Transcript Diapositive 1

EUROPEAN PATENT
SYSTEM UPDATES
6th Annual International
Seminar on
“Intellectual Property Rights:
Advantage Business ”
February 13-14, 2010
Patricia S. Lecca
European &
French patent
attorney
INTRODUCTION and SCOPE OF PRESENTATION
 EPC 2000
 London Agreement
6th
International
Annual
Changes
in Divisional filing practice
Seminar on
“Accelerating
Growth of IPRresponses
in
 Mandatory
to ESR
Global Village”
 Insufficiency & priority issues
 EPO decisions
European Patent Convention
2000
6th Annual International
“EPC 2000”
Seminar on
“Accelerating Growth of IPR in
Global Village”
December 13, 2007
EPC 2000 – Deadlines
 Many deadlines can be now saved if missed by further
processing

31 month deadline for entering the EPO regional
phase;

deadlines for paying filing, search, designation,
claims, examination fees;
 ... otherwise can be saved by restoration if unintentional

1 year convention year to claim priority date;

2 month delay for appeal;

2 month delay for request further processing;

6 month delay for paying annuity;

16 month for claiming priority ;
EPC 2000 – Medical treatment claims
 1st medical use
“ Product X as a drug”
 2nd and subsequent medical uses:
 Swiss claim format:
“ Product X for the preparation of a drug for
treatment of disease Y”
 New format claim:
“ Product X for use as a medicament in treating
disease Z”
EPC 2000 - Request of limitation of EP patent
 filed by the patentee
 at any time
 no need to invoke any reasons or interests
 just file amended claims, description and figures of the
granted patent
 BUT does NOT work if the patent is under opposition
 MAY work if filed before a national lawsuit
 the EPO will just check whether claims are indeed limited
 the EPO will not check patentability
 pay the granting fees + file translations
 Request of limitation may be withdrawn at any time
 the limitation of the patent will be effective ab initio
EPC 2000 – Request of revocation
EUROPEAN PATENT SYSTEM UPDATES
 filed by the patentee
 at any time
 no need to invoke any reasons or interests
 just request revocation of the patent
 BUT does NOT work if the patent is under opposition
 MAY work if filed before a national lawsuit
 the European patent revocation will be effective ab
initio
 the request of revocation may be withdrawn at any time
London Agreement
for translation requirement
6th Annual International
Seminar on
“Accelerating Growth of IPR in
Global Village”
May 1st 2008
London Agreement – post-grant
Waiver of translation requirements post grant & of the registration
of address of service
In case of an EP patent in English
 No translations required
France, UK, Germany, Switzerland, Liechtenstein, Luxembourg,
Monaco

Translations of the claims
Denmark, Netherlands, Sweden, Croatia, Iceland, Latvia,
Slovenia, Lithuania

Translations of the whole patent
Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Estonia, Finland,
Greece, Hungary, Ireland, Italy, Malta, Norway, Poland,
Portugal, Romania, San Marino, Slovak Rep, Spain, Turkey
Divisional filings
New rules & strategies
6th Annual International
Seminar on
“Accelerating Growth of IPR in
Global Village”
April 1st 2010
Divisional applications – New rules


Restricting the opportunity & timing for filing a divisional
Currently, divisional applications may be filed at any time
up to the grant of the parent application

As of April 1st - divisionals may be filed at 2 occurrences:
6th Annual
 International
a voluntary divisional application may be filed within
Seminar on
24 months
“Accelerating
Growth of from
IPR in the first OA of the earliest application ;
Global Village”
and/or
 a divisional may be filed further to an objection of
non-unity within 24 months from said objection
Divisional applications – New Strategies
6th Annual International
Seminar on
“Accelerating Growth of IPR in
Global Village”
Divisional applications – Strategies

6 month transition period: up to October 1, 2010

if the time limits have expired before April 1, 2010 or is
still running on April 1, 2010, a divisional may still be filed
within 6 months, i.e., up to October 1, 2010;
6th Annual International
Seminar on

Recommendations:
CHECK
“Accelerating
Growth of IPR in
Global Village”
YOUR FILES !!
 If 1st non-unity objection / 1st OA was received on or
before October 1st, 2008
 then consider filing a divisional NO LATER THAN October
1st, 2010
Pending decision from
EPO Enlarged Board of Appeal
G 1/09
Concerns Rule 36(1) EPC: "pending" of parent
application in case of divisional application
"Is an application which has been refused by a
decision of the Examining Division thereafter still
pending within the meaning of Rule 25 EPC 1973
(Rule 36(1) EPC) until the expiry of the time limit for
filing a notice of appeal, when no appeal has been
filed?"
Mandatory responses
to European Search Report
6th Annual International
New rules
Seminar on
“Accelerating Growth of IPR in
Global Village”
April 1st 2010
Mandatory responses to WO, ESR, SESR

Currently, there is no obligation to respond to European
search reports, written opinions, etc...

As of April 1st 2010
6th Annual
International
 Euro-direct
applications
Seminar on
“Accelerating Growth of IPR in
Global Village”
(Rule 70(1)a EPC)
- Applicant is invited to comment/correct within 6 months
of the publication of the ESR
- In absence of a response: Application is deemed
withdrawn
Mandatory responses to WO, ESR, SESR

Euro-PCT applications
 EPO # ISA
(Rule 70(2)a EPC)
Applicant is invited to comment/correct within the period
for indicating he wishes to proceed further with the
application
6th Annual
International
- In absence
of a response: Application is deemed
Seminar
on
withdrawn
“Accelerating Growth of IPR in
 EPO
= ISA
(Rule 161 EPC)
Global
Village”
- Applicant is invited to comment/correct within 1 month of
the invitation
- In absence of a response: Application is deemed
withdrawn
Mandatory responses to ESR – Strategies

New rules will apply where the ESR or communications
under Rule 161 have not been issued before April 1, 2010

Recommendations
 Prepare a response to objections raised during the
6th Annual
International
international
phase early because deadlines for answering
Seminar
areonshort
“Accelerating Growth of IPR in
Global Village”
 Comply with the EPO requirements early : clarity, multiple
independent claims, and conciseness
 Consider that the European search report as the 1st official
action
Insufficiency issues
&
6th Annual International
Priority issues
Seminar on
“Accelerating Growth of IPR in
Global Village”
EPO trends
Insufficiency
T 409/91: Exxon v Fuel oils
“The extent of the patent monopoly as defined by the claims
should correspond to the technical contribution to the art.”
T 226/85 – T 1011/01 : Matsushita
“Any embodiment of the invention as defined by the broadest
claim must be capable of being realized on the basis of the
disclosure. It is irrelevant whether or not the feature objected to
was essential.”
T 609/02 : Salk Institute
“if the description provides no more than a vague indication of a
possible medical use claim for a chemical compound yet to be
identified, more detailed evidence filed later cannot remedy to
the insufficiency of the disclosure.”
Insufficiency
T 1743/06 - experiments v. undue burden
Even though a reasonable amount of trial and error is permissible
when it comes to assessing sufficiency of disclosure, there must
still be adequate instructions in the specification, or on the basis
of common general knowledge, leading the skilled person
necessarily and directly towards success, through evaluation of
initial failures. This is not the case here, since the preparation of
the amorphous silicas claimed is made dependent on the
adjustment of different process parameters for which no
guidance is given in the patent in suit, so that the broad
definition of an amorphous silica as presently claimed is no more
than an invitation to perform a research program in order to find
a suitable way of preparing the amorphous silicas over the whole
area claimed.
Insufficiency
T 63/06 - Hitachi v. DaimlerChrysler
The burden of proof generally lies upon an opponent to establish
insufficiency of disclosure. When the patent does not give any
information of how a feature of the invention can be put into
practice, only a weak presumption exists that the invention is
sufficiently disclosed . In such case, the opponent can discharge his
burden by plausibly arguing that common general knowledge
would not enable the skilled person to put this feature into
practice.
The patent proprietor then has the burden of proof for contrary
assertion that common general knowledge would indeed enable
the skilled person to carry out the invention.
Priority issues
T 1212/05 – Breast and ovarian cancer



Priority claim for DNA sequences
Priority document contained sequence errors
G 2/98: same invention = same subject-matter


Priority of claim 1 of patent as granted : invalid
Priority of limited auxiliary request: accepted
Priority issues
T 1178/04 – T 382/07 – T 62/05

Right of priority should be transferred before the date of filing the
application which claims benefit of said priority rights
“The Appellant had tried to remedy the situation by transferring the patent
to the legal person who had filed the application from which the priority
had been claimed by an assignment executed nearly seven years after the
filing date of the application for the opposed patent. »
“Such a retroactive transfer could not render the priority claim valid if the
right to claim the priority did not lie, at the time of filing, with the
applicant who actually filed the application for the opposed patent. »
EPO recent & pending decisions
6th Annual International
Enlarged
Board
of
Appeal
Seminar on
“Accelerating Growth of IPR in
Global Village”
Patentability of dosage regimens
T1020/03 -
pre EPC 2000
 related to specific discontinuous administration regimen of IGF-1
 But was claimed using the Swiss type format : “ ... For me
manufacture of a medicament for the treatment of ...”
 The board argue that there was no interference with the
freedom of the physician because the patent proprietor would
have a remedy only against the maker of, or dealer in the
composition.
Patentability of dosage regimens
G2/08 Kos life sciences
The relevant part of claim 1 reads:
“The use of nicotinic acid … for the manufacture of a sustained
release medicament for use in the treatment by oral
administration once per day prior to sleep, of
hyperlipidaemia…”
As this application was pending when EPC 2000 entered into
force, it is to be considered under the provisions of Articles 53(c)
and 54(4) and (5) EPC 2000.
Patentability of dosage regimens
Article 54(5) EPC 2000 reads:
Paragraphs 2 and 3 shall also not exclude the
patentability of any substance or composition referred to in
paragraph 4 for any specific use in a method referred to in
Article 53(c), provided that such use is not comprised in the
state of the art.
Patentability of dosage regimens
1.
Where it is already known to use a particular medicament to
treat a particular illness, can this known medicament be
patented under the provisions of Articles 53(c) and 54(5) EPC
2000 for use in a different, new and inventive treatment by
therapy of the same illness?
2.
If the answer to question 1 is yes, is such patenting also
possible where the only novel feature of the treatment is a
new and inventive dosage regime?
3.
Are any special considerations applicable when interpreting
and applying Articles 53(c) and 54(5) EPC 2000?"
Patentability of stem cells
G 2/06 "Use of embryos/WARF“
 Rule 28(c) EPC forbids the patenting of claims directed to
products which - as described in the application - at the filing
date could be prepared exclusively by a method which
necessarily involved the destruction of the human embryos
from which the said products are derived, even if the said
method is not part of the claims
 It is NOT of relevance that AFTER the filing date the same
products could be obtained without having to recur to a
method necessarily involving the destruction of human
embryos
Essential biological process
for plant production
G 2/07 and G 1/08
Concern Article 53(b) EPC: exclusion of essentially
biological processes for production of plants
Referral decisions: T 83/05 "Glucosinolates/PLANT
BIOSCIENCE" (OJ 2007, 644) and T 1246/06
"Tomatoes/STATE OF ISRAEL" (OJ 2008, 517)
Patentability of surgical methods
G 1/07
Concerns Article 53(c) EPC: exclusion of surgical
methods
Referral decision T 992/03 "Treatment by surgery/
MEDI-PHYSICS" (OJ 2007, 557)
Thank you !
Feel free to contact me:
[email protected]