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Report of 2015 EPO Meeting 1

R E P O R T O F E P O - F I C P I M E E T I N G , O C T O B E R 2 0 1 5

Working Lunch hosted by EPO President Battistelli Mr. Benoît Battistelli President Mr. Raimund Lutz Vice President, Legal/International Affairs Mr. Niclas Morey Director, International Organisations, Trilateral and IP5 Ms Heli Pihlajamaa Director, Patent Law Mr. Alfred Spigarelli Director, Patent Procedures Management Meeting hosted by Vice-President Raimund Lutz Mr. Raimund Lutz Vice President, Legal/International Affairs Mr. Niclas Morey Director, Int. Organisations, Trilateral and IP5 Ms Heli Pihlajamaa Director, Patent Law Mr. Alfred Spigarelli Director, Patent Procedures Management FICPI Delegation (at both meetings) Mr. Douglas Deeth President Mr. Jürgen Schmidtchen Deputy Secretary General Mr. Didier Intès President of Training & Education Commission (TEC) Mr. Antonio Pizzoli Chair of CET 4 Mr. Robert Watson Vice-President, Work and Study Commission, Europe Members

Commission

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Report of 2015 EPO Meeting 2

Lunch meeting hosted by EPO President

1. Signing of MoU re: EPO Funding of SEAD Course

At the commencement of the meeting, Mr. Benoît Battistelli and Douglas Deeth signed a Memorandum of Understanding providing substantial EPO funding for FICPI’s training courses in patent drafting. Under this MOU, the EPO has agreed to provide funding to assist the operation of FICPI’s SEAD course in South-East Asia over the next three years (2016-2018), as well as funding to assist in the start-up of a similar course in South America.

2. Update on EPO

Benoît Battistelli warmly welcomed the FICPI delegation and gave us a short overview of the EPO activities.

On geographical scope, he referred to the validation state approach, and the agreement signed with Moldova the previous day. Tunisia will be the next validation state (probably in early 2016), and the EPO is talking to states in Asia, Latin America and Africa about further agreements. Morocco is heading for a 5 fold increase in patents per annum due to the validation agreement.

The EPO has focussed its efforts on improving patent quality, and there has been an increased perception of quality recently. The quality control is carried out by checking a sample (5%) of all files and by systematically verifying all positive search reports before sending them to the applicant. Quality indicators are also regularly published. The EPO is seeking certification of the quality of its Patent Information Services.

With restricted budgets and an increasing workload, effort has also been placed on increasing production and productivity, as can be seen from the attached information (Annex A attached) provided in the meeting. Work products are either Search Reports, or final decisions in Examination or Opposition. While no increase in fees or staff is envisaged, the backlog is being reduced, also by aiming to motivate the staff (through a performance system instead of relying only on seniority) and by creating new “worktools”.

The success of the CPC was also discussed (see below) with 19 Offices now participating.

The EPO is carrying out about 40% of International Searches under the PCT, and about 55% of the International Examinations. The International Search fee is being frozen for a further two years.

The EPO would welcome signing more bilateral, but not multilateral, PPH agreements (with an agreement with AU having been signed the day before).

3. Unitary Patent

Mr. Battistelli welcomed the progress towards implementation of the Unitary Patent, and said that the EPO are happy with the Top 4 solution for renewal fees. The distribution key for these fees between the National Offices is to be discussed very soon.

Regarding FICPI’s resolution in Cape Town (EXCO/ZA15/RES-004) that appropriate legislation should be in place to regulate the grant of an SPC for a Unitary Patent, the EPO are ready to help but await legal developments.

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Report of 2015 EPO Meeting 3

4. Update on the reform of the Boards of Appeal

It is likely that a decision on the Disciplinary matter with a Board of Appeal member will be taken at the upcoming Administrative Council meeting. The EPO expect the ongoing reform process to be concluded by next spring, with a physical separation of the Board of Appeal from the management and Examiners of the EPO being seriously considered – Berlin and Vienna are being considered. FICPI submitted a response to the public consultation on this issue in June 2015 (EPO Boards of Appeal).

Meeting hosted by Vice-President Raimund Lutz

1. Pharmaceutical Patenting

FICPI resolved in Cape Town (EXCO/ZA15/RES-001) that follow on patents in the pharmaceutical area should be treated in the same way as other applications, and in particular that:

relevant authorities at a regional and/or national level to refrain from introducing any new restrictions in their laws, practices and/or regulations and to remove any existing restrictions concerning the patentability of inventions on a known or patented pharmaceutical active principle

relevant authorities at a regional and/or national level to implement their laws, practices and/or regulations in order to achieve a competent, strong and consistent patent examination process as well as a reliable, predictable and affordable patent enforcement and invalidation system, equally with respect to both previous and follow on patent rights

This resolution arose out of a session involving originators, generics, and those in interested in public health – patent laws were seen as not being the correct tool for ‘political’ goals relating to medicines and health.

The FICPI delegation explained that we understood the EPO is in line with our resolution, and that our point in raising it with them was to help influence other jurisdictions.

Heli Pihlajamaa agreed that the EPO is in line with the resolution, not only offering protection for the use of compounds for further diseases, but also for dosage regimens, patient groups and the like. The EPO is active in training on this issue and understands FICPI’s position.

2. Patent figures in colour

FICPI resolved in Cape Town, (EXCO/ZA15/RES-005), that it should be possible to file patent applications and publish patent applications and patents with colour figures, given the advances in technology and the elimination of paper publications. Allowing the use of colour figures would be a means to providing a better understanding of the inventions disclosed.

Heli Pihlajamaa said that although r.46 EPC currently prevents the use of colour drawings, this topic is under active consideration in the PCT system, at the MIA (Meeting of International Authorities) with an outcome envisaged in about two years from now. The EPO consider it important that international standards are agreed on how to handle drawings first, such that the actual colours are accurately reproduced, before accepting these at the EPO. They are, however, actively pursuing this issue.

It was commented that the EPO can currently store and use colour documents, but that these can’t be seen in the online file inspection system.

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Report of 2015 EPO Meeting 4

3. Double Patenting

FICPI resolved in Barcelona, (EXCO/ES14/RES-003), that double patenting prohibitions should be narrowed to prohibit only claims that have identical scope in co-pending applications and/or patents that have been filed by the same applicants, with the same effective filing date.

Heli Pihlajamaa gave a brief presentation on this issue (see Annex B attached) to convey the message that the EPO is also in line with FICPI’s position in this regard. This topic is also part of the Group B+ harmonisation work (see below)

4. Patent Harmonisation

The FICPI delegation introduced FICPI’s continued involvement in the Patent Harmonisation process through, for example:

Our White Papers, on key issues: o Grace Period - FICPI/WP/2013/001 o Prior User Rights - FICPI/WP/2015/001

Our Submission on the IP5 User Consultation

Our attendance at the recent Group B+ meeting in Geneva on patent harmonisation

Niclas Morey explained that they consider to be three streams of ongoing work:

Technical harmonisations, such as the Global Dossier, the Common Citation Document (CCD) and the Collaborative Patent Classification (CPC)

Procedural – the list of topics for consideration under this heading came from industry, and were agreed by the IP5 in Trieste. The list is:

o Unity of Invention – led by EPO & SIPO o Citation of prior art – led by USPTO o Written description/sufficiency of disclosure – led by JPO

The group considering this planned to meet in the US at the end of October.

On Unity of Invention, all the IP5 countries agree to apply the international standard to PCT derived cases, and the members except the US agree the standard should be applied to all cases. The USPTO is not in a position to change their national restriction practice, but this is likely only a matter of timing.

On citation of prior art, this project is currently moving forward with a technical IT solution based on the Common Citation Document (CCD), with possibly a non-public phase version of this system. The USPTO are prepared to look at the IDS requirement again.

On Sufficiency of disclosure, the EPO stated that they are looking into this and may have a symposium as the practices vary to give clear guidance for the examination.

At the Group B+ meeting, work streams for various issues were agreed as follows:

1. Grace period, to be chaired by the EPO 2. Conflicting Applications, to be chaired by the USPTO 3. Prior User Rights, to be chaired by the JPO

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4. Implementation stream, to be chaired by the Hungarian Patent Office (to consider whether, for example, a treaty would be the right approach)

It was also noted that Group B+ would prefer work on substantive harmonisation to be done in international forum, with user involvement, rather than in Trade Agreements (such as TTIP).

5. Rule 141 EPC

The FICPI delegation introduced two concerns over the application of Rules 141 EPC and 70b EPC, which relate to the filing of the results of any search carried out on a priority application.

One issue is the limited list of countries with whom the EPO have an agreement to gather the results automatically, which avoids the applicant taking any action. The EPO is working to increase this list, and it is likely that Switzerland and the Czech Republic will join soon.

The second issue is that the issuance of one of the actions creates costs for applicants, as in many cases there are no results to be filed. The EPO promised to look into the statistics on positive replies to these communication, and also to consider whether an optional question could be added to the Form 1200 (for PCT Regional Phase Entry).

6. Update on Early Certainty from Search (ECfS)

Alfred Spigarelli gave an update on this EPO project (see Annex C attached), which is seen as a way of reducing the EPO’s backlog in a logical manner and in handling new cases in an efficient manner.

Regarding third party observations, the handling of anonymous third party observations is at the discretion of the Examiner. If acceleration of the case is desired, the observations have to be in someone’s name. Examiners do appreciate 3rd party observations. 80% of third party observations are found by Examiners to be useful and 50% cause them to change their opinion.

PACE is being reformed to make it more reliable, and we should expect an announcement on this soon. It is also vitally important for attorneys to track PACE requests, and say if they are not happy with the results.

The FICPI delegation asked whether the EPO is considered or has considered that the introduction of the Unitary Patent system (with its low renewal fees in early years) would cause more applicants to request accelerated prosecution.

7. The EPO Global Dossier

Niclas Morey gave a presentation on the progress of this system.

It was useful to learn (or be reminded) that the Global Dossier is available both through the EP register and also Espacenet, which is useful if there is no EP case.

Thought is being given how to advance this project, with five topics being prepared for consideration:

Alerts

Text Based Documents

Applicant Name Standardisation (the same name and address on all registers)

Legal Status Standardisation

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Report of 2015 EPO Meeting 6

Cross filing proof of concept o This could include at this stage the options to change addresses across all offices or

to record assignments across offices

8. Extra Topics

The FICPI delegation mentioned the issues caused by the EPO’s new Druckexemplar procedure, handing over a particular egregious example. We were given the impression that this type of problem is being considered.

The FICPI delegation also mentioned a noticeable increase in 2 month deadlines set for substantive issues – the EPO explained this shouldn’t happen, and agreed that we should raise these issues.

Robert Watson Vice-President CET

[End of document]

Heli Pihlajamaa 8 October 2015 Director, Directorate Patent Law

Prohibition on double patenting under the European Patent Convention

European Patent Office

Prohibition on double patenting

• No explicit provision in the EPC dealing with the prohibition on double patenting

• G 1/05 and G 1/06 accepted in obiter dictum that the principle of

the prohibition on double patenting exists on the basis that an applicant has no legitimate interest in proceedings leading to the grant of a second patent for the same subject-matter if he already possesses one granted patent for that subject-matter

• G 2/10 mentioned the prohibition on double patenting

• T 2461/10 considered that the legitimate interest in the

proceedings is a generally recognised principle of procedural law within the meaning of Article 125 EPC

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European Patent Office

No objection on double patenting ...

... should be raised in the following cases:

Broader or stricter subject-matter

(see T 587/98, T 1391/07, T 1491/06, T 2402/10, T 2461/10, G 2/10)

Partially overlapping subject-matter (see T 877/06)

(see T 877/06, T 1391/07, T 1491/06)

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granted patent

pending application

pending application

granted patent

pending application

granted patent

European Patent Office

No objection on double patenting (cont)

• A product and its use, or a product and a method for its

manufacture (see T 1766/13 and T 1765/13)

• Claims formatted under Article 54(5) EPC and Swiss-

type claims directed to the same second or further therapeutic use

(see T 1780/12 and T 879/12)

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European Patent Office

Conclusion

• The prohibition on double patenting applies in the grant proceedings before the EPO: The applicant has no legitimate interest in proceedings leading to the grant of a second patent for the same subject-matter

• An objection on double patenting should only be raised

when the subject-matter claimed in the conflicting applications is identical – A product and its use, or a product and a method for its

manufacture are not “the same subject-matter” – Purpose-limited process claims and purpose-limited product

claims also claim different subject-matter

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Mr Alfred Spigarelli 8 October 2015

Early Certainty from Search Setting operational priorities for improving timeliness with focus on users interests

Early Certainty from Search (ECfS) Maximise legal certainty in Europe on pending patent applications by

optimising the use of available examiner resources. Review examiners workflow management, i.e. (re)define priorities for

examining patent applicants with an aim of providing the key information to all users of the patent system as early as possible,

Early Certainty from Search in a nutshell: − Issue all searches with opinion on time (about 6 months after file

reception) − Finish already started examination files instead of starting new cases − Issue direct grants shortly following a positive search opinion − Fast track examination for 3rd parties (not anonymous and substantiated

observation)

PACE still in top priorities with stricter compliance to committed time line

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ECfS Priorities

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Priority 1: MUST BE DONE ON TIME

First filings searches − Search for First Filings (National, EP, PCT Chapter I

and PCT Supplementary International Searches) − Divisional applications not claiming a priority

PCT Chapter I second-filings searches

Searches with committed dates: − Searches with request for acceleration (PACE) − Searches with promised date (reply to enquiry)

PCT Chapter II examination Opposition, Limitation, Revocation Second filings searches − A1 publications for all EP second filings − Divisional applications claiming a priority

Euro-PCT supplementary searches

National second filings

Fast track examination − Direct Grants after positive written opinion or positive

International Preliminary Examination Report − Examination files with request for acceleration (PACE) − Examination files with promised date (reply to enquiry) − Examination files with non-anonymous and

substantiated third party observations

Priority 2: finishing started examination files

− Further examination actions (except for PACE files)

Priority 3: starting new examination files − First examination actions (except for PACE files)

Priority 4: Search backlog on 01/07/2014 (to be dealt when sufficient capacity is available) − EP second-filings which have been published without

a search report (A2) before 01 July 2014 − Euro-PCT supplementary searches which are overdue

on 01 July 2014, i.e. already later than 6 months after the receipt of the reply to the Rule 161 communication (opportunity to amend)

Optimum match between society and offices interests

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Maximum legal certainty – RtB philosophy

Better for applicants (early search results and no rush to start examination)

Better for the public (overview on prior art and patentability very early)

No blind spots in European IP

(Euro-PCT with ISA≠EPO searched on time)

Applicants and third party can

accelerate procedure on sensitive cases

Enhance service to users (similar time limits for examiners' replies to applicants' submission as for applicants' replies to examiners communication)

Efficiency in Examination (once

started, examination completed speedily with enhanced applicant's cooperation)

Reward for applicants filing high quality

applications (quick grant after positive search opinion)

At least neutral for production and

improved control on EPO workload

Application Pendency All search reports issued within 6 months after reception: EP 1st filings: 6 months after filing date PCT Chap. I: 3 months after reception of search copy EP direct 2nd filings: A1 publication at 18 months Euro-PCT with EPO not ISA: Supplementary EP search 6 months after entry

into regional search or after reply to Rule 161 communication (which ever is the latter)

Old applications with long overdue search (See side 3, Priority 4) searched within 6 months in case of accelerated prosecution (see next slide)

Further examination actions: target set at 4 months after applicants reply

1st communication of examining division: issued 26.9 months after the start of the EP grant procedure (2013 median) →May be delayed in future, however issued within 3 months in case of accelerated prosecution (see next slide)

Final decisions: 41 months after start of the grant procedure (2013 median)

Should not significantly change apart for grants after positive search opinion (4 months after allocation to division)

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Users driven accelerated prosecution Acceleration from applicants: Since 1 July 2014, all search reports and written opinions issued in 6

months.

PACE (EPO fast track procedure) requested for about 7% applications (7600 for search and 12600 for examination)

In examination: After a PACE request, a communication should be issued within 3 months from request reception (5,9 months current average)

Patent Prosecution Highway filings are treated according to PACE

Acceleration from third parties: Since 01/07/2014 applications for which not anonymous and substantiated third party observations have been filed are treated according to PACE (75% considered useful by examiners and 50% resulted in restriction or refusal) Acceleration of direct grants after positive search opinion: R. 71(3) communication issued 4 months after allocation to division

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ECfS timeliness – priority 1

Priority 1 backlog: • ECfS start: 40000 • August 2015 value:

22860 (slight seasonality increase)

• Estimation September 2015: below 20000

• Target 2015: 5000

Significant decrease of the priority one backlog since ECfS start 1st of July 2014

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ECfS timeliness – PCT Chap I and PACE

Accelerated files (PACE) backlog: • ECfS start: 5425 • August 2015 value: 3386 • Target 2015: 500

Decreasing steadily, small seasonality increase in August

Percentage of ISRs, where the dossier is received on time, delivered in time for A1 publication: • July 2015 value: 87,1% Timeliness based on Rule 43.1 PCT: • August 2015 value: 83,2 % • Target 2015: 85 %

Substantial improvement

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ECfS is producing the expected results

Priority 4: • ECfS start: 73069 • May 2015 value: 46731 • Target 2015: 61000

Already ahead of plan

ECfS is a challenging and aggressive policy or improving timeliness according to applicants wishes with a fair balance with public interests.

Roughly a year after its introduction there are tangible evidences that EPO is walking the talk.

2015 is still a transition year. Once priority 1 backlog reaches the 5000 target, then focus will be set

on clearing the examination backlogs Priority 4 not forgotten and rapid progress achieved evidencing that

this priority group is a buffer and not the elephants cemetery

European Patent Office

Need more information?

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or mail me at aspigarelli@epo.org

European Patent Office 11

Thank you for your attention