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DRAFTING WITHOUT BORDERS
LIFE SCIENCES
Introduction
Clarissa Regler
Patent Attorney, Winter Brandl, Germany
Co-Founder, TRUVENTO GmbH
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Clarissa Regler
Germany
Rana Gosain
Brazil
Serge Shahinian
Canada
Archana Shanker
India
STRENGTHENING THE PRACTICE OF THE INDEPENDENT IP ATTORNEY
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CHEMICAL AND BIOTECHNOLOGICAL
INVENTIONS UNDER THE EPC
Clarissa Regler
Patent Attorney, Winter Brandl, Germany
Co-Founder, TRUVENTO GmbH
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STRENGTHENING THE PRACTICE OF THE INDEPENDENT IP ATTORNEY
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Life Sciences
6
Introduction
7
„
Biotechnological inventions
“ are inventions which concern a product consisting of or
containing biological material or a process by means of which biological material is
produced, processed or used (Rule 26(2) EPC).
•
EU Biotech Directive (Directive 98/44/EC)
„
Biological material“
means any material containing genetic information and capable
of reproducing itself or being reproduced in a biological system (Rule 26(3) EPC).
Patent subject-matter eligibility
8
•
European patents shall be granted for any invention, in all fields of technology, provided that
they are
new
, involve an
inventive step
and are susceptible of
industrial application
(Art.
52(1) EPC).
•
An invention is not
a) a discovery, scientific theory or mathematical method;
b) an aesthetic creation;
c) a scheme, rule or method for performing a mental act, playing a game or
doing business, or a computer program; or
d) a presentation of information (Art. 52(2) EPC).
•
Invention
Does its subject-matter fall under the exceptions to patentability? (Art. 53 EPC)
Exceptions to patentability (Art. 53 EPC)
9
Plant / animal
varieties
Art. 53(b),
R. 26(4) EPC
Ordre public,
morality
Art. 53(a) EPC
Excluded biotechnological inventions:
•
Processes for cloning human beings;
•
Processes for modifying the germ line genetic identity of human
beings;
•
Uses of human embryos for industrial or commercial purposes;
•
Processes for modifying the genetic identity of animals which are
likely to cause them suffering without any substantial medical benefit
to man or animal
R. 28(1) EPC
Essentially biological
processes for the
production of plants or
animals
Art. 53(b), R. 26(5) EPC
Human body,
discovery gene
R. 29(1) EPC
Methods for treatment of the
human or animal body by
surgery or therapy and
diagnostic methods practised
on the human or animal body
Art. 53(c) EPC,
Art. 54(5) EPC
Exclusions for biotechnological
inventions
•
G 3/19
(reversing G 2/12 and G2/13)
•
No patent for plant or animal exclusively obtained by an
essentially
biological process
.
•
This negative effect does not apply to European patents granted
before 1 July 2017 and European patent applications which were filed
before that day and are still pending.
10
A plant produced by introgression of gene, i.e. by introducting it into the
genome by crossing and selection
(not allowable any more).
A plant part obtained exclusively by means of an essentially biological process which is
propagation material, e.g. a seed or plant embryo
(not allowable any more).
Patentable biotechnological inventions
11
Biotechnological
inventions concerning
plant / animal not
confined to variety
R. 27(b) EPC
Biotechnological inventions:
•
Biological material isolated
or technically produced
•
Plants / animals not confined
to variety
•
Microbiological process or
other technical process of
product thereof (not variety)
R. 26(1), (2) EPC,
Art. 53(b), R. 26(6), R. 27 EPC
Element isolated from the
human body, e.g. sequence or
partial sequence of a gene
+
Disclosure of the industrial
application
R. 29(2), (3) EPC
Patentable biotechnological inventions
12
Method of producing a (transgenic) plant having trait X comprising introducing
by transformation a vector comprising the sequence of SEQ ID NO: 1.
Use of the nucleic acid of SEQ ID NO:1 to select a plant having trait X.
A transgenic plant carrying transgene X.
Patentabilty
European patents shall be granted for any invention, in all fields of
technology, provided that they are new, involve an inventive step and
are susceptible of industrial application (Art. 52(1) EPC).
13
Invention
New
Inventive step
Industrial application
Unity
Sufficiency of
Disclosure
Clarity
Industrial application (Art. 57 EPC)
•
Biotechnological inventions are quite often concerned with
substances found in nature (e.g. a protein, a DNA sequence, etc.)
•
Indication of a profitable use of the invention in industry.
14
General novelty related issues (Art. 54
EPC) in the context of Life Sciences
•
Generic – specific: a generic disclosure does not usually take away
the novelty of any specific example falling within the terms of that
disclosure
•
Novelty of chemical inventions:
•
Art. 64(2) EPC: Protection of process patent extends to directly obtained
products
•
T 150/82
: Product-by-process claim admissible if product patentable and no
other definition possible
•
T 296/87
: Chemical substance is new if it differs from a known substance in a
reliable parameter
15
General novelty related issues (Art. 54
EPC) in the context of Life Sciences
•
“Reach-through” claims
•
Are defined as claims attempting to obtain protection for a chemical product
(and also uses thereof, compositions thereof, etc.) by defining that product
functionally in terms of its action on a biological target such as an enzyme or
receptor.
•
In many such cases, the applicant functionally defines chemical compounds
in this way by reference to a newly identified biological target.
•
However, compounds which bind to and exercise this action on that
biological target are not necessarily novel compounds simply because the
biological target which they act on is new.
•
Selection inventions: lists, numerical ranges
16
Selection Inventions (lists)
•
A selection from a single list of specifically disclosed elements does not confer
novelty.
•
However, if a selection from two or more lists of a certain length has to be made in
order to arrive at a specific combination of features then the resulting
combination of features, not specifically disclosed in the prior art, confers novelty
(the "
two-lists principle
").
•
Examples of such selections from two or more lists are the selection of:
•
(a)
individual chemical compounds from a known generic formula whereby the
compound selected results from the selection of specific substituents from two or
more "lists" of substituents given in the known generic formula. The same applies to
specific mixtures resulting from the selection of individual components from lists of
components making up the prior art mixture;
•
(b)
starting materials for the manufacture of a final product;
•
(c)
sub-ranges of several parameters from corresponding known ranges.
17
Claiming purity of a compound
•
A claim defining a
compound
as having a
certain purity lacks novelty
over a prior-art disclosure describing the same compound only if the
prior art discloses the claimed purity at least implicitly, for example by
way of a method for preparing said compound, the method inevitably
resulting in the purity as claimed.
•
Such a claim, however,
does not lack novelty if the disclosure of the
prior art needs to be supplemented, for example by suitable
(further) purification methods
allowing the skilled person to arrive at
the claimed purity.
18
Drafting medical use claims
•
Allowed claims:
•
Substance / composition X (novel substance/composition)
•
Substance / composition X
for use
as a medicament (First medical indication, Art.
54(4) EPC)
•
Substance / composition X
for use
in the treatment of cancer (Second medical use
claim, Art. 54(5) EPC)
•
Dosage regime: Substance / composition X
for use
in the treatment of cancer by
“dosage regime” (e.g. by oral administration once per day, i.e. different dosage,
administration regime, group of subjects or route of administration)
•
Allowed medicine claims for a combined preparation (kits of parts):
•
Combined preparation of X and Y
for
simultaneous, separate or sequential
use
in
therapy (first medical indication)
•
NOT
allowed:
Use of
substance / composition X for treatment of disease Y
•
Such a claim will be regarded as relating to a method for treatment explicitly
excluded from patentability by Art. 53(c) EPC and therefore will not be accepted.
19
Product-by-process claims
•
Product-by-process claims are only exceptionally allowed, when there
is no other way to describe the product with structural features.
•
This typically occurs for substances such as polymers or glasses for
which no definable structure is available.
•
The claimed product must itself be new and have distinct properties
due to its modified method of manufacture.
„
Product X obtainable by process Y
“.
20
Inventive step in the field of
biotechnology (Art. 56 EPC)
•
Definition of the person skilled in the art in the field of biotechnology
•
Expectation of success, especially in the field of genetic engineering
and biotechnology
•
Inventive step of antibodies:
•
The subject-matter of a claim defining a novel, further antibody
binding to a known antigen does not involve an inventive step unless
i)
a surprising technical effect is shown by the application or
ii) unless there was no reasonable expectation of success of obtaining
antibodies having the required properties.
21
Antibodies under the EPC
•
An antibody can be claimed by:
•
structural
definitions, e.g. amino acid sequences
AND / OR by
•
functional
definitions, e.g. by reference to the (target) antigen, by identification of the
bound epitope (or target), by the production process
•
The Board provided guidance when functional features are acceptable
(
T 68/85
):
•
the features provide instructions for the skilled person to reduce the invention to
practice without undue burden; and
•
such features could not otherwise be defined more precisely without restricting the
scope of the invention.
„
Antibody specifically binding to target X
“.
22
Claim drafting - Antibodies
•
Antibody specifically binding to target X.
•
Product claims charcterizing an antibody by its structure:
•
An antibody X having the amino acid sequence of SEQ ID NO. 1.
•
An antibody having a VH of SEQ ID NO. 1 and a VL of SEQ ID NO. 2.
•
An antibody having 6 CDR regions with SEQ ID NOs. 1-6.
•
Product-by-process claims characterizing an antibody by a process for
its preparation:
•
An antibody X obtainable by a process comprising steps ….
•
Product claims comprising antibodies as essential elements:
•
A kit for detecting compound X comprising antibody Y.
•
A pharmaceutical composition comprising antibody X.
•
Process claims for antibodies:
•
A process for isolating antibodies X from source Y comprising the steps of …
•
A process for preparing antibody X, comprising the steps of expressing SEQ ID NO.Y in host cell
Z and obtaining the antibody from the cultivated cells.
23
Plausibility at the EPO
•
If the technical effect is
not in the claim
, but contributes to the
solution of the technical problem
, the evidence will need to be
considered under the heading of
inventive step
(Art. 56 EPC).
•
If the technical effect is
in the claim
the evidence for this will need to
be considered under the heading of
sufficiency of disclosure
(Art. 83
EPC).
24
The requirements of sufficiency of
disclosure (Art. 83 EPC)
•
One way of implementing invention over whole scope of claim
•
Repeatability
•
Requirements relating to nucleotide and amino acid sequences
•
Attention is drawn to the new WIPO Standard ST.26 for sequence listings that
apply to applications filed on and after 1 July 2022.
•
Deposit of living material
25
BEST PRACTICES IN FILING AND PROSECUTING
PHARMA & BIOTECH INVENTIONS
Rana Gosain
Partner, Daniel Law, Brazil
alive
STRENGTHENING THE PRACTICE OF THE INDEPENDENT IP ATTORNEY
www.ficpi.org
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PATENTS IN BRAZIL:
RECENT DEVELOPMENTS
28
Brazil has finally
tackled the
backlog problem
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4.7 years
is the average time to obtain a notice of allowance in
2023.
\
The BPTO implemented specific programs to tackle the backlog problem and to allow expedited examination that already have had great
outcomes, but reducing the backlog is still a work in progress.
Source: BPTO
Beating the backlog in Brazil
30
9.3
9.0
8.7
8.1
7.2
6.4
5.3
4.7
4.5
2016
2017
2018
2019
2020
2021
2022
2023
2024
Average time to obtain patent protection
(order 9.1; in years)
Fast-track programs
as tools to expedite examination
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73
179
252
PPH Request to PPH Acceptance
PPH Request to Formal Exam.
PPH Request to 1st OA
PPH Request to Decision
32
The PPH is a program resulting from international agreements between several patent offices. It accelerates the prosecution of Brazilian patent applications
containing a member of its patent family that has already been examined in other countries with which the BPTO has an PPH agreement. Since the program
began at the BPTO in 2016, there were 3287 PPH requests made by applicants in Brazil.
In 2023, the annual limit for PPH requests (800) was reached in July. In 2024, the 800 cap was also hit in July.
Source: BPTO
[1] Requests filed between 2020 and September 2024
Average timeframes¹ (days)
96%
4%
Accepted
Rejected
Most applications are accepted
into the PPH Program¹
13%
87%
Allowed
Rejected
BPTO Decision¹
49
% of these cases were
granted
without further office actions.
PPH – PATENT PROSECUTION HIGHWAY IN BRAZIL
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40
41
55
58
83
86
105
109
111
33
PPH – PATENT PROSECUTION HIGHWAY IN BRAZIL
Source: BPTO
[1] Requests filed between 2020 and September 2023
Top 10 PPH Requests by applicants’ country of origin¹
Top 10 PPH applicants¹
39
66
79
96
166
180
236
257
305
1225
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Status of such requests¹
34
GREEN PATENTS
This program accelerates the prosecution of patent applications related to “green” technologies in the following areas:
•
Alternative energy (e.g. biofuels, wind energy, solar energy etc);
•
Transport (e.g. electric vehicles, hybrid vehicles etc);
•
Energy conservation/saving (e.g. electric or thermal power storage, saving power consumption etc);
•
Waste management (e.g. waste treatment, waste disposal etc); and
•
Sustainable agriculture (e.g. reforestation techniques, irrigation techniques, alternative pesticides etc).
79%
21%
Accepted
Rejected
Average timeframes¹ (days)
79
62
220
324
Fast-track Request to Acceptance
Fast-track Request to Formal
Exam.
Fast-track Request to 1st OA
Fast-track Request to Decision
Requests for participation into
this program¹
663
61%
39%
Rejected
Allowed
BPTO Decision¹
Source: BPTO
[1] Requests filed between 2020 and September 2023
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TECHNOLOGY AVAILABLE IN BRAZILIAN MARKET
The prosecution of the patent application can be accelerated through this program if the patent
application covers (totally or partially) a technology already made available in the Brazilian
market, through commercialization, licensing, import or export.
Source: BPTO
[1] Requests filed between 2020 and September 2023
Average timeframes¹ (days)
68
57
171
258
Fast-track Request to Acceptance
Fast-track Request to Formal Exam.
Fast-track Request to 1st OA
Fast-track Request to Decision
262
70%
30%
Rejected
Allowed
BPTO Decision¹
Requests for participation into
this program¹
98%
2%
Accepted
Rejected
Status of such requests¹
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FAST-TRACK FOR CASES OF POSSIBLE INFRINGEMENT
If unauthorized third parties are reproducing the object of a patent application, expedited
prosecution of application may be requested under this program.
Average timeframes¹ (days)
58
37
183
299
Request to fast-track accept.
Request to formal exam.
Request to 1st OA
Request to Decision
Requests for inclusion into
this program¹
341
82%
18%
Accepted
Rejected
Status of such requests¹
54%
46%
Rejected
Allowed
BPTO Decision¹
Source: BPTO
[1] Requests filed between 2020 and September 2023
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HEALTHCARE PRODUCTS
This program accelerates the prosecution of patent applications related to pharmaceutical
products, processes and materials used in healthcare for the diagnosis, prophylaxis and
treatment of AIDS, cancer, and rare or neglected diseases.
Average timeframes¹ (days)
77
68
218
332
Fast-track Request to Acceptance
Fast-track Request to Formal Exam.
Fast-track Request to 1st OA
Fast-track Request to Decision
Requests for participation into
this program
341
93%
7%
Accepted
Rejected
59%
41%
Rejected
Allowed
BPTO Decision¹
Status of such requests¹
Source: BPTO
[1] Requests filed between 2020 and September 2023
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APPLICANT OVER 60 YEARS OLD, SERIOUS ILLNESS, MENTAL/PHYSICAL DISABILITY
This program expedites the prosecution of patent applications filed by an individual who is 60
years or older; or has a serious illness; or physical/mental disability
Average timeframes¹ (days)
54
73
166
264
Fast-track Request to Acceptance
Fast-track Request to Formal
Exam.
Fast-track Request to 1st OA
Fast-track Request to Decision
Requests for participation into
this program
1,525
89%
11%
Accepted
Rejected
63%
37%
Rejected
Allowed
BPTO Decision¹
Status of such requests¹
Source: BPTO
[1] Requests filed between 2020 and September 2023
BPTO
Patent Backlog Combat Program
initiated in 2019
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PATENT BACKLOG COMBAT PROGRAM
Cases eligible to receive a Preliminary Office Action (6.23 order)
Applications that have been already examined abroad
Filing date from January 1
st
, 2017
No office actions on patentability issued by the Brazilian PTO
No requests for fast-track examination
No third-party observations (similar to a pre-grant opposition)
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PATENT BACKLOG COMBAT PROGRAM
Cases eligible to receive a Preliminary Office Action (6.23 order)
Applications examined abroad
BPTO selects prior art identified by foreign patent offices and issues the preliminary office action
Response amending BR claims in
view of claims allowed abroad,
overcoming listed prior art and
observing local rules
Response presenting other
amendments and/or technical
arguments
No response
Granted
Rejected with
right to appeal
Additional
office action
Dismissed with
no right to appeal
Granted
(...)
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RESULTS SO FAR...
653
1,562
11,043
12,432
100,634
23,634
81,693
63,311
265
4,140 195
286
•
The BPTO created the program to beat the brazilian patent backlog. In Sep. 2019, the BPTO had about 148 thousand cases waiting for a decision. Out of these cases,
there are only 4.9 thousand remaining.
Changes from
2019
to
2023
September 2019
Backlog: 147,743
October 11
th
2023
Backlog: 4,886
17 months
in average for the BPTO to decide a case after a preliminary office
action has been issued.
89%
is the allowance rate of the cases decided after a preliminar office action.
64%
of the cases were allowed without further office actions.
98%
of the eligible cases to the program were decided.
Under formal
examination
Under technical
examination
Lapsed
Definitely lapsed
Decided
Applications eligible for
receiving preliminary
office actions
Source: BPTO
Changes regarding the sequence of the
patent examination queue
•
The examination queue for patent applications will now be determined by the date
of the request for examination, a step that must be completed within 36 months of
the filing date.
•
Previously, applications entered the queue based on their filing date once
examination was requested.
•
This strategic shift aims to streamline patent prosecution in Brazil, aligning it with
global practices.
•
The change also empowers applicants by granting them more control over the
examination timeline for their patent applications.
Patent examination queue changed
New rules
restricting claim
amendments at appellate stage
Key changes and Concepts
Administrative Preclusion
:
•
All objections must be thoroughly addressed during the regular stage.
•
Failure to address objections precludes addressing them later.
Filing Amendments
:
•
First Instance of examination:
•
Before Examination Request: Broadening scope and adding new
claims permitted.
•
After Examination Request: Only restrictive amendments allowed.
•
Translation corrections allowed anytime.
•
Appellate Stage:
•
Only restrictive amendments permitted.
•
Amendments must address specific objections from the first
instance of examination.
Key changes and Concepts
Reassessment at First Instance of Examination
:
•
Possibility to revert to first instance of examination if
specific arguments were overlooked.
•
Allows addressing unresolved issues and making further
amendments.
No Defined Deadline for Rejection Decisions
:
•
No specific deadline for issuing rejection decisions.
•
Every office action response should be treated as
potentially final.
Retroactive Application of New Rules
•
New rules do apply retroactively.
•
Applications that received the first substantive office action from
April 1
st
are subjected to the new rules
•
Applications that received the first substantive office action before
April 1
st
will be examined according to the previous rules
•
Brazilian PTO will issue a special type of office actions in the appeal
procedures of applications that received the first substantive office
action until April 1
st
2024.
•
The objective is to “educate” the applicants and explain how the case
would be examined if the new rules were applied
Best practice and recommendations
Responding to Office Actions
•
Add dependent claims to overcome objections related to patentability.
•
Ensure compliance with formal objections even if contested.
•
Provide well-founded reasons for not complying with objections.
Preparing an Appeal
•
Appeals should not be seen as a continuation of examination.
•
Primary claim set examined is the rejected claim set.
•
Present arguments defending the rejected claim set.
•
Assist appellate examiners by pointing out examination errors.
Best practice and recommendations
Conclusion
•
Thorough and strategic responses are crucial
under the new guidelines.
•
Emphasis on addressing all objections and
preparing comprehensive appeals.
Patent litigation
and the enforcement of
standard-essential patents
in Brazil
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FAVORABLE LEGAL FRAMEWORK
•
Independent judiciary system
•
Bifurcated system
•
No bias against foreign companies
•
Civil law system (no binding precedents)
•
No juries, no trials (only written bench decisions)
•
Pro-plaintiff, pro-patentee jurisdiction
INJUNCTIONS ARE WIDELY AVAILABLE
No need to give notice to the defendant
No need to post a bond or give security
No discussions regarding balance of hardships or public interest
Plaintiffs are allowed to have
ex parte
in-chambers meetings
Forum shopping strategy is key
Chances of obtaining PI >60% in certain venues
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ENFORCEMENT OF SEPS IN BRAZIL
Two leading cases:
Vringo v. ZTE
and
Ericsson v. TCL
More recent disputes:
DivX v. Netflix
and
Nokia v. Lenovo
Preliminary injunctions available for SEPs even when encumbered with FRAND commitments
Injunctions also available for NPEs
Injunctions can be broad in scope
WHAT WE LEARNT SO FAR
Injunctions more likely if:
•
There is evidence that defendant is an unwilling licensee, refuses to negotiate in good faith,
refuses arbitration re royalties
•
Defendant’s competitors acknowledge patent and pay royalties
•
Defendant denies infringement and only talk about FRAND later
•
Other arguments: defendant has no assets in Brazil, potential for obsolecence of the
technology, defendant’s bad reputation, no harm to consumers
•
Antitrust authority (CADE) normally does not interfere
Brazil officially joined
the HAGUE SYSTEM
The Hague System for International registration of designs came into effect for Brazil on 1 August
2023 and introduced several changes on Brazilian Industrial Designs Rules
HAGUE SYSTEM IN BRAZIL
INCLUSION OF DASHED/BROKEN LINES OR SHADED SURFACES TO DISCLAIM ELEMENTS OR PORTIONS.
The Hague System for International registration of designs came into effect for Brazil on 1 August
2023 and introduced several changes on Brazilian Industrial Designs Rules
HAGUE SYSTEM IN BRAZIL
DESIGNS INCLUDING AN ASSOCIATION OF ELEMENTS
The Hague System for International registration of designs came into effect for Brazil on 1 August
2023 and introduced several changes on Brazilian Industrial Designs Rules
HAGUE SYSTEM IN BRAZIL
DESIGNS INCLUDING TRADEMARKS. HOWEVER, THE PROTECTION WILL NOT COVER THE TRADEMARK.
The Hague System for International registration of designs came into effect for Brazil on 1 August
2023 and introduced several changes on Brazilian Industrial Designs Rules
HAGUE SYSTEM IN BRAZIL
PROTECTION FOR TYPOGRAPHY FONTS.
The Hague System for International registration of designs came into effect for Brazil on 1 August
2023 and introduced several changes on Brazilian Industrial Designs Rules
HAGUE SYSTEM IN BRAZIL
DESIGNS INCLUDING TEXT.
The Hague System for International registration of designs came into effect for Brazil on 1 August
2023 and introduced several changes on Brazilian Industrial Designs Rules
HAGUE SYSTEM IN BRAZIL
IMPROVEMENTS ON GUIs PROTECTION
The Hague System for International registration of designs came into effect for Brazil on 1 August
2023 and introduced several changes on Brazilian Industrial Designs Rules
HAGUE SYSTEM IN BRAZIL
Transition images will be accepted. Previously they were understood as individual designs, which
sometimes required divisional applications for each reproduction.
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Rana Gosain is a Senior Partner at Daniel Law. He has worked
with Intellectual Property for more than 30 years. He is an
Intellectual Property Agent accredited by the Brazilian PTO
and has a postgraduate degree in Intellectual Property from
the Pontifical Catholic University in collaboration with the
Brazilian PTO.
Rana specializes in patents and industrial design and has
great experience of handling patents, litigation strategies,
validity and infringement studies and providing legal advice.
Much of his work focuses on the pharmaceuticals and
biotechnology area.
Rana’s current role is to develop the best strategies for
protecting and managing IP Portfolios. He also advises clients
on a broad range of issues related to Intellectual Property.
GOSAIN
RANA
S E N I O R PA R T N E R
PRATICE AREAS
•
Biotechnology
•
Industrial Design
•
Litigation
•
Patents
EDUCATION
•
Degree from the Veiga Almeida University Law School (UVA) in 2005;
•
Postgraduate degree in Intellectual Property from the Pontifical Catholic
University of Rio de Janeiro.
AFFILIATIONS, COMMISSIONS AND COLLEGIATE
•
Member of the Brazilian Bar Association, registered in the States of Rio de
Janeiro and São Paulo;
•
Member of the Brazilian Intellectual Property Association – ABPI;
•
Member of the Association Internationale pour la Protection de la Propriété
Intellectuelle – AIPPI;
•
Member of the Fédération Internationale des Conseils en Propriété Industrielle
– FICPI;
•
Member of the Licensing Executives Society – LES;
•
Member of the American Intellectual Property Law Association – AIPLA;
•
Member of the Director Council from ABPI;
•
Member of the Brazilian Association of Industrial Property Agents – ABAPI.
RANKINGS
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63
63
Gustavo is an accomplished patent attorney with over 19 years of experience
in patents and industrial designs. He holds a BSc in Electronic Engineering, an
MSc in Mechanical Engineering, and a law degree, combining technical
expertise with legal acumen. Recognized for his outstanding skills, Gustavo
has been cited in prestigious legal rankings such as The Legal 500, IP Stars,
IAM, and Leaders League.
Throughout his career, Gustavo has worked in renowned intellectual property
firms in Brazil and gained industry experience as a patent engineer in a large
mining company. In addition, he worked at a large technology company, in
the department responsible for deploying the 3G access network and
overseeing the quality of installation for base stations, antennas, links, and
other components, equipment, and nodes of the access network. At an
Intellectual Property firm, he worked on one of the first major patent
litigation cases involving telecom standard essential patents in Brazil.
His diverse background has equipped him to handle inventions from various
technical fields. With a deep understanding of both technology and the law,
Gustavo also represents clients in patent-related lawsuits.
With a solid reputation, extensive experience, and a comprehensive
understanding of patent law, Gustavo is a valuable asset for clients seeking
effective patent protection and strategic legal guidance.
SARTORI
GUSTAVO
P A R T N E R |
C o - H E A D
O F P A T E N T
P R O S E C U T I O N
PRATICE AREAS
•
Competitive Intelligence
•
Industrial Design
•
Patents
•
Mechanical, Electrical, Automotive, Industrial Equipment, Medical Devices,
Agricultural Machinery and Telecommunications.
EDUCATION
•
Electrical Engineering Degree with emphasis on electronics from “Instituto
de Tecnologia Mauá” (2008);
•
Bachelor in Law at the “Universidade Presbiteriana Mackenzie” (2016);
•
Master’s Degree in Mechanical Engineering (2019).
AFFILIATIONS, COMMISSIONS AND COLLEGIATE
•
Member of the Regional Council of Engineering, Architecture and
Agronomy (CREA-SP);
•
Member of the Brazilian Association of Industrial Property Agents – ABAPI.
ARTICLES
Successful Patent Prosecution Highway program reaches annual
Patent Prosecution Highway Acceleration Program between Brazil
Brazilian Patent Prosecution Highway shows strong results in the
Speeding up the patent process in Brazil
Can you patent a software in Brazil?
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www.daniel-ip.com
Drafting without borders – life sciences
The Canadian perspective – eh?
Serge Shahinian
Partner, Patent Agent
Lavery, Canada
alive
STRENGTHENING THE PRACTICE OF THE INDEPENDENT IP ATTORNEY
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Most subject matter in the life sciences is
patent-eligible in Canada
STRENGTHENING THE PRACTICE OF THE INDEPENDENT IP ATTORNEY
www.ficpi.org
•
Chemical or biological molecules/products
•
Living matter
•
Therapeutics
•
Diagnostics
•
Personalized medicine
•
Research tools, reagents
•
Methods/processes
•
New uses of known compounds
invention
means any new and useful art, process, machine, manufacture or composition of
matter, or any new and useful improvement in any art, process, machine, manufacture or
composition of matter
(
Patent Act
, S. 2)
… As always – the devil is in the details!
Chemical or biological molecules/products
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•
Chemical compounds
•
Salts; crystal forms/polymorphs
•
Nucleic acids; proteins/peptides (sequence listing); can have combined structural (%
identity) + functional definition
•
Vectors
•
Antibodies, antigen-binding molecules
•
No exclusion
per se
based on occurrence in nature
•
Compositions (including vaccines) comprising the above (at least 2 components –
additionally recite generic carrier/excipient)
•
Packages or kits comprising the above (for kits, need at least 2 components – additionally
recite a further, generic component)
Antibodies
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No strict “rule” as to what is required; fact-specific
•
Functional definitions possible based on:
•
antigen
•
specific epitope of antigen
•
binding properties
•
Structural definition
•
Sequences of 6 CDRs
Generally, not as strict as other jurisdictions, however, there has been considerable
development in this area = growth of “prior art” regarding antibodies, especially for
certain therapeutic targets – this raises the bar for disclosure and claim details for
new antibodies against such targets
Living matter: “Lower” vs. “higher” life forms
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Lower life forms – patent-eligible
•
Cells (eukaryotic or prokaryotic), cultures, cell lines (can make biological
deposits under Budapest treaty), host cells
•
OK as long as the cell cannot become a higher life form:
•
Pluripotent and multipotent stem cell: patent-eligible
•
Fertilized embryo, totipotent stem cell: not patent-eligible
Higher-life forms – not patent-eligible
•
Animals, plants, fertilized eggs, totipotent stem cells
•
Certain plant parts (cutting, seed, tuber, fruit)
•
Note: CA also offers Plant Breeders' Rights protection for new, distinct, uniform
and stable plant varieties
In most cases, can obtain coverage for a higher-life form by claiming the
corresponding cell.
Therapeutics – acceptable formats
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Typically, simply a matter of recasting claims into “product for use” and “use”
formats
-
X for use in treating Y (similar to EPO)
-
Use of X for treating Y
-
Use of X for the preparation of a medicament for treating Y (Swiss-type)
Note: Avoid “active” language:
Bad:
Use of X for treating Y, comprising administering X subcutaneously.
Good:
Use of X for treating Y, wherein X is for subcutaneous administration.
Therapeutics – general principles
STRENGTHENING THE PRACTICE OF THE INDEPENDENT IP ATTORNEY
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Prohibition of “method” claims only applies to medical treatment
•
e.g., can claim a method of contraception in “method” format (because pregnancy is
not a disease)
•
e.g., can claim a method of administering an agent to a subject for imaging/diagnostics
(as long as the agent does not also have a therapeutic benefit)
Regardless of claim format, claim cannot require professional skill
•
Ranges of values may provoke an objection:
•
Dosage ranges
•
Ranges in frequency/timing of administration
Such issues, if raised can often be overcome by argument/amendment, and various
precedents have been set by the CA authorities
Diagnostics
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•
Diagnostic methods are generally patentable as long as there is some kind of
physical step
•
e.g., physical step of measuring analyte/marker (vs. “receiving data”)
•
In vivo
OK, as long as no therapy involved – e.g., can claim a method of
administering a non-therapeutic agent for imaging/diagnostics
•
Can also claim in “use” or “product for use” formats if necessary
•
Personalized medicine (treat a “responsive” patient subpopulation)
•
Patent eligible; can also use “use” or “product for use” formats
•
Possible prior art inherency issues
Unity of invention; divisionals
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CA divisionals cannot be used as “continuation” applications:
•
“Voluntary” divisionals prone to “double patenting” objections
•
No “terminal disclaimer” practice
•
Reserved for pursuing claims removed due to a unity objection
•
In view of new CA claim fee regime, take into account potential
unity issues when preparing reduced claim set (to ensure
representation of all potential invention groups)
•
Don’t need to put “favorite” invention first (but will probably be
first anyway due to PCT practice)
Chemical & Biotech inventions
Archana Shanker
Senior Partner, Anand and Anand, India
alive
STRENGTHENING THE PRACTICE OF THE INDEPENDENT IP ATTORNEY
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Chemical & Biotech inventions
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1. Inventions u/s 2(1)(j)
2. Naturally corollary-what is not “product” or “process” is not allowed [claim format] e.g. USE claims and Swiss-type claims
3. Five pillars
i. Novelty
ii. Inventive step
iii. Industrial applicability
iv. Sufficiency
v. Patent eligible subject matter
4. Patent eligible: under sections 3(b), 3(c), 3(d), 3(e), 3(i), 3(j)
5. Claim formats
a) Pharma products
o
New chemical entities
o
Formulations/concepts
o
Combinations
o
New forms of known substances (polymorphs , salts)
o
Kits
o
Product by process
Chemical & Biotech inventions
STRENGTHENING THE PRACTICE OF THE INDEPENDENT IP ATTORNEY
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o
Method of manufacturing
o
Intermediates and method
o
Selection invention
b)
Biotech Inventions
o
Polynucleotides/gene sequences
o
Protein sequences
o
Vectors
o
Host cells, microorganisms, stem cells
o
Vaccines
o
Antibodies /antigen bending fragment
o
Diagnostic kits
o
Assays
Monoclonal Ab - MHC
Genmab A/s V. Assistant Controller
Imclone LLC V. Assistant Controller of Patents and Designs
- MHC observed that the qualifier “mere” in section 3(c) is
limited to “discovery of a scientific principle” and does not
extend to “the discovery of any living thing or non-living
substance occurring in nature.”
- The qualifier “occurring in nature” apply only to “non-living
substances”.
Novartis V. Natco- DHC
Novozymes V. Controller
Novartis V. UoI- SC
BMS V. Controller
-
MHC
clarified that Section 3(d) only
restricts incremental inventions and does
not prohibit it.
- Increased bioavailability may not always
lead to enhanced
therapeutic efficacy
D.S Biopharma PMS
Chinese University V. Asst. Controller
Anthrogen GmbH V. Controller
-
Scope of method of diagnostic methods have to be
discerned from the specification to determine whether the
claims in substance relate to a method of diagnosis or not.
Decco Worldwide V. Controller of Patents
-
Calcutta HC opined that Controller
failed to explain why a way of treating plants to
combat fungal diseases would not fall inside
section 3(h), which includes traditional practices
of agriculture.
VIFOR V. MSN
-
DHC mentioned that 8.
Claim protection over process
does not act as a limitation on a product, in a product-by-
process claim.
- Product-by-process claims are tested on the touchstone of
novelty of the product
Product by
process
Some Important Cases
3(d)
3(i)
3(h)
3(c)
3(j)
Plants and animals or parts
thereof, host cells
Chemical & Biotech inventions
STRENGTHENING THE PRACTICE OF THE INDEPENDENT IP ATTORNEY
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Novelty
•Chemical
- Genus vs species
- Selection invention: therefore, include data to demonstrate selections even if not "a selection"
•Biotech
- Define the sequences
- Claims with properties not allowed
- Identify differences with wild type sequences
Inventive Step
•Chemical + Biotech
- Comparative data with closest prior art
- Do include technical advantage of invention to be able to later provide post-filing date (
AstraZeneca - before DHC
)
.
- Unexpected & surprising technical effect
- Experimental studies with examples
Industrial
Application
• Low threshold
• Distinction between commercial utility + patentable utility (
Roche vs Cipla Delhi HC-DB order
)
Sufficiency
• Enabled
• Working example (
Titan, Nestle, Bayer
)
• Scope of Markush: every substituent should be supported by one example
e.g. Halogen -> e.g. for chlorine is Ok
C1-C3 alkyl -> e.g. ethyl is Ok
Chemical & Biotech inventions
STRENGTHENING THE PRACTICE OF THE INDEPENDENT IP ATTORNEY
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In Biotech cases
-> Include if possible, at least one example of full polynucleotide
-> If claim has expressions like "at least 95% identity" include one example of 98, 99 , 96 % similarity
-> eukaryotic cells not patentable
-> host cells generally not allowed
GENERAL TIPS
- AMENDMENT- if the claims relate to non eligible subject matter, do amend the claims as soon as possible
- DIVISIONAL APPLICATIONS;
- File divisional applications for unclaimed subject matter provided they relate to “ distinct inventive concept”
or else move an amendment to the claims of the parent application;
- Don’t abandon the parent application in the hope that the claims of the divisional will be allowed. Ensure that
the claims of parent and divisional are distinct even before you decide to give up the parent case.
THIS SESSION IS POWERED BY DERIS
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