1. Patent strategies in Europe
Dr Ulrich Storz, Michalski Hüttermann & Partner
Dr Golo Henning, Siemens AG
Rachel Wallis, Withers & Rogers LLP
Moderator: James Nurton, Managing IP

2. Structural changes in the EP System
M I C H A L S K I H Ü T T E R M A N N
P A T E N T A T T O R N E Y S
Structural changes in the EP System
Ulrich Storz, PhD, MSc. Biol.
German and European Patent Attorney
Senior Partner at Michalski · Huettermann & Partner, Duesseldorf

3. Agenda London Agreement EPC 2000
M I C H A L S K I H Ü T T E R M A N N
P A T E N T A T T O R N E Y S
Agenda
London Agreement
EPC 2000
Subsequent amendments of the anxillary regulations
Community patent
Ulrich Storz – Michalski · Huettermann & Partner

4. London Agreement Waiver of post-grant translation requirement
M I C H A L S K I H Ü T T E R M A N N
P A T E N T A T T O R N E Y S
London Agreement
Waiver of post-grant translation requirement
Biggest cost factor of EP patents is thus reduced
Most important EP member states (i.e., UK, DE and FR) have signed the agreement, whereas less important (i.e., IT, ES, PL) have not
Number of waiver states will increase (word is that, among others, IT and AT will sign soon)
Ulrich Storz – Michalski · Huettermann & Partner

5. London Agreement Ulrich Storz – Michalski · Huettermann & Partner
M I C H A L S K I H Ü T T E R M A N N
P A T E N T A T T O R N E Y S
London Agreement
no translation at all
only claims DE LT UK LV FR
DK* CH
SE* LU
HR* MC SL
(IE)*
IS*
(MT)*
NL*
211 million citizens
43,5 million citizens
36,6 % of population of all EP member states
7,5 % of population of all EP member states
46 % of GDP of all EP member states
8,64 % of GDP of all EP member states
*if spec is in English
Ulrich Storz – Michalski · Huettermann & Partner 5

6. London Agreement Came into force May 2008
M I C H A L S K I H Ü T T E R M A N N
P A T E N T A T T O R N E Y S
London Agreement
Came into force May 2008
Competition among EP patent law firms has increased
In most states no national representatives are necessary; law firms start to offer one-stop-services with package fees
Cost disadvantage compared to US and JP will decrease
Highest benefit if specification is in English, thus importance of English as patent language will rise
Ulrich Storz – Michalski · Huettermann & Partner

7. M I C H A L S K I H Ü T T E R M A N N
P A T E N T A T T O R N E Y S
London Agreement
In many cases it makes sense to validate a patent only in signing states (46 % of GDP with no translations at all)
In pharmaceuticals, however, reimportation problem occurs due to EEA-wide patent exhaustion principle
Here, EP blanket coverage is mandative
Translation into national language may be necessary in case of legal action
Ulrich Storz – Michalski · Huettermann & Partner

8. EPC 2000 Came into force Dec 2007 Applicable in all EPC member states
M I C H A L S K I H Ü T T E R M A N N
P A T E N T A T T O R N E Y S
EPC 2000
Came into force Dec 2007
Applicable in all EPC member states
Whenever possible applicable to pending applications, but transitional regulations available
Harmonization with TRIPS and PLT
Legal framework for the “raising the bar campaign”
Ulrich Storz – Michalski · Huettermann & Partner

9. M I C H A L S K I H Ü T T E R M A N N
P A T E N T A T T O R N E Y S
EPC 2000
Requirements for obtaining a filing date are reduced (no claims necessary, any language possible)
Formal requirements for claiming a priority are reduced (re-establishment into priority term possible, priority claim can be corrected, missing documents in 2nd filing can be handed in later if already comprised in the priority application)
1st filing from a WTO member state is accepted as priority application, even if not a Paris convention state
Ulrich Storz – Michalski · Huettermann & Partner

10. EPC 2000 – key amendments Attorney-client privilege (Art 134a(1)d)
M I C H A L S K I H Ü T T E R M A N N
P A T E N T A T T O R N E Y S
EPC 2000 – key amendments
Attorney-client privilege (Art 134a(1)d)
post-grant limitation procedure (Art 105a)
IDS-like procedure (Art. 124; R. 141), but less strict than in the US (i.e.: EPO will retrieve parallel search reports which are available online by itself; no “duty of candor”)
Ulrich Storz – Michalski · Huettermann & Partner

11. EPC 2000 – claim fees Claim fee (200 € ) for each claim exceeding 15
M I C H A L S K I H Ü T T E R M A N N
P A T E N T A T T O R N E Y S
EPC 2000 – claim fees
Claim fee (200 € ) for each claim exceeding 15
Claim fee (500 € ) for each claim exceeding 50
Page fee (12 €) for each page exceeding 35
flat designation fee for all contracting states (500 €)
Ulrich Storz – Michalski · Huettermann & Partner

12. M I C H A L S K I H Ü T T E R M A N N
P A T E N T A T T O R N E Y S
New Search Policy
Non unity a posteriori: If claim 1 is found unpatentable, EPO stays the search, objects unity, defines groups of “sub-inventions” and requires additional search fees (two months time limit)
Assignee must decide which subinventions he wants to pursue further
Assignee can not refer to unsearched matter during prosecution, has to file divisional applications in such case (cave: restricted term for divisionals under new R. 36)
Ulrich Storz – Michalski · Huettermann & Partner

13. Need to response to ISR/EESR
M I C H A L S K I H Ü T T E R M A N N
P A T E N T A T T O R N E Y S
Need to response to ISR/EESR
From April 2010, applicant must respond to ISR/EESR (i.e., address objections made therein)
For EP regional phases where EPO was ISA, time limit is only one month after respective communication (R. 161/162)
ISR should be studied and a response be prepared, if possible, prior to regional phase entry
Ulrich Storz – Michalski · Huettermann & Partner

14. M I C H A L S K I H Ü T T E R M A N N
P A T E N T A T T O R N E Y S
Community patent
EU Council strives to introduce a unitary Community Patent with effect to all member states
Prosecution will remain at the EPO, Patent litigation and invalidation will be taken over by European Courts
Recent plans say: no translations needed (only claims in FR, DE and EN), enterprises in EU states with other languages shall be reimbursed for necessary translations
EU seems to have a negative attitude towards patents (anti-competitive, moral issues), legal expertise mediocre
Ulrich Storz – Michalski · Huettermann & Partner

15. Ancillary regulations
M I C H A L S K I H Ü T T E R M A N N
P A T E N T A T T O R N E Y S
Ancillary regulations
Some regulations have been transferred from EPC to ancillary regulations (“rules”)
Rules can be amended more easily by the adminstrative council
Frequency with which rules are amended is unique, and has some severe consequences
Ulrich Storz – Michalski · Huettermann & Partner

16. Thank you for your attention !
M I C H A L S K I H Ü T T E R M A N N
P A T E N T A T T O R N E Y S
Thank you for your attention !
Michalski · Huettermann & Partner Duesseldorf - Munich Internet

17. Recent Changes to the EPC
Dr. Golo Henning
Siemens AG, CT IP
Recent Changes to the EPC
Dr. Golo Henning, Siemens AG, CT IP

18. Overview Recent Changes to the EPC Implementing Regulations:
Dr. Golo Henning
Siemens AG, CT IP
Recent Changes to the EPC Implementing Regulations:
amended passages marked blue, conclusions are marked in red
Changes affecting the search stage (new/amended Rules 62a, 63, 64):
Changes in the examination procedure (amended Rules 137, 161)
Changes regarding divisional applications (amended Rule 36).
Summary: How to deal with these changes:
Advice for Applicants

19. Dr. Golo Henning
Siemens AG, CT IP
Since April 1st, 2010: New Rule 62a Applications containing a plurality of independent claims
If the European Patent Office considers that the claims as filed do not comply with Rule 43, paragraph 2 (one independent claim per category), it shall invite the applicant to indicate, within a period of two months, the claims complying with Rule 43, paragraph 2, on the basis of which the search is to be carried out. If the applicant fails to provide such an indication in due time, the search shall be carried out on the basis of the first claim in each category (R 62a (1)).
The Examining Division shall invite the applicant to restrict the claims to the subject-matter searched unless it finds that the objection under paragraph 1 was not justified (R 62a (2)).
The EPO will now only search the first independent claim in each category (e.g. method, apparatus): it is advisable to adapt US style claims before entry of the EP phase such that onyl 1 independent claim per category remains.

20. Since April 1st, 2010: Amended Rule 63 Incomplete search
Dr. Golo Henning
Siemens AG, CT IP
Since April 1st, 2010: Amended Rule 63 Incomplete search
If the European Patent Office considers that the European patent application fails to such an extent to comply with this Convention that it is impossible to carry out a meaningful search regarding the state of the art on the basis of all or some of the subject-matter claimed, it shall invite the applicant to file, within a period of two months, a statement indicating the subject-matter to be searched (R 63(1)).
Non-extendible two month period to identify which subject matter should be searched. Failure to respond within time limit may result in a partial search report or a statement that it is impossible to carry out a meaningful search (R 63(2), abbr.).
In case a partial search report is issued, claims must be restricted to the searched subject matter (R63(3), abbr.).
If EPO carries out an incomplete search, Applicant will be restricted to searched subject matter.

21. Dr. Golo Henning
Siemens AG, CT IP
Since April 1st, 2010: Amended Rule 64 European search report where the invention lacks unity
(1) If the European Patent Office considers that the European patent application does not comply with the requirement of unity of invention, it shall draw up a partial search report on those parts of the application which relate to the invention, or the group of inventions within the meaning of Article 82, first mentioned in the claims. It shall inform the applicant that, for the European search report to cover the other inventions, a further search fee must be paid, in respect of each invention involved, within a period of two months. The European search report shall be drawn up for the parts of the application relating to inventions in respect of which search fees have been paid (R 64(1)).
Non-extendible two month period to pay for additional search fees, if desired. In the case of failure to pay, a partial search report is drawn up.

22. Dr. Golo Henning
Siemens AG, CT IP
Since April 1st, 2010: Amended Rule 137 Voluntary amendment of the European patent application
Before receiving the European search report, the applicant may not amend the description, claims or drawings of a European patent application unless otherwise provided (R 137(1)).
Together with any comments, corrections or amendments made in response to communications by the European Patent Office under Rule 70a, paragraph 1 or 2, or Rule 161, paragraph 1, the applicant may amend the description, claims and drawings of his own volition (R 137(2)).
No further amendment may be made without the consent of the Examining Division (R 137(1)). .
Opportunity for voluntary amendments is further reduced/ reglemented by the amendments of Rule 137(2) and (3).

23. in a Euro-direct application:
Dr. Golo Henning
Siemens AG, CT IP
Since April 1st, 2010: Amended Rule 137 Voluntary amendment of the European patent application
According to amended Rule 137 EPC (voluntary amendments) the applicant may amend the application on his own volition only in the following cases:
in a Euro-direct application:
in reply to the extended European search report (EESR); or
in a Euro-PCT application: if the EPO did not act as International Search Authority (ISA):
in reply to the supplementary European search report;
If the EPO did act as International Search Authority (ISA):
in reply to the written opinion of the International search report.

24. Since April 1st, 2010: Amended Rule 161
Dr. Golo Henning
Siemens AG, CT IP
Since April 1st, 2010: Amended Rule 161
Amendment of the European patent application (Euro_PCT)
(1) If the European Patent Office has acted as the International Searching Authority [...], it shall give the applicant the opportunity to comment on the written opinion of the International Searching Authority or the International Preliminary Examination Report and, where appropriate, invite him to correct any deficiencies noted in the written opinion or in the International Preliminary Examination Report and to amend the description, claims and drawings within a period of one month from the respective communication. [...]. If the applicant does not comply with or comment on an invitation in accordance with the first or second sentence, the application shall be deemed to be withdrawn.
(2) Where the European Patent Office draws up a supplementary European search report on a Euro-PCT application, the application may be amended once within a period of one month from a communication informing the applicant accordingly. The application as amended shall serve as the basis for the supplementary European search.

25. Since April 1st, 2010: Amended Rule 36(1) EPÜ
Dr. Golo Henning
Siemens AG, CT IP
Since April 1st, 2010: Amended Rule 36(1) EPÜ
The applicant may file a divisional application relating to any pending earlier European patent application, provided that: (a) the divisional application is filed before the expiry of a time limit of twenty-four months from the Examining Division's first communication in respect of the earliest application for which a communication has been issued, or (b) the divisional application is filed before the expiry of a time limit of twenty-four months from any communication in which the Examining Division has objected that the earlier application does not meet the requirements of Article 82 (unity), provided it was raising that specific objection for the first time.
-> The EPO now only allows a limited time window for filing divisonals!

26. The decision is in force starting 1. April 2010.
Dr. Golo Henning
Siemens AG, CT IP
New Rule 36(1) EPC
The decision is in force starting 1. April 2010.
New Rule 36 (1) and (2) is applicable for divisional applications filed from that date on, i.e. currently pending parent applications are already affected!
Transitional provision: For parent applications, for which the time limit of 24 months from the Examining Division's first communication has already expired, there is a grace period of 6 months.
The remedy of further processing cannot be used if the time limits of Rule 36 are missed.
Advice: Review your EP portfolio well before Oct.1, 2010, to determine, if divisional applications should be filed!

27. Since April 1st, 2010: Amended Rule 36(1) EPÜ
Dr. Golo Henning
Siemens AG, CT IP
Since April 1st, 2010: Amended Rule 36(1) EPÜ
The applicant may file a divisional application relating to any pending earlier European patent application, provided that: (a) the divisional application is filed before the expiry of a time limit of twenty-four months from the Examining Division's first communication in respect of the earliest application for which a communication has been issued, or (b) the divisional application is filed before the expiry of a time limit of twenty-four months from any communication in which the Examining Division has objected that the earlier application does not meet the requirements of Article 82 (unity), provided it was raising that specific objection for the first time.
-> The EPO now only allows a limited time window for filing divisonals!

28. Dr. Golo Henning
Siemens AG, CT IP
Summary
The EPO has implemented a number of changes to accelerate examination proceedings, there is a strong impetus to force the applicant to one invention per application („raising the bar“).
Some of these changes will force applicants to make earlier decisions which subject matter should be pursued.
Unless addidtional search fees are paid, non-unitary claims will result in only a partial search:
- Non searched subject matter can only be pursued in a divisional application at increased cost.
- The decision, whether an application is non-unitary cannot be formally appealed

29. Dr. Golo Henning
Siemens AG, CT IP
Summary
4. Opportunity to file divisional applications will be limited and corresponding time limits should be watched closely.
5. Ideally, applicant should identify a set of claims that is unitary and has one independent claim per category before entering the Euro-PCT phase to obtain defined search results.

30. Case Law Review

31. Case Law Review
Rachel Wallis
Withers & Rogers LLP

32. Case Law Review G1/07 - Surgical Methods G2/08 - Dosage Regimens
G3/08 - The EBA

33. G1/07 - Surgical Methods
Previously not possible to patent surgery at EPO
Even if surgery was not therapeutic, e.g. cosmetic
Any intervention on body could provoke objection
Reconsidered in G1/07

34. G1/07 Concerned a diagnostic method
Included the step of injecting contrast agent into a subject's heart
Was this step surgical?
What effect did its presence have on the patentability of the diagnostic method?
Can the step be disclaimed?

35. Surgical step? What is surgery? Invasive
Substantial physical intervention
Medical expertise
Substantial health risk

36. Surgery or diagnosis?
Surgical methods as part of a method of diagnosis
Therapy, surgery and diagnosis considered separately
What about when diagnosis and surgery are linked?

37. Claims Can "disclaim" excluded steps Use positive wording
Disclaimer if necessary
Must still be clear

38. But what is surgery? Where is line drawn? Injections - IV, IM, SC
Could vary greatly case by case

39. G2/08 - Dosage regimens
Question over whether dosage regimens etc are patentable
Important where inventiveness only lies in dosage regimen
E.g. Same drug, same condition, new regimen

40. EPO v UK Courts
Previously acceptable at EPO, but queried in recent cases
UK Courts initially rejected, but then allowed

41. Decision EPO now in line with UK Courts
Novelty lies in way treatment given, e.g. dosage regimen
Patentable

42. Claim format EPC 2000 confirmed 2nd medical use is patentable
Claims in form:
"X for use in treatment of disease Y"

43. Claim format Previously used Swiss-style:
"Use of X in preparation of medicament for treatment of disease Y"
G2/08 states these claims are no longer allowable
As of 3 months from publication of decision

44. Claim format Can the EBA do this?
How will National Courts interpret new claims
Maintain basis for both in applications
Different scope - difficult to amend granted patents

45. Enlarged Board of Appeal (EBA)
Referral of questions by EPO President
Patentability of software
Admissibility of referrals to EBA

46. Purpose of the EBA
General aim of the EBA is to ensure uniform interpretation of the EPC and decide on petitions for review.
Official responsibilities of the EBA are to give:
decisions on points of law referred to it by Boards of Appeal (BoA);
opinions on points of law referred to it by the President of the EPO;
decisions on petitions for review of decisions of BoA.
Not an additional level of appeal

47. The law on referral Article 112 EPC
To ensure uniform application of the law, or if a point of law of fundamental importance arises:
the BoA shall refer any question to the EBA during proceedings on a case if it considers that a decision is required for the above purposes;
BoA may refer either of its own motion or following a request from a party to the appeal.
If the BoA rejects a request, it must give the reasons in its final decision.
the President may refer a point of law to the EBA where two Boards of Appeal have given different decisions on that question.

48. BoA Referrals Admissible: Inadmissible:
BoA need answer to decide on Appeal (T 520/01).
BoA cannot resolve question on an important point of law has without any doubt (J 5/81).
Inadmissible:
No contradictory case law & no reason to depart from earlier decisions (T 170/83).
When appeal itself is inadmissible, unless referral concerns admissibility of the appeal (G 8/92).

49. G3/08
'Computer programs as such' exclusion is of fundamental importance.
'Different decisions' = divergence or conflict in case law.
Legal development or 'different decisions'
President's referral was inadmissible.

50. What does this mean? The EBA is not a second instance appeal board
Require conflict between decisions
Software situation is unchanged

51. Rachel Wallis Withers & Rogers LLP

52. Patent strategies in Europe
Dr Ulrich Storz, Michalski Hüttermann & Partner
Dr Golo Henning, Siemens AG
Rachel Wallis, Withers & Rogers LLP
Moderator: James Nurton, Managing IP