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Case Law EPO - Managing Intellectual Property Law 2016/Case law... · 2016. 6. 21. · 22 Euro Law Conference 2016 Interpretation of Art 88(2) EPC, second sentence, in G 2/98 r.6.7

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Page 1: Case Law EPO - Managing Intellectual Property Law 2016/Case law... · 2016. 6. 21. · 22 Euro Law Conference 2016 Interpretation of Art 88(2) EPC, second sentence, in G 2/98 r.6.7
Page 2: Case Law EPO - Managing Intellectual Property Law 2016/Case law... · 2016. 6. 21. · 22 Euro Law Conference 2016 Interpretation of Art 88(2) EPC, second sentence, in G 2/98 r.6.7

2 Euro Law Conference 2016

Dr. Axel Esser

Case Law EPO

German and European Patent Attorney

Dr. James OgleBritish and European Patent Attorney

Dr. Martin Bachelin

German and European Patent Attorney

Page 3: Case Law EPO - Managing Intellectual Property Law 2016/Case law... · 2016. 6. 21. · 22 Euro Law Conference 2016 Interpretation of Art 88(2) EPC, second sentence, in G 2/98 r.6.7

3 Euro Law Conference 2016

TABLE OF CONTENTS

• Clarity in Opposition Proceedings – G 3/14

• Partial priorities – G 1/15

• Third Party Observations in Opposition

Proceedings

• Computer-implemented Inventions

• Inventive Step in Pharma Inventions

Page 4: Case Law EPO - Managing Intellectual Property Law 2016/Case law... · 2016. 6. 21. · 22 Euro Law Conference 2016 Interpretation of Art 88(2) EPC, second sentence, in G 2/98 r.6.7

4 Euro Law Conference 2016

Clarity in Opposition

Proceedings - G 3/14

Page 5: Case Law EPO - Managing Intellectual Property Law 2016/Case law... · 2016. 6. 21. · 22 Euro Law Conference 2016 Interpretation of Art 88(2) EPC, second sentence, in G 2/98 r.6.7

5 Euro Law Conference 2016

CLARITY IN OPPOSITION PROCEEDINGS

Grounds of opposition exhaustively listed in Art

100 EPC:

(a) Subject-matter is not patentable

(b) Lack of sufficiency

(c) Added matter

Clarity is no Ground for Opposition

Page 6: Case Law EPO - Managing Intellectual Property Law 2016/Case law... · 2016. 6. 21. · 22 Euro Law Conference 2016 Interpretation of Art 88(2) EPC, second sentence, in G 2/98 r.6.7

6 Euro Law Conference 2016

CLARITY IN OPPOSITION PROCEEDINGS

... but amended claims must conform with the

requirements of the EPC (Art. 101(3) EPC)

Is clarity (Art 84 EPC) relevant

only for amendments incorporating features from the

description or changing the wording of granted claims

– standard practice of the EPO

or also for combinations of granted claims?

– suggested by the BoA in T 472/88, T 459/09 et al.

Page 7: Case Law EPO - Managing Intellectual Property Law 2016/Case law... · 2016. 6. 21. · 22 Euro Law Conference 2016 Interpretation of Art 88(2) EPC, second sentence, in G 2/98 r.6.7

7 Euro Law Conference 2016

CLARITY IN OPPOSITION PROCEEDINGS

Enlarged Board of Appeal in G 3/14

Enlarged Board Reasoning:

• Legislator‘s Intention

• Clarity no ground for opposition

• Law not changed in connection with EPC2000

• Distinction between examination and opposition procedings

• Avoid arbitrary distinctions between different factual scenarios

• Maintain consistency within European patent system

(e.g. with G 9/91 and G 10/91)

Page 8: Case Law EPO - Managing Intellectual Property Law 2016/Case law... · 2016. 6. 21. · 22 Euro Law Conference 2016 Interpretation of Art 88(2) EPC, second sentence, in G 2/98 r.6.7

8 Euro Law Conference 2016

CLARITY IN OPPOSITION PROCEEDINGS

Enlarged Board of Appeal in G 3/14

For purpose of Article 101(3) EPC, the claims of the patent

may be examined for compliance with the requirements of

Article 84 EPC

only when,

and then only

to the extent that the amendment introduces non-compliance

with Article 84 EPC.

No general clarity examination in Opposition proceedings

Enlarged Board disapproves T472/88

Page 9: Case Law EPO - Managing Intellectual Property Law 2016/Case law... · 2016. 6. 21. · 22 Euro Law Conference 2016 Interpretation of Art 88(2) EPC, second sentence, in G 2/98 r.6.7

9 Euro Law Conference 2016

CLARITY IN OPPOSITION PROCEEDINGS

G3/14 in practice

Page 10: Case Law EPO - Managing Intellectual Property Law 2016/Case law... · 2016. 6. 21. · 22 Euro Law Conference 2016 Interpretation of Art 88(2) EPC, second sentence, in G 2/98 r.6.7

10 Euro Law Conference 2016

CLARITY IN OPPOSITION PROCEEDINGS

G 3/14 and deletion of granted features

T 882/14

Feature "brake operation output signal" of granted claim

amended by deleting "output"

Board of Appeal:

An objection to omission of the term "output" in the term "the brake

operation signal" of feature (i) amounts to a clarity objection to a

granted feature, which is not admissible (cf. decision G 3/14).

Page 11: Case Law EPO - Managing Intellectual Property Law 2016/Case law... · 2016. 6. 21. · 22 Euro Law Conference 2016 Interpretation of Art 88(2) EPC, second sentence, in G 2/98 r.6.7

11 Euro Law Conference 2016

CLARITY IN OPPOSITION PROCEEDINGS

Clarity Problem in granted Claim?

T 830/11

• Claim 1 was amended

• Claim 1 was clear after amendment

• Claim 6 was not amended

• BUT Amendment caused contradiction between claims 1 & 6

• Clarity was examined and denied

Page 12: Case Law EPO - Managing Intellectual Property Law 2016/Case law... · 2016. 6. 21. · 22 Euro Law Conference 2016 Interpretation of Art 88(2) EPC, second sentence, in G 2/98 r.6.7

12 Euro Law Conference 2016

CLARITY IN OPPOSITION PROCEEDINGS

G 3/14 restricted to clarity assessment?

T 161/11

• G 3/14 applies to assessment of support under Art. 84 EPC

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13 Euro Law Conference 2016

CLARITY IN OPPOSITION PROCEEDINGS

Art. 83 or 84 EPC: a small but subtle difference!

Insufficient disclosure: mentioned in Art. 100(b) EPC

Ground of opposition

Can be a basis for complete revocation of a patent

Lack of clarity: not mentioned in Art. 100 EPC

No ground of opposition

Can not be a basis for complete revocation of a patent

Possible to attack unclear claim under Art. 100(b) EPC?

Page 14: Case Law EPO - Managing Intellectual Property Law 2016/Case law... · 2016. 6. 21. · 22 Euro Law Conference 2016 Interpretation of Art 88(2) EPC, second sentence, in G 2/98 r.6.7

14 Euro Law Conference 2016

CLARITY IN OPPOSITION PROCEEDINGS

T 608/07, T 593/09, T 2620/11, T 1834/11, T 2233/12

• Does the ambiguity present in the claims deprive the skilled

person of reaching the promise of the invention?

• Is the skilled person able to identify

• without undue burden

• on the basis of the disclosure in the opposed patent and

• using his common general knowledge

• the technical measures necessary to solve the problem underlying the patent at issue?

Disclosure is sufficient. Disclosure is not sufficient

yes no

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15 Euro Law Conference 2016

CLARITY IN OPPOSITION PROCEEDINGS

Criteria:

• Relationship between the scope of the “grey area” and the

scope of the claim?

• Clarity critical for success?

• Undue burden to identify those variants that allow to solve

the problem underlying the invention?

or

Page 16: Case Law EPO - Managing Intellectual Property Law 2016/Case law... · 2016. 6. 21. · 22 Euro Law Conference 2016 Interpretation of Art 88(2) EPC, second sentence, in G 2/98 r.6.7

16 Euro Law Conference 2016

Partial Priorities – G 1/15

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17 Euro Law Conference 2016

The legal problems giv ing rise to pending Enlarged Board of Appeal case G 1/15

An il lustration:

granted claim

15°C

10°C

20°Cpriority application

25°C

On or after the priority date, there is a disclosure of 17 °C.

Is this novelty-destroying? Do conditions apply?

Does/should it matter whether this disclosure originates from the same

applicant? – E.g. issue of “ toxic div isionals”.

intervening disclosure

Page 18: Case Law EPO - Managing Intellectual Property Law 2016/Case law... · 2016. 6. 21. · 22 Euro Law Conference 2016 Interpretation of Art 88(2) EPC, second sentence, in G 2/98 r.6.7

18 Euro Law Conference 2016

Partial priority: legal foundations

Art 88 EPC

(2) 1Multiple priorities may be claimed in respect of a European patent

application, notwithstanding the fact that they originated in different

countries. 2Where appropriate, multiple priorities may be claimed for any one claim

(3) I f one or more priorities are claimed …, the right of priority shall cover

only those elements of the European patent application which are included in

the application or applications whose priority is claimed .

Page 19: Case Law EPO - Managing Intellectual Property Law 2016/Case law... · 2016. 6. 21. · 22 Euro Law Conference 2016 Interpretation of Art 88(2) EPC, second sentence, in G 2/98 r.6.7

19 Euro Law Conference 2016

Interpretation of Art 88(2) EPC, second sentence, in G 2/98

G 2/98 (May 2001)

The EPO Enlarged Board of Appeal interpreted Art 88(2) EPC, second sentence,

by a teleological and historical approach.

r.6.3: In order to understand the legislative intent underlying this provision, it is

necessary to consult the historical documentation related to the EPC …

r.6.4: This provision goes back to proposals … subsequently analyzed in a

memorandum drawn up by FICPI … Based on this memorandum, the

provision that mult iple priorities may be claimed for any one claim (Art.

88(2) EPC, second sentence) was f inally adopted … Thus, the

memorandum can be said to express the legislative intent underlying

Art icle 88(2) EPC, second sentence.”

Page 20: Case Law EPO - Managing Intellectual Property Law 2016/Case law... · 2016. 6. 21. · 22 Euro Law Conference 2016 Interpretation of Art 88(2) EPC, second sentence, in G 2/98 r.6.7

20 Euro Law Conference 2016

Interpretation of Art 88(2) EPC, second sentence, in G 2/98

r.6.7 – first sentence: the “OR claim”

As regards the "OR"-claim … i t is held in the memorandum that where a f irst

priority document discloses a feature A, and a second priority document

discloses a feature B for use as an alternative to feature A, then a claim directed

to A or B can enjoy the f irst priority for part A of the claim and the second priority

for part B of the claim …

A BOR

P1 P2

Page 21: Case Law EPO - Managing Intellectual Property Law 2016/Case law... · 2016. 6. 21. · 22 Euro Law Conference 2016 Interpretation of Art 88(2) EPC, second sentence, in G 2/98 r.6.7

21 Euro Law Conference 2016

The FICPI Memorandum – “ legislative intent” (G 2/98, r.6.7)

“OR claims” within the meaning of the FICPI Memorandum

Page 2 of the Memorandum:

Type A or B claim

(“OR”- claim, claim too broad to be supported

by the disclosure of the first priority document).

… there seems to be no reason why it should not be possible to claim the

f irst priority for part A … and the second priority for part B of the claim.

I t is of course immaterial whether the word "or" actually occurs in the

claim, or is implied through the use of a generic term , or otherwise .

BA

genus

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22 Euro Law Conference 2016

Interpretation of Art 88(2) EPC, second sentence, in G 2/98

r.6.7 – second sentence: “OR claim” in form of generic term or formula

… It is further suggested [ i.e. IN THE MEMORANDUM – “legislative intent” ]

that these two priorities may also be claimed for a claim directed to C, if the

feature C, either in the form of a generic term or formula, or otherwise,

encompasses feature A as well as feature B. …

A: P1 B: P2

F A S T E N I N G M E A N S

Page 23: Case Law EPO - Managing Intellectual Property Law 2016/Case law... · 2016. 6. 21. · 22 Euro Law Conference 2016 Interpretation of Art 88(2) EPC, second sentence, in G 2/98 r.6.7

23 Euro Law Conference 2016

Interpretation of Art 88(2) EPC, second sentence, in G 2/98

r.6.7 – third sentence: “OR claim” in form of generic term or formula

…The use of a generic term or formula in a claim for which mult iple priorities are

claimed in accordance with Art icle 88(2) EPC, second sentence, is perfectly

acceptable under Art icles 87(1) and 88(3) EPC, provided that it gives rise to the

claiming of a l imited number of clearly defined alternative subject-matters.

A: P1 B: P2

F A S T E N I N G M E A N S

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24 Euro Law Conference 2016

The FICPI Memorandum – “ legislative intent” (G 2/98, r.6.7)

First Memorandum Example: “Broadening of a chemical formulae”

1.1 Abstract example

P1: “relatively narrow chemical formula”

P2: “broader chemical formula” encompassing the narrower formula of P1

EP: claims the broader formula from P2

“I f mult iple priorities for one and the same claim are allowed, it wil l suffice to

draw up a single claim directed to the broad formula . This claim will then enjoy

… the first priority date … within the scope of the narrow formula, and the

second priority for the rest of its scope.”

P1 P2

(Formulae not in the Memorandum;

for illustration only)

R1

R2

Page 25: Case Law EPO - Managing Intellectual Property Law 2016/Case law... · 2016. 6. 21. · 22 Euro Law Conference 2016 Interpretation of Art 88(2) EPC, second sentence, in G 2/98 r.6.7

25 Euro Law Conference 2016

The FICPI Memorandum – “ legislative intent” (G 2/98, r.6.7)

First Memorandum Example: “Broadening of a chemical formulae”

1.2 Halogen example

“When the applicant f i les his EP application he accordingly draws up a principal

claim directed to the use of a halogen. He is clearly entitled to the first priority

to the extent that the halogen is Cl , and entitled to the second priority to the

extent that the halogen is Br, I or F. In this situation the claiming of mult iple

priorities makes sense, seeing that one of the possible embodiments within

the scope of the claim is clearly disclosed in the first priority document .”

HALOGEN

P1

P2

EP

Page 26: Case Law EPO - Managing Intellectual Property Law 2016/Case law... · 2016. 6. 21. · 22 Euro Law Conference 2016 Interpretation of Art 88(2) EPC, second sentence, in G 2/98 r.6.7

26 Euro Law Conference 2016

The FICPI Memorandum – “ legislative intent” (G 2/98, r.6.7)

Second Memorandum Example:

“Broadening of range (temperature, pressure, concentration, etc.)”

“I f mult iple priorities for one and the same claim are allowed,

it wil l suffice in the European patent application to draw up

a claim directed to the temperature range 10-25 °C”.

P2

15°C

10°C

20°CP1

25°C

Page 27: Case Law EPO - Managing Intellectual Property Law 2016/Case law... · 2016. 6. 21. · 22 Euro Law Conference 2016 Interpretation of Art 88(2) EPC, second sentence, in G 2/98 r.6.7

27 Euro Law Conference 2016

The FICPI Memorandum – “ legislative intent” (G 2/98, r.6.7)

Third Memorandum Example: “Broadening of field of use”

(Memorandum, pages 4-5)

P1: “method of coating … a pipe”

P2: “the same method for … bottles or any other hollow bodies”

EP: “If multiple priorities for one and the same claim are allowed, it wil l suffice

… to draw up a claim to … hollow bodies”.

Undesirable alternative: “have to draw up two parallel claims”

1. “pipes” (P1 date)

2. “hollow bodies not being pipes” (P2 date)

“Legislative intent” :

Therefore, Art 88(2) second sentence should be introduced into the EPC.

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28 Euro Law Conference 2016

The FICPI Memorandum – “ legislative intent” (G 2/98, r.6.7)

Origin of the words “where appropriate” in Art 88(2) EPC

Memorandum (“legislative intent”)

recognized that part ial priorities are not appropriate in the case of claims with

feature combinations of the form “A AND B”.

Therefore , the Memorandum suggested adding the wording “where appropriate”.

Suggested wording:

Where appropriate, mult iple priorities can be claimed for one and the same

claim of the European patent.

EPC Art 88(2), second sentence

Adopted wording:

Where appropriate, mult iple priorities may be claimed for any one claim.

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29 Euro Law Conference 2016

Strict EPO case law denying “partial priorities” for numerical subranges

T 476/09 (Board 3.3.09, Sep 2012)

5.6 In this respect, decision G 2/98 … is relevant. In this decision the

Enlarged Board of Appeal allowed the use of a generic term … under the

provision that such term "gives rise to the claiming of a l imited number of

clearly defined alternative subject-matters" (see point 6.7 of the Reasons ).

In the present case, however, the claimed range represents a continuum of

a numerical range of values which does not correspond to distinctive

alternative embodiments . Consequently, no separable alternative

embodiments can be identified within this continuum which could enjoy

the priority date…

Granted claim

not the same invention

0.94

0.930

0.99

Prio

0.990

At least partial priority for 0.94 – 0.99?

Applying T 1877/08

(Board 3.3.10, Feb 2010)

Page 30: Case Law EPO - Managing Intellectual Property Law 2016/Case law... · 2016. 6. 21. · 22 Euro Law Conference 2016 Interpretation of Art 88(2) EPC, second sentence, in G 2/98 r.6.7

30 Euro Law Conference 2016

Strict EPO case law denying “partial priorities” for numerical subranges

EPO cases denying “partial priorities” for numerical ranges

G 2/98, r.6.7: “… provided that it gives rise to the claiming of a l imited number of

clearly defined alternative subject-matters”.

Interpretation e.g. for numerical ranges? Is the word “or” required?

granted claim

15°C

10°C

20°Cprio

25°C

>20-25°C”“10°C to <15°C 15-20°Cor or

Page 31: Case Law EPO - Managing Intellectual Property Law 2016/Case law... · 2016. 6. 21. · 22 Euro Law Conference 2016 Interpretation of Art 88(2) EPC, second sentence, in G 2/98 r.6.7

31 Euro Law Conference 2016

Strict EPO case law requiring individualization in the claim

T 1127/00 (Board 3.3.10, Dec 2003) – generic RNA (ribozyme) formula

Main Request:

Claim 1: RNA compounds with broad structural variation

targeting “XUX” sequences [X=any nucleotide]

Claim 2: Same RNAs targeting only “GUX” sequences [ independent claim]

Description: Targets XUX; preferably GUX

First prio doc: Target sequence GUX

r.5: Express reference to “memorandum” as “ legislative intent” (G2/98, r.6.7)

r.6: Claim 1 relates to a generic formula which covers a great number of

alternative compounds. …

However, the alternative compounds are not, as such, spelled out in the

claim. The fact that they might be intellectually envisaged to fall within the

scope of the claim does not make up for a clear and unambiguous presence

of these alternatives, individualized as such, in the claim .

Claim 1 does not embrace a limited number of clearly defined alternative

subject-matters in the form of an "OR"-claim which could be split up into

groups of different priorities.

Page 32: Case Law EPO - Managing Intellectual Property Law 2016/Case law... · 2016. 6. 21. · 22 Euro Law Conference 2016 Interpretation of Art 88(2) EPC, second sentence, in G 2/98 r.6.7

32 Euro Law Conference 2016

1. Toxic priority applications

2. Toxic divisional / parent constellations

SELF-COLLISION

Claim 1 Prio

This wil l be much less of a hazard if G1/15 rules that part ial priorities are

acknowledged more easily, in l ine with the FICPI memorandum.

3. Other intervening disclosures corresponding to the priority application

during the priority year by the applicant / inventor

OUCH

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33 Euro Law Conference 2016

Strict EPO case law – e.g. “toxic priority application”

T 1443/05 (Board 3.3.01, Jul 2010)

Opposed patent

Claim 1: biocidal composition

• comprising components A and B

• but excluding component C (disclaimer)

Explanation of reason for disclaimer in description: C causes allergies

Priority document

Published EP application, disclosing components A, B

C is mentioned (“positively”) as an optional further component.

However, no disclaimer and no mention of the disadvantages of C

• One specific example contained A, B and C

• Various specific examples of compositions consisting only of A and B

Not the same invention, different teaching, no priority entitlement (at all)

comprising

A and B,

but no C AB

only

Page 34: Case Law EPO - Managing Intellectual Property Law 2016/Case law... · 2016. 6. 21. · 22 Euro Law Conference 2016 Interpretation of Art 88(2) EPC, second sentence, in G 2/98 r.6.7

34 Euro Law Conference 2016

Strict EPO case law – e.g. “toxic priority application”

T 1443/05 (Board 3.3.01, Jul 2010)

Consequence of loss of priority:

Published EP priority application was prior art

under Art 54(3) EPC for entire claim

• Patentee argued that at least the specific examples in the priority

document consisting only of A and B should be entitled to part ial priority.

• Board, cit ing G2/98 r.6.7, denied this on the basis that the generic

wording of the claim did not contain any “unambiguous alternative”

that was suitable to define a part ial priority domain covering the examples

(r.4.2.6).

Therefore, instead of providing a “part ial priority domain”, within the genus that

allowed for other components (except C),

the specific examples containing only A and B in the priority document thus

destroyed the novelty of opposed patent .

comprising

A and B,

but no C AB

only

OUCH

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35 Euro Law Conference 2016

Strict EPO case law – e.g. “toxic priority application”

T 1443/05 – what might have been a remedy?

Might the Board have afforded partial priorities

i f the opposed claim had read …

“1. Biocidal composition

(i) consisting of A and B or

(ii) comprising A and B and at least one further component

but not comprising C”

instead of the more concise, generic form in the opposed patent:

“1. Biocidal composition comprising A and B but not C” ?

Applying part ial priority in l ine with the FICPI Memorandum

would have rescued the patent.

comprising

A and B,

but no C AB

only

T 1127/00

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36 Euro Law Conference 2016

Permissive EPO case law on partial priority entitlement – Board 3.3.07

T 1222/11– Generic compositions (hair cosmetics)

– interpretation and application of the “proviso” of G2/98 r.6.7

r.11.5.1 …when the "OR"-claim is drafted using a generic term…

r.11.5.2 … the assessment required by Article 88(3) EPC, as to which elements

(alternatives) of the "OR"-claim are covered by any of the mult iple

priority claims can be achieved only by a comparison of the claimed

subject-matter of that "OR"-claim with the disclosure of the mult iple

priority documents.

Therefore, … the words "gives rise to the claiming of a l imited number of

clearly defined alternative subject-matters" refer to the ability to

conceptually identify by said comparison a limited number of clearly

defined alternative subject-matters to which the mult iple rights of priority

claimed can be attributed or not.

r.11.5.3 That this comparison should give rise to a l imited number of clearly

defined alternative subject-matters is obviously necessary in order to

identify which parts of the claims benefit from the effect of the priority

right…

P1 EPP2

hollow bodieshollow bodies

cf.

FICPI

Memo

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37 Euro Law Conference 2016

Permissive EPO case law on partial priority entitlement – Board 3.3.07

T 1222/11 – Interpretation and application of the “proviso” of G2/98 r.6.7

r.11.8 Regarding …subject-matter disclosed in a priority document and

encompassed by … a claim of a European application which compared

to the disclosure of the … priority document has been broadened …,

the decision on whether priority can be acknowledged for this subject-

matter … is independent of whether said subject-matter … is

identified in the "OR"-claim of the European application as a separate

alternative embodiment.

T 571/10 (Jun ‘14) – broadened chemical formula compared to priority appln

r.4.5.12 Express approval of T1222/11; textual basis and fulf i lment of the

“proviso” (G2/98, r.6.7) for part ial priority domains (“conceptual”) is

required only in the priority document(s).

… i t is not necessary that the clearly defined alternative subject -

matters are spelt out as such in the application , nor that the word

"or" actually occurs .

P1 EPP2

Halogen

cf.

FICPI

Memo

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38 Euro Law Conference 2016

Permissive EPO case law on partial priority entitlement – Board 3.3.07

T 1222/11: is this approach always good for applicants? – No!

T 1222/11 applied the same approach to assessing whether the priority

application was really the f irst application, for all part ial priority domains it

“conceptually” encompassed. This destroyed priority and thus novelty.

r.11.8 … in v iew of the necessary coherence of ru les of law on the subject of c la iming pr ior ity

def ined in the EPC, …when an appl icat ion on the basis of which a pr ior ity date is c la imed

encompasses a narrower subject -matter already disclosed by the same appl icant in an

ear l ier appl icat ion, the decis ion on whether the cla im to pr ior ity on the basis of the later

appl icat ion is val id does not depend on whether the narrower subject -matter disclosed in

the ear l ier appl ication is ident if ied in said later appl icat ion. The lat ter s ituat ion is

precisely the one underlying the case under appeal.

PCT/JP EPPrio

malic acid

excluding 4 %

(G 1/03)4% malic

acidWO publication

+ subsequent EP phase

PCT

malic acid!!

A54(3) EPC?

Not the first application

for 4% malic acid

!!54(2)

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39 Euro Law Conference 2016

Permissive EPO case law on partial priority entitlement

T 1222/11: is this approach always good for applicants? – No!

According to this approach, any application disclosing an embodiment

fall ing within the more generic claim of a subsequent f i l ing by the same applicant

is the first application in the sense of Art 87 EPC, as far as that embodiment

is concerned.

• This affects f i l ing strategies!

• Need to take careful account of any “encompassed” content of earlier f i l ings.

• Priority-year deadlines appear “shorter”; Art 87(4) more crit ical.

1 Jan 2015 1 Aug 20161 Aug 2015

malic acid4% malic

acid

malic acid

1 Jan 2016

malic acid

FIRST APPLICATION?PRIORITY YEAR?

T 1222/11 T 1227/00

OUCH?

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Referral G 1/15 to the Enlarged Board (from case T 557/13 – 3.3.06)

“Test case” for partial priorities and/or “toxic parents / divisionals”

Opposition Div ision: div isional application lacked novelty over Example 1 of the

parent (Art 54(3) EPC).

• Denied priority for whole claim; denied part ial priority for the compound of

Example 1 (or any relevant subgenus) because such narrower subject matter

was not recited separately in the claim (following T1127/00 etc.).

“… the number of embodiments covered by claim 1 is not l imited”.

• Also rejected Patentee’s separate l ine of arguments that parents should, as a

matter of principle, not be citable prior art for div isionals (and v ice versa).

GB Prio Parent

PCT/EPEP Divisional

Claim:

more generic

compound

Disclosed:

more generic

compound

Example 1:

specific cmpd

Disclosed:

“amine salt

and/or

amide...”

Example 1:

specific cmpd

PCT WO publication

+ subsequent EP phase

A54(3) EPC?

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The questions referred in G 1/15 (simplified version)

1. When a generic expression encompasses alternative subject -matters

(“generic "OR"-claim”), can partial priority be refused in respect of any such

alternative subject-matter that was disclosed directly and unambiguously

(and in an enabling manner) for the f irst t ime in the priority document?

2. If the answer is “yes, subject to certain conditions ”,

is “the proviso” of G 2/98 the correct legal test?

( i .e.: part ial pr ior i ty can only be acknowledged i f i t “gives r ise to the claiming of a

l imited number of clearly defined alternative subject -matters")

3. If “the proviso” is the correct test, how are the criteria " l imited number" and

"clearly defined alternative subject-matters" to be interpreted and applied?

4. If “the proviso” is not the correct test, how is entitlement to part ial priority to

be assessed for a generic "OR"-claim instead?

5. If in a case according to question 1 part ial priority may in principle indeed be

refused, can a parent or div isional application be prior art under Art 54(3)

against subject-matter disclosed in the priority document and encompassed

as an alternative in the generic "OR"-claim?

Answers expected in November 2016!

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Avoiding and resolving problems relating to priority and self -coll ision

• All definitions, subgenera and examples contained in

spec. right from first f i l ing should ideally meet a

“clarity” standard: “ l imited number of clearly

defined alternative subject matters ”

• After f irst f i l ing never “change”, only “add” (use “OR”).

• Recite subgenera/-ranges and logical complements (G2/10)

as express fall -back for “OR” wordings (in case strict approach is confirmed).

• [File priority application outside “EPC territory”?]

• But: no effect against toxic div.; and e.g. AU, NZ: Astra Zeneca v Apotex;

“toxic prio” cannot occur if prio appln not published.

• Observe priority year after earliest narrow disclosure! (T1127/11 f l ipside!)

• Avoid publication of priority appln (but: no effect against toxic divs)

• Review priority situation of parent & div. claims before f i l ing div.

• When fi l ing div. consider removing content from the specification that might

anticipate parent claims; f i le clear “OR” claims if part ial priorities required.

• Consider disclaimers (Art 54(3)/G1/03 or G2/10) depending on circumstances,

other claim amendments during prosecution …. – or arguments…!

Claim 1

Prio

DIV

publ.

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43 Euro Law Conference 2016

Third Party Observations in

Opposition Proceedings

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3rd PARTY OBSERVATION

3rd Party Observations in Opposition /Appeal

Possibility to circumvent late filing rules?

T 1756/11 – Possible to file? When?

• Possible

• No time limit for filing 3PO - Art. 114(2) does not apply

• BUT risk of abuse of procedure

Fiction of „late filing“

Test for relevance of 3PO

(also in later T 694/10, T 1657/11, T 1181/12)

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3rd PARTY OBSERVATION

T 1756/11 – Filing during Appeal

• 3PO usually has to be disregarded

• Exception: if 3PO pertains to newly introduced amendment

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3rd PARTY OBSERVATION

T 1756/11 – Need to consider 3PO by OD?

• 3rd party is no party to proceedings,

• 3rd party has no “right to be heard”

OD need not discuss 3PO at all in the decision

(but should mention 3PO in preliminary opinion)

BUT if party of proceedings relies on content of 3PO:

OD must exercise discretion whether to admit late filed

facts/arguments into the proceedings

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3rd PARTY OBSERVATION

Take-home Lessons:

3PO no means to circumvent late-filing rules

As 3rd party: File 3PO in first instance proceedings, if possible

As opponent: Expressly rely on 3PO in later submissions

As patentee: respond to 3PO only if prompted by opponent / OD

(or if strong argument available)

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Computer-implemented

Inventions

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Computer-Implemented Inventions

Computer-implemented Abstract Business method

inventions (software)

Patentable computer-implemented Patentable business method

Invention (software)

Technical Character ?

Game rulesMathematical Methods

Patentable Mathematical Methods

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Problems with mixed inventions

Only features that are purely non-technical (i.e. have notechnical meaning, no technical effect, no possible technicalconnotation) should be viewed, in principle, as “non-technical“

This distinction of features is in practice often very difficult and contentious between examiners and applicants

What is “technical“ / “technical character“?

Where does “technical charater“ requirement come from?

Mixed inventions

Technical featuresPurely non-technical

features

Not purelynon-technical

features

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Basic Requirements in EPC

• According to Art. 52(1) EPC EP patents shall begranted for any inventions, in all fields of technology, if they are new (A.54), involve an inventive step(A.56), and are susceptible of industrial application(A.57)

TRIPS Art 27

Legal context

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What is an invention? There is no positive definition of an invention in the EPC, the EPC defines inventions by exclusions in Art. 52(2):

Not regarded as invention:

a) discoveries, scientific theories, mathematical methods;

b) aesthetic creations;

c) schemes, rules and methods for performing mental acts,

playing games or doing business, and programs for

computers;

d) presentations of information;

… but only to the extent to which a EP patent application relates to such subject matter or activities as such (Art. 52(3)).

Legal context

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Technical character requirement at the EPO

In the EPC:

the invention must be of “technical character” to the extent that it- must relate to a technical field → Rule 42(1)(a)- must concern a technical problem → Rule 42(1)(c) - must have technical features so that the claims define the

matter for which protection is sought in terms of the technical features → Rule 43(1)

In the Case Law:(e.g. T1173/97, T935/97, T931/95, T641/00, T258/03, T1670/07)

When does claim have “technical character”?

Legal context

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Technical character requirement at the EPO

not a defined legal term / no general definition by thecase law

G3/08 „We do not attempt to define the term "technical". … It is to be hoped that readers will accept these assertions without requiring a definition of exactly what falls within the boundaries of "technical".”

… technical considerations in the sense that the programmer has to construct a procedure that a machine can carry out, is not enough to guarantee that the computer program has a technical character: "further technical considerations".

Legal context

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Technical character requirement at GPTO (“to solve a

concrete technical problem with technical means”)

Systematic teaching using controllabe natural forces to achieve a result with clear cause and effect (BGHZ 53, 74 – Rote Taube 1969)

„Technical“ is to operate with the means of natural forces(BGH, X ZB 1/15 – Flugzeugstand 2015)

A mathematical method may be considered non-technicalonly if it is not related to a specific application of naturalforces (BGH, X ZB 1/15 – Flugzeugstand 2015)

Legal context

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Overview

Daniel Closa et. al. EPO„Examination of CII andBusiness MethodsApplications“ 2012

Assessment of mixed inventions

Overview

COMVIK (T 0641/00) HITACHI (T 0258/03)2 steps

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Non-Technical Specification

Assessment of mixed inventions

The EPO Model – Imaginary Situation

Business person has an idea-> non-technical specification-> instructions given to engineeror programmer summarizing the requirements of the idea

Question: does the engineer/programmer make a technical invention when implementing the non-technical specification?

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General features with “technical character“

processing physical data parameters or control values of an industrial process

Processing affecting the way a computer operates (e.g. saving

memory, increasing speed, security of a process, rate of data transfer etc.)

the physical features of an entity(e.g. memory, processor etc.)

Examples

Euro Law Conference 2016

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59

Non-technical features:

aesthetic effects of music and video

new rules for an auction scheme

selling and booking sailing cruise packages

calculation of pension schemes

Technical vs. Non-technical features:

Technical features:

control of a brake in a car

communication between mobile phones

secure data transmission, e.g. by encryption

resource allocation in an operating system

Examples

Euro Law Conference 2016

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Ebay-like auction scheme:

Problem Areas

• At the end of the bidding process „the competition becomesfiercer“

• … effects and advantages inherent in the underlying non-technical method or scheme. The latter are at best to be regarded as incidental to that implementation (T 1543/06).

Euro Law Conference 2016

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Problem Areas

Note principle from T 258/03: “Method steps consisting of modifications to a business scheme and aimed at circumventing a technical problem rather than solving it by technical means cannot contribute to the technical character of the subject-matter claimed”

One must therefore be careful to consider whether the invention is solving a technical problem or just avoiding it

Assessment of mixed inventions

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Problem Areas

Problems for patentability can occur when user action comesinto play

This is due to the fact that “mental acts“ are excluded frompatentability and consequently claim features that involve(intelligent) decision making on the part of a user areconsidered non-technical

EP examiners are also skeptical of inventions that theyconsider to be predominantly administrative ororganizational

-> is an abstract scheme recognizable in a claim that workswithout any of the technical elements?

Assessment of mixed inventions

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Recent Case Law: T 0651/12

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6. A computer-implemented method for displaying a bird's eye view map using a database device (2) that includes at least a height data portion in which a plurality of height data respectively corresponding to altitudes of a plurality of areas into which a two-dimensional map is divided are respectively stored in correspondence to the areas, each one of the plurality of areas being assigned with only one of the plurality of height data, and a road data portion in which a road (R) extending within the two-dimensional map is expressed with a plurality of element points (0, 1, 2, ..., n-1, n) and positional coordinates (X, Y) of each of the element points in the two-dimensional map are stored, the method comprising:

• performing a calculation to determine in which of the areas each of the element points read out from the road data portion is located;

• reading out height data corresponding to one of the areas ascertained through the calculation from the height data portion to use as height data for each of the element points; and

• calculating coordinate values of each of the element points on the bird's eye view map to be displayed on a monitor screen based upon positional coordinates read out from the road data portion and the height data read out from the height data portion."

Recent Case Law: T 0651/12

Program for computer

Mathematicalmethods

Presentations of information

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A computer-implemented method. Not “as such” excluded from patentability under A52(3) EPC. „It involves the use of technical means in the form of a computer“ , i.e. „invention“ A52(1) EPC.

Not a mathematical method „as such“. „Meant are in A52(2)(a) EPC, in the boards view, merely abstract mathematical methods, i.e. calculations for the sake of the calculation. In the present case, however, the outcome of the calculation is used for a technical purpose, namely to display information in an ergonomically improved manner.

It is noted in this respect that in the board's judgement, displaying the three-dimensional bird's eye view map, e.g. in a car navigation system, provides a more realistic view of the road to the user and supports the user in better orienting himself, ultimately assisting the user in taking the right turn, and thus adds to the ergonomics of the map display.

In the board's opinion, ergonomics, understood as the applied science of refining the design of products to optimize them for human use, in the context of the map display of the present case, is a technical field. Displaying the three-dimensional bird's eye view map is, thus, considered to provide a technical solution to a technical problem.

Recent Case Law: T 0651/12

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Moreover, it is noted that in the context of e.g. a car navigation system, the immediate apprehension of the presented information results in the driver being less distracted from the road and traffic and, thus, also adds to safety. Accordingly, also in this respect, displaying the three-dimensional bird's eye view map provides a technical solution to a technical problem.

As such, the board sees no fundamental difference between the present case and a method for operating a computer-controlled machine where the outcome of some calculation is used for operating the machine in an improved manner, which is generally considered technical in all aspects.

Moreover, in the board's judgement, the method of claim 6 does also not relate to presentations of information within the meaning of Article 52(2)(d) EPC. Generally, the view is taken that the reference to presentations of information in Article 52(2)(d) EPC is meant to relate exclusively to the information content and not to the way the information is presented.

Recent Case Law: T 0651/12

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Recent Case Law: T 1370/11

Software Object 1Property 1

Software Object 2Property 2

Callback function

Callback function

Indefinite circularities. Difficult to detect!

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1. A computer-implemented method for managing properties (216, 218, 232, 234, 236, 238, 240) of objects (404), the method comprising:

associating an expression (212, 214, 222, 224, 226, 228, 230) with a property of an object, the expression defining a relationship between the property and at least one source property;

in response to a request for a value of the property, checking (502) a cache to determine whether a value of the property has been previously cached, and if not, evaluating (506) the expression to determine the value of the property, returning the value of the property and updating (512) the cache; and

invalidating (608, 706) the value of the property if the at least one source property changes, wherein invalidating comprises clearing (706) the value of the property from the cache.

Recent Case Law: T 1370/11

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At the same time, the board considers that objects, properties, relationships and expressions are merely abstract concepts used to structure and model an application domain so that it can be implemented on a computer device. The modelling however inevitably precedes the implementation and is, as such, an entirely mental activity which remains within the domain of non-technical knowledge and cannot, by itself, constitute the technical solution to a technical problem.

However, for the sake of argument, it is assumed that the claimed cache does indeed have the alleged advantage of reducing the computing time required. Is the reduction of computing time a technical problem?

By way of illustration, let it be assumed that the method in question is a non-technical one, for example a mathematical method or a method of doing business.

Under Article 52(2)(a) and (c) and (3) EPC, this method will not be regarded as an invention in the sense of Article 52(1) EPC.

Recent Case Law: T 1370/11

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Any computer program implementing that method will, of necessity, need a particular amount of computing resources, in particular time. This is merely a consequence of the "normal" physical interactions between program (software) and computer (hardware). According to established jurisprudence of the boards of appeal, the computer program would thus be found not to comply with Article 52(2)(c) and (3) EPC for lack of a "further" technical effect.

These findings cannot be changed by a document which discloses an alternative, earlier non-technical method which takes longer to carry out on a computer. In other words, it cannot be argued that a computer program must be regarded as an invention in the sense of Article 52(1) EPC, i.e. as a technical invention, for the sole reason that an earlier computer program happens to exist which solves the same, non-technical problem more slowly.

Therefore, for a computer-implemented method or a computer program to be patentable it must be established that it has a "further" technical effect and solves a technical problem independently of its absolute or relative computing time. Speed-up has to contribute to a technical effect.

Recent Case Law: T 1370/11

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1. A user interface for an extracorporeal blood treatment machine …

the plurality of data [related to the machine, being displayed in a visually associated position to a touch key] comprising operating instructions for readying the machine for use

the at least two images being pictographs which represent configurations of the machine correlated to the operating instructions.

Recent Case Law: T 0336/14

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T 1194/97 (OJ EPO 2000, 525) "appropriate to distinguish ... between data which encodes cognitive content, e.g. a picture, in a standard manner and functional data defined in terms which inherently comprise the technical features of the system ... in which the record carrier is operative”.

The operating instructions and the corresponding pictographs are cognitive rather than functional data in the sense of T 1194/97, since they address directly the user of the blood treatment machine and are consequently meaningful only to a human mind. It is also evident that, contrary to the respondent's view, the distinguishing features are related to the content of the information, i.e. to "what" is presented, rather than to the manner in which the information is presented, i.e. to "how".

Does the underlying user interface and the content presented credibly assist the user in performing a technical task by means of a continued and guided human-machine interaction process? So, this question is basically related to "why" (i.e. "for what purpose") the content is presented.

Recent Case Law: T 0336/14

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(Why? Purpose?) It has to be established whether the information presented constitutes "technical information", which credibly enables the user to properly operate the underlying technical system and thus has a technical effect, or rather "non-technical information", which is exclusively aimed at the mental activities of the system user as the final addressee.

However, not everything that supports a technical task has itself a technical character.

Here, information nor related to any internal system state (proper functioning of the underlying machine). In accordance with T 1143/06 (see reasons 3.4), making reference to T 619/98, an action (possibly) performed by a user in response to a message concerning the technical functioning of an apparatus does not necessarily render technical the information conveyed.

Aids the user in better comprehending and/or memorising the steps to be taken for setting up the blood treatment machine, minimise errors of interpretation or improve the "average user's" intelligibility about what he is supposed to do during the various machine set-up phases. Hence, it only addresses the human mental process of an "average user“.

Recent Case Law: T 0336/14

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The board fully agrees that the mere fact that mental activities on the part of the user are involved does not necessarily qualify subject-matter as non-technical.

„How“ is something presented rather than “what“ is presented.

Recent Case Law: T 0336/14

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75 Euro Law Conference 2016

1. A method for displaying an image stream, the method comprising:

receiving images acquired by a swallowable capsule, the images forming an

original image stream (1,2,3,4,5,6,7,8, …); and

displaying simultaneously on a monitor at least two subset image streams,

each subset (1,3,5,7…), (2,4,6,8, …)image stream including a separate subset of images from the original image stream.

Recent Case Law: BGH - Bildstrom (Image Stream) X ZR 37/13

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Instructions relating to the (visual) presentation of information which do not primarily focus on the conveyance of particular content or its conveyance in a particular layout but on the presentation of image content in a manner that takes into account the physical characteristics of human perception and reception of information and are directed towards making possible, improving or making practical the human perception of the displayed information serve the solution of a technical problem with technical means.

Conveying of specific information – i.e., certain information content – cannot be monopolized, whereas a technical teaching for enabling a human user to efficiently percept such information is accessible to patent protection. Distinction between “what is displayed” (excluded from patent protection) versus “how it is displayed” (not excluded)

a technical effect to an improved perception of the information by the user’s mindvs. psychological effect on a user’s mind

Recent Case Law: BGH - Bildstrom (Image Stream) X ZR 37/13

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• the mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention. Stating an abstract idea “while adding the words ‘apply it’” is not enough for patent eligibility.

• Nor is limiting the use of an abstract idea “‘to a particular technological environment.’”

• Stating an abstract idea while adding the words “apply it with a computer” simply combines those two steps, with the same deficient result. Thus, if a patent’s recitation of a computer amounts to a mere instruction to “implemen[t]” an abstract idea “on . . . a computer,” that addition cannot impart patent eligibility.

Alice Corp. v. CLS Bank International

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Alice Test:

(1) determine whether the claims at issue are directed to one of those patent-ineligible concepts; and

(2) search for the ‘inventive concept’ —i.e., “an element or combination of elements that is “sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the [ineligible concept] itself.

Alice Corp. v. CLS Bank International

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79 Euro Law Conference 2016

Alice Corp. v. CLS Bank International

(USPTO, June 25, 2014)

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80 Euro Law Conference 2016

Inventive Step in Pharma

Inventions

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81 Euro Law Conference 2016

CLOSEST PRIOR ART

T 177/13 Enteric Risedronate Formulation /

Warner Chilcott

Patent pertained to

Oral dosage form comprising

risedronate

Na2EDTA and

enteric coating

Objective: Reduce “food effect” of formulation

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82 Euro Law Conference 2016

CLOSEST PRIOR ART

T 177/13 Risedronate / Warner Chilcott

Opponent’s closest prior art O1:

Oral dosage form comprising

bisphosphonate

chelating agent and

enteric coating

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83 Euro Law Conference 2016

CLOSEST PRIOR ART

T 177/13 Risedronate / Warner Chilcott

Proprietor criticized O1 as closest prior art:

Multiple selection required

No reference to “food effect”

Other bisphosphonate (alendronate) preferred

No experimental data in O1

Teaching speculative and non-enabling

O11 (commercially available risedronate) proposed as better

closest prior art

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84 Euro Law Conference 2016

CLOSEST PRIOR ART

T 177/13 Risedronate / Warner Chilcott

BoA Decision:

O1 reasonable starting point

O1 concerned with similar problem (improvement of absorption of

bisphosphonate)

No concrete reasons to question efficiency of compositions of O1

Disclosure of O1 sufficient to enable

skilled person

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85 Euro Law Conference 2016

CLOSEST PRIOR ART

T 177/13 Risedronate / Warner Chilcott

BoA Decision:

Regarding O11 as alternative starting point:

If there are several reasonable starting points (O1, O11), inventive

step must be established with respect to each of these documents

as closest prior art

Conversely, inventive step is to be denied if only one closest prior

art renders the invention obvious

O1 was used as closest prior art

Inventive step denied

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86 Euro Law Conference 2016

CLOSEST PRIOR ART

T 1841/11 Semiconductor / Shin-Etsu

Closest Prior Art can also be document relating to similar purpose

…provided that it would be immediately apparent to the skilled

person that

what is disclosed in the document could be adapted to the

purpose of the claimed invention in a straightforward

manner,

using no more than common general knowledge

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87 Euro Law Conference 2016

CLOSEST PRIOR ART

T 1841/11 Semiconductor / Shin-Etsu

Said difference in purpose…

(here: growing of SiGe film versus growing of Ge film)

…does not contribute to inventive step

If transfer of teaching to other purpose requires more than common

general knowledge:

Document does not qualify as closest prior art

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88 Euro Law Conference 2016

CLOSEST PRIOR ART

Risedronate & Semiconductor Cases

Take-home lessons:

As Opponent consider developing alternative attacks based on

different closest prior arts

As Patentee, when criticizing choice of closest prior art

as non-enabling speculative disclosures: try to find reasons

why the disclosed teaching is not considered plausible by the

skilled person (internal inconsistencies? contradiction to state

of the art?)

as being too remote: try to find reasons why possibility to

transfer knowledge is not immediately apparent

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89 Euro Law Conference 2016

DEFINITION OF OBJECTIVE TECHNICAL PROBLEM

T 644/11 Freeze-dried Pantoprazole / Takeda

Patent pertained to

method for preparing pantoprazole preparation comprising

step of freeze-drying pantoprazole

together with EDTA and

NaOH or Na2CO3

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90 Euro Law Conference 2016

DEFINITION OF OBJECTIVE TECHNICAL PROBLEM

T 644/11 Freeze-dried Pantoprazole / Takeda

Closest Prior Art disclosed

method for preparing pantoprazole preparation comprising

step of freeze-drying pantoprazole

together with metallic ion complexing agent and

pH conditioning agent

Distinguishing Feature: Two-fold selection of components

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91 Euro Law Conference 2016

DEFINITION OF OBJECTIVE TECHNICAL PROBLEM

T 644/11 Freeze-dried Pantoprazole / Takeda

Technical Effect

Examples of opposed patent: Reduction of subvisible particles after

reconstitution

Opponent filed experimental report reworking of examples and

showing opposite effect of more subvisible particles

Patentee criticized experiments as differing from original

experiments

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92 Euro Law Conference 2016

DEFINITION OF OBJECTIVE TECHNICAL PROBLEM

T 644/11 Freeze-dried Pantoprazole / Takeda

Technical Effect

Both Opponent and Patentee filed further experimental reports

with contradicting results

Patentee given the benefit of doubt in case of contradicting

evidence (T 219/83)?

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93 Euro Law Conference 2016

DEFINITION OF OBJECTIVE TECHNICAL PROBLEM

T 644/11 Freeze-dried Pantoprazole / Takeda

BoA Decision

Beneficial effect of less subvisible particles not acknowledged

Reason: Serious doubts that beneficial effect is accomplished for

all claimed embodiments

Problem: Provision of further process

Patent revoked

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94 Euro Law Conference 2016

DEFINITION OF OBJECTIVE TECHNICAL PROBLEM

T 256/13 Donepezil Solid Form / Krka

Patent pertained to

Solid pharmaceutical composition comprising

donepezil HCl in form of hydrate

and excipients

having water content of 3-10%

Objective: Avoidance of interconversion of polymorphs

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95 Euro Law Conference 2016

DEFINITION OF OBJECTIVE TECHNICAL PROBLEM

T 256/13 Donepezil Solid Form / Krka

Closest prior art pertained to

Solid pharmaceutical composition comprising

donepezil HCl in form of hydrate

and excipients

water content not being further specified

Objective: Stability of polymorphs in general

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96 Euro Law Conference 2016

DEFINITION OF OBJECTIVE TECHNICAL PROBLEM

T 256/13 Donepezil Solid Form / Krka

Technical Effects:

Opposed patent contained

data demonstrating stability of inventive pharmaceutical

compositions against interconversion into other polymorph

BUT no data demonstrating that effect is not accomplished

when water content is outside claimed range

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97 Euro Law Conference 2016

DEFINITION OF OBJECTIVE TECHNICAL PROBLEM

T 256/13 Donepezil Solid Form / Krka

BoA Decision:

Technical effect cannot be taken into account

Because no comparison with closest prior art possible

Objective technical problem: provision of further pharmaceutical

composition with donepezil HCl

Inventive step denied

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98 Euro Law Conference 2016

DEFINITION OF OBJECTIVE TECHNICAL PROBLEM

T 1478/13 Controlled Release Tolterodine / Pfizer

Patent pertained to

Use of

oral formulation of

tolterodine

providing controlled release

with mean fluctuation index not higher than 2.0

for treatment of unstable or overactive bladder

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99 Euro Law Conference 2016

DEFINITION OF OBJECTIVE TECHNICAL PROBLEM

T 1478/13 Tolterodine / Pfizer

Closest Prior Art disclosed

Use of

oral formulation of

tolterodine

providing immediate release

with mean fluctuation index not being specified

for treatment of unstable or overactive bladder

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100 Euro Law Conference 2016

DEFINITION OF OBJECTIVE TECHNICAL PROBLEM

T 1478/13 Tolterodine / Pfizer

Technical Effect:

Patent contained experimental data

demonstrating that ratio of therapeutic effect / side effects was

improved

BUT employed method was acknowledged to be “rudimentary” and

“difficult to obtain accurate results”

Patentee filed post-published experimental results of clinical trial

demonstrating enhanced therapeutic effect

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101 Euro Law Conference 2016

DEFINITION OF OBJECTIVE TECHNICAL PROBLEM

T 1478/13 Tolterodine / Pfizer

BoA Decision did not accept improved efficacy over entire scope:

Post-published clinical trial was carried out with formulation having

different fluctuation index as in patent examples (1.5 vs 0.68)

Not possible to conclude on this basis that enhanced therapeutic

effect is accomplished also for patent examples

Problem defined without taking improved efficacy into account,

Inventive step denied

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102 Euro Law Conference 2016

DEFINITION OF OBJECTIVE TECHNICAL PROBLEM

T 382/13 Telmisartan Composition/ BI

Patent pertained to

tablet comprising

telmisartan

in amorphous form

sorbitol

with specific surface area 0.75-3.5 m2/g

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103 Euro Law Conference 2016

DEFINITION OF OBJECTIVE TECHNICAL PROBLEM

T 382/13 Telmisartan Composition/ BI

Closest prior art D1:

tablet comprising

telmisartan

in amorphous form,

sorbitol

with no information on specific surface area of sorbitol

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104 Euro Law Conference 2016

DEFINITION OF OBJECTIVE TECHNICAL PROBLEM

T 382/13 Telmisartan Composition/ BI

Technical Effect:

Patent contained experimental data

demonstrating

increased tablet hardness

while maintaining good dissolution rates

BUT effect shown only for one specific surface area

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105 Euro Law Conference 2016

DEFINITION OF OBJECTIVE TECHNICAL PROBLEM

T 382/13 Telmisartan Composition/ BI

BoA Decision did not accept accomplishment

of effect over entire scope:

Patentee argued based on cgk that

increasing hardness impairs dissolution

Adequate evidence required to contradict

such cgk; a single data point is not enough

Problem defined without taking effect into account,

Inventive step denied

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106 Euro Law Conference 2016

DEFINITION OF OBJECTIVE TECHNICAL PROBLEM

Take-home Lessons:

As Patentee: Try to file experimental evidence

to contradict all experiments of opponent

to supplement any deficient experiments in opposed patent

to allow proper comparison with closest prior art

to make effect credible over entire scope

As Opponent: Consider performing experiments that deviate from

examples of opposed patent

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107 Euro Law Conference 2016

REASONABLE EXPECTATION OF SUCCESS

T 1577/11 Anastrozole / AstraZeneca

Patent pertained to

2nd medical use of anastrozole

for reduction of rate of recurrence of cancer

in post-menopausal women

having early breast cancer

wherein anastrozole is provided in absence of tamoxifen

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108 Euro Law Conference 2016

REASONABLE EXPECTATION OF SUCCESS

T 1577/11 Anastrozole / AstraZeneca

Closest Prior Art disclosed

Use of tamoxifen

for reduction of rate of recurrence of cancer

in post-menopausal women

having early breast cancer

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109 Euro Law Conference 2016

REASONABLE EXPECTATION OF SUCCESS

T 1577/11 Anastrozole / AstraZeneca

Objective Technical Problem defined as

Provision of means

for reduction of rate of recurrence of cancer

in post-menopausal women

having early breast cancer

in a more efficacious way

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110 Euro Law Conference 2016

REASONABLE EXPECTATION OF SUCCESS

T 1577/11 Anastrozole / AstraZeneca

Obvious?

Closest Prior Art also disclosed

Use of aromatase inhibitors such as anastrozole

In endocrine treatment of

in post-menopausal women

having advanced breast cancer

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111 Euro Law Conference 2016

REASONABLE EXPECTATION OF SUCCESS

T 1577/11 Anastrozole / AstraZeneca

Obvious?

Closest Prior Art also disclosed

Use of anastrozole

in clinical trial of

in post-menopausal women

having early breast cancer

… and mentions “expectation that new generation of aromatase

inhibitors will improve efficacy”

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112 Euro Law Conference 2016

REASONABLE EXPECTATION OF SUCCESS

T 1577/11 Anastrozole / AstraZeneca

BoA Decision (after considering further pros and cons):

Reasonable expectation of success given because

of superior efficacy in advanced breast cancer

Not credible that skilled person would have seen significant

difference between early and advanced breast cancer

Better than expected results for anastrozole were merely

quantitative bonus effect

which in itself cannot establish an inventive step

Patent revoked

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113 Euro Law Conference 2016

REASONABLE EXPECTATION OF SUCCESS

Take-home Lessons:

Importance of secondary indications re possibility to transfer

teaching from closest prior art:

Significance of difference between claimed invention and closest

prior art?

Knowledge of skilled person at priority date?

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Dr. Axel Esser

Dr. James Ogle

Dr. Martin Bachelin