxiliary requests etc. are really a problem when filed at a late stage. More robustness in handling such late filings is needed. Test results (which may take a long time to be prepared) may have to be distinguished from other documents which can instead be filed upfront (i.e. with the opposition briefs for the opponents, with the observations to the oppositions for the patentee). The EPO directors also rely on the principle that any late filed document which is not more relevant than what has been filed upfront, should not be admitted into the proceedings.
4. Time limits in shortened opposition proceedings
While the recent time reduction is appreciated, the time between a response to a notice of opposition and summons may become too short, such as two weeks or so, and this can be a problem e.g. in the event of auxiliary requests.
(Directors): EPO agrees that the parties may have a problem, but this is the consequence of the accelerated system. This is the way we go, not waiting until all parties have taken their additional responses. The opportunity to comment on the comments was expressly removed.
C. Procedural matters
1. National prior rights affecting European patents with Unitary effect
Is there any preparation for top-up searches in view of the UP/UPC entering into force at the end of this year so as to reveal potentially damaging national prior rights (Art. 3. EU Reg 1257/2012)?
Yes, EPO will carry out top-up searches for national prior rights, using automatic translation where necessary. No arrangements have been made yet as to how the searches will be done. To the extent that national patent publications are full prior art, and thus relevant in the present system, these are included in standard searches already.
2. Introduction of statements in the R71.3 text by examiners
Some examiners introduce statements about allegedly "closest" prior art into the description when issuing an allowance. Statistics show that this happens quite frequently, in about 1% of all applications, though varying from one technical field to another. This is not only questionable under Art. 123(2), but may also be detrimental for the patent later on.
(Directors): EPO agrees that this is undesired. The PAOC examiners are not known to do this, and they will be instructed that it should not be done. Users should send EPO a message if they do not want amendments, because examiners sometimes think that applicants appreciate proposed amendments by examiners. (epi): proposed amendments are fine, but not at the R71.3 stage. Amendments are preferably (epi) discussed in telephone consultations, and the result should always be confirmed in minutes to be sent afterwards. epi has forwarded statistics about "closest prior art" initiatives by examiners.
3. Preliminary Opinions
Examining Divisions and especially Opposition Divisions should have a much higher awareness of the impact of preliminary opinions on national litigation, particularly when those opinions are being rushed out to meet the new tighter timelines. As an example a preliminary opinion which could be read as a mature opinion on novelty or inventive step runs the risk of being understood by a court as a high-rank decision-like statement which can hardly be modified even with arguments and evidence not available to the division issuing it.
Point taken that it would be wiser to state e.g. "novelty may need to be discussed in view of D1" rather than "the claim may lack novelty over D1".
4. Third Party Observations
Despite all general reassurances to the contrary, TPO's are often dealt with seriously only if they have clear novelty implications. Violations of the EPC raised by third parties before grant that cannot be addressed after grant, in particular clarity and breadth of claims, should especially be taken seriously.
In the directors' opinion, TPO's are being taken seriously in all aspects. They agree that there should be an argued case about the objections. The objections are taken into account in the recommendation for grant ("votum"); however, these are not accessible to the public. In epi's view, this should in one way or the other be visible to the (third) parties, perhaps already when passing the TPO to the applicant. EPO will look into how to show to the public that the TPO's objections have been taken into account. Mr. Mercer will send examples of cases where there is no trace of the examiner taking the issues of (serious) TPO's.
D. Topics presented by EPO
1. Amendments (1)
Would it help if the examiner indicated more precisely what needs to be excised from the description or at least indicated as falling outside the scope of the invention (for ex. among the examples)?
epi: Yes, it would, and preferably at a stage preceding allowance, so that the applicant can choose the most appropriate formulation. Most representatives nowadays are not in favour of deleting any examples, since in one way or the other they may become relevant later on. By simple annotation, it can be clarified that the examples as such are no longer covered by the accepted claims, while parts thereof may still be needed for support or sufficiency of disclosure.
2. Amendments (2)
What do you think of the proposal of not modifying passages in the description related to a "Method of treatment" (typically US applications) as it is obvious that a method of treatment cannot be claimed and thus not serve as a basis of such an amendment?
Issue was discussed under topic A.4 above. It was agreed that there is no need to modify the references to "method of treatment" and that these can be understood as providing basis for "use in treatment".
The meeting was, as usual, very constructive and open. While the EPO directors are naturally somewhat reluctant to express opinions on specific cases, they show a willingness to explain their motivations and practices and to at least try to understand the problems that representatives sometimes experience at the interface between the office and the users. Both sides appear to be increasingly open in looking for practical solutions.
To be continued again.